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FDA grants clearance to duodenoscope with disposable elevator component
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The first duodenoscope with a sterilized and disposable elevator component that reduces the number of parts in need of cleaning and disinfection between uses has received FDA clearance for marketing in the United States, according to an FDA press release.
The device, the Pentax Medical Video ED34-i10T2, provides visualization and access to the upper gastrointestinal tract to treat bile duct disorders and upper GI problems, the release stated.
As previously reported by Healio Gastroenterology and Liver Disease, the FDA recommended duodenoscope manufacturers and health care facilities transition to duodenoscopes with disposable components.
“Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to lifesaving care for many patients in the U.S,” Jeff Shuren, MD, JD, the director of the FDA’s Center for Devices and Radiological Health, said in the release. “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. Today’s clearance is another step in the FDA’s ongoing effort to advance the development and availability of safer duodenoscopes.”