Reprocessing Endoscopes and Other Reusable Medical Equipment (RME): Lessons from the

NMVA

Carol Moore, MSN, RN, CICInfection Control Practitioner,

NMVAHCS

Updated Guidelines

VA Health Care in the News

Valve Problem Cited In Colonoscopy Issue (Lambert, 2009)VA Hospital: Patients Exposed To HIV, Hepatitis (JustNews, 2009)VA Continues Notification Process for Veterans Affected by Reprocessing Issues (Reuters, 2009)Congressional panel to analyze VA hospitals' mistakes (Poovey, 2009) Inspections find many VA facilities lack colonoscopy safety (CNN, 2009)VA Endoscope Problem is Department-Wide (House Committee on Veterans' Affairs, 2009 )VA Allocates $26M for Endoscopy Sterilization Equipment (EndoNurse, 2009)

Safety Communication from FDA, CDC, and the VA

• Preventing Cross-Contamination in Endoscope Processing, November 2009

(FDA, 2009a)

The Joint Commission

Infection Control Focus:• Updated Position on Steam Sterilization

(JC, 2009a)

• Reducing Infection Risks Associated with Medical Equipment, Devices, and Supplies(JC, 2009b)

Reusable Medical Equipment (RME)• RME is medical equipment designed by the

manufacturer to be reused for multiple patients. – Medical equipment designed to be used multiple

times by one patient is not RME unless the manufacturer provides instructions for reprocessing between patients.

– Single-use disposable medical devices are not reprocessed for reuse.

Reprocessing RME• Reprocessing (cleaning, disinfection and/or

sterilization) RME is essential to ensure that the equipment does not transmit infectious pathogens to patients.

• Failure to properly clean, disinfect or sterilize equipment creates a risk for:– person-to-person transmission

(e.g., Hepatitis B virus, HIV, Salmonella, M. tuberculosis, etc.)

– transmission of environmental pathogens (e.g., Pseudomonas, atypical mycobacteria, etc.)

– transmission of multi-drug-resistant organisms (MDRO)

(Rutala, Weber, & HICPAC, 2008)

Reprocessing Methods

• The selection of reprocessing method (cleaning, disinfection or sterilization) is determined by the:– intended use of the equipment– instructions of the RME’s manufacturer– compatibility of the device with the methods

available– impact of the method on the device over time

(Rutala, Weber, & HICPAC, 2008)

Intended UseThe Spaulding Scheme classifies RME according to the degree of risk for infection based on the intended use of the item.• Critical • Semi-Critical • Non-Critical

(Rutala, Weber, & HICPAC, 2008)

Reprocessing Method by Intended Use

Critical Sterilization

Semi-Critical High Level (some Intermediate Level) Disinfection or Sterilization

Non-Critical Cleaning and/or Low-Level Disinfection

Transmission Risk to Patients

• The most common reasons pathogens are transmitted to patients from RME include:– Inadequate cleaning– Improper selection of disinfecting agent– Failure to follow recommended procedures for

set-up and use or reprocessing the RME• More healthcare-associated outbreaks have been

linked to endoscopes than to any other RME

(Rutala, Weber, & HICPAC, 2008)

Use and Reprocessing RMEThe Process

• Set-up & Use• Pre-cleaning / Cleaning• Disinfection or Sterilization• Storage

SET-UP & USE

Patient Safety AlertsVHA Dec 08 / Olympus Feb 09

Washing Tube vs Auxiliary Water Tube

Set-up & Use

• Record use of each endoscope, including model, serial number, and unique identifier

• Document the patient upon whom the endoscope was used, the date and time of use, the location of use, and the type of procedure

• Record the system (model and serial number of the Automatic Endoscope reprocessor (AER), if applicable, used to reprocess the endoscope and the identification of the person(s) responsible for reprocessing the scope.

