75 St. Clair Hospital patients treated with unsterile device
State health officials are investigating why 75 patients at St. Clair Hospital underwent endoscopies with an instrument that was not properly disinfected, a spokeswoman at the Pennsylvania Department of Health said Tuesday.
Officials at the Mt. Lebanon hospital said they notified patients this week that the endoscope was cleaned with a special solution, but one of its two channels might not have been flushed completely with disinfectant.
The hospital consulted public health authorities and said the chance of infection is minimal.
"We're quite confident that we're in really good shape," said Dr. Alan Yeasted, senior vice president and chief medical officer.
Health department spokeswoman Holli Senior did not immediately know when the investigation would be completed.
The patients underwent endoscopies dating to April 2005. Over the past five years, hospital officials estimate they performed about 50,000 endoscopies, in which doctors use special instruments to look inside the body.
The instrument in question is a two-channel scope that Yeasted said is used rarely. The scope is used on patients who experience gastrointestinal bleeding, an urgent condition commonly known as a GI bleed. Most other procedures are performed with a single-channel scope.
The two-channel scope was cleaned weekly regardless of whether or not it was used. On Nov. 12, a staff person noticed a spot on the instrument while removing it from a shelf. Officials alerted the manufacturer, Olympus, whose representative determined the scope did not have a special piece of tubing needed to complete the disinfecting process.
Yeasted said workers in the past did not need the piece of tubing to clean the endoscope because the hospital used a different instrument before April 2005. That device, manufactured by Steris Corp., did not need the special tubing to pull the disinfectant through the second channel.
Hospital officials advised patients to return to the hospital for blood work to check for hepatitis or other blood-borne pathogens. Patients who underwent an endoscopy at St. Clair but did not receive a letter or phone call do not need follow-up testing, Yeasted said.
"Given the facts, the risk to patients is minuscule," said Dr. Bruce Dixon, director of the Allegheny County Health Department.
The endoscope no longer is in use.
"We won't bring it back to use until we're convinced that our cleaning method is impeccable," Yeasted said, noting that all nurses and technicians were retrained on how to clean the instrument.