WASHINGTON -- A was cleared by the FDA on Friday, a major milestone on the road to eliminating contamination problems associated with such devices.
In announcing the Pentax Medical Video ED34-i10T2's clearance, Jeffrey Shuren, MD, PhD, director of the agency's Center for Devices and Radiological Health, said it's part of a policy to "encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess."
Duodenoscopes are critical to endoscopic retrograde cholangiopancreatography (ERCP) procedures, of which some half a million are performed in the U.S. each year. These devices are too expensive to throw away after one use and therefore must be "reprocessed," i.e., sterilized, after each procedure. Following a 2015 outbreak of abdominal "superbug" infections associated with ERCP scopes that remained contaminated with bacteria after reprocessing, it became apparent just how difficult it is to sterilize them completely.
Manufacturers beefed up instructions on proper procedures and the FDA issued multiple notices urging users to follow them. Yet in a December 2018 report, the agency said it was still finding "up to 3% of properly collected samples testing positive for high concern organisms."
The reprocessing problem has become even more urgent with several contract providers shutting down operations or being threatened with orders to do so, on account of ethylene oxide (the principal sterilant used in reprocessing) leaking into the environment.
This past August, the FDA told gastroendoscopists that it was time to "transition" toward duodenoscopes with disposable parts. At that time, the agency had approved two with disposable endcaps.
The introduction of a device with a disposable elevator mechanism represents a bigger step. Past studies have indicated that this component, with its moving part, is a key hiding place for pathogens where sterilants and mechanical cleaning don't reliably reach.