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See today's BioWorld MedTech
Home » FDA cites device design as possible culprit in reprocessing-associated endoscope events
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FDA cites device design as possible culprit in reprocessing-associated endoscope events

April 6, 2021
By Mark McCarty
Device reprocessing has intermittently prompted FDA action in an effort to tamp down on infection-driven adverse events for various types of endoscopes, and the latest spate of events involves endoscopes used in urological applications. While the three associated fatalities all took place outside the U.S., the FDA nonetheless indicated that it is considering the possibility that a device redesign is in order, a move the agency endorsed in connection with infections blamed on duodenoscopes.
BioWorld MedTech Regulatory Diagnostics Endoscope U.S. FDA

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