FDA orders postmarketing review of duodenoscopes
The FDA today ordered three duodenoscope manufacturers to conduct postmarketing studies to determine how the devices are reprocessed in real-world settings.
“This is a significant step in the effort to combat infections spread through duodenoscopes,” William Maisel, MD, MPH, chief scientist at the FDA’s Center for Devices and Radiological Health, said in a press release. “The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used.”
The FDA gave Olympus America, Fujifilm Medical Systems, U.S.A, and Hoya Corp. (Pentax Life Care Division) 30 days to submit their plans to conduct the studies.
Previously, the FDA found evidence that linked duodenoscopes to outbreaks of infections in hospital settings. It also determined that their complex design makes it more difficult to remove pathogens compared with other types of endoscopes. In addition, the FDA found that clinicians do not always follow the manufacturers’ reprocessing instructions, which are “labor intensive and prone to human error.”
Maisel said these studies will determine the effectiveness of the current reprocessing instructions and that the postmarketing studies “may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections.”