March 11, 2015
Patients and medical device innovators will benefit if the United States is able to launch a National Device Postmarket Surveillance System (MDS), says a new report by the Brookings Institution with input from a wide swath of public-private players including the Office of Surveillance and Biometrics Center for Devices and Radiological Health.
The Brookings paper, “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,” calls for an MDS that’s responsible for coordinating medical device postmarket evidence activities, then builds and facilitates access to a network of data partners. The report also stresses, however, that the MDS should not work in a vacuum. Instead, it should be built upon and coordinate with existing public and private sector programs to better leverage existing expertise and resources.
Brookings envisions a system that collaborates with other groups to support other high-priority evidence needs that may benefit from the same infrastructure, including product tracking and utilization, clinical quality improvement, and economic analysis of medical device-related care.
The Brookings Planning Board (PB) suggests the new MDS be implemented and managed by a wide array of stakeholders. But none of this is going to happen overnight. The PB envisions a seven-year rollout, with the first two years devoted to an incubator project tasked with developing a five-year MDS implementation plan.
Ideally, the incubator project would be initiated by the FDA. The report lays it out pretty clearly. “Without some initial seed funding and active FDA engagement, it will be difficult to assure the purpose and sustain the momentum necessary for other stakeholders to fully engage in the development of MDS.”
Finding funds won’t be easy, the report authors acknowledge. For example, the FDA does not currently have any specific appropriations dedicated to paying for the initiative. Congress enacted legislation in 2012 mandating the agency expand the Sentinel system to include medical devices. Unfortunately, folks on Capitol Hill didn’t come up with or identify other sources for the cash to fund it. The PB calls for “more explicit Congressional support” to support and fund the infrastructure required to emerge with a robust system of medical device surveillance in this country.
While Washington’s culture of gridlock isn’t exactly encouraging, maybe the prospect of safer medical devices developed in a climate that encourages innovation is the kind of thing a few of them can actually support on the same day. We’ll see.
