U.S. FDA Knew Devices Spread Fatal ‘Superbug’ but Does Not Order Fix
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 (7733.T), Pentax and Fujifilm Holdings Corp (4901.T). UCLA uses an Olympus model.