US joint initiative by FDA and CMS to improve medical product safety

US Health and Human Services Secretary Mike Leavitt has announced efforts underway at the Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) that will complement each other 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," Secretary Leavitt said. "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," he added.

In a white paper released by the FDA, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable it to query a broad array of information to identify possible post-market adverse events. This Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.