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Medical devices safe, but could be safer with better regulation

nt 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.


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Contact: Trent Stockton
tstockt1@jhmi.edu
410-955-8665
Johns Hopkins Medical Institutions
15-Jan-2003


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