(FDA, 2009a)

PRE-CLEANING / CLEANING

Pre-cleaning• At the point of use (immediately after use)• Removes visible biomaterial so it does not dry

and harden• Flush all channels• May include enzymatic detergents – follow

manufacturers guidelines• May use enzymatic sprays to prevent drying

(Catalone & Koos, 2005)

Cleaning• Cleaning is the removal of biomaterial and

microorganisms using water with detergents or enzymatic products

• Accomplished manually or mechanically• Cleaning alone reduces bioburden by an average of 4 logs

( 99.99%)• Is essential before high-level disinfection and sterilization

because debris will interfere with these processes• Cleaning and low-level disinfection of non-critical RME is

sometimes completed at the same time with a combination detergent and disinfectant product

(Rutala, Weber, & HICPAC, 2008)

Enzymatic Detergent Errors• Improper dilution of the detergent

– measure the detergent and the water

• Reuse of the Enzymatic Detergent Solution– dispose after each use

• Device is not fully submerged– make sure the sink or container is large enough

• Inadequate contact time– use a timer

• Inadequate rinse– determine the rinse volume and total number of rinses

required(Catalone & Koos, 2005)

Cleaning Endoscopes• Leak test• Enzymatic detergent recommended by the manufacturer (or

equivalent)• Channel brushes – the right size, single use or reusable

brushes that are processed after each use, inspect before use• Clean all channels, even if not used during the procedure• Some scopes have unique channels• Use cleaning adapters supplied by the manufacturer • If using an AER, compare AER and endoscope manufacturer’s

instructions – ensure they are compatible• Prevent splash and aerosol contamination of processed scopes

if cleaning and disinfection occur in the same room

Preventing Exposure to Infectious Agents & Chemicals

• Transporting Soiled RME– Transport to the reprocessing location in

covered containers (impervious bags, covered/closed carts, tote-boxes, or red bags) identifiable as BIOHAZARDOUS

• Handling Contaminated RME– Personal Protective Equipment (PPE) is required

to reduce the risk of healthcare worker exposure to pathogens and to the chemicals used for cleaning/disinfection

– The choice of PPE is determined by the risk of exposure during the cleaning process or from the environment

– Disinfection is required before handling RME without PPE

Disinfection & Sterilization

Reprocessing MethodsChoose the correct process

• Sterilization– Destroys or eliminates all forms of microbial life

• High level disinfection– Eliminates all microorganisms, except large numbers of bacterial spores– Clostridium difficile spores are reliably killed by high-level disinfection

methods

• Intermediate level disinfection– Kills vegetative bacteria, mycobacteria, most viruses, most fungi, but

not bacterial spores – Effective against bloodborne pathogens

• Low level disinfection – Kills most vegetative bacteria, some fungi, and some viruses

(Rutala, Weber, & HICPAC, 2008)

Reprocessing Methods• Sterilization methods include:

Heat (steam or hot air), Ethylene oxide (EtO), Peracetic acid (e.g. Steris System 1) and Hydrogen peroxide gas plasma (e.g. Sterrad)

• High level disinfection methods include: Orthophthalalde-hyde (Cidex OPA), >2% Glutaraldehyde , Hydrogen Peroxide (H2O2) and Wet Pasteurization

• Intermediate level disinfection methods include: Ethyl or Isopropyl alcohol (70-90%), Sodium hypochlorite (diluted bleach solution) Phenolic or Iodophor germicidal detergents

• Low level disinfection methods include: Same as Intermediate plus Quaternary ammonium germicidal detergents

(Rutala, Weber, & HICPAC, 2008)

Environmental Conditions: Central Processing & Endoscopy

• Physical barrier between the decontamination area and the clean area to prevent droplet contamination

• Work flows from contaminated to clean without backtracking• Constructed of impervious surfaces that withstand scrubbing

(floors, walls & ceilings) • Flush ceilings with enclosed fixtures, no exposed pipes• Appropriate PPE (e.g. gloves, fluid-impervious gowns, face-

shields, etc) available• Daily (when in use) cleaning schedule• Eye Wash Station(s)• Dedicated handwashing sink• Traffic restricted to authorized personnel

(AIA, 2006; AAMI, 2006)

Ventilation, Temperature & HumidityWork Area Air

Exchange/Hour

Air movement

Temperature / Humidity

Decontamination (Central Service)

6 (AIA)10 (AAMI)

In 68-730F / 30-60% H

Endoscopic Processing

10 In No recommendation

Sterilizer room 10 In EtO only: 750F / 30-60%H

Clean Workroom (assembly)

4 (AIA)10 (AAMI)

Out 750F / 30-60%H

(AIA, 2006; AAMI, 2006)

Reprocessing Location“In hospitals, perform most cleaning, disinfection, and sterilization of patient-care devices in a central processing department in order to more easily control quality” Category II • Issues:

– Do you chemically sterilize or high-level disinfect in the decontamination room or the prep (clean) room?

