The U.S. FDA has cleared the first fully disposable duodenoscope for marketing in the United States. The EXALT Model D Single-Use Duodenoscope, from Marlboro, Mass.-based Boston Scientific Corp., is intended to provide visualization and access to the upper gastrointestinal (GI) 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 United States each year,” says Jeff Shuren, MD, JD, 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.”
Duodenoscopes are used as a less invasive method than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The flexible, lighted duodenoscope is threaded through the patient’s mouth and stomach to access the top of the small intestine. Traditionally, these devices have been intended for use on multiple patients, which has required them to be cleaned and disinfected (“reprocessed”) between uses to reduce the potential for infection between patients.
However, duodenoscopes have many small working parts that can trap contaminated tissue or fluid in crevices that are difficult to clean and disinfect. The EXALT Model D Single-Use Duodenoscope is intended for use on only a single patient, therefore removing the potential risks of ineffective reprocessing.
The FDA had previously issued communications to healthcare facilities about these risks. In August 2019, the FDA released a safety communication recommending that duodenoscope manufacturers and healthcare facilities transition to devices with partially or fully disposable designs. The FDA previously cleared duodenoscopes with disposable endcap and elevator components. The current clearance is the first fully disposable duodenoscope device.
Risks of using the EXALT Model D Single-Use Duodenoscope include the potential for injuries, such as burns, electric shock, perforation, infection, and bleeding.