In letters sent to Olympus Corporation of the Americas, Pentax Medical and Fujifilm Medical Systems — all manufacturers of the devices — on Tuesday, U.S. Sen. Patty Murray (D-Wash.) addressed continuing concerns about infection transmission linked to duodenoscopes.
“I have become increasingly concerned by the failure of Olympus to proactively warn patients and providers in the United States of the potential for infections,” Sen. Murray said in the letter.
For years, government health officials have raised concerns over cleaning guidelines and procedures for the devices, attempted to enhance disinfectant protocols and identify design features that may be contributing to the transmission of infection.
Sen. Murray demanded that device makers turn over copies of any cleaning guidance, safety alerts or warnings sent to hospitals or regulatory agencies in the U.S. and other countries in the past decade related to the ERCP procedure the scopes are routinely used in. She also asked for unredacted copies of documents pertaining to multi-drug resistant infections linked to the devices and all medical-device reports from the same period of time.
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