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Bacterial Outbreaks Triggering Tougher FDA Reprocessing Standards

Inadequate validation testing paired with highly-publicized bacterial outbreaks in Illinois and California involving use of contaminated duodenoscopes has led to stricter reprocessing standards for those devices. And FDA is likely moving towards tougher reprocessing requirements more broadly for reusable devices in an upcoming guidance.

Prior to recent bacterial outbreaks at hospitals involving lingering carbapenem-resistant (CRE) bacteria on duodenoscopes, FDA was only requiring statements from endoscope manufacturers that they have validated their reprocessing instructions for disinfecting the reusable scopes. But now, after seeing some inadequate cleanliness test results from the companies – “we are asking to see a higher safety margin," FDA told “The Gray Sheet” March 5.

“Given the complexity of these devices, and our knowledge that failure to follow the cleaning instructions is the most common...

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