FDA Recommends Healthcare Providers Switch to Disposable Duodenoscopes

Celiac.com 04/20/2022 - The US Food and Drug Administration (FDA) is directing healthcare facilities and providers to transition to fully disposable duodenoscopes, and those with disposable components.

The FDA made the announcement after an analysis of post-market surveillance studies supported the agency's concerns about the difficulty of fully cleaning fixed endcap duodenoscopes. 

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Among other things, the agency noted that older reusable duodenoscope models had contamination rates as high as 6%, compared with just .5% for disposable models. The agency notes that disposable duodenoscopes and components reduce patient contamination risk "by half or more as compared to reusable, or fixed endcaps."

The contamination concerns, coupled with the increasing availability of disposable duodenoscopes led the agency to update its April 2020 recommendations on the subject. 

Duodenoscopes are used in more than half a million medical procedures annually in the United States, and play an important part in evaluating and treating diseases and problems of the pancreas and bile ducts.

While duodenoscope manufacturers no longer sell fixed endcap models in the United States, numerous healthcare facilities still use them. To decrease infections, the FDA now recommends that all fixed endcap models be replaced.

The agency notes that some companies have programs in place to upgrade their old models with a disposable component at no cost.

The FDA has approved two fully disposable duodenoscope models, along with five that use disposable components. Only four of the disposable components are currently available in the U.S.

FDA-approved fully disposable duodenoscopes include:

• Ambu Innovation GmbH, Duodenoscope model aScope Duodeno
• Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope

FDA-approved disposable duodenoscope components include:

• Fujifilm Corporation, Duodenoscope model ED-580XT 
• Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V 
• Pentax Medical, Duodenoscope model ED34-i10T2 
• Pentax Medical, Duodenoscope model ED32-i10 

Read more at Medscape.com