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QUOTED. 20 November 2019. Jeff Shuren.

Executive Summary

The US FDA has cleared the Pentax Medical Video ED34-i10T2, the first duodenoscope for the US market with a sterile, disposable elevator component designed to reduce the number of parts that need to be disinfected between uses. See what Jeff Shuren, director of the agency’s device center, said about it here.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices.” – Jeff Shuren, director, US FDA Center for Devices and Radiological Health (CDRH)

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