Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network

On April 9, the Engelberg Center for Health Care Reform hosted a roundtable, “Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network.” The Medical Device Epidemiology Network (MDEpiNet) was launched by FDA to develop the infrastructure and methodological approaches for conducting robust analytic studies that will improve FDA’s understanding of medical device performance.

The roundtable featured presentations from Danica Marinac-Dabic, Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Mary Beth Ritchey, Associate Division Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA; Benjamin (Ben) Eloff, Senior Scientific Program Manager, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA; Frederic (Fred) Resnic, Director, Cardiac Catheterization Laboratory, Brigham and Women’s Hospital and Assistant Professor of Medicine, Harvard Medical School; and Art Sedrakyan, Associate Professor of Public Health, Director, Patient-Centered Comparative Research Program, Weill Cornell Medical College. The presentations included a discussion about MDEpiNet’s role as part of a comprehensive postmarket national medical product surveillance strategy, an update on the current status of MDEpiNet, an overview of its methods and infrastructure work streams, and a discussion about its future direction.