Sen. Patty Murray is demanding the Food and Drug Administration turn over internal documents regarding the agency’s oversight of medical scopes linked to ‘superbug’ infections in Seattle and across the U.S.

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U.S. Sen. Patty Murray demanded Friday that the federal Food and Drug Administration (FDA) turn over internal documents regarding the agency’s oversight of specialized medical scopes linked to dangerous “superbug” outbreaks in Seattle and across the nation.

The letter sent to FDA Commissioner Dr. Margaret Hamburg is the second in two months urging the agency to step up its monitoring efforts regarding the devices used in 500,000 potentially lifesaving procedures each year — and it expands the inquiry to include other kinds of scopes and the equipment used to disinfect them.

Her action follows the FDA’s release last week of long-awaited guidance for reprocessing, or cleaning, devices to prevent the transmission of multidrug-resistant bacteria, which can cause deadly infections. The agency’s draft guidance, which had been pending since 2011, was released following several recent reports of superbug outbreaks, including an outbreak at Virginia Mason Medical Center in Seattle between 2012 and 2014.

That outbreak included 32 people who developed multidrug-resistant infections tied to the scopes. Eleven of those patients died, though it’s not clear what role the infections played, if any.

“The additional information raises questions about why updated guidance, including enhanced cleaning protocols, was not released sooner and the rigor of FDA’s examination of post-market data to assess the risks of these devices for patients if not adequately cleaned during reprocessing,” Murray’s letter stated.

Murray, D-Wash., asked Hamburg to provide the Senate Health, Education, Labor and Pensions Committee with several documents.

They include FDA’s internal review of reprocessing procedures, including review of the validation procedures that ensure disinfection, for all currently marketed duodenoscopes, bronchoscopes, endoscopes and other devices.

She also requested a summary of all adverse events reports from 2011 forward regarding the devices, including how and when FDA responded to the reports.

Murray also called for updates on the FDA’s work with manufacturers of duodenoscopes and any necessary revisions to design and labeling, particularly as it includes reprocessing information.

And she asked for an assessment of the adequacy of the so-called 501(k) process that allows manufacturers to put new devices on the market without new applications if they don’t differ substantially from already-approved models.

As a matter of policy, FDA responds directly to lawmakers regarding letters sent to the agency, a spokeswoman said. However, she added, the agency responded to the Feb. 3 letter by issuing a safety communication warning that devices may still transmit dangerous bacteria, even after cleaning according to manufacturers’ directions, and by finalizing the device reprocessing guidelines.

Hamburg is stepping down as FDA commissioner on March 31.