3/13/2019

1

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

2

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

3

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

4

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

5

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

6

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

7

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

8

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

9

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

10

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

11

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

12

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

13

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

14

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

15

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

16

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

17

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

18

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116

3/13/2019

19

Keeping Your Endoscopes Patient Safe

Nancy Chobin, RN, AAS, ACSP, CSPM, CFER

Sterile Processing University, LLC

Copyright, Sterile Processing University, LLC, 2019

Objectives

Review the issues with processing flexible GI endoscopes

Discuss AAMI Document (ST-91) and its components for effective endoscope reprocessing

Discuss the FDA and CDC recommendations for processing ERCP (duodenoscopes) scopes

Issues with Flexible Endoscopes

• Valuable diagnostic and therapeutic tool

• Dealing with microbes that are more resistant than ever

◦ Listed # 1 in top ten technology hazards for patients for several years in a row (ECRI)

◦ Was # 2 in 2018 cybersecurity was # 1)

◦ # 5 for 2019

◦

◦ ECRI - Emergency Care Research Institute

◦

ECRI Findings

Failure to precisely follow a robust reprocessing protocol can lead to debilitating or even fatal infections.

Improper handling and storage practices can recontaminate previously disinfected scopes, heightening the risk of patient infections.

If endoscopes are not completely dried after being subjected to high-level disinfection, any remaining viable microbes can rapidly proliferate and colonize the instruments.

To promote drying, ECRI Institute and relevant professional societies recommend purging endoscope channels with clean air at the end of the reprocessing process.

ECRI 2019

The disinfected status of endoscopes can also be compromised if the instruments are handled with unclean gloves.

Endoscopes that have been cleaned but not yet high-level disinfected are still contaminated with viable microbes; gloves used to handle an endoscope at that stage must not be used to remove the scope from the reprocessing machine.

Recontamination can also occur when transporting and storing endoscopes.

Disinfected and dried endoscopes should be transported in a clean enclosed container, dedicated to that purpose, and should be prevented from contacting potentially unclean surfaces.

Issues

“Grandfather” of all specialty devices

Most instances of nosocomial infections occurring through instrumentation caused by flexible fiber optic scopes

Dealing with microbes that are more resistant than ever

Lack of properly trained personnel

Endoscopes very expensive – pressure to book as many cases as possible

◦ Reduced reimbursements

◦ Cleaning suffers when time is short

Issues

A major risk - introduction of pathogens that can lead to infection.

“Failure to properly disinfect or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission (e.g., hepatitis A&B virus) and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa)”. [CDC]

Resources

SGNA Guidelines

AORN Guidelines

AAMI Reprocessing of Flexible and Rigid Endoscopes

CDC

MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011Petersen et al. ICHE. 2011;32:527

CDC

Approximately 11 million gastrointestinal endoscopies are performed yearly –numbers continue to rise

Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection.

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES

Require high level disinfection

Long narrow lumens

Right angle turns

Blind lumens

May be heavily contaminated with pathogens,

Cleaning and HLD essential for patient safe scope

Issue: Cleaning

Multiple studies in many countries have documented lack of compliance with established guidelines for cleaning and disinfection for all types of flexible endoscopes

Failure to comply with scientifically-

based guidelines has led to numerous

outbreaks

Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

Need

Microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment.

Microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patient.

Risks

• Chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• Devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

•

•

Help is Here!!!!

“Flexible and semi-rigid endoscope processing in health care facilities”

New document available from AAMI

ANSI/AAMI ST 91:2015: Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities

Being updated

Education, Training and Competency Assessments

All personnel performing processing of endoscopes be certified as a condition of employment.

At a minimum, personnel should complete a certification exam.

CDC

Documentation

Education, training, and competency verification activities should be provided and documented for

All processing personnel on procedures for processing of all endoscopes and

Use of all AERs and sterilizers in use at the facility.

Education, Training and Competency Recommendations

Processing activities should be closely supervised until competency is verified and documented for each processing task, from cleaning through storage of the endoscope.

