FDA Calls on Duodenoscope Makers to Shift to Newer Designs

January 16, 2020

Devicemakers should end production of fixed-endcap duodenoscopes and move towards modern, disposable ones, the FDA said, citing safety concerns.

Current duodenoscope designs use hard-to-clean components that may transfer tissue or fluid from one patient to another if device reprocessing is not conducted sufficiently, potentially causing infection, the agency said. It urged manufacturers to help increase the supply of disposable cap duodenoscopes to thwart the risk of infection.

In December, the agency cleared the first fully disposable duodenoscope, which removes the need for reprocessing.

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