Three years ago, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), and an American Society for Microbiology working group on duodenoscope culturing released guidelines for facilities to measure reprocessing quality.

But institutions implementing these protocols need to take “realistic steps,” according to Dr. Michelle Afla, a microbiologist who has done extensive research on endoscope reprocessing.

With the time and resources needed for adequate culturing of duodenoscopes post-reprocessing, it is simply not feasible to do at the end of every reprocessing cycle.

“This can’t be done every day on every patient-used endoscope,” Alfa said in a recent Olympus-sponsored webinar, which Gastroenterology & Endoscopy News covered in a recent Priority Report. “Sites need to be selective about taking realistic steps.”

Alfa assisted with developing the microbial surveillance and culturing protocol for duodenoscopes — a way to measure the efficacy of reprocessing — that was released in 2018. Reprocessing duodenoscopes has been an ongoing issue in GI endoscopy and has in recent years received high-profile media attention following deadly multidrug-resistant outbreaks at large medical centers.

The 2018 guidelines provide a standard methodology for culturing scopes to help eliminate inconsistencies in how contamination data is collected.  Implementing the protocol requires training two staff members with duodenoscope experience, such as a reprocessing technician or endoscopy staff.

Responding to reported contamination or outbreaks requires fast action, and more staff and resources, according to the G&E News writeup.

Despite the increase in cost and manpower, institutions need a viable way to measure the success of reprocessing because “you don’t know what you don’t know,” Alfa said.

“Everybody involved in reprocessing believes they are following the manufacturer instructions and doing the best job possible,” she said during the webinar. “But if you’re not monitoring, you don’t know for sure what’s going on inside the scope channel. By doing scope cultures periodically, it can help you rectify the problem before it becomes a persistent issue affecting a lot of people.”

Prior to establishing a clear way to see if reprocessing worked, contamination rates of duodenoscopes post-reprocessing varied widely. Checking periodically to see if duodenoscopes are indeed sterile and patient-ready helps audit the reprocessing process and improve patient safety, Alfa said.

Duodenoscopes are considered the most difficult endoscopes to clean and disinfect due to their multiple working channels and the elevator mechanism on the distal end.

The FDA recommended an industry transition to single-use or partially disposable duodenoscopes in August 2019 as a way to combat cross-contamination risk in endoscopic retrograde cholangiopancreatography (ERCP), the procedure duodenoscopes are used for.