Type and Level of Microbial Contamination

• Flexible endoscopes acquire high levels of bioburden (population of viable microorganisms on a product and/or a package – AAMI ST 79) because of the cavities they enter

• CDC reports that the bioburden found on flexible gastrointestinal endoscopes after use can be as high as 10 billion.

Disease Transmission

Major reasons for transmission are:

Inadequate cleaning

Improper selection of a disinfecting agent

Failure to follow recommended cleaning and disinfection procedures

Flaws in endoscope design or automated endoscope reprocessors

Spaulding’s Classifications

• Semicritical items contact intact mucous membranes or non-intact skin, do not ordinarily penetrate tissues or otherwise enter sterile areas of the body.

• These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible.

• This category includes endoscopes.

▫ Does not consider problems with reprocessing of complicated, heat sensitive devices

•

Cleaning

Cleaning - removal of visible soil (e.g., organic and inorganic material) from objects and surfaces.

Can be performed manually or mechanically using water with detergents or enzymatic products.

Cleaning

Thorough cleaning is essential before high-level disinfection or sterilization

Inorganic and organic materials that remain on the surfaces of instruments can interfere with the effectiveness of these processes

HLD cannot make direct contact with all surfaces of the device if soil or other residue remains

There is a discussion about returning to sterilization of ERCP scopes? All scopes?

•

Microbial Contamination

The highest level of microbial contamination is found in suction channels

All channels must be cleaned whether they were used or not!

Studies have shown that proper cleaning reduces the level of microbial contamination by 4–6 log (safe to handle)

Reference: Centers for Disease Control: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Microbial Contamination

The larger the number of microbes, the more challenging the cleaning.

More time may be needed with the germicide to destroy all of them.

Reducing the number of microbes increases the margin of safety when the germicide is used according to the IFU.

High Level Disinfection – HLD

• A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

• Each of the various factors that affect the efficacy of disinfection can impact or limit the efficacy of the process.

• Concentration of and exposure time to the germicide can affect outcome.

• Temperature, pH, and chemical makeup of the disinfection process can also affect outcome.

•

Sterilization

• Dependant on adequate cleaning, rinsing, and device preparation

• Low temperature sterilization methods

▫ Liquid Chemical Sterilants (LCS)

▫ Liquid Chemical Reprocessing (AER)

▫ Low temperature Sterilization methods

• Potential for steam sterilization?

• First single use colonoscope cleared by the FDA Sept. 2016.

Factors Impacting HLD/Sterilization

Ineffective cleaning of the devices

Type and amount of microbial contamination present

Physical nature of the object (e.g., crevices, hinges, and lumens)

Presence of biofilms

Cross-contamination during rinsing or storage

Education, Training and Competency Recommendations

• Personnel involved in endoscope processing should be provided education, training, and complete competency verification activities related to their duties

▫ upon initial hire;

▫ annually;

▫ at designated intervals;

▫ or whenever new endoscopic models, new processing equipment, or products such as new chemicals are introduced for processing.

•

Training Requirements

Facility policies and procedures for processing flexible endoscopes;

Infection prevention, attire, hand hygiene, and compliance with local, state, and/or federal regulations;

Workplace safety, including all relevant OSHA standards related to chemical use and biological hazards in that department, as well as workplace safety processes and procedures related to endoscope processing;

Processing of each type of flexible endoscopes, including GI endoscopes and bronchoscopes and those from different from different manufacturers;

Training Requirements

Leak testing of endoscopes (when recommended in the manufacturer’s instructions for use (IFU);

Manual cleaning and high-level disinfection including methods to verify the effectiveness of the cleaning process;

Use of automated flushing devices (if applicable);

Manual cleaning (including methods to verify the effectiveness of the cleaning process) followed by automated cleaning and high-level disinfection;

Documentation of quality monitoring results.