– How do you transport items that are packaged & sterilized?

– Are chemical sterilization or high-level disinfection point of use methods only?

(Rutala, Weber, & HICPAC, 2008)

The Joint Commission

Update: Steam Sterilization• Flash Sterilization

– Unwrapped instruments for 3 minutes at 2700F at 27-28 pounds of pressure

– Survey process-related issues:• Flash sterilization utilization• Cleaning process before flash• Chemical indicators• Transport back to sterile field

(JC, 2009a)

Laparoscopes / Arthroscopes / Cytoscopes

• Sterilize or at least high level disinfect, follow high level disinfection with sterile water rinse

• Endoscopes used in normally sterile body sites are critical and must be sterilized. – Steam– Low temp chemical gas/plasma/vapor– Liquid chemical sterilants only if incompatible

(Rutala, Weber, & HICPAC, 2008)

(FDA, 2009a)

Endoscope Accessories• Reusable accessories inserted into endoscopes

that break the mucosal barrier are critical items – sterilize between uses (e.g. biopsy forceps)

• Check manufacturers instructions - sterile processing is recommended for many accessories used with endoscopes (e.g. in-sheath baskets, savory guide wires and water bottles)

(Rutala, Weber, & HICPAC, 2008)

Protective Sheaths • OK to use probe covers to reduce

the level of contamination – Condoms Can Fail

Do not use a lower category of disinfection or cease to follow the appropriate disinfectant recommendations

• Ultrasound probes used during surgical procedures also can contact sterile body sites - Use sterile sheath• Sterilize between each patient use or if not possible at a

minimum high-level disinfect • Replace non-immersible probes with fully immersible probes

as soon as possible(Rutala, Weber, & HICPAC, 2008)

Peracetic Acid Ortho-phthaldehyde

Glutaraldehyde Hydrogen Peroxide (7.5%)

HLD Claim NA 12 m @ 20oC, 5 m @ 25oC AER

20-90 m @ 20o-25oC

30 m @ 20oC

Sterilization Claim

12m @ 50-56oC None 10 h @ 20o-25oC

6 h @ 20o

Reuse Life Single use 14d 14-30 d 21d

Materials Compatibility

Good Excellent Excellent Good

Monitor MEC No Yes (0.3% OPA) Yes (1.5% or higher

Yes (6%)

Safety Serious eye and skin damage (conc soln)

Eye irritant, stains skin

Respiratory Serious eye damage (safety glasses)

OSHA exposure limit

None None None 1 ppm TWA

Disposal None Local Local None

FDA notice and recommendations for Steris System 1

Dec 2009:• FDA has not determined whether the SS1 is safe or effective for its labeled

claims, including claims that it sterilizes medical devices• Assess patient care needs and disinfection and sterilization requirements

and transition to an alternative as soon as possible (within 3-6 months)• Some reports of malfunctions of the SS1 that had the potential to cause or

contribute to serious injuries to patients, such as infections. – No confirmed infections (no patient notification required)– Reports of injuries, mostly burns from exposure to the sterilant

solutionFeb 2010:• Steris Corporation has chosen not to seek FDA clearance of this device,

discontinue use as soon as practicable.• Transition period extended to 18 months

(FDA, 2009b; FDA, 2010b)

FDA-cleared Endoscope Washer Disinfectors / Automated Endoscope Reprocessors

Manufacturer Device Name LCS / HLD Used

Advanced Sterilization Products (ASP)

