All U.S. manufacturers of duodenoscopes have been ordered to undertake postmarket surveillance studies of their devices to better determine how they are used in the real world, according to a press release from the Food and Drug Administration.
Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP), a minimally invasive procedure that drains built-up fluid from liver and biliary ducts blocked by tumors, gallstones, and other conditions. However, duodenoscopes are complex instruments that require an exhaustive cleaning process called reprocessing to be reused, and have been linked to the transmission of infection in patients who have undergone ERCP.
As a result, Olympus America, Fujifilm Medical Systems, U.S.A., and Hoya Corp., the three manufacturers and marketers of duodenoscopes, have been mandated by the FDA to conduct surveys detailing how well physicians understand the cleaning and disinfecting process, and to determine the rate of contamination of used duodenoscopes. Each manufacturer must submit a study plan to the FDA within 30 days.
“The results of the postmarket surveillance studies could help inform the FDA’s next steps and future risk-mitigation strategies, such as informing new labeling for the devices to include different reprocessing instructions or other administrative or regulatory actions necessary to protect the public health,” the FDA said in the press release.
Find the full press release on the FDA website.