Report Released by Brookings Institution Details National Medical Device Surveillance System Plan

(February 25, 2015)–On Monday, the U.S. Food and Drug Administration (FDA) and the Brookings Institution issued a new report called, "Strengthening Patient Care:  Building a National Postmarket Medical Device Surveillance System."  This report outlines new infrastructure to enhance device safety and efficacy; a two-staged approach for building a public-private partnership intended to manage the system. 

Millions of Americans are using medical devices such as pacemakers and artificial joints while there is no health information infrastructure to capture, aggregate or analyze data on the safety, effectiveness, and quality of medical devices.  So in 2013, the FDA commissioned the Engelberg Center to convene a planning board to deliberate the fundamental aspects of a national system.  Carol Walton, CEO of The Parkinson Alliance was part of this 22-member planning board as announced on our website May of 2014.

The full report can be accessed on the Brookings website.  In addition to the report, there was a public event with a webcast.