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Medical Devices / Regulatory Affairs

Senator Demands Answers From Companies Over Duodenoscopes

May 14, 2019
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Washington Democratic Senator Patty Murray is demanding answers from the leaders of three device companies at the center of an ongoing FDA investigation of contaminated duodenoscopes that regulators worry are spreading deadly bugs.

“I remain concerned about the risk of infection posed by these devices and [I am] committed to ensuring rigorous oversight,” Murray said in letters to Olympus, Pentax and Fujifilm.

Last month, the FDA threatened to take regulatory action against the three devicemakers after analyses found that the contamination rates of the scopes had actually risen since regulators first flagged the devices in March 2018.

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