Training Requirements

Processing of all accessories;

Selection and use of detergents;

Selection and use of high-level disinfectants (HLDs);

Use of personal protective equipment (PPE), including correct donning and doffing of PPE ;

Transport of used endoscopes;

Transport and storage of endoscopes that have been high-level disinfected;

Training and Competency

Competencies required for:

All types of scopes used (e.g. different manufacturers, GI scope vs. bronchoscope)

Leak Testing

Manual cleaning and manual high level disinfection (HLD)

Manual cleaning followed by automated cleaning and HLD

Competencies Required

Use of AER

Use of automated flushing devices

Processing of all accessories

Selection and use of detergents

Selection and use of HLD

Use of PPE when handling contaminated devices

Transport of used scopes

Transport/storage of HLD scopes

CDC

To ensure reprocessing personnel are properly trained, each person who reprocesses endoscopic instruments should receive initial and annual competency verification

Competency Assessment

Should be performed annually and include

Compliance with facility policies and procedures and manufacturer’s written IFU for each type of endoscope reprocessed at the facility, and

Level of proficiency in processing procedures. (AAMI - ST-91)

A competency-based, certification exam specific to flexible endoscope processing is available from the Certification Board for Sterile Processing & Distribution, Inc. (CBSPD) (exam accredited by the NCCA) and IAHCSMM (2017)

Steps in the Process

Pre-cleaning at point of use

Soiled transport

Leak testing - inspection

Manual cleaning – inspection (enhanced visual inspection)

Rinsing – inspection

HLD (manual or AER)

Drying – inspection

Storage

Pre-Cleaning of Used Scopes

Endoscopes and accessories should be immediately cleaned after each patient procedure.

Pre-cleaning/flushing of biopsy channels helps prevent drying of organic and inorganic debris in lumens.

Need supplies for pre-cleaning (now available in kits).

Should document the time of the pre-cleaning to communicate to technician who will manually clean the scope.

Transportation of Used Scopes

Scope Transfer Systems

Manufacturer’s Instructions

• NEVER reprocess a scope without written instructions from the scope manufacturer.

• Use the cleaning agents, cleaning implements and disinfecting/sterilizing agents VALIDATED by the manufacturer or an equivalent.

• Copy the cleaning/HLD instructions; keep in scope processing room.

• The reusable device manufacturer is responsible for ensuring that the device can be effectively cleaned, disinfected or sterilized.

•

Environment

Separate rooms for cleaning and HLD preferred

Cleaning room

Hand wash sink

2-well sink for cleaning/rinsing

Eyewash station for chemicals

Space for cleaning equipment

Space for chemicals and implements

Leak Testing

The single most effective means of preventing flexible scope damage due to fluid invasion.

Follow scope manufacturer’s instructions for process including the equipment and methods recommended.

Remove all detachable valves and apply fluid protective caps prior to testing.

Connect air source to scope and turn on.

Insufflate the scope and then FULLY immerse in utility (tap) water to perform the test.

Wipe off all air bubbles from surface

Leak Testing

Confirm there are no continuous series of bubbles in water

Massage all areas of the scope.

Angulate distal end – push all buttons

Remove scope from water

Release pressure from endoscope

Powered Leak Testers

Electric powered leak testers are preferable because they provide a continuous flow of air that prevents fluid from invading the scope during inspection.

Manual Dry Leak Testing

More subjective than mechanical process

If using the hand-operated leak tester, extra care and time must be taken.

If a drop in the pressure gauge, the scope should be re-pressurized.

Pay attention to even a slight loss of pressure on the gauge, since this can help identify a small leak

Leak Testing (Continued)

Keep valves and adapters with scope throughout the process

Angulate bending section while immersed.

Confirm there are no continuous series of bubbles in water.

Document results

If leak detected – refer

to IFU how to proceed

Damage from Fluid Invasion

Leak Testers

Decontamination

If no leaks detected, proceed to manual cleaning.

MANUAL cleaning MUST be performed before any automated cleaning.

Must clean all surfaces, channels and ports whether they were used or not!!!!!

EXCEPT automated endoscope reprocessors validated for no manual cleaning (may change).

