The Food and Drug Administration Friday cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal tract to treat bile duct disorders and other upper GI problems.
“The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the U.S. each year,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing. Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients, and the FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices.”