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Wednesday, May 14, 2003

By Christopher Snowbeck, Post-Gazette Staff Writer

The U.S. Food and Drug Administration has closed its investigation of a bacterial outbreak last fall at Allegheny General Hospital and says it cannot determine what was the exact cause of the problem.

FDA spokeswoman Sharon Snider said the case was closed recently, but would not provide further information.

Allegheny General Hospital wrote FDA in January saying that the probable cause of the outbreak, in which one patient died, was the Steris System I, a machine used by hospitals across the country to clean bronchoscopes.

All 16 of the patients affected by the outbreak, including the man who died, had undergone bronchoscopies, a diagnostic procedure in which doctors use long, flexible scopes to examine the lungs. The hospital determined that problems with the cleaning machine allowed its bronchoscopes to become contaminated with Pseudomonas bacteria.

But Steris countered that the hospital might not have been properly using the cleaning machine.

Allegheny General spokesman Tom Chakurda had no comment on the FDA's decision. Dr. Richard Shannon, chairman of medicine at the hospital, was out of town and unavailable for comment.

The announcement that FDA has closed the case without passing judgment on the matter follows the filing of a lawsuit last month in Cuyahoga County, Ohio, in which a former Steris employee made charges similar to those from Allegheny General.

Larry Joslyn of Las Vegas, Nev., claims he was wrongly fired by Steris Corp., of Mentor, Ohio, in October 2001 after he raised concerns about its cleaning machine.

Joslyn's lawsuit, filed April 23, does not say specifically what's wrong with the Steris machine, which is widely used by hospitals. But the former employee 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 that after he gave a presentation to Steris employees regarding limitations of sterilization technologies, he was told that all videotapes of the talk had been collected and destroyed. He was told not to raise those issues again, according to the lawsuit.

He later learned of more problems and attempted to raise them on several occasions, according to the lawsuit. But Steris officials told him they knew about the problems and didn't want to hear about them, according to the lawsuit. Joslyn was ultimately fired after he kept raising the issue, the lawsuit claims.

But a statement issued yesterday by Steris tells a very different story.

The company insists its machine 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."