FDA, Brookings release plan for medical device postmarket surveillance system

Brookings Institution, in collaboration the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), has issued a report containing a proposal for a $250 million seven-year plant to develop and implement a National Medical Device Postmarket Surveillance System (MDS).

The goal of such a system would be to collect and store information about the safety, effectiveness, and quality of medical devices.

According to the report, which was written by the Engelberg Center for Health Care Reform at the Brookings Institution, MDS will support “optimal patient care by leveraging the experiences of patients to inform decisions about medical device safety, effectiveness, and quality in order to promote the public health.”

In a blog post announcing the release of the report, CDRH Director Jeffrey Shuren, MD, wrote that despite “robust” premarket evaluation of medical devices, what really counts is how well they work when used on a day-to-day basis by patients, caregivers, and clinicians.

“Our vision of a National Medical Device Postmarket Surveillance System is a 21st Century solution to an age-old problem,” he wrote. “The system relies on the experience gained by health care providers in their daily use of medical devices leveraged by modern technology. This experience, made possible by new tools and systems unimaginable a generation ago, gives us real-time data about what happens to patients in clinical practice. We will be able to leverage these capabilities not only to quickly identify poorly performing devices, but also to facilitate device approval/clearance and patient access, to reduce postmarket data collection for manufacturers, and to better inform healthcare decisions by providers and patients alike.”

The Brookings report recommends that MDS should be implemented and managed by a multi-stakeholder public-private partnership with the authority—and resources—to support its activities.

The seven-year plan calls for the establishment of an incubator project during the first two years that will develop an implementation plan for MDS through fact-finding activities and pilot programs. The second phase of the plan—years 3 through 7—will focus on the implementation plan and address key challenges such as:

  • Supporting a multi-pronged approach to ensure widespread adoption and use of Unique Device Identifications (UDI) in electronic health care data
  • Minimizing the burden of data capture and sharing
  • Developing policies to ensure the protection of patients and their privacy
  • Building the capabilities to provide value to a broad group of stakeholders