Safety

FDA: Case closed on PA bacteria deaths

Ambulatory Safety Monitor, May 21, 2003

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The Food and Drug Administration (FDA) closed an investigation into the deaths of eight Pennsylvania patients who may have been exposed to pseudomonas bacteria through improperly sterilized bronchoscopes, according to the Associated Press on May 15. The FDA could not come to a conclusion on the cause of the deaths.

A total of 16 patients were exposed to the bacteria at Allegheny General Hospital in October, according to a hospital announcement. The hospital could only link one of the eight deaths to the pseudomonas bacteria, according to the AP.

The hospital and Steris Corp., the company that manufactures the sterilization equipment, disagree on who was at fault for the bacteria exposure, according to the AP. The hospital, which no longer uses Steris equipment to sterilize bronchoscopes, cites a flaw in the machine's filters. Steris says the problem could be user-related.



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