WASHINGTON -- Pentax's , which comes with a disposable distal cap to improve access for reprocessing, is cleared for U.S. marketing, Wednesday.
It's the first such device to reach market, the agency said, and it represents the first technical solution to a problem that has dogged duodenoscope makers for years -- the difficulty in completely sterilizing duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP) procedures because of the multiple, small moving parts.
"The new features of the Pentax ED34-i10T include a single use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved image quality, and a reduced length," the FDA said in a statement.
"We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in the statement. "Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients."
Hundreds of patients have become infected, some fatally, after undergoing ERCP and related procedures with duodenoscopes that remained contaminated after reprocessing. Up to now, the response has been to beef up cleaning protocols and to urge users to scrupulously follow manufacturers' instructions for reprocessing. Fully disposable duodenoscopes have not been seen as economically feasible, and device makers have struggled to come up with new materials or designs that would facilitate more complete sterilization.
An FDA advisory committee in 2015 expressed frustration with the situation -- voting that safety of current devices could not be reasonably assured, but also that the devices should remain on the market because there were no feasible alternatives for patients with pancreatic disorders.