Evotech Endoscope Reprocessor/Evotech Endoscope Cleaner and Reprocessor

Cidex OPA Concentrate

Custom Ultrasonics System 83 Plus Miniflex Washer-Disinfector or System 83 Plus Endoscope Washer-Disinfector

Most FDA Cleared

Langford IC Systems Manzi Mach 1 Instrument Cleaner-Processor System

Manzi Sterilant MS10 (PA)

Steris Corp. Reliance Endoscope Reprocessing System Reliance DG Dry Germicide (PA)

Medivators DSD-91 Disinfector for Flexible Endoscopes or MDS for Endoscope Reprocessing

Most FDA Cleared

Medivators Advantage Plus Endoscope Reprocessing System MDS for Endoscope Reprocessing

Rapicide PA High Level Disinfectant (Glut)

FDA-Cleared Low Temperature Sterilizers Using Hydrogen Peroxide or Ozone

Manufacturer Device Name Sterilant

TSO3, Inc. TSO3 ozone sterilizer, model 125L

Ozone

Steris Amsco V-pro 1 or VHP 136

Hydrogen Peroxide Vapor

Advanced Sterilization Products (ASP)

Sterrad NX sterilizerSterrad 100NX sterilizer or Sterrad 200 sterilizer

Hydrogen Peroxide Vapor

Ortho-phthaldehyde

Glutaraldehyde• Glutaraldehyde is noncorrosive to metal and does not damage

lensed instruments, rubber. or plastics. – Might have toxic effects on the gametes and embryos –consider other

HLD for transvaginal transducers

• Acute or chronic exposure can result in skin irritation or dermatitis, mucous membrane irritation (eye, nose, mouth), or pulmonary symptoms

• Enforcement of the OSHA ceiling limit was suspended in 1993 by the U.S. Court of Appeals 577– ACGIH recommends limiting employee exposure to 0.05 ppm (>0.05 can

irritate the eyes, throat, and nose) – Ducted exhaust hoods, ductless fume hoods with absorbents, provide 7-

15 AEH, tight-fitting lids on immersion baths– PPE: nitrile or butyl rubber gloves but not natural latex gloves and

goggles to minimize skin or mucous membrane contact– Schedule Monitoring (AAMI, 2005)

Hydrogen Peroxide

• Haag-Streit reusable tonometer tips (prisms):– 3% hydrogen peroxide and soak for 10 minutes– 3% hydrogen peroxide solution must be disposed

of and replaced after 4 hours, once poured out of the bottle

– Rinsing under running cold tap water suitable for drinking for ten minutes

(VHA, 2007)

Rinse & Drying• Remove all residual solution

– Rinse according to manufacturers (device and HLD) instructions (duration, number of water exchanges, running water, water exchanges, water quality, etc)

– Flush all channels multiple times with water, followed by air

• Flush channels with alcohol, followed by forced air to facilitate drying (see manufacturers instructions)

• External surfaces of instruments should be thoroughly wiped dry with a sterile, lint-free cloth.

• Transport in a manner to protect from contamination (handle with clean gloves)

Delayed Endoscope Reprocessing

• More than 1 endoscope used during same procedure, scopes used in beginning of an OR case

• Weekend and Emergent Use (GI scopes, bronchoscopes, TEE)

• Some manufacturers' recommend a 10 hour soak in the event of delayed reprocessing, yet unnecessary or extended immersions may damage the scope

(Catalone & Koos, 2005)

STORAGE

Storage RMEStore in a manner that reduces the potential for contamination

• Sterile products – Limited access area that is well-ventilated, protected from

dust, moisture, insects and temp/humidity extremes– 8 to 10 inches above the floor, at least 18 inches below the

ceiling or the level of the sprinkler heads, and at least 2 inches from outside walls.

