Report details proposal for national medical device postmarket surveillance system

A new report details a seven-year, $250 million proposal to study and launch the National Medical Device Postmarket Surveillance System.

The U.S. Food and Drug Administration (FDA) commissioned the Engelberg Center for Health Care Reform at the Brookings Institution, which wrote the report, to oversee the Medical Device Postmarket Surveillance System Planning Board.

The FDA's vision for medical device postmarket surveillance calls for "a national system that quickly identifies poorly performing devices, accurately characterizes and disseminates risk and benefit information about real-world device performance, and efficiently generates data to help support premarket clearance or approval of new devices and new uses of currently marketed devices," according to a blog post coauthored by Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), and Thomas Gross, director of the Office of Surveillance and Biometrics at CDRH.

A blog post on the Brookings Institution's website describes initiation of an incubator project during the first two years that would develop a five-year implementation plan for medical device postmarket surveillance (MDS) through fact-finding activities and pilot programs. The board recommends that the incubator project be initiated by FDA, adequately staffed and resourced, and guided by a multi-stakeholder group with relevant medical device experience.

Subsequent years would focus on a second phase of work implementation the plan produced by the incubator project. The experienced group selected would set and oversee the system's strategic development priorities, begin to build and sustain broader stakeholder participation, oversee implementation of the organizational plan, and establish system performance measures.

The report identifies the following challenges to implementation:

• Supporting a multi-pronged approach to ensure widespread adoption and use of UDIs in electronic healthcare data;
• Minimizing the burden of data capture and sharing;
• Developing policies to ensure the protection of patients and their privacy; and
• Building the capabilities to provide value to a broad group of stakeholders.

For more information, read the full report.