Defective Bronchoscopes Used After Medical Recall
WASHINGTON, D.C. -- June 7, 2002 -- Olympus brand bronchoscopes, used to diagnose pneumonia and lung cancer, were still in use at major hospitals at least three months after their recall, according to an article in the Baltimore Sun (May 27, 2002). A bronchoscope is a thin, lighted tube for the examination of the inside of the trachea and bronchi, the air passages that lead to the lungs. In the Olympus bronchoscope, the plastic biopsy port may become loose, allowing the growth of the bacteria pseudomonas. One hundred patients at Johns Hopkins hospital tested positive for pseudomonas after bronchoscopies, and two died, although it is not clear how many of these infections were due to the defective devices.
In cooperation with the Food and Drug Administration, Olympus America, Inc. first recalled the bronchoscopes in November, 2001, after reports that use of the defective bronchoscopes led to patient infections. In March, however, officials at Johns Hopkins and several other hospitals say they discovered that their recall notices had been sent to wrong addresses or misdirected within the facility.
According to the Sun, federal regulators conclude that sometimes notices are misrouted due to hospital bureaucracies. But manufacturers may also be routing items to outdated addresses or producing notices that downplay the seriousness of a recall, the article reported. For example, the Olympus notice instructs the medical facility to "return the bronchoscope at your convenience" so that the device can be "upgraded."
Problems with medical recalls are not new. In a 1997 report, the Government Accounting Office (GAO), the investigating unit of Congress, criticized the FDA for its recall practices: "...it does not act systematically to ensure that reported problems are resolved promptly, thus defeating the system's usefulness as an early warning about defective medical devices" (GAO Archives, scroll to Report Number, search on "HEHS-97-21"). In a later, more detailed report, the GAO also found that less than one-third of the 54 medical device recalls initiated from 1994 through 1996 were completed by manufacturers within the time specified by FDA guidelines (GAO Archives, scroll to Report Number, search on "HEMS-98-211").
For more information about safety and legal aspects of medical devices, see our discussion, Defective Medical Devices and Products. At Brayton Purcell, we are experienced in handling legal cases concerning medical devices and drug injuries. If you have a medically-related legal question, please feel free to contact us.