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Bacterial Outbreaks Triggering Tougher FDA Reprocessing Standards

This article was originally published in The Gray Sheet

Executive Summary

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.

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