– Positioned to prevent crushing or puncture– Time or event related shelf-life

• Just-in-time processed products (Sterilization or HLD)– Protect from contamination or damage– Storage container must be cleanable (AAMI, 2006)

Endoscope Storage Cabinets• Doors that close• Vented- allows air circulation• Adequate height to allow endoscope to hang

vertically without touching the bottom• Internal surfaces with cleanable materials • Hangers constructed to support endoscopes• Sufficient space to store without touching• Do not store in the carrying case

(Burlingame, 2009; Rutala, Weber, & HICPAC, 2008 )

Reprocessing before use• No recommendation is made regarding the reprocessing of an

endoscope again immediately before use if that endoscope has been processed after use according to the recommendations in this guideline. Unresolved issue. (Rutala, 2009)

• American Association for the Study of Liver Diseases (AASLD), American College of Gastroenterology (ACG), American Gastroenterological Association (AGA) and American Society for Gastrointestinal Endoscopy (ASGE) jointly recommend the processed flexible endoscopes should be reprocessed within 10-14 days (VA memo, Dec 2, 2009) – VHA Policy: Reprocess after 12 days– Scopes not used frequently should be stored separately, consider

sterilizing and storing sterile.

QUALITY ASSURANCE

Standard Operating Procedures

• SOPs• Endoscopes are NOT all processed the same –

review manufacturer guidelines for differences (e.g. you cant have one SOP for all GI scopes)

• “Cheat sheets” – make sure they match

Performance Measures

• Supervision / Authority / Responsibility / Accountability

• Training• Competency• Monitoring - Audits• Reporting

Verification of processing• No recommendation is made about routinely

performing microbiological testing of either endoscopes or rinse water for quality assurance purposes. Unresolved issue

• VHA highly recommended: Testing to ensure bio-burden has been removed after reprocessing endoscopes that have been used for biopsy, (both the biopsy and suction channels). (VHA Directive, 2009)

(Rutala, Weber, & HICPAC, 2008 )

Surveillance

“A method for detecting clusters of infections or pseudo-infections associated with endoscopic procedures (e.g., a surveillance system). If a cluster is discovered, this should be reported to the manufacturer of the endoscope, the endoscope accessories, the AER, and the germicide”

(FDA, 2009a)

Infection control breach

• ID nature of breach, procedure, biologic substances involved• Review recommended reprocessing methods• Institute corrective action

Additional data gathering

• Determine time frame, # patients exposed• ID exposed patients with evidence of HBV, HCV or HIV• Literature Review, consult experts

Notify & involve key stakeholders

• ICP / ID, Risk, Affected providers• DOH, Licensing / Regulatory agencies (if applicable)

Qualitative assessment

• Category A – gross error or high-risk• Category B – breach with lower likelihood of blood exposure

Patient Notification &

testing

• Category A – patient notification/testing is warranted • Category B – Consider: Potential risk of transmission, public

concern, duty to warn vs. harm of notification

Communication & Logistical issues

• Develop material• Consider post-exposure prophylaxis; determine who will conduct testing,

counseling; determine if follow-up needed• Facilitate public inquiry & communication• Address media & legal issues

Adapted from Patel, Srinivasan, Perz, 2008

Reprocessing Quality Assurance

Central Processing

Chief

HLD Solution QC

Flash Sterilization

QC

Central Sterilization

QC

HVAC TestingEducation / Competency

QC

Preventative Maintenance

SOP Updates

Audits / Inspections /

Risk Man.

Infection Control

Cmt

Med Exec Cmt

IP(HAI)

The Final Frontier: Non-Critical RME

• Inventory• General SOP

– Contact times for intermediate to low-level disinfection

– Include some environmental surfaces (e.g. keyboards)

• Specific SOP for difficult to clean/disinfect items or items with very precise instructions

ReferencesAmerican Institute of Architects [AIA]. (2006). Guidelines for design and construction of hospital and health care

facilities. Washington, DC: The American Institute of Architects Press.Association for the Advancement of Medical Instrumentation [AAMI]. (2005). Chemical sterilization and high-level

disinfection in health care facilities. ANSI/AAMI ST58. Arlington, VA: AAMIAssociation for the Advancement of Medical Instrumentation [AAMI]. (2006a). Comprehensive guide to steam

sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79. Arlington, VA: AAMIBurlingame, B. (2009). Reprocessing flexible endoscopes before use. AORN Journal, 89(2). 403-405.Catalone, B. & Koos, G. (2005). Reprocessing flexible endoscopes. Avoiding reprocessing errors critical for infection

prevention and control. Managing Infection Control, June. Retrieved January 30 from http://www.olympusamerica.com/msg_section/files/mic0605p74.pdf

