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Company Discovered Defect in Medical Equipment Two Months Before Recall
March 5, 2002 Olympus, a Melville, N.Y.-based maker of bronchoscopes that may have spread potentially life-threatening bacteria, waited two months to begin recalling the defective equipment, federal officials said. In recall letters, Olympus described the defect as a loose valve that can trap bacteria. Dr. William Jarvis of the CDC said Monday that the company didn't let the Food and Drug Administration know of the defect until December. The defective bronchoscopes -- a device that takes pictures and collects cultures inside lungs -- spread Pseudomonas bacteria, which can cause pneumonia and be life-threatening in patients already suffering from critical illnesses, said John Hopkins Hospital officials. Two patients examined by the devices at Hopkins have died, but doctors were still trying to determine if the defective bronchoscopes were responsible. Hopkins officials said they mailed certified letters to 415 patients who may have been examined with contaminated bronchoscopes to ask patients to call their doctors if they experience fever, coughing, phlegm or shortness of breath. Most patients who have the bronchoscope procedure suffer from lung cancer, cystic fibrosis or AIDS, or recently had a lung transplant.
Back to other CDC news for March 5, 2002 Associated Press 03.05.02; Gretchen Parker This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. |