News From Transplant Week of March 10, 2002 / Vol. 3 No. 10

 

Johns Hopkins Finds Lung Transplant Patients Put at Risk by Defective Instrument
 

An unknown number of lung transplant patients who have had bronchoscopies since June 1, 2001 at Johns Hopkins Hospital may have received a potentially fatal lung infection from a defective medical instrument.

Hospital officials told The Baltimore Sun that some patients examined by one of three contaminated bronchoscopes have died after being infected with the bacterium pseudomonas, but that they do not yet know if they died from the bacteria or from their existing illness.

The hospital said it had sent certified letters to 415 lung transplant recipients, and patients suffering from cystic fibrosis, lung cancer of AIDS, warning them to contact their doctors if they experience symptoms including fever, coughing, phlegm or shortness of breath.

Hospital officials said they discovered the problem after realizing that 128 patients had been infected with pseudomonas -- a number 200 to 300 percent higher than would have been expected. Two of the patients have died, according to hospital officials.

"Although it's not possible to know whether you are now at increased risk, it is important you be alert to any sign of infection ...," the letter said.

The bronchoscopes -- a tiny instrument with a camera on one end used to inspect a patient's lungs and take tissue samples -- are made by Olympus America, which described the defective instruments as having a loose valve that trapped bacteria.

Dr. William Jarvis of the Centers for Disease Control and Prevention said Olympus learned of the problem in September, but did not start sending recall letters to hospitals that used the defective devices until November.

The company didn't inform the Food and Drug Administration of the defect until December, Jarvis added. He said he was "perplexed" that neither the FDA or Olympus posted the recall notice on their Web sites.

Other medical centers that used the Olympus America bronchoscope are reported now checking their medical charts to see if they may have a problem similar to the one at Johns Hopkins.

"We don't know what the magnitude of the problem is yet," said Dr. Daniel B. Jernigan, a medical epidemiologist with the CDC.

Other sources: Baltimore Sun