"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 implement and enforce standards more like those used for drug recalls.
"We suggest a federal mandate that recall notices be sent to all physicians who may use a device to help ensure that future recalls are handled expeditiously and the safety of medical devices is maximized," said study senior author Trish Perl, M.D., associate professor of medicine and director of hospital epidemiology and infection control at Johns Hopkins.
Outbreaks such as the one at Johns Hopkins have led patients and physicians to question the safety of bronchoscopy. The authors believe that the procedure is safe, but new standards to test and review the design of instruments before they are used in patients may help ensure safety, said Srinivasan.
At Johns Hopkins, the review showed that 414 patients underwent bronchoscopy during the outbreak; 48 respiratory tract and bloodstream infections were identified among 39 of these patients. P. aeruginosa was recovered in 32 infections, and exposure to a potentially contaminated bronchoscope may have had a role in the deaths of three critically ill patients. When the three contaminated bronchoscopes were identified and removed from service, P. aeruginosa levels returned to normal.
Other authors of the study are Linda Wolfenden, M.D., Xiaoyan Song, M.D., Karen Mackie, R.N., Theresa Hartsell, M.D., Gregory Diette, M.D., Jonathan Orens, M.D., Rex Yung, M.D., Tracy Ross, B.S., William Merz, Ph.D., Paul Scheel, M.D., and Edward Haponik, M.D., of Johns Hopkins, and Heather Jones, M.D., of the National Heart, Lung and Blood Institute. The study was funded by the Centers for Disease Control and Prevention.
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Journal
New England Journal of Medicine