CNN.com (2009). Inspections find many VA facilities lack colonoscopy safety. Retrieved July 11, 2009 from http://www.cnn.com/2009/HEALTH/06/16/veterans.colonoscopies/

EndoNurse. (2009). VA allocates $26M for endoscopy sterilization equipment. Retrieved July 11, 2009 from http://www.endonurse.com/hotnews/va-allocates--26-million-to-fix-endoscopy-pro.html

House Committee on Veterans' Affairs .(2009). VA endoscope problem is department-wide. Retrieved July 11, 2009 from http://www.military.com/news/article/va-endoscope-problem-is-departmentwide.html

Joint Commission on Accreditation of Healthcare Organizations, [JC]. (2009a). Update: The Joint Commission’s position on steam sterilization. Joint Commission Perspectives,29,(7)

Joint Commission on Accreditation of Healthcare Organizations, [JC]. (2009b). Clarification: Reducing infection risks associated with medical equipment, devices, and supplies. Joint Commission Perspectives,29,(10)

JustNews. (2009). VA hospital: Patients exposed to HIV, Hepatitis. Retrieved July 11, 2009 from http://www.justnews.com/health/18996113/detail.html

Lambert, D. (2009). Valve Problem Cited In Colonoscopy Issue. WSMV.com. Retrieved July 11, 2009 from http://www.wsmv.com/news/18439461/detail.html

Olympus America Inc. (2009). Important safety notice. Retrieved January 30, 2010 from http://www.olympusamerica.com/files/MAJ-855_CustomerLetter_2112009.pdf

Patel, PR., Srinivasan, A., & Perz,JF. (2008). Developing a broader approach to management of infection control breaches in health care setting. American Journal of Infection Control,36(10). 685-690.

Poovey, B. (2009). Congressional panel to analyze VA hospitals' mistakes. Associated Press. Retrieved July 11, 2009 from http://www.boston.com/news/nation/articles/2009/05/30/congressional_panel_to_analyze_va_hospitals_mistakes/

Reuters. (2009). VA continues notification process for veterans affected by reprocessing issues. Retrieved July 11, 2009 from http://www.reuters.com/article/pressRelease/idUS196904+03-Apr-2009+PRN20090403

Rutala, W.A., Weber, D.J., & Healthcare Infection Control Practices Advisory Committee [HICPAC]. (2008). Guideline for disinfection and sterilization in healthcare facilities, 2008. Retrieved January 30, 2010 from http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf

US Food and Drug Administration [FDA]. (2009a) Preventing Cross-Contamination in Endoscope Processing. Safety Communication from FDA, CDC, and the VA. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm

US Food and Drug Administration [FDA] (2009b). FDA Notice: Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191585.htm

US Food and Drug Administration. (2010a). Alternatives to STERIS System 1. FDA cleared sterilization and disinfection products. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194429.htm

US Food and Drug Administration [FDA]. (2010b) Steris System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities To Transition to Legally-Marketed Alternatives. Retrieved January 30, 2010 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm199567.htm

Veterans Health Administration [VHA]. (2007). Patient safety alert AL08-03; Addendum to patient safety alerts AL07-06 and AL07-02: Reprocessing instructions for Haag-Streit reusable tips (prisms) used to measure intraocular pressure. Retrieved February 1, 2010 from http://vaww.ncps.med.va.gov/Guidelines/alerts/Docs/TonometerTipsReprocessingAL08-03.pdf

Veterans Health Administration [VHA]. (2008). Patient safety alert: Improper set-up and reprocessing of flexible endoscope tubing and accessories. Retrieved January 30, 2010 from http://www.patientsafety.gov/alerts/OlympusScopesAlertAL09-07-WWW.pdf

Veterans Health Administration [VHA]. (2009) VHA Directive 2009-031: Improving safety in the use of reusable medical equipment through standardization of organizational structure and reprocessing requirements. Retrieved January 30, 2010 from http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2039