Cleaning And Sterilization Needs Require Closer Attention By Reusable Device Makers – FDA
This article was originally published in The Gray Sheet
With the increasing mechanical complexity of devices that are intended to be reused by hospitals, the challenge is getting steeper for manufacturers to design the products and provide appropriate instructions to allow proper cleaning and sterilization, an FDA official stressed at a recent meeting.
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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.
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.