First Fully Disposable Duodenoscope Approved By FDA

Federal regulators have approved the first fully disposable duodenoscope, after years of struggling to figure out a way to prevent the spread of infectious diseases between patients undergoing procedures involving the same endoscopic device, due to an inability to adequately sanitize previously approved product designs.

On December 13, the FDA issued a press release announcing the approval of the EXALT Model D Single-Use Duodenoscope; which is a first of its kind, manufactured by Boston Scientific Corporation.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning device manufactured by several different companies have resulted in reports of serious hospital infection outbreaks, typically involving aggressive, antibiotic-resistant “superbugs”, which have caused a number of severe injuries and deaths.

Questions about the safety of the devices first emerged after a  duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

Last month, the agency approved a design with a disposable elevator piece as well. The new designs come after several failed attempts to address the problem, with previous efforts focusing on ways to clean duodenoscopes properly. However, the design of the elevator tip in particular proved problematic because of its penchant to trap biological debris, such as blood and tissue, which could then spread infections to other patients.

In August the FDA announced it was giving up on the old design and called on manufacturers to develop a new design which was easier to clean.

“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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “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.”