Sinks

Must be large and deep enough to fully immerse scope

If cleaning and HLD performed in same room, there should be procedural barriers with unidirectional flow of processing

Sinks should not be so deep that personnel must bend over to clean instruments.

An ideal decontamination sink is approximately 36 inches (91 centimeters [cm]) from the floor and 8 to 10 inches (20 to 25 cm) deep, enabling a person of average size to work comfortably without undue strain on his or her back;

foot stools should be readily available to accommodate shorter employees.

Sink for cleaning scopes

General Decontamination Steps

Fill sink with solution of enzymatic detergent (measure water and detergent!).

Immerse scope and clean exterior surfaces using soft cloth or brush.

Detach suction and air/water valves, biopsy channel cover and other removable parts.

Enzymatic Detergents

Rinse well and discard enzymatic cleaners or detergents after each use

Are not microbicidal

Will not retard microbial growth

Clean sink after each use.

Not all scope manufacturers recommend enzymatic detergents

MAY BE AFFECTED BY:

Water quality

Contact time

Expiration date

Activity at use dilution

Single or multiple enzymes

Enzyme Detergents

May be affected by

Concentration –automated dispensing? Sink marked with water level?

Temperature of solution

Should monitor water temperature if mfr has specified temperature range. Do not exceed 110oF

Decontamination

• All parts of the scope must be cleaned.

• Use brushes of correct diameter and length to ensure thorough cleaning of all internal lumens.

• MUST use brushes of the diameter and length recommended by the scope manufacturer (or equivalent).

• After passing brush through channel, use fingers to remove debris from brush before pulling brush back into channel.

• Continue cleaning until no debris left on brush.

Rinsing

Rinsing endoscopes and flushing channels with critical water (sterile), filtered water, or utility (tap) water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis)

Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas

Accessories

Mechanically clean reusable accessories inserted into endoscopes that break the mucosal barrier and then sterilize these items between each patient after cleaning

Use ultrasonic cleaning for reusable endoscopic accessories, such as biopsy forceps to remove soil and organic material from hard-to-clean areas

Inspection Prior to HLD

ALWAYS INSPECT SCOPE FOR DAMAGE/CLEANLINESS

High Level Disinfection

• Should be performed in a separate room from the cleaning

• Issues with cross contamination

• HLD accepted as the standard for GI scopes

◦ More cost effective

◦ Quicker turn around

• Need for sterilization of GI scopes due to C. difficile not substantiated by scientific evidence

AERs vs. Manual Process

• Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing

▫ Automate and standardize several important reprocessing steps

▫ Reduce the likelihood that an essential reprocessing step will be skipped

▫ Reduce personnel exposure to high-level disinfectants or chemical sterilants

•

AERs

AER Advantages:

Final rinse with filtered tap water

Reduces likelihood that essential steps will be skipped

Automated Endoscope Reprocessors

AERs

Disadvantages: failure of AERs linked to outbreaks, may not eliminate precleaning (BMC Infect Dis 2010;10:200)

Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector (MMWR 1999;48:557)

Must ensure exposure of internal surfaces with HLD/sterilant

Must ensure correct adapters used for specific scope manufacturer and type of scope.

Automated Cleaning

Place endoscope and all accessories in soaking basin

Follow instructions for preparation and loading of scope

Follow instructions for testing of the HLD (some units use single shot technology)

Start machine and allow to complete all cycles

If a final alcohol rinse is not included in the automated re-processor, this step should be done manually followed by purging all channels with air

AERs

Some endoscopes such as the duodenoscopes (e.g., endoscopic retrograde cholangiopancreatography [ERCP]) contain features (e.g., elevator-wire channel) that require a flushing pressure that is not achieved by most AERs and must be reprocessed manually using a 2- to 5-mL syringe,

Outbreaks involving removable endoscope parts (i.e. suction valves and endoscopic accessories (i.e. biopsy forceps) emphasize the importance of cleaning to remove all foreign matter before high-level disinfection or sterilization.

