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News From the Food and Drug Administration
November 7, 2017

Duodenoscope Design Aimed at Infection Prevention

JAMA. 2017;318(17):1644. doi:10.1001/jama.2017.16043

A newly designed duodenoscope intended to reduce patients’ risk of infection has received FDA approval.

The Pentax ED34-i10T model is the first duodenoscope to feature a single-use, disposable distal cap that enables more effective cleaning and disinfecting. An earlier model, the Pentax ED-3490TK, was the subject of an FDA safety communication in January that warned of cracks and gaps in the adhesive that sealed the distal cap to the device’s distal tip. Such breaches can allow microbes and body fluid into areas of the device that are difficult to clean and disinfect, increasing the risk of infection among patients.