Will Disposable Caps Solve Dirty Scope Problems?

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 complet...
Source: MDDI - Category: Medical Devices Authors: Tags: MD & M Minneapolis Sterilization Regulatory and Compliance Source Type: news