The FDA sent warning letters to three duodenoscope manufacturers — Olympus Corp., Fujifilm and Pentax — March 9 for failing to conduct mandatory postmarket surveillance studies into the efficacy of device reprocessing protocols.
Here are four things to know.
1. The agency in 2015 ordered the devicemakers to conduct the postmarket surveillance studies to assess whether healthcare providers could properly clean and disinfect their duodenoscopes. The mandate stems from the agency's ongoing efforts to prevent patient infections associated with contaminated duodenoscopes.
2. As part of the postmarket surveillance, the devicemakers are supposed to "conduct a study to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, as well as a human factors study to assess how well trained hospital staff are following the reprocessing instructions," according to the FDA.
3. As of March 9, Olympus has not started data collection, while Pentax and Fujifilm have not provided sufficient data. Fujifilm has met requirements for its human factors study to assess how well hospital employees follow reprocessing instructions, but Olympus and Pentax have not complied with these requirements.
4. The FDA expects Olympus, Fujifilm and Pentax to submit a plan for future study milestones by March 24. The manufacturers must also collect 50 percent of duodenoscope samples by August 31, with the remaining half collected by the end of 2018. For the human factors studies, companies must finish half of the testing by May 31, before finishing the other half by June 30.
"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, MD, 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."
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