Infection Control – How Requirements and Processes Differ Amongst Specialties

Mind Exercise???

Pick a number between 1 and 10. Multiply by 9. If your number is two digits, add them together to make

one number. Subtract 5. If your number is 1, remember the letter “A”, if 2

remember “B”, 3 = C, 4 = D, etc. Think of a country that starts with that letter. Think of the second letter of that country and then think

of a mammal whose name starts with that letter. Now think of the color that mammal.

Denmark

A GREY ELEPHANT FROM DENMARK

Learner Objectives

Discuss the history of complex surgical instruments. Describe the impact that complex surgical instruments

have on the Sterile Processing department. Identify basic protocols important to each step of the

complex surgical instrument process. List the steps to implement a complex instrument

policy in your facility.

Why do I talk about Complex Surgical Inst

Experience – St. David’s =

22,000 in 2009 / 24,000 in 2010

Avg = 150 per day 237 one day record 77 = 1 patient

record Huge impact =

huge frustration

My story….the experience….2003 moved to Texas

Interview/issues/expectations

Paul Harvey….

Instrument reprocessing is a patient safety issue!

9/11/15, the CDC issued an official Health Advisory to healthcare facilities, such as hospitals, ambulatory surgery centers, clinics and doctors’ offices that utilize reusable medical devices urging them to "immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines."

Instructions For Use (IFU)

It is critical to follow the instrument MFR’s instructions for use (IFU) with regards to water temperature, cleaning solution, brush type, and cleaning procedures.

For complex devices, specific times will be validated for the soaking, ultrasonic cleaning and/or rinsing.

IFU’s

I-FU’s

Communication Breakdown

What if you cannot comply?

If this is an issue, you must secure the proper resources, or you must contact the device manufacturer and ask them to revalidate to your standard reprocessing procedures.

Not complying with device MFR’s IFUs is a patient safety issue and could cause you to lose accreditation.

What are Loaner Instruments?

Instruments or sets borrowed from a vendor for emergency or scheduled surgical

procedures that will be returned to the vendor following use

Why Do We Get So Many Loaners?

New technologies

Trial instruments

Specific patient needs

Multiple cases

Cost issues

Storage issues

Instructions For Use (IFU)

https://www.onesourcedocs.com/ifu.html

The History

How have instruments changed through

the years?

The History

The History

The History

The History

Fiber Optics

The History

Powered Instruments

Receiving

Receiving

All instruments should be considered contaminated & handled accordingly

From the time that they are received at your facility, you accept responsibility for them

The Issue

Challenging Desing

Challenging Designs

Challenging Designs

Challenging Designs

Brent Parkinson <brent.parkinson@aesculapusa.com>Mon 8/12/2019 9:51 AMBob Marrs

Bob,I hope you are doing well. It seems that Calif is on the top of making SPD life difficult. Here is negative that a California hospital was dinged for. What can they do?

Observed inTracer Activities site . In the outpatient surgery center, manufacturer's instructions for use (IFUs) for various ophthalmologic instruments were not being followed. Specifically, staff stated that instruments for ophthalmic cases were all subjected to a uniform process post surgery, but due to concerns about Toxic Anterior Segment Syndrome (TASS), chemical treatment, including use of enzymatic pretreatment sprays, was avoided. Alternatively, staff stated they were keeping the instruments moist with sterile water. However, the case sets contained instruments from a variety of manufacturer's, including needle holders, Sinskey hooks, forceps and a variety of specula by the Katena corporation, scissors by Aesculap, scissors, needle holders, forceps and other instruments from the Storz corporation, a blade handle by V. Mueller corporation and a retinol holder from Alcon. While the hospital described that all such instruments were treated the same in a case/set observed to be transported from the OR to decontamination, Katena IFUs indicated that its instruments should be kept submerged in a basin with demineralized water; Storz IFUs advised to keep instruments moist; Aesculap IFUs specified to remove debris with a damp cloth and then keep the instruments dry for transport; V. Mueller IFUs simply recommended that instruments be handled according to hospital policy; the Alcon handle IFUs stated that the instrument should be cleaned and dried immediately after surgery. Given these divergent and discordant IFU requirements, treating all instruments within the case in the same fashion was contrary to the IFUs for some of the contents, as described above. This observation was confirmed by area and hospital leadership participating in the tracer activity.

I would appreciate your thoughts

Thank you,

Inventory

Inventory Control Sheet Date Time Signature of delivery person Signature of receiving person Doctor’s name Number of trays Number of implants

DisinfectionDISCLAIMER….

Never trust the cleaning or sterilization processes of loaner instruments coming in from outside your facility!!!!!!!!!

HAVE YOU EVER DONE THIS WITH BAD OUTCOMES???

Decontamination

As you know, the decontamination process is the MOST IMPORTANT step in the care and handling of loaner instrumentation. The manufacturer’s instructions for cleaning

& disinfection must be followed.

