FDA Warns Duodenoscope Makers to Complete Reprocessing Studies

The Food and Drug Administration Friday issued warning letters to all three duodenoscope manufacturers for failing to comply with a 2015 order to conduct postmarket surveillance studies to determine whether health care facilities are able to properly clean and disinfect the devices. “The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We expect these device manufacturers to meet their study obligations to ensure patient safety.” The letters were sent to Olympus, Fujifilm and Pentax, who are expected to submit a plan by March 24 outlining how study milestones will be achieved.