Widely used sterilizer under attack

By Julie Appleby, USA TODAY

A system widely used by hospitals to clean medical scopes between patients may not provide adequate sterilization, say hospital officials in Pennsylvania following a bacterial outbreak that sickened 16 patients and led to one death.

In a letter to the Food and Drug Administration on Monday, officials at Pittsburgh's Allegheny General Hospital say a cleaning system failed to remove bacteria from devices called bronchoscopes, which allow doctors to see into patients' lungs.

The hospital stopped using the sterilization system made by Ohio-based Steris — one of the most widely used systems — after tests performed by it and the Centers for Disease Control found bacteria on the system's water filters and in rinse water.

About 500,000 bronchoscopies are performed in the USA annually. The risk of infection is estimated at 1%, although no one keeps a precise count.

"This risk happens every day in every hospital performing these procedures," says Dr. Richard Shannon, chairman of the hospital's department of medicine. He investigated the October outbreak of pseudomonas bacteria.

Steris Senior Vice President Gerry Reis called the allegations "outrageous" and "false and misleading." More than 16,000 of the Steris cleaning systems have been used by more than 5,000 hospitals and clinics since 1988, he says. They are used to clean all types of medical scopes, including those used in knee surgery and for looking into the gastrointestinal tract. "The equipment works," Reis says. "It sterilizes when you follow the specific procedures outlined in the manual and training."

Steris is cooperating fully with the FDA, he says, and will respond to each of the allegations made by the hospital.

The hospital also says it was not notified of a recall of a part on the cleaning system. The part is listed on the FDA's Web site under recalls. But Reis says the part wasn't recalled, it was "replaced."

The debate over the cleaning system comes shortly after a similar outbreak sickened patients at Johns Hopkins University hospital last year. In that case, the cleaning system was not blamed. Rather, a defective bronchoscope — a model that had been recalled — was at fault. Hopkins says it was never properly notified of the recall.

Debate over how best to clean scopes is not new. Some hospitals and clinics use sterilization equipment. Others use disinfecting agents. Some advocates say waterborne bacteria like that which sickened patients at Allegheny can be removed by adding an alcohol rinse to the final stage of cleaning.

An FDA spokeswoman on Tuesday said the agency is investigating the outbreak at the 450-bed Allegheny hospital and does not have enough information to either agree or disagree with the hospital's conclusions. But the FDA has issued several warning letters to Steris, dating to 1998.

"The association of the Steris System 1 processor with patient infections usually caused by waterborne organisms leads us to question the ability of the process to provide a sterile water rinse," says an April 2001 letter from the FDA to Steris.