Appendix O. Part 2: A Clear View of Flexible Endoscope Processing: Disinfection/Sterilization Record Keeping - Implementation Guide

Slide 1: Appendix O. Part 2: A Clear View of Flexible Endoscope Processing: Disinfection/Sterilization Record Keeping

Susan Klacik B.S., CRCST, CIS, FCS

Slide 2: Objectives

After viewing this video you will be able to—

• List basic endoscope processing steps.
• Explain infection prevention guidelines for scope disinfection/sterilization, record keeping, and scope storage.

Slide 3: High-Level Disinfection/Sterilization: Instructions for Use (IFU)

• Equipment needed.
• Type of high-level disinfectant (HLD)/sterilants compatible with scope.
• Measurement of solution.
• Specific steps for thorough rinsing.
• Exact measurements for rinsing.
• Step-by step process.

Slide 4: High-Level Disinfection

• Don fresh personal protective equipment (PPE), including gloves and skin and eye protection.
• Use a closed container labeled with a biohazard symbol.
• The container should be large enough to completely immerse the endoscope in the liquid chemical sterilant (LCS)/HLD solution.
• Prepare according to the manufacturer's written IFU.
• Document:
    – name of solution
    – expiration date
    – date of preparation
    – date of use
• Test the minimum recommended concentration (MRC) before each use with the disinfectant-specific test strip.
• Follow the label directions for the test strip.
• Document results.

Slide 5: Automatic Endoscope Reprocessor (AER)

• Check to ensure the scope can be processed
    – Validated.
    – Compatible with high-level disinfectant.
• PPE used for decontamination should not be worn when handling a scope or any of the accessories after they have gone through the disinfection process.

Slide 6: Automatic Endoscope Reprocessor (AER)

• Incoming water should be filtered using bacterial retentive filters as recommended in the AER manufacturer's written IFU.
• Quality testing devices are available for many AERs to ensure the solutions are flowing.
• Testing should be performed at least weekly, after major repairs, or whenever there is a concern about equipment function.

Slide 7: Sterilization

• Terminal sterilization is the preferred method.
• Terminal sterilization is recommended for flexible and semi-rigid endoscopes that enter sterile body cavities.

Susan Klacik (author), 2015

Image: showing sterilization

Slide 8: Storage IFU

• Criteria for scope storage cabinet.
• How to prepare scope for storage
  – Angulation knobs.
  – Attachments.
  – If the scope should be hung or coiled.

Susan Klacik (author), 2015

Image: photo of scope storage

Slide 9: Storage ST91

• Store hanging vertically with the distal tip hanging freely in a clean well-ventilated cabinet.
• Angulation lock should be in the open position.
• Leave sufficient space around scopes to prevent them hitting into one another.
• All removable parts (e.g., valves and caps) should be detached and kept with the scope.

Slide 10: Storage ST91

• A tag or label should be attached to the scope to document that the scope has been cleaned or high-level disinfected.
• The tag should be labeled with the following information:
  • Date of processing.
  • Name(s) of person(s) who performed the processing.
  • Date of high-level disinfection.

Susan Klacik (author), 2015

Image: Tag or label shows the scope has been cleaned or disinfected

Slide 11: Storage ST91

• Channels should be dry to help prevent bacterial growth and biofilm formation.
• To help ensure that no moisture is left on or in any part of the endoscope, all channels should be flushed with 70–80 percent alcohol to facilitate drying.
• All channels should be purged with filtered medical-grade air at the correct pressure.
• Temperature and humidity in the area where the scopes are stored should be monitored.

Slide 12: Hang Time

Existing Guidelines

Slide 13: Hang Time Risk Assessment

• Type of endoscope (with lumen or without lumen).
• Condition of the endoscope after processing (e.g., dry or wet).
• Way the endoscope was transported from processing to storage.
• Use of aseptic technique to remove the endoscope from the AER.
• Conditions of storage environment.

Slide 14: Hang Time Risk Assessment

• Excessive handling during storage.
• Manufacturer’s written IFU for storage.
• Compliance with professional organization guidelines for storage.
• Frequency of use.
• Frequency, type, and results of quality monitoring of processing.
• Quality of final rinse water (consult AAMI TIR34:2014, Water for the reprocessing of medical devices).

Slide 15: Transport of Disinfected Scopes

• Protect from recontamination.
• Don new exam gloves before removing the endoscope from the storage cabinet.
• Transport using an impervious barrier method that will prevent recontamination.
• The endoscope should be loosely coiled to prevent damage.
• The transport system should not be reused for clean transport.

Slide 16: Quality Control Ability To Track Scope Use

Identify—

• The sterilizer, AER, or soaking container.
• The date chemical sterilization or high-level disinfection was performed.
• The sterilization or high-level disinfection cycle number.
• Patient identifier.

Slide 17: Record Keeping

• Lot number.
• Specific name of the item.
• Patient identifier.
• Procedure/physician.
• LCS/HLD expiration date.
• Exposure time and temperature.
• Cycle date & time.
• Name of LCS/HLD.
• Name/initials of person performing HLD/sterilization.
• Results of quality monitoring testing.

Slide 18: References

1. American National Standards Institute and Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities. 2015. http://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=2477.