FDA develops plan for national medical device postmarket surveillance system
The FDA’s Center for Devices and Radiological Health laid out next steps in developing a national medical device postmarket surveillance system in an April 2013 report.
The foundation of such a system will be routinely collected EHR information containing unique device identification (UDI) and device-specific registries in selected product areas as well as data including adverse event reports, and administrative and claims data, according to the report.
“Such a system would have broad patient capture, real-world generalizability, scalable and reusable infrastructure, continuous accrual of information for near real-time analysis, and use structured data with standardized nomenclature and definitions,” the agency stated in the report.
Further, it would provide assessments of medical devices’ risks and benefits throughout their marketed life.
Registries will serve as a “critical, complementary” role in the surveillance due to its information about patients, procedures and devices not otherwise in EHRs.
The agency identified the following steps to establish the postmarket surveillance system:
- Establish a planning board to identify the governance structure, practices, policies, procedures, methods and business models to support a system;
- Establish a UDI system and promote its incorporation into EHR information;
- Promote the development of device registries for selected products;
- Modernize adverse event reporting and analyses; and
- Develop and use new methods for evidence generation, synthesis and appraisal.
As it is complementary to other programs, the FDA wrote that its establishment can occur within its existing budget. The future medical device postmarket surveillance system is intended to be “collaborative and transparent” because “we recognize that our postmarket vision cannot be implemented or achieved by the FDA alone,” according to the report.