By Susan Klacik
The Association of periOperative Registered Nurses (AORN) released its updated Guideline for Processing Flexible Endoscopes. The revised guideline adds 10 new topics that provide more detailed guidance and delivers best practices for all stages of flexible endoscope processing based on a review of extensive evidence-based research. This article provides an abbreviated summary of some of those updates.
Sterilization versus HLD
The revised guideline separates sterilization and high-level disinfection (HLD) into separate sections. Similar to ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities, the updated AORN guideline recommends sterilizing reusable flexible endoscopes that have a manufacturer validation for sterilization whenever possible. This recommendation is also consistent with the Spaulding Classification system that labels items, such as flexible endoscopes, which come in contact with non-intact skin or mucous membranes as semi-critical devices and are recommended to be processed by sterilization. Not every flexible endoscope can undergo sterilization according to its manufacturer’s instructions for use (IFU); however, the sterilization recommendation notes that sterilization provides the highest level of assurance that processed items are free of viable microbes, and packaging systems protect the integrity of the sterilized contents until the package is opened for use while permitting the aseptic delivery of the contents.
If a liquid chemical sterilization (LCS) system will be used to sterilize an endoscope for a critical procedure, the endoscope should be immediately transported to the point of use in a closed processing container. Endoscopes used for a semi-critical procedure and are processed in a LCS system may be processed in the same manner as those that receive HLD. If processing flexible endoscopes using HLD, it is recommended to use a compatible FDA-cleared AER in accordance with the manufacturer’s IFU. This recommendation includes verifying that all connections are correctly connected and then monitoring the cycle using all recommended monitoring tools. If manual HLD is performed, it is recommended to process endoscopes with a compatible FDA-cleared high-level disinfectant in accordance with the manufacturer’s IFU and the AORN Guideline for Manual Chemical High-Level Disinfection. Using an automated process for HLD is recommended instead of a manual process because automated processes may be more efficient and reduce personnel exposure to high-level disinfectants. It is recommended to have flexible endoscopes reprocessed in the same manner across all processing locations and shifts, including weekends.
Point-of-use treatment, leak testing
Transport to the decontamination area now includes a hand-over process from the transporter to decontamination personnel and a list of information that should accompany the endoscope. The list should include the time that point-of-use treatment was completed; whether that treatment began immediately after use of the endoscope (and, if not, the time that endoscope use was completed); and whether the endoscope was kept moist until point-of-use treatment could be performed.
Leak testing is a critically important aspect of flexible endoscope processing, and verification of the leak tester’s pressure accuracy or calibration of automatic leak testers ensures that the leak tester is producing the correct pressure. A new recommendation was added to verify the pressure of the leak tester in accordance with the manufacturer’s IFU. When using an AER that has a mechanical leak test, it is also recommended that the leak test performed by the AER be considered as an adjunct to leak testing performed before manual cleaning. Note: Mechanical leak testing in an AER is not a substitute for leak testing performed before manual cleaning as recommended in the endoscope manufacturer’s IFU.
Cleaning, inspection, CV, drying and storage
The previous version of the guideline had a conditional recommendation that internal channels may be inspected with a borescope; however, the new version recommends using a clean borescope to visually inspect accessible channels of flexible endoscopes before sterilization or HLD. Health care organizations should identify high-risk flexible endoscopes, including duodenoscopes, bronchoscopes, ureteroscopes and cystoscopes, and these high-risk endoscopes should undergo CV testing after each use, and the results of those tests should be recorded.
Thorough drying of flexible endoscopes is necessary because any moisture remaining on the surfaces of an endoscope can facilitate microbial growth and biofilm formation during storage. It is recommended to perform drying even when using an AER with an air purge cycle or extended dry time feature. It is also recommended to dry all accessible channels for at least 10 minutes; if visible moisture is still present, extend the dry time until visible moisture is no longer observed. The guideline also features a conditional recommendation that a compatible automated drying system, such as a drying cabinet with pressure-regulated, HEPA-filtered air, may be used to dry endoscope channels. To help determine endoscope storage time, a new conditional recommendation was added on conducting a storage time risk assessment. A list of considerations pertinent to the storage time risk assessment is included. Further, new recommendations were provided regarding how to transport endoscopes, which type of container to use, and how to properly clean and disinfect the container.
Water bottles, prions and data capture
Water and irrigation bottles can be a source of endoscope contamination. It is recommended to label the water bottle with its contents and the date the bottle was filled or opened. Evidence has shown that simethicone may be difficult to remove from water bottles, tubing and endoscope channels; therefore, it is not recommended to add simethicone to water or irrigation bottles.
There has been concern regarding the use of flexible endoscopes on patients with suspected prion disease (e.g., Creutzfeldt-Jakob Disease). Evidence shows that flexible endoscopes may be used on patients who are at an increased risk for prion diseases as long as the devices are processed using standard procedures for cleaning and sterilization or HLD.
The record keeping topic has been expanded and new recommendations now call for recording leak testing, CV and borescope inspection. Specific record-keeping recommendations are provided for AER or LCS processors. It is recommended to record all repairs and maintenance for all endoscopes and endoscope accessories, processing equipment, water filtration systems (e.g., filter changes) and storage cabinets.
Leadership, quality control recommendations
Leaders are responsible for the safe working conditions and process management, so they must be knowledgeable about sterilization and HLD and confirm that endoscope processing is being performed to the latest standards and regulations. Education is a critical part of endoscope processing. The revised guideline includes education recommendations for personnel at the point of use who handle flexible endoscopes. A list of specific activities in which point-of-use personnel should receive education and competency verification is included in the guideline. A conditional recommendation has been added to consider increasing the frequency of competency verification for endoscopes that are used infrequently. Note: Flexible endoscopes are not just used in surgery and endoscopy settings. A new recommendation now includes education and competency verification for all who handle and process endoscopes, regardless of the location.
The revised guideline recommends a systems approach to quality assurance and performance improvement to help prevent endoscope processing errors. It lists several important systems that should be reviewed, such as providing adequate resources (e.g., time, personnel, inventory, space), prioritizing worker safety and ergonomics, standardizing processes among departments and establishing systems to improve traceability. Audits are an important part of a quality system and can identify problem areas, assist in evaluating and improving the quality of endoscope processing and formulate plans for corrective actions.
Another recommendation was added to evaluate water quality and water filtration systems at established times and after major maintenance to the water supply system. Other recommendations pertain to preventative maintenance for flexible endoscopes and equipment used in their processing. It is a regulatory requirement that health care organizations report any suspected device-related serious injury or death to the FDA and the manufacturer (or only to the FDA if the manufacturer is unknown). A conditional requirement is also included in the revised guideline that states that a health care facility may report any device malfunction to the FDA.
The revised AORN Guideline for Processing Flexible Endoscopes has been updated in the eGuidelines Plus at https://www.aorn.org/eguidelinesplus. The 2023 print version will be available for purchase at www.aorn.org.
– Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, is a HSPA clinical educator.
