Olympus Corporation Fought With the FDA for Tighter Rules for Devices That Spread Superbugs

Olympus, the leading maker of the endoscopes linked to recent superbug outbreaks at hospitals around the U.S., asked the Food and Drug Administration to water down guidelines on cleaning medical devices that the agency proposed four years ago.

The FDA published a draft of the new guidelines in May 2011; they still haven’t been finalized. They would set non-binding recommendations for manufacturers of many types of medical devices, including the complex, hard-to-clean instruments called duodenoscopes that recently harbored deadly drug-resistant bacteria at UCLA Medical Center and other hospitals.

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