Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic

Given the growing use and significance of medical devices in the health care system, there is broad recognition of the importance of having an effective system for monitoring medical device use and the associated patient outcomes. In order to regulate medical devices to ensure they are safe and effective once they are on the market, it is becoming increasingly critical to conduct near real-time, active surveillance using routinely collected electronic health information. Medical devices present a unique set of challenges (e.g., iterative medical device lifecycle, lack of standardized identification system) which has hampered progress towards the development of a robust National Medical Device Postmarket Surveillance System. The U.S. Food and Drug Administration (FDA) launched the Medical Device Epidemiology Network (MDEpiNet) in 2010 as part of a national strategy to achieve its vision of an enhanced postmarket surveillance system by exploring methodological and infrastructure tools for the improvement of medical device safety and understanding throughout the device lifecycle. A number of issues related to governance, methodology, and data infrastructure need to be addressed in order to establish a robust National Medical Device Postmarket Surveillance System. These issues require input from relevant external subject matter experts and a coordinated structure for engaging stakeholders to develop short- and long-term strategies. The Engelberg Center for Health Care Reform (ECHCR) at the Brookings Institution proposes to support the implementation of the National Medical Device Postmarket Surveillance System, in collaboration with FDA, by providing a unique, structured approach to broad stakeholder engagement and program coordination to support the ongoing work of the Medical Device Epidemiology Network (MDEpiNet), other long-term partnerships and program strategies of the Center for Devices and Radiologic Health (CDRH). ECHCR will form and support: 1) Planning Board, composed of key stakeholders and content area experts, that will establish the high-level priorities through the Annual Strategy and Implementation Plan; 2) Implementation Council, composed of FDA, ECHCR, the MDEpiNet Methodology Center, the MDEpiNet Science and Infrastructure Center, and other center(s) or organization(s) that are components of the MDEpiNet structure, that will facilitate the ongoing coordination and communication of the three major work streams (i.e., Governance/Strategy, Methodology, Data Infrastructure), their priorities, and their activities. ECHCR will convene expert workshops to support the activities of the work streams to gather external expertise to address emerging technical issues. Broad public communications, in the form of an Annual Public Workshop, roundtable webinars and additional materials, will augment this effort by helping engage broader audiences.