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FDA cleared the first duodenoscope—a medical device that provides a less invasive way to treat gastrointestinal conditions than traditional surgery—with a molded disposable end cap this week. The cap on the Pentax ED34-i10T model from Pentax of America Inc. (Montvale, NJ) is designed to improve access to the device for cleaning and reprocessing. “We believe the new disposable distal cap represents a major step toward 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.
Duodenoscopes made headlines in the early part of 2015, when it was revealed that contaminated devices had infected hundreds of patients and contributed to several deaths. At the time, Olympus, the leading maker of these types of endoscopes, claimed that the infections were the result of improper cleaning methods used in the hospitals. However, following an outbreak of infections at the UCLA Medical Center in Los Angeles, FDA issued a warning to hospitals that some of the infections may be caused by the device design, which makes it more effective in procedures but also complicates thorough cleaning prior to reuse.
Earlier this year, FDA issued a Safety Communication alerting healthcare providers to a design issue with a previous version of the Pentax duodenoscope. The agency noted “the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope’s distal cap onto the scope. These cracks and gaps could allow fluids and tissue to leak into the duodenoscope.”
The single-use, detachable end cap along with a “simpler user interface, improved ergonomics, improved image quality and reduced length” of the new Pentax ED34-i10T have addressed the earlier concerns.
“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,” said Maisel.
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