Disposable Duodenoscope Elevator Reduces Reprocessing Needs

A novel duodenoscope with a sterile, disposable elevator component reduces the number of parts that need to be cleaned and disinfected in between uses.

The Pentax Medical (Tokyo, Japan) Video ED34-i10T2 duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract for diagnostic and therapeutic endoscopic retrograde cholangio-pancreatography (ERCP) procedures, and other upper gastrointestinal (GI) problems. High definition (HD) images and combined i-scan and i-scan optical enhancement (OE) provide detailed visualization of the mucosal structures, supporting detection and characterization of lesions, location of the minor papillae, and better visualization and anatomical interpretation of papillary structures.

A key feature of the ED34-i10T2 is the sterile disposable elevator cap (DEC), designed to meet the needs of enhanced patient safety in endoscopy, the result of increasing incidences of Carbapenem-resistant Enterobacteriaceae (CRE) and other infections. The material couplings and disposable design allow the use of a new elevator every time a procedure is performed, with no risk of wear-out-effects. In addition, the improved elevator shape and ergonomic design of the duodenoscope facilitate easy cannulation, as well as precise and controlled positioning of devices during ERCP procedures.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, MD, director of the FDA Center for Devices and Radiological Health (CDRH). “We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and 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.”

Duodenoscopes are side-viewing (rather than forward-viewing) endoscopes that have the advantage of looking at the major duodenal papilla head-on. Duodenoscopes have a lever that is used to manipulate an elevator located at the tip of the endoscope. By maneuvering the elevator, an endoscopist can raise and lower accessories passed through the working channel and into the field of view, aiding access to the bile duct and pancreatic duct, which is helpful for cannulation of the papilla.

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