The Food and Drug Administration Friday approved the first duodenoscope with a disposable elevator component, a part difficult to clean and reprocess. The Pentax Medical Video Duodenoscope ED34-i10T2 was reviewed through the 510(k) premarket clearance pathway, a submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. FDA has previously cleared duodenoscopes with removable endcap components.
 
“Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S.,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess.”
 
In 2015, FDA 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. The agency also ordered Olympus, Fujifilm and Pentax to conduct postmarket surveillance studies to determine whether health care facilities are able to properly clean and disinfect the devices.

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