Lumened Device Designs Should Facilitate Reprocessing – FDA/AAMI Meeting
This article was originally published in The Gray Sheet
Manufacturers of reusable devices with lumens and difficult-to-reach channels should design them so that they can more easily be disassembled for cleaning and subsequently reassembled, according to participants at a recent medical device reprocessing summit.
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The agency sped up release of a final guidance on reprocessing reusable devices, including a strict set of protocols for endoscope cleaning, disinfection data, and design guidelines, following reports of serious bacterial infections linked to duodenoscopes.
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.
Reports are being developed with input from FDA and will cover endoscope reprocessing, standardized cleaning instructions and human factors for device reprocessing.