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FDA Orders Studies on Contaminated Duodenoscopes

Studies to review cleaning instructions, disinfection process, ways to make scopes easier to clean

MONDAY, Oct. 5, 2015 (HealthDay News) — Recent outbreaks of infections linked to duodenoscopes led the U.S. Food and Drug Administration on Monday to order manufacturers to conduct postmarket studies of the devices in health care facilities.

The FDA has been working with the three manufacturers of duodenoscopes to improve the safety of the devices, including reviewing the companies’ cleaning instructions, looking at ways to improve the disinfection process, and considering design changes to make the scopes easier to clean. The findings from the postmarket surveillance studies may help identify additional ways to reduce risks associated with the scopes, such as new labeling with different cleaning/sterilization instructions or new regulations to protect patient safety, the FDA said in a news release.

“These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections,” William Maisel, M.D., M.P.H., the deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the news release.

The three companies that sell duodenoscopes in the United States — Olympus America, Fujifilm Medical Systems USA, and Hoya Corp. (Pentax Life Care Division) — have 30 days to submit postmarket surveillance plans to the FDA, the agency said. The plans must outline how the companies will conduct the studies in order to find out how well health care workers follow instructions to clean and disinfect the scopes between use in different patients, and to learn more about the rate of contamination associated with the devices.

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