FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies

Editor's Note

The Food and Drug Administration on October 5 ordered three manufacturers of duodenoscopes marketed in the US to study the reprocessing of their devices in the clinical setting where they are used.

The three manufacturers—Olympus America, Inc; Fujifilm Medical Systems, USA, Inc; and Hoya Corp (Pentax Life Care Division)—will have 30 days to submit postmarket surveillance plans to the FDA.

The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings. "This is a significant step in the effort to combat infections spread through duodenoscopes.