The Food and Drug Administration (FDA) today ordered three duodenoscope manufacturers to conduct studies in healthcare facilities to better understand how the devices are reprocessed, according to an article on the Infection Control Today website.
“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," said William Maisel, MD, of the FDA’s Center for Devices and Radiological Health.
The three manufacturers – Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division) — will have 30 days to submit postmarket surveillance plans to the FDA.
The plans must detail their plans to conduct studies to evaluate how well Healthcare facility staff are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination.
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