In 2012, FDA issued a report, “Strengthening Our National System for Medical Device Postmarket Surveillance,” outlining four key steps for creating a national surveillance system that would quickly identify poorly performing medical devices. One step was to encourage the development of national and international device registries, which contain information on patients who use or are treated with a specific device.
In response to FDA’s report, The Pew Charitable Trusts, the Blue Cross Blue Shield Association, and the Medical Device Epidemiological Network (MDEpiNet) Science Infrastructure Center at Weill Cornell Medical College partnered to develop a set of recommendations—which emerged from several multistakeholder convenings of practitioners, regulators, payers, patients, and industry—on the use of registries to improve patient safety.
The report outlines five objectives for stakeholders to work toward so that medical device registries can better contribute to the national surveillance system, including:
- Establishing criteria for determining if a device registry is the appropriate tool for postmarket surveillance;
- Ensuring registry data—as well as information about a registry’s governance and financing—are publicly available;
- Implementing efficiencies that can help streamline registry data collection and reduce the time and cost of reporting;
- Leveraging registry data to accelerate medical device innovation and help fulfill related regulatory responsibilities; and
- Resolving varying legal interpretations of provisions governing quality improvement activities and research, as they apply to registries.
Registries in Action
Sponsored by Pew, AcademyHealth developed case studies—featuring Kaiser Permanente and the Australian Orthopaedic Association—that illustrate how medical device registries can benefit public health and postmarket surveillance activities in the United States and abroad.
Case studies: Kaiser Permanente’s Total Joint Replacement Registry
Case studies: Australian Orthopaedic Association’s National Joint Replacement Registry