Latest FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k) Status Alerts

17 Aug 2015

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.

FDA sent warning letters to duodenoscope makers Fujifilm Medical Systems USA Inc., Hoya Corp./Pentax Life Care Division, and Olympus Medical Systems Corp. on Aug. 12 as part of its ongoing investigation into reprocessing lapses with the reusable scopes that led to patient contamination incidents, illnesses and deaths from 2013-2015. (See Also see "FDA Lays Down Strict Disinfection Guidance In Wake Of Scope Incidents" - Medtech Insight, 16 March, 2015..)

In addition to issuing the recent warning letters, FDA also sent so-called "510(k) status" letters on Aug. 12 to two...