(HHS: Washington, D.C.) -- The U. S. Department of Health and Human Services stated that efforts are underway between the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS) to improve patient safety and the quality of medical care.
“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” says HHS secretary Mike Leavitt. “We are moving from reactive dependence on voluntary reporting of safety concerns, to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”In The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety (May 2008), the system would enable the 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.
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