Mishaps With Medical Devices Go Unreported
May 21, 2001
According to a new report, the Food and Drug Administration plans to actively encourage hospitals and other healthcare facilities to report deaths and injuries associated with medical devices. Currently, reports made by hospitals, nursing homes, outpatient surgery and medical care centers and dialysis centers only account for 5% of the total number of reports made to the FDA concerning patient deaths and injuries due to medical devices. On the other hand, the manufacturers of these devices report 90% of the adverse events associated with their products.
Manufacturers of medical devices are required by law to report any patient who dies or suffers a serious injury due to a medical device. The medical staffs of hospitals and healthcare centers are also required to report such injuries and deaths. Apparently, hospitals and medical centers are simply not following the law.
In 1997, the Food and Drug Administration Modernization Act called upon the FDA to devise a plan in which hospitals would be strongly encouraged to report deaths or injuries due to medical devices. To follow the guidelines set out in the Act, the FDA and the Office of Surveillance have targeted 25 facilities to participate in a pilot study of this new procedure.
-- Article Courtesy of InjuryBoard.com
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