Brigham and Women’s Hospital in Boston, the FDA, Harvard Medical School in Boston and Vanderbilt University Medical Center in Nashville, Tenn., took part in a study to test a computerized tracking system to find faulty medical devices, according to a Reuters report.
Researchers used an automated computer monitoring tool to analyze electronic medical data on more than 47,400 interventional coronary procedure in which patients received one of seven newly introduced cardiovascular devices. Two out of seven devices involved in the study had potential safety problems — the Tazus Express 2 and the Angio-Seal STS.
Device companies are required to tell the FDA when a physician or patient reports problems with their products, but only about 5 percent of these complaints are actually reported. Traditionally, the FDA then relies on inadequate notes or anecdotes to track problems, so a computerized tracking system may alleviate the challenge.
Read the Reuters report on the study of faulty devices.
Read the Brigham and Women’s news release on the study.
Read more about the 30 Best Hospitals in America:
-Duke Earns Praise for Community Care Model in North Carolina
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Researchers used an automated computer monitoring tool to analyze electronic medical data on more than 47,400 interventional coronary procedure in which patients received one of seven newly introduced cardiovascular devices. Two out of seven devices involved in the study had potential safety problems — the Tazus Express 2 and the Angio-Seal STS.
Device companies are required to tell the FDA when a physician or patient reports problems with their products, but only about 5 percent of these complaints are actually reported. Traditionally, the FDA then relies on inadequate notes or anecdotes to track problems, so a computerized tracking system may alleviate the challenge.
Read the Reuters report on the study of faulty devices.
Read the Brigham and Women’s news release on the study.
Read more about the 30 Best Hospitals in America:
-Duke Earns Praise for Community Care Model in North Carolina
-Cleveland Clinic Selects 2011’s Top 10 Medical Innovations
-Fitch Assigns ̎AA- ̎ Rating to University of Chicago Medical Center