NEW YORK, Feb 19 (Reuters) – U.S. health regulators have known since at least 2009 that the medical devices at the center of the “superbug” outbreak at UCLA can transmit lethal infections but have not recommended any new safety requirements, a lapse that threatens patient safety, experts in hospital-acquired infections said.
The latest outbreak involving the reusable devices called duodenoscopes, which are inserted down the throat, may have exposed 179 patients at UCLA’s Ronald Reagan Medical Center in Los Angeles and contributed to two deaths.
It is far from the first time medical investigators traced the sometimes-fatal spread of pathogens to the devices, which are manufactured by the medical units of Japanese companies Olympus Corp, Pentax and Fujifilm Holdings Corp. UCLA uses an Olympus model.
In 2013 and 2014, the U.S. Food and Drug Administration received a total of 75 reports of adverse events associated with the devices, resulting in harm to 135 patients, the agency said. Because healthcare providers do not always submit such reports, the FDA said, that is likely an underestimate.
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A third option would be for the FDA to require manufacturers to redesign the devices. The agency and researchers agree that the most problematic part is a movable “elevator” mechanism at the tip of the duodenoscope: Its moving parts have microscopic crevices where bodily fluids can lurk after standard cleaning.
Fujifilm spokeswoman Diane Rainey said the company is reviewing the FDA safety alert and is “working in cooperation with the FDA to evaluate and respond to concerns” about disease transmission.
Olympus spokesman Mark Miller said the company is “aware of reports of patient infections following procedures involving duodenoscopes,” and is “monitoring this issue closely.”
Pentax did not immediately respond to questions. (Reporting by Sharon Begley in New York and Toni Clarke in Washington; Editing by Eric Effron and Cynthia Osterman)