AER

If multiple basins in unit

Label each basin to track scopes processed in respective unit

Automated Endoscope Reprocessors

• Units can

▫ Clean only

▫ Disinfect only

▫ Clean and disinfect

▫ Sterilize only

• Check mfrs instructions before purchasing

• If a final alcohol rinse is not included in the automated reprocessor, this step should be done manually followed by purging all channels with air

•

Accessories

Never reprocess accessories in an AER unless the accessory and AER manufacturer validated this process.

Includes dilators

Manual HLD

• Only surfaces that directly contact the germicide will be disinfected

▫ There must be no air pockets -use a syringe to pull solution into all channels

▫ The equipment must be completely immersed for the entire exposure period

▫ Completely immerse the endoscope in the high-level disinfectant, and ensure all channels are perfused

Full Immersion

Manual High Level Disinfection

Rinsing - must be thoroughly rinsed

Follow the HLD manufacturer’s IFUs for the volume of water and number of rinses recommended

Do not re-use water. Fresh water for each rinse

Critical or sterile water preferred since tap water is not pure (AORN)

Alcohol Flush

A multidisciplinary team including Infection Prevention, endoscopy and perioperative personnel should conduct a risk assessment to determine if endoscope lumens should be flushed with 70% or 90%% ethyl or isopropyl alcohol. (AORN)

Flushing may not be necessary if the scope is effectively dried (AORN)

Many publications still recommend the flush because it facilitates drying of the lumens and prevents colonization and transmission of waterborne bacteria.

Some AERs automatically flush the scope with alcohol; others do not.

Drying

After mechanical manual processing

Dry the exterior of the scope with s soft, lint free cloth or sponge

Dry the channels by pursing with instrument air or mechanically dried within an AER

Removable parts and accessories should be dried

Follow the scope manufacturer’s IFU for the recommended pressure to be used to avoid damaging the sheath

Some sources now saying drying should take approximately 10 minutes!

Instrument Air

Instrument air: (Previously called compressed air or medical air):

A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is filtered to 0.01 micron, free of liquids and hydrocarbon vapors, and dry to a dew point of -40º F (-40º C).

Instrument Air

Instrument air may be supplied from cylinders, bulk containers and/or medical air compressors.

The definition of a medical air compressor (per NFPA) is a compressor that is designed to exclude oil from the air stream and compression chamber and that does not, under normal operating conditions or any single fault, add toxic or flammable contaminants to the compressed air.

NOW IN AAMI STANDARDS (updated ST-79)

Instrument Air

Use the pressure recommended by the endoscope manufacturer to prevent damaging the sheath.

Need a pressure gauge on the air nozzle.

Also need air to dry items for for low temperature sterilization.

AAMI only recommends instrument air for drying sets and scopes.

Avoid “drying” cabinets.

Not an Endoscope Drying Cabinet

Documentation

Document the time the endoscope was pre-cleaned and by whom

Can use a tag or other mechanism

Send with scope to processing room

The technician assigned to processing the scope will know how much time elapsed since the scope was pre-cleaned.

Some facilities documenting on a log form as well.

Delayed Reprocessing

• If reprocessing is delayed beyond one hour, extended soaking/cleaning protocols may be required

• Follow the scope manufacturer’s instructions for delayed reprocessing

• Can occur when scopes are used on Nursing Units or ER during off hours

•

Storage of Flexible Scopes

Store in a secure location in the clean workroom (in 2-room design) or in a separate clean area close to but not within the endoscopy procedure room. (AORN)

Storage cabinets should have doors and be at least 3 ft from any sink.

Store according to the scope manufacturer’s written IFU

Store in a drying cabinet with HEPA filtered circulated air that is under pressure and forced through the endoscope channels. (NOTE: Not the traditional drying cabinets)

HEPA Filtered Storage/Drying Cabinet

Storage of Flexible Scopes

If a drying cabinet is not available, the scopes may be stored in a closed cabinet with HEPA filtered air that provides positive pressure and allows for air circulation around the scopes.

