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FDA Missed Early Warning Sign about Dirty Scopes

The Federal Drug Administration (FDA) missed early warnings signs about dirty scopes that could spread infections among patients, according to a recent Senate inquiry into superbug outbreaks caused by contaminated duodenoscopes. Staff at the FDA lost a report about an outbreak at a Pennsylvania hospital in late 2012 related to the devices.

The FDA’s existing database of medical-device-related deaths and injuries relies on hospitals and manufacturers to report incidents. All 16 of the U.S. hospitals that had duodenoscope-related outbreaks failed to properly file the required federal report, according to the Senate inquiry. While some of the hospitals did eventually report these incidents to the device manufacturers, the manufacturers can essentially rewrite these reports before submitting them to the FDA.

Medical device maker Olympus, the dominant duodenoscope supplier in the U.S., submitted incomplete or misleading reports about the outbreaks, investigators found. In some cases, Olympus blamed the hospital for failing to follow cleaning procedures. The FDA later found these cleaning procedures were themselves inadequate. Contaminated endoscopes have been linked to multiple outbreaks, illnesses and fatalities across the U.S.

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