The FDA authorized marketing of the first fully disposable duodenoscope on Dec. 13.
Duodenoscopes are used in more than 500,000 procedures in the U.S. each year, and the FDA has encouraged innovative ways to improve their safety and effectiveness, particularly with regard to cleaning and disinfecting, the agency said in a news release. The EXALT Model D single-use duodenoscope is intended for use on a single patient, removing the infection risks associated with ineffective reprocessing.
The FDA has previously cleared duodenoscopes with disposable endcap and elevator components. Risks of using the fully disposable duodenoscope include the potential for injuries, including burns, electric shock, perforation, infection, and bleeding.