Reprocessing duodenoscopes after they’ve journeyed through a patient’s GI tract has been a pain in the you-know-what for pretty much everyone involved. These flexible lighted instruments are quite complex, with a lot of small working parts that are difficult to clean. So it’s all too easy for contaminated tissue or fluid to get trapped in the crevices of the device and allow nasty little superbugs to spread to other patients.
And yet, duodenoscopes enable more than 500,000 necessary procedures a year for patients with bile duct disorders and other upper GI problems, according to FDA. That’s why the agency is optimistic that new disposable distal caps for duodenoscopes could go a long way toward addressing the infection risk associated with these devices. This week FDA cleared the first such device, noting that the disposable distal cap feature of the Pentax ED34-i10T model from Pentax of America Inc. will improve access for cleaning and reprocessing.
“We believe the new disposable distal caps represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, MD, acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.
Maisel said improving the safety of duodenoscopes is a top priority for FDA, and he urged companies to continue to pursue innovations that will help reduce the risk to patients.
FDA noted that the risk of infection transmission cannot be completely eliminated, but for many patients, the benefits of duodenoscopes still outweigh the risks.
In January the agency issued a safety communication to health care providers about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. FDA pointed out at that time the potential for cracks and gaps to develop in the adhesive that seals the distal cap onto the scope, and that fluids and tissue could leak into the device through those cracks and gaps.
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, FDA noted.