The U.S. Food and Drug Administration (FDA) has cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing, the agency said Wednesday.
The decision marks the latest step in the agency’s four-year battle to reduce bacterial infections linked to duodenoscopes even when users were following proper disinfection or sterilization instructions.
Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). The device is used in more than 500,000 procedures each year as a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions.
It is critical that hospitals and healthcare facilities follow the manufacturer’s reprocessing instructions for cleaning and disinfecting duodenoscopes, for the device can trap contaminated tissue or fluid in its crevices, transmitting infections among patients.
In January 2017, the FDA issued safety signs to alert health care providers about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. The agency identified potential cracks and gaps to develop in the adhesive that seals the duodenoscope’s distal cap onto the scope.
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 to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. The FDA granted clearance of the ED34-i10T to Pentax of America.
“We believe the new disposable distal cap represents a significant step towards lowering the risk of future infections associated with these devices,” said William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “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.”