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.


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