FDA Approves Duodenoscope With Disposable Elevator Piece

November 15, 2019

A duodenoscope that has a sterile disposable elevator component has been cleared for market and represents an important step in the fight against infection, according to the US Food and Drug Administration (FDA). The elevator component can be a breeding ground for infectious contamination if not cleaned properly, and that’s traditionally been a difficult process because it has so many parts.

Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a press release called the approval a “major step toward lowering the risk of infection among patients who undergo procedures with these devices.”

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures; there are about 500,000 such procedures each year. They’re less invasive than traditional surgery in draining fluids from pancreatic and biliary ducts blocked by cancerous tumors or gallstones.The elevator part of the duodenoscope facilitates access to the bile and pancreatic ducts and is used to position endoscopic instruments during the procedure.

The FDA wants hospitals and other healthcare facilities to begin using devices with disposable componentsas soon as possible. The particular device the FDA approved is called the Pentax Medical Video Duodenoscope ED34-i10T2. PentaxMedical is a global corporation that manufactures endoscopic products. 

The announcement does not come as a complete surprise. In August, the FDA asked that duodenoscope manufacturers and healthcare facilities transition to duodenoscopes with disposable components.“Disposable designs can simplify or eliminate the need for reprocessing of certain components, which may reduce between-patient duodenoscope contamination,” the agency said in its approval announcement. 

The FDA has previously cleared duodenoscopes with removable endcap components.