Scopes that have been mechanically processed should be stored in a cabinet that is either

Designed/intended by the cabinet mfr for horizontal storage of flexible scopes

Of sufficient height, width and depth to allow flexible scopes to hand vertically, without coiling and without touching the bottom of the cabinet

Horizontal Endoscope Storage Cabinet

Storage of Flexible Scopes

Store with all valves open, all removable parts detached but stored with the endoscope.

Many companies offer products (e.g. mesh bags)

CDC recommends that all HLD scopes be identified with a tag

Removal – use gloves (clean, low protein, powder free latex or latex free) and protect scopes from contamination while being transported to the procedure room (i.e. tote bin)

Storage (AORN)

Cabinets should be visually inspected for cleanliness before scopes are placed into or removed from storage.

If any evidence of contamination of the scope, do not use, reprocess.

If any evidence of contamination of the cabinet (e.g. wet spots, soil), all the scopes in the cabinet should be removed and reprocessed and the cabinet cleaned.

Improper Storage of Scope

Scopes Stored Improperly

Duodenoscopes

Flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum).

Used during ERCP procedures, a potentially life-saving procedure.

Application to diagnose and treat problems in the pancreas and bile ducts.

Duodenoscopes

• Duodenoscopes are complex instruments that contain many small working parts.

• If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.

• In rare cases, this can lead to patient-to-patient infection.

•

•

Decontamination

• Very small lumens (ERCP scopes) cannot be cleaned properly in automated system alone.

• Need to use 2-5ml syringe to flush out channels x 3 times.

• Use brushes as recommended and clean x 3.

• Despite adapters for automated systems still must be manually cleaned first.

•

FDA Recommendations

Follow manufacturer’s instructions for cleaning and processing. (Over 125 steps!)

Adherence to general endoscope reprocessing guidelines and practices established by the infection control community.

Follow specific reprocessing instructions in the manufacturer’s labeling for each device.

Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

FDA Recommendations

• Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection.

• The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.

• Deviations from the manufacturer's instructions for reprocessing may contribute to contamination.

• Reference “Design of Endoscopic Retrograde Chloangiopancreatography (ERCP) Duodenoscopes: May Impede Effective Cleaning”: FDA Safety Communication posted 2/19/2015

•

•

•

•

CDC Guidance March, 2015

Duodenoscope Reprocessing: Facilities should review all steps in duodenoscope reprocessing several times a year (e.g., quarterly) and ensure strict adherence to the manufacturer’s instructions, paying particular attention to the following:

Manual cleaning: Ensure that the elevator mechanism located at the distal tip of the duodenoscope is thoroughly cleaned and free of all visible debris.

Inspection: Visible inspection is to be done with the elevator in the “open/raised” position as well as with the elevator in the “closed/lowered” position to ensure there is no visible debris above or below the elevator mechanism

Use of a lighted magnifying glass (e.g., 10x) to improve detection of residual debris around the elevator mechanism.

Reference: Centers for Disease Control – Memo on “Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. Posted 3-11-15

Elevator Raised and Lowered

CDC Guidance March,2015

• Drying: Ensures that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

• This should include an alcohol flush followed by forced air drying if these procedures are compatible with the duodenoscope per the manufacturer’s instructions.

• If channels and the elevator mechanism are not completely dry, bacterial growth can occur, forming a biofilm that is difficult to remove and could result in persistent contamination.

•

•

•

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

• Interval of storage after which endoscopes should be reprocessed before use

▫ Data suggest that contamination during storage for intervals of 7-14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms

▫ Data are insufficient to recommend a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016. Infection Control and Hospital Epidemiology, 2016. ASGE – SHEA Guideline.

▫

▫

▫ AAMI and AORN recommend that a multidisciplinary team in each healthcare facility should conduct a risk assessment to determine the maximum storage time for an endoscope before it needs to be processed for use on the next patient.

