CMS and FDA to monitor use of medical products as means of keeping patients safer

Patient Safety Monitor Alert

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May 28, 2008

Health and Human Services Secretary Mike Leavitt announced that the Centers for Medicare and Medicaid Services and the Food and Drug Administration (FDA) will be working together to monitor the use of medical products. The effort, called the Sentinel System, will track claims data and rely on it to divulge any trends in how medications and medical products are being used. This will allow the FDA to examine much more potentially important patient safety-related data faster to appropriately warn consumers.

This type of active surveillance system was recommended by the Institute of Medicine's 2006 report on ways to improve medication safety. Using this database, the Sentinel System will be able to identify the possibility of an adverse event occurring with a medication or medical device.

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