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FDA approves new endoscope with disposable cap to prevent infections
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The FDA has cleared the first duodenoscope to feature a disposable distal cap for easier cleaning and reprocessing.
The Pentax ED34-i10T for endoscopic retrograde cholangio-pancreatography (ERCP) procedures, which the manufacturer called “a breakthrough solution in infection prevention,” was also just recently cleared for marketing in Europe.
“We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a news release. “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.”
In addition to the single use disposable distal cap, the new scope features a simplified user interface, better ergonomics and image quality, and a shorter length, according to the news release.
The FDA has been working with duodenoscope manufacturers to improve the safety of these devices since its initial safety communication in February 2015, which warned that their complex design may prevent effective cleaning and expose patients to serious infections like carbapenem-resistant Enterobacteriaceae (CRE).
Disclosures: Maisel is employed by the FDA.