Hospitals Should Transition To Disposable Duodenoscopes Or Those With Disposable Parts: FDA

Federal regulators are calling on hospitals to begin transitioning to duodenoscopes that are disposable or use certain disposable parts, in order to prevent the spread of infections between patients.

On January 15, the FDA issued a safety communication indicating hospitals should move away from fixed endcap duodenoscope designs, which are used in about half a million procedures every year, and replace the older products with newer designs that reduce or eliminate the need for sterilization between patients. The agency cautioned that it knows the transition may take a significant amount of time.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning device manufactured by several different companies have resulted in reports of serious hospital infection outbreaks, typically involving aggressive, antibiotic-resistant “superbugs”, which have caused a number of severe injuries and deaths.

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Questions about the safety of the devices first emerged after a  duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate, and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

In November 2019, the FDA approved a duodenoscope design with a disposable elevator tip; the most problematic and hard to clean part of the duodenoscope. A month later the agency approved the first disposable, single-use duodenoscope. It wants hospitals to begin using them as soon as possible.

“We are now recommending that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer design features that facilitate or eliminate the need for reprocessing,” the safety communication states. “Please note, we recognize that a full transition away from conventional duodenoscopes to the newer, innovative models will take time.”

In addition to switching over to disposable components, the FDA is reminding hospitals to also ensure staff “meticulously” follow reprocessing instructions, and institute a quality control program which includes sampling and microbiological culturing. The agency also recommends hospitals consider supplemental reprocessing measures such as liquid chemical sterilant systems, monitor reprocessing procedures to make sure they are being done correctly, and develop schedules for routine inspections and maintenance according to the duodenoscope manufacturers’ instructions.


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