Society Attends 2nd Annual Sentinel Initiative Public Workshop

Congress directed the U.S. Food and Drug Administration (FDA) to establish an active surveillance system for monitoring post-market drugs and medical products. In May 2008, FDA unveiled the Sentinel Initiative in response. The Sentinel Initiative is a national electronic data system designed to track drug and medical product performance, with the goal of ultimately improving the health of the public.

On January 11, 2010, the Heart Rhythm Society participated in the Second Annual Sentinel Initiative Public Workshop, hosted by the Engelberg Center for Health Care Reform of The Brookings Institution. At the multi-stakeholder meeting, participants discussed a range of issues, including the recently completed FDA contracts for the development of the Sentinel System and ongoing pilot projects tracking medical product safety.

Panel discussions also addressed concerns about maintaining patient privacy while conducting medical product safety surveillance; developing the Sentinel System as a national resource for medical product safety surveillance that would allow access to others beyond FDA; and developing a multi-purpose distributed system to conduct safety surveillance work, comparative effectiveness research, and product quality assessment.

Visit the workshop website for additional information and to download event materials.