FDA Orders Duodenoscopes Surveillance Studies
In a press release dated 10/5/2015, the FDA States:
The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
“This is a significant step in the effort to combat infections spread through duodenoscopes. 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,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “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.”
The three manufacturers – Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division) – that market duodenoscopes sold in the U.S will have 30 days to submit postmarket surveillance plans to the FDA. These proposals must detail their plans to conduct studies to evaluate, among other things, how well health care personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes. These studies are based on the FDA’s current understanding of factors that may be contributing to infection outbreaks following endoscopic retrograde cholangiopancreatography procedures (ERCP), as well as the information needed to help fill gaps in knowledge.