The FDA has spent the better part of the last decade examining the contamination risk of reusable, reprocessed duodenoscopes—and, based on those findings, urging medical devicemakers to develop scopes that are at least partially disposable.
Now, with six partially or fully disposable duodenoscopes cleared by the FDA to date, the agency is ramping up its push for hospitals to use only those products.
In letter issued to healthcare providers Tuesday, the FDA urged them to accelerate and complete the transition to “innovative duodenoscope designs,” which include both fully disposable devices and those with single-use components such as endcaps and elevators.
Even the latter options can hugely cut down on contamination risk, according to the agency, since bacteria and biomatter can remain lodged inside the hard-to-clean crevices of the fixed endcaps and internal elevators of reusable duodenoscopes even after standard reprocessing procedures.
“Duodenoscope manufacturers no longer market fixed-endcap duodenoscopes in the U.S., and fixed-endcap duodenoscopes still in use at healthcare facilities should be replaced with newer duodenoscope models,” the FDA wrote.
Beginning in 2015, the FDA called on all developers of reusable duodenoscopes cleared in the U.S.—namely Olympus, Fujifilm and Pentax—to perform postmarket surveillance studies of their devices’ contamination rates. They found that up to 6.6% of samples may continue to test positive for “high-concern organisms” after reprocessing, such as E. coli and Pseudomonas.
Those findings—which the FDA said depicted higher-than-expected rates of contamination—attributed the heightened risk to environmental contamination, damage to the duodenoscopes and errors in following reprocessing procedures, often stemming from difficulty understanding the manufacturers’ cleaning instructions.
Due to those study results and the FDA’s urging, all three companies began the process of taking their scopes with fixed endcaps off the market and replacing them with disposable versions, as other medtech makers also began rolling out their own single-use devices.
Though studies of the disposable tech are still underway, the FDA reported that early results for Fujifilm’s single-use endcap model show only 0.5% of the tested devices have held onto high-concern organisms after the endcap is replaced, and none have tested positive for enough low-concern organisms to indicate a failure in sterilization.
Since the FDA last issued an update on its push for the use of disposable duodenoscopes in 2020, it noted that two more devices with disposable elevator components—both from Pentax—have been cleared for U.S. sales.
They joined disposable endcap models from Olympus and Fujifilm as well as two entirely single-use devices from Ambu and Boston Scientific, the latter of which became the world’s first fully disposable duodenoscope upon its 2019 clearance.