Seventy-one percent of reusable medical scopes deemed ready for use on patients tested positive for bacteria at three major U.S. hospitals, according to a new study published in the American Journal of Infection Control.
Citing those “willful discovery violations” by the Japanese device giant, King County Superior Court Judge Steve Rosen ordered a new trial Tuesday in a wrongful death case. More than 25 lawsuits against the medical scope maker have been filed nationally.
How can AI benefit and improve patient outcome in the emergency department? Watch the latest episode to find out.
More than 25 patients and families, from Pennsylvania to California, have sued Olympus alleging wrongful death, negligence or fraud.
Since 2015, federal prosecutors, lawmakers and government regulators have been investigating a series of outbreaks of antibiotic-resistant “superbugs” across the country tied to scopes.
At least 35 patients in American hospitals have died since 2013 after developing infections tied to tainted Olympus duodenoscopes.
Rep. Ted Lieu (D-California) said internal Olympus emails about that decision were “incredibly disturbing” and the company officials involved should face questions at a congressional hearing.
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The company’s internal emails, filed in a Pennsylvania court this month as part of a patient lawsuit, reveal conflicts inside Olympus over how to respond to a growing threat to patient safety, pitting U.S. executives against their superiors in Japan who had the final say.
The DEVICE Act would impose new requirements on manufacturers. The companies would have to notify the FDA when they issue safety warnings in other countries related to the design and cleaning of their devices.