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FDA has no conclusion on scopes in bacteria cases
Ex-Steris employee who raised concerns files suit
The Food and Drug Administration (FDA) could not come to a conclusion on the cause of an outbreak at Allegheny General Hospital in Pennsylvania in which patients may have been exposed to pseudomonas bacteria through improperly sterilized bronchoscopes.
The FDA has closed the investigation.
Sixteen patients were affected by the outbreak, and all of them, including one man who died, had undergone bronchoscopies.
The hospital said that problems with the Steris System 1 Sterile Processing System, manufactured by Mentor, OH-based Steris, allowed its bronchoscopes to become contaminated with pseudomonas bacteria. Steris said that hospital staff might have been improperly using the machine.
The FDA action, reported in the Pittsburgh Post-Gazette, follows a lawsuit filed in April in which a former Steris employee made charges similar to those of Allegheny General. Larry Joslyn of Las Vegas, NV, claims he was fired wrongly by Steris in October 2001 after he raised concerns about the System 1 Sterile Processing System.
Joslyn’s lawsuit doesn’t state specifically what he thinks is wrong with the machine. However, Joslyn said he determined that certain scientific inadequacies meant the machine did not "properly sterilize hospital equipment as represented in label claims, due to a systemic contamination problem," the lawsuit states.
Joslyn claims the following in his lawsuit:
Steris released a statement saying the System 1 Sterile Processing System is safe and effective. More than 16,000 Steris System I units have been used in more than 5,000 hospitals since 1988 with no evidence that the machine has ever caused or contributed to a reported infection, the company said.
"If there was any systemic’ problem as claimed by Mr. Joslyn, it would be blatantly obvious," the company stated. "In fact, no such problems have been experienced."