FDA issues safety update on duodenoscopes

Health care providers should not cancel duodenoscope procedures based on the fact that one specific model made by Olympus does not have a 510(k) clearance, the Food and Drug Administration said yesterday. Olympus has a pending 510(k) application for the device (the TJF-Q180V) and continues to market the product while the application is under review, because removing the device from the market could lead to a shortage of duodenoscopes to meet U.S. clinical demand, the agency said. FDA last month issued safety recommendations to prevent possible microbial infections from reprocessed reusable duodenoscopes – flexible, lighted tubes that are threaded through the mouth into the small intestine to drain fluids from blocked pancreatic and biliary ducts. According to the advisory, the agency has received in the past two years 75 reports involving possible microbial transmission from reprocessed duodenoscopes, including multidrug-resistant bacterial infections. “The FDA’s analysis indicates that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers,” the agency said. “At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections.”