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...