FDA May Take Additional Regulatory Actions On Duodenoscopes, Shuren Says

The US FDA continues to find unacceptable levels of “high concern” disease-causing bacteria on duodenoscopes that have gone through cleaning and reprocessing steps, and is poised to take further action with three duodenoscope manufacturing firms to reduce patient risks.

an Olympus TJF-Q180V duodenoscope
The Olympus Evis Exera II, TJF-Q180V duodenoscope has been redesigned to make cleaning, reprocessing easier for users

US FDA device center Director Jeffrey Shuren has issued a new statement on duodenoscope risks, saying the agency continues to receive reports of unacceptable contamination rates, and plans additional actions to reduce patient exposures.

“While our recent actions to stop patient infections have yielded improvements, we also received reports of three deaths of US patients in 2018 related to infections associated with duodenoscopes. That’s...

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