Latest FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k) Status Alerts
This article was originally published in The Gray Sheet
FDA takes new enforcement actions against duodenoscope makers in Aug. 12 warning letters to Fujifilm Medical Systems, Hoya and Olympus Medical Systems, charging adulterations to scopes, and noting troubles with CAPAs and reprocessing validation activities. Meanwhile, Fujifilm and Hoya also received so-called "510(k) status" letters.
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FDA says that additional pre-cleaning, cleaning and high-level disinfection steps spelled out in Fujifilm Medical Systems’ updated reprocessing rules for the firm's ED-530XT duodenoscopes can effectively disinfect the scopes and may reduce risk of infection.
FDA orders three duodenoscope manufacturers – Olympus America, Fujifilm Medical Systems and Hoya Corp.'s Pentax Life Care Division – to conduct postmarket surveillance studies to better understand how the scopes are being reprocessed and how to reduce the risk of patient infection. The firms told "The Gray Sheet" that they will comply with the agency's request.