The US Food and Drug Administration today cleared for marketing the first fully disposable duodenoscope.
The US Food and Drug Administration (FDA) has cleared the EXALT Model D Single-Use Duodenoscope for marketing. This is the first fully disposable duodenoscope which is intended to provide visualization and access to the upper gastrointestinal tract. The clearance was granted Boston Scientific Corporation.
Traditionally duodenoscopes have been designed to withstand use for multiple patients. This requires the devices to be cleaned and disinfected in between uses in order to reduce the threat of infection. However, the design of the device made it a complex process to clean. If devices are not properly sanitized, contaminated tissue or fluid can persist in the device and transmit infections between patients.
"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. 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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health in the statement. “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.”
Previously the FDA has pushed for a move away from conventional duodenoscopes. In August the agency recommended a move towards scopes with disposable components, specifically endcaps.
In August, the FDA cleared for marketing the Pentax Medical Video ED34-i10T2 model duodenoscope, the first device with a sterile, disposable elevator piece.
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.