News from the FDA/CDC

FDA approves first duodenoscope with disposable distal cap


The Food and Drug Administration has approved the Pentax ED34-i10T model duodenoscope, the first with a disposable distal cap, according to an FDA press release.

A disposable distal cap will improve the ability to clean and reprocess the duodenoscope. Without being thoroughly cleaned and disinfected, contaminated tissue can remain and potentially can be transmitted to other patients.

“We believe the new disposable distal cap represents a major step toward lowering the risk of future infections associated with these devices,” William Maisel, MD, acting director of the Office of Device Evaluation at the FDA Center for Devices and Radiological Health, said in a 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.”

A previous version of the Pentax duodenoscope, the ED-3490TK, was subject to a January 2017 FDA Safety Alert, because of the potential for cracks and gaps to develop in the adhesive sealing the duodenoscope’s distal cap.

“Since the issue of duodenoscope-associated transmission of infections first received widespread attention in 2015, the AGA Center for GI Innovation and Technology has been working closely with regulators and endoscope manufacturers to identify and address problems in scope design and develop a path forward to ensure zero device-associated infections,” said V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair, AGA Center for GI Innovation and Technology. “We applaud Pentax for answering our call for innovation to improve patient safety for this common and life-saving GI procedure. We encourage all device manufacturers to continue on a path of innovation to better support gastroenterologists and, most importantly, the patients we serve.”

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