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New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
Date:5/22/2008

f most Americans having access to an interoperable electronic health record by 2014.

FDA's Proposed Sentinel System Will Strengthen Safety Monitoring of Drugs and Other Medical Products

The new FDA white paper, titled "The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety," describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it. The report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html. The system would enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems.

"With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people," said FDA Commissioner Andrew C. von Eschenbach, M.D. "The era of 'wait and see' is going to become the era of 'tell me right now.' By harnessing the world's most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, we will have the ability to monitor a product's performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface."

Creating an active surveillance system such as the Sentinel System was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional FDA needs.

Access to CMS Data Will Facilitate Public Health and Safety Research and Quality
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SOURCE U.S. Department of Health and Human Services
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