Hang Time Devices

Have tag that turns when the date is up (e.g. 7 days, 14 days)

Easy identification of time to reprocess scope

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

The optimal frequencies for replacement of clean water bottles and tubing for insufflation of air and lens wash water and waste vacuum canisters and suction tubing have not been determined.

No data exist pertaining to the safety or potential risk of per procedure versus per day exchange of these attachments, and most guidelines do not address either issue.

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2016

AAMI ST-91 states “Manually clean and high-level disinfect or sterilize the water bottle (used for cleaning the lens and for irrigation during the procedure) and connecting tube according to manufacturer's written IFU, or at least daily.”

AORN recommends that water and irrigation bottles should be high-level disinfected or sterilized at least daily

Simethicone

The FDA does not recommend the use of simethicone for use in bowel preparation.

Multiple recalls of these formulations because of contamination.

Ingredients include sugars and thickeners which could foster biofilm development and create a perfect habitat for microbial growth.

Difficult if not impossible to remove – not soluble in water, detergent solutions, HLD solutions or alcohol .

Neither endoscope nor FDA recommend its use.

Can detect inside a scope using a borescope – appears as a cloudy, white substance.

Scopes with simethicone should be take out of service and not be used.

Risk Analysis

The JC is recommending that facilities perform risk analysis of problem prone areas/procedures

Sample Risks in GI/Endo

More complicated instruments (e.g. flexible endoscopes, ERCP scopes)

Variety of cleaning equipment, supplies used

Variety of cleaning chemicals

Variety of disinfectants used and automated reprocessors

Variety of sterilization processes and equipment

Lack of time for training, competency assessments and monitoring of processing

Risk Analysis

There should be a planned, systematic, and ongoing process for verifying compliance with procedures.

Quality processes can be enhanced by audits

Should be conducted on a regular basis (no other way to ensure compliance with stated policies and procedures).

The JC links their standards to ANSI/AAMI ST-79.

Processing Risk Assessment

A team of GI/endo nursing and processing staff should perform the analysis to be able to

Identify the risks

State the reasons for the risks

Determine which risk is the biggest threat

Suggest ways to reduce the risks/be knowledgeable about the best practices and manufacturer’s written instructions.

Risks range from 1(lowest) to 10 (highest)

Inspection

All endoscopes should be inspected at each step of the process

Many facilities now using a borescope to view inside

lumened devices

Includes a distal tip composed of a light source and camera lens at the end of a 50cm, flexible shaft.

Designed for instruments/lumens 3.2mm in diameter or larger.

Permits visualization of any potentially soiled device.

Software is included, allows viewing and recording from most computers.

Borescope

Documentation

Maintain log with the following information:

Name of Patient/Medical Record #

Serial # of the scope with traceability to the patient

Document scope cleaned and by whom

Document the HLD/sterilization process

Documentation of the final alcohol rinse

Procedure performed

Quality Assurance

AAMI recommends cleaning verification should be performed weekly, preferably daily. (each scope???)

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates.

ATP is another option as a verification marker.

Test all ERCP scopes after cleaning?

Quality Assurance

Weekly cleaning verification (AAMI) should be performed

Product capable of testing virtually any lumened instrument for residual organic soils, including flexible endoscopes, no matter the channel size.

Tests for three common organic soils at once: blood, protein and carbohydrates

In Summary

Follow all scope manufacturer’s instructions for use carefully.

Keep on file in processing area(s).

Follow the HLD/sterilant manufacturer’s instructions for use:

Water quality

Soak time

Temperature of solution/concentration

Rinsing

Summary

Verify competencies

Perform annual competency check on all scope

processing personnel

Encourage flexible endoscope certification for processing personnel.

Certification for Flexible Endoscope Reprocessing is available from the Certification Board for Sterile Processing: www.sterileprocessing.org. AND IAHCSMM (IAHCSMM.ORG).

1

2

3

4

5

6

7

8

9

10

1

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

1

2

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

81

82

83

84

85

86

87

88

89

90

91

92

93

94

95

96

97

98

99

100

1

2

101

102

103

104

105

106

107

108

109

110

111

112

113

114

115

116