The written recommendations of the devicemanufacturer should always be followed.AAMI ST79 : 7.2.2

Sterilization Best Practices (Point of Use)

Instruments should be kept free of gross soil duringsurgical procedures as blood, body fluids and saline candamage instruments and if allowed to dry, be difficult toremove during the decontamination process.

Gross soil should be removed from all instruments at POU

Cleaning Challenges

Cleaning Challenges

Inspection

After cleaning and disinfection, the CSD technician must inspect each device for:

Cleanliness

Functionality

Reporting of defective devices

Sterilization

Sterilization

Ergonomics/Weight

Vendor IFU’s

Extended Cycles

25 LBS

Extended Cycle Issues

Many users feel that extended cycles have a detrimental effect on efficiency & sterility assurance for healthcare facilities

For example….

1. Extended cycles tie up the sterilizer & can backlog sterilizer loads needing to be processed

Extended Cycle Issues

2. Devices validated for standard cycles may be damaged in extended cycles. Run load specific cycles

3. Barrier characteristics of sterile packaging (disposable wrap, tape & rigid container filters) may be adversely affected What testing has been done by manufacturer to validate their packaging’s barrier effectiveness in extended cycles?

Extended Cycle Issues

4. Self-contained BI’s may not be resistant enough or appropriate to use. ISO standard 12161 (Biological Indicators) states:

“User should not over process the culture medium, as extended sterilization may induce changes that can affect its growth-promoting properties. The ability of culturing medium to promote the growth of

low numbers of microorganisms should be demonstrated.”

What testing has your SCBI mfg done to validate their media’s growth promotion ability in extended cycles?

Extended Cycle Examples

HOW BAD CAN IT BE? REALLY???? 84

EXAMPLE - MFR’s Cleaning IFUOrthopedic Instruments

1. Submerge in enzymatic detergent.2. Flush port with 50 ml enzymatic detergent.3. Soak for 10 min in protein soluble detergent.4. Scrub with soft bristled brush (agitate instrument

while scrubbing).5. Rinse with warm tap water (38-49°C)6. Flush port with 50 ml warm tap water.7. Place in bath of warm water (agitate by hand for at least

1 min). Repeat this process 2 additional times.

8. Ultrasonic for 10 min with neutral pH detergent (flush port with 50 ml prepared detergent before sonication).

9. Flush port with clean tap water (3 times).10. Rinse for at least 1 min with tap water.11. Dry with clean, lint free cloth.12. Inspect.13. Lubricate tip mechanism and finger slot (do not

lubricate flush port).

EXAMPLE - MFR’s Cleaning IFUOrthopedic Instruments

EXAMPLE MFR’s Cleaning IFUZimmer Orthopedic Surgical Instruments

1. Completely submerge instruments in enzyme solution and allow to soak for 20 min.

2. Rinse in tap water for minimum of 3 min.3. Ultrasonic clean for 10 min.4. Rinse in purified water for at least 3 min.5. Repeat sonication and rinse steps.6. Remove excess moisture from the instrument with

a clean, absorbent and non-shedding wipe.

Handling

Who transports your loaner trays

How are your loaner trays transported?

Do you get holes in loaner trays?

Does the OR ever rush into your area with a torn wrapper?

What about storage?

INSTRUMENT HANDLING

All personnel should be trained to minimize the handling of sterile items. Sterilized items should not be touched while cooling and should remain on the sterilizer cart for a minimum of 30 minutes.

Limited Storage Space

COMMUNICATION

BREAKDOWN

What if you cannot comply?

If this is an issue, you must secure the proper resources, or you must contact the device manufacturer and ask them to revalidate to your standard reprocessing procedures.

Not complying with device MFR’s IFUs is a patient safety issue and could cause you to lose accreditation.

Policies & Procedures

A partnership must be developed between the OR, CS/SPD & the vendor

Policies & Procedures must be followed to ensure proper “patient care” procedures are being followed

Policies & Procedures help to ensure that everyone in our areas (both employees & visitors) are always on the same page

Policies & Procedures

Policies should discuss: Ordering Education Transport in Check-in Processing Charging (if applicable) Post procedure processing Check-out Transportation out

NO CHASING-CATS POLICY

Remember……

YOU ARE RESPONSIBLE FOR THE CLEANING AND STERILIZATION OF ANY

INSTRUMENTATION USED ON YOUR PATIENTS

Why Maintain Best Practice?

44,000 to 98,000 people die each year from preventable medical errors

Focus on patient safety and infection prevention is of utmost importance

Surgical site infections remain problematic

Surgical Site Infections

Most common and most expensive hospital acquired infection: 2-5% of ALL surgical patients will sustain an SSI Cost is $3.5- $10 billion annually

Defined by CDC as “an infection that occurs after surgery in the part of the body where the surgery took place.”

Questions?

THANK YOU!

Sterile Processing Speakers Bureau | Weekly International PodcastSurvey Preparedness | Interim Management

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Bob Marrs | VP Organizational Development

| Beyond Clean Education | Consulting | Media| We Fight Dirty.

| phone: 512-568-0162| email: Bob@beyondclean.net| site: www.beyondclean.net| address: Texas, USA