FDA Releases Report on Medical Device Postmarket Surveillance

September 11, 2012

Recently, the Food and Drug Administration (FDA) released a report titled “Strengthening our National System for Medical Device Postmarket Surveillance.” The agency released the report to serve as a roadmap on improving safety monitoring of potentially dangerous devices. The report proposes four changes to FDA’s current medical device postmarket surveillance system. We have summarized these changes below:

1. Establish a unique device identification (UDI) system and promote its incorporation into electronic health information. In July 2012, FDA issued a proposed rule for a UDI system. According to FDA, UDIs will enhance postmarket surveillance activities by providing a standard and unambiguous way to document device use in electronic health records (EHR), clinical information systems and claims data sources. As a result, this information would potentially become available for use in assessing the benefits and risks of medical devices. FDA believes that the incorporation of medical device identifiers into EHRs is important to improve patient safety, to make the conduct of postmarket surveillance more efficient and to make queries of de-identified responses from electronic health information more readily usable to support device approval or clearance.

2. Promote national and international medical device registries for “selected products.” FDA believes that registry development in targeted product areas can both enhance public health and be cost-effective for industry, healthcare providers and payers. To foster the development of medical device registries in key product areas, FDA plans to convene registry experts and key stakeholders, including representatives from national and international registries, for registry development.

3. Modernize adverse event reporting and analysis. FDA is exploring automated adverse event reporting systems that would facilitate the submission of device-related adverse events and minimize the effort required by the reporter.

4. Develop and use new methods for evidence generation, synthesis and appraisal. According to FDA, “the development of new tools and methods to generate, synthesize, and interpret postmarket information will improve the efficiency and quality of decision-making by identifying new and better ways to leverage existing data sources by providing more timely information about the benefits and risks of marketed products, and by translating data into knowledge to help better inform regulatory and clinical decisions.”

FDA will host public meetings throughout September to obtain feedback from stakeholders regarding its proposed changes to the medical device postmarket surveillance system. To obtain a copy of the report click here.