Boston Scientific Disposable Duodenoscope Cleared

FDA has cleared a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope, which is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. Traditionally, duodenoscopes have been intended for use on multiple patients, which has required that they be cleaned and disinfected (reprocessed) in between uses to reduce the potential for infection between patients. However, the devices have been a challenge to clean due to many small working parts. FDA previously issued communications to health care facilities regarding risks associated with ineffective reprocessing of duodenoscopes. “Risks of using the EXALT Model D Single-Use Duodenoscope include the potential for injuries, such as, but not limited to, burns, electric shock, perforation, infection and bleeding,” an FDA notice says.