Infection Control Summit on endoscope reprocessing

Recently, the American Society for Gastrointestinal Endoscopy (ASGE) held an Infection Control Summit outside Washington, D.C. to provide a state-of-the-art review of endoscope disinfection and reprocessing from regulatory, practice and training perspectives. The meeting also explored future avenues of technological advancement and research for endoscope disinfection and reprocessing.

The Summit provided presentations from key stakeholders and allowed for open discussion regarding next steps in the process of identifying recommendations and guidance for practitioners to ensure patient safety. The International Association of Healthcare Central Service Materiel Management was invited to attend and was represented by Executive Director Susan Adams and myself.

 Key endoscope reprocessing experts and regulators provided insight into the current state of endoscope reprocessing. The overriding theme was that cleaning flexible endoscopes is the most important part of the process and that many challenges exist that must be overcome to ensure these devices can be effectively cleaned. Among the primary challenges is the design of flexible endoscopes. These devices feature long, narrow interior channels (lumens), including those with internal surfaces that are not smooth, have ridges or sharp angles, or are too small to permit a brush to pass through; hinges; sleeves that surround rods, blades, activators, inserters, etc.; adjacent device surfaces where debris can be forced or become caught during use; O-rings; valves that regulate the flow of fluid through a device (stopcocks), and other design features that cannot be disassembled for reprocessing.

Role of human factors

Human factors also present notable challenges for endoscope processing, a point that was addressed in a presentation by Cori Ofstead, MSPH, President and CEO of Ofstead & Associates Inc. She presented data that originated from audits she and her team performed during site visits to over 60 institutions, as well as from 2017 and 2018 surveys of IAHCSMM members. These studies established that personnel processing flexible endoscopes are often:

• Expected to memorize and perform complex tasks involving hundreds of steps from all of the instructions for use (IFU) involved;
• Subjected to a hostile work environment;
• Not provided with adequate training (some receive no training). Study findings showed, however, that certified technicians perform at a higher level;
• Unable to understand or follow the manufacturer’s reprocessing IFU. A survey showed 84% of respondents had read the endoscope’s IFU, but it could not be consistently understood or followed;
• Bothered by odors and pain during endoscope reprocessing (47% of survey respondents admitted this is a workplace issue);
• Pressured to move quickly. Up to 17% of survey respondents admitted skipping steps/cutting corners or doing steps faster due to time pressures; and
• Bullied by others in the workplace. A survey showed that 40% of endoscope reprocessing technicians either witnessed bullying or experienced it themselves – with bullying including both verbal and physical attacks.
• The US Food and Drug Administration’s (FDA’s) Post-Market Surveillance Studies: Human Factors and Microbiological Sampling/Culturing Data was also presented during the Summit. The results from human factors studies indicate that reprocessing instructions in current user manuals should be strengthened because they are difficult for reprocessing staff to comprehend and follow. Many reprocessing professionals missed one or more steps in the process and needed additional training to complete the process properly. Also, it was noted that descriptions of some of the processing steps in the user manuals were unclear.

It was noted that drying is another critical part of the process because moisture facilitates proliferation of microorganisms and wet storage may promote formation of biofilm. Data presented supported that the duration of drying should be 10 minutes and that automated drying is more effective than manual drying. Training and education are also vital for improving the processing of flexible endoscopes, the presenters concluded, and many presenters suggested that certification of processing professionals should be required.

 ASGE, the American Gastroenterological Association, the American College of Gastroenterology and the Society of Gastroenterology Nurses and Associates discussed actions they’ve taken to improve flexible endoscope processing:

• Improved communication with members, manufacturers, the FDA and Centers for Disease Control and Prevention (CDC)

• Monitoring of the FDA’s Manufacturer and User Facility Device Experience database and other resources, setting up a website to track communications and inform members of issues and updates

• Joining the Association for the Advancement of Medical Instrumentation (AAMI) to participate in the revision of ANSI/AAMI ST91, Flexible and semi-rigid endoscope processing in healthcare facilities (this revision is nearly complete)

Other solutions included implementing the use of disposable duodenoscopes. There are many considerations regarding their use, such as cost, environmental impact and physician preference. Note: Since this meeting took place, the FDA cleared the first fully disposable duodenoscope.

This article is a condensed version of one that will be published in the March/April 2020 issue of PROCESS, the publication of the International Association of Healthcare Central Service Materiel Management.