FDA Approves First Disposable Duodenoscope, Reducing Infection Risk

FRIDAY, Dec. 13, 2019 -- Improperly cleaned duodenoscopes -- a type of endoscope used to diagnose illness in the pancreas and bile ducts -- have been linked to hundreds of cases of severe, sometimes fatal, infections in patients.

Now, U.S. Food and Drug Administration approval of the first disposable duodenoscope should pave the wave for procedures that nearly eliminate that worry.

"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," said Dr. Jeff Shuren, who directs 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," he said in a statement Friday.

As reported earlier this year by The New York Times, outbreaks of serious illness tied to germ-laden duodenoscopes have been reported in the United States and Europe over the past decade.

One of the most notorious outbreaks occurred in Seattle between 2012 and 2014, when more than 30 patients undergoing duodenoscopy were infected with antibiotic-resistant bacterial strains. Eleven patients died in that outbreak.

Dozens of other cases occurred in 2013 in a hospital in Park Ridge, Ill. And in 2015, two patients died and five more were made ill at Ronald Reagan UCLA Medical Center in Los Angeles, after undergoing procedures using improperly sterilized duodenoscopes, the Times reported.

The problem, experts say, is that these instruments are extremely intricate, so it's nearly impossible to fully eliminate germs from all surfaces.

As the FDA explained, "the flexible, lighted duodenoscope is threaded through the patient's mouth and stomach to access the top of the small intestine."

However, "duodenoscopes are complex medical devices with many small working parts that can be difficult to clean," the agency said. "The device can trap contaminated tissue or fluid in its crevices and, if not thoroughly cleaned and disinfected, it can transmit infection-causing bacteria between patients."

In fact, tests conducted on duodenoscopes that underwent strict cleaning as mandated by guidelines still showed that about 1 in every 20 retained "organisms that are more often associated with disease," the FDA said.

However, the newly approved EXALT Model D Single-Use duodenoscope is intended for use on a single patient, and then thrown away. That could help put an end to risk of patient-to-patient infections, while still allowing patients access to a minimally invasive procedure.

"Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to lifesaving care for many patients," Shuren said.

A disposal device has long been a goal of the FDA, which fast-tracked the development and approval of the EXALT device.

"The FDA previously cleared duodenoscopes with disposable endcap and elevator components," the agency said, but "today's clearance is the first fully disposable duodenoscope device."

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Posted: December 2019