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FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes


FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes
Agency is taking action to remind health care providers about the proper way to clean certain devices for reuse
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SILVER SPRING, Md., April 1, 2021 /PRNewswire/  Today, the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes devices used to view and access the urinary tract. Reprocessing these types of medical devices involves both cleaning and high-level disinfection or sterilization so the devices can be reused. ....

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FDA investigates contributing factors for reported infections from reprocessed urological endoscopes