Knowledge gaps on proper cleaning and surveillance techniques lead to decontamination failures in endoscope reprocessing. There are common misconceptions on the guidelines and protocols among reprocessing personnel that increase risk of patient cross-contamination.

This is according to a review article from Michelle Alfa, CEO of AlfaMed Consulting, who has more than 30 years research experience in medical device reprocessing.

The ongoing quest to understand endoscope reprocessing failures to reduce patient cross-contamination risk has included several studies analyzing the human factors that play into reprocessing success. Contributing factors previously studied include challenging work conditions for reprocessing technicians and pressure for a quick turnaround from physicians that force technicians to skip steps in the process.

Alfa’s latest review article addresses the lack of understanding of how best to perform crucial reprocessing steps, like manual cleaning, microbial surveillance testing and proper drying and storage techniques.  

Manual cleaning has long been understood to be the most crucial reprocessing step. If contaminants remain on endoscope working channels prior to high-level disinfection, they may not be removed by the AER.

Alfa’s review – published in Gastrointestinal Endoscopy in August 2020 under the title, “Quality Systems Approach for Endoscope Reprocessing: You Don’t Know What You Don’t Know!” –  notes a wide variance in manual clean compliance across endoscopy suites. Ongoing monitoring of this step is essential but not currently done, she says.

In the case of monitoring manual cleaning, endoscopy units often use microbial surveillance tests like rapid ATP tests after high-level disinfection (HLD) to check for dangerous organisms. These types of tests, however, are not sensitive enough to detect microorganisms post-HLD, Alfa notes. Rapid ATP tests should be performed following manual cleaning and would help determine if it needed to be repeated prior to HLD.

Another popular misconception, Alfa writes, is that automated endoscope reprocessors (AERs) can adequately dry endoscope working channels with an alcohol flush and an air flush post-HLD. This leads to a false sense of security and too many endoscopes stored with moisture levels that can facilitate biofilm growth.

Endoscope reprocessing is a long, complex process requiring 50 to 100 steps that must be carefully followed. Endoscopes – such as bronchoscopes, duodenoscopes, cystoscopes, and colonoscopes – are difficult to clean and disinfect due to their delicate nature and long, narrow working channels. Inadequate reprocessing can put patients at risk of cross-contamination, as numerous outbreaks have been traced back to contaminated “patient-ready” scopes.

Neither society guidelines nor manufacturer endoscope instructions for use offer a standard requirement for reprocessing monitoring in endoscopy units in North America, Alfa writes. That makes it difficult to know the protocols and practices that need to be improved if they are not audited adequately or regularly.

“Endoscopy clinics in North America (large and small) do not perform much monitoring,” Alfa concludes, “and as such they do not know how well or how poorly they are doing with respect to many of these disconnect issues (i.e. ‘you don’t know what you don’t know’).”