FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order
US FDA sent the letters to
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The US FDA continues to find unacceptable levels of “high concern” disease-causing bacteria on duodenoscopes that have gone through cleaning and reprocessing steps, and is poised to take further action with three duodenoscope manufacturing firms to reduce patient risks.
An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.
Duodenoscope-makers Olympus, Fujifilm and Pentax Medical failed to conduct post-market surveillance study activities mandated by US FDA in 2015; quality systems violations noted at firms that make dental diagnostic X-ray devices and laser fiber-optic surgical devices. Six device-related warning letters were released by the agency this week.