CMS, FDA launch initiative to improve safety of medical devices, drugs

HHS Secretary Mike Leavitt shakes hand of FDA Commissioner Andrew C. von Eschenbach. Source: HHS

Health & Human Services Secretary Michael Leavitt Thursday announced efforts underway at the FDA and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

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

An accompanying CMS final regulation published Thursday will make it possible for federal agencies, states and academic researchers to use claims data from the Medicare prescription drug program (Part D) – subject to protections for beneficiary privacy and commercially sensitive data – for public health and safety research, quality initiatives, care coordination and other research and analysis.

“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Leavitt said. “We are moving from reactive dependence on voluntary reporting of safety concerns – to proactive surveillance of medical products on the market.”

CMS said that the Sentinel System is an important example of how EHRs and other electronic health information, such as Medicare data, can help move the United States toward a system that delivers safer and better quality healthcare.

“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. “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 healthcare 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,” he said.

The FDA report is available online.