Johns Hopkins Hospital is alerting 415 patients and their families that a defective medical instrument may have given them a potentially life-threatening lung infection. The instrument, made by Olympus American, was used to perform bronchoscopies, which inspect a patient's lungs and take tissue samples. Olympus described the defective instruments as having a loose valve that trapped bacteria.
In a bronchoscopy, a thin, tube-like instrument, about the width of a pencil, is placed through the nose or mouth and into the lungs. The tube has a tiny camera at the tip and uses fiber-optic technology to produce pictures of airways. Some patients who were examined by one of three contaminated bronchoscopes have died.
Hospital officials discovered the problem after realizing that 128 patients had been infected with a bacterium known as pseudomonas. The number was two to three times higher than the hospital would expect, said Dr. Paul J. Scheel, Jr., vice-chair of medicine.
Hospital officials told The Baltimore Sun that they had not determined how many patients have been infected or died but sent certified letters warning 415 patients. Those at risk include anyone who had a bronchoscopy procedure between June 1, 2001, and Feb. 4, 2002, the letter said.
The letter asked patients to call their doctors if they experience symptoms that include fever, coughing, phlegm, or shortness of breath. The national Centers for Disease Control and Prevention and the Food and Drug Administration (FDA) are investigating the problem, in part to determine if the device has triggered outbreaks elsewhere, The Sun reported.
Most of those treated at Johns Hopkins were suffering from cystic fibrosis, AIDS, or lung cancer, or had recently had lung transplants. "We don't know the cause and effect between patients who died and this infection," Scheel said. "People are going through medical charts to try to ascertain this."
The University of Maryland Medical Center in Baltimore has also stopped using the tool and is searching its records for patients with the infection. The Maryland Department of Health and Mental Hygiene and the Baltimore health department were trying to determine if the problem exists in other hospitals.
Dr. Ross J. Brechner, the state's epidemiologist, said he sent e-mails to colleagues throughout Maryland and the country detailing the Hopkins discovery and asking whether they have noticed the same elevated infection levels after using the popular device.
The recall letter to Hopkins, dated Nov. 30, wasn't immediately acted on because it was mistakenly addressed to the loading dock of the Hopkins physiology department, the paper said.