Two problems with a bronchoscope cleaning machine used in hospitals. Two problems with a bronchoscope cleaning machine used in hospitals across the country were the probable cause of a bacterial outbreak in October at Allegheny General Hospital, according to the hospital’s investigation of the incident.
The hospital’s findings amplify concerns that the federal Food and Drug Administration has raised previously about the Steris System I sterilizer, wrote Dr. Richard Shannon, chairman of medicine at Allegheny General, in a letter sent this week to the FDA.
However, the machine’s manufacturer replied today that its investigation indicated the problem was with hospital personnel.
As part of its cleaning cycle, the Steris machine rinses bronchoscopes in water that is made sterile by special filters. But the hospital found that those filters can be contaminated with pseudomonas bacteria and become biologically defective. As a result, the sterile water rinses can in fact be contaminated, Shannon wrote.
Steris also failed to adequately and appropriately notify the hospital
Steris also failed to adequately and appropriately notify the hospital about defects in connectors that hook scopes to cleaning machines, Shannon wrote.
“The Steris System I can contribute both to incomplete decontamination of bronchoscopes, as well as potentially direct contamination of sterile bronchoscopes through break down of their sterile water filter,” Shannon wrote.
The outbreak at Allegheny General affected 16 patients, one of whom died from a pneumonia caused by pseudomonas. The other possibilities considered by the hospital staff error and defects with the scopes were deemed improbable by the investigation.
Ohio-based Steris said it was outraged by the hospital’s letter, calling the statements false
In a prepared response, Mentor, Ohio-based Steris said it was outraged by the hospital’s letter, calling the statements false, misleading and not refelcting an appropriate investigation of the outbreak. The real problem, according to Steris, was hospital staff.
“Steris’s analysis of the situation last October … indicated the cause was improper hospital operating procedures in utilizing the equipment,” the company said. “Since its introduction in 1988, more than 16,000 System 1 units have been used safely and effectively in more than 5,000 hospitals and clinics in the United States.”