"The regulation of devices used for medical procedures should be as rigorous as the regulation of drugs prescribed by doctors," said Arjun Srinivasan, M.D., assistant professor of medicine at Johns Hopkins.
In the Jan. 16, 2003, issue of the New England Journal of Medicine, Srinivasan and colleagues report that between June 2001 and January 2002 at Johns Hopkins Hospital, the rate of Pseudomonas aeruginosa, a common bacterium that can cause lethal infections in patients who are critically ill or have weakened immune systems, was three times higher than the usual rate in patients undergoing bronchoalveolar lavage. Bronchoalveolar lavage is a common procedure in which a bronchoscope is used to put sterile saline into the lower airways and then remove it so potential infectious agents and other causes of respiratory illness can be identified.
In late November 2001, a group of Olympus bronchoscopes were recalled nationwide because of a loose port that could permit contamination. The manufacturer first sent letters to facilities using the scopes. Because these letters were not addressed to individual physicians who use the devices, several institutions, including Johns Hopkins, were not aware that the bronchoscopes had been recalled.
A faster and more effective recall of the devices may have shortened the duration of the outbreak at Johns Hopkins and decreased the number of patients at risk, according to Srinivasan.
Currently, the U.S. Food and Drug Administration (FDA) relies on manufacturers of medical devices to take full responsibility for product recalls, including follow-up checks to insure that recalls are successful. Srinivasan's team believes the federal government should impleme
Contact: Trent Stockton
Johns Hopkins Medical Institutions