A new report lays out a seven-year, $250 million proposal to study and launch the National Medical Device Postmarket Surveillance System.
The U.S. Food and Drug Administration 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, and Thomas Gross, Director of the Office of Surveillance and Biometrics at CDRH.
Or, as Yale cardiologist and healthcare outcomes expert Harlan Krumholz told the Minneapolis Star Tribune: "If a million people have had a device, we should have the benefit, as a society and as the next patient, of what you could learn from the experience of a million people."
The effort calls for creating a voluntary public-private partnership with input from device makers, healthcare providers, insurance companies and patients to avoid merely top-down regulation from the FDA, Krumholz said.
It will not be a stand-alone system, but build upon and coordinate with existing programs, support Congress' mandate to include medical devices into the Sentinel Initiative, as well as coordinate with PCORI on its efforts to build a national research network.
The plan calls for, in the first two years, the FDA to create an incubator program to develop a five-year plan based on fact-finding activities and pilot programs, with the next five years to be spent on implementation.
Expected challenges include:
- Minimization of the burden of data capture and sharing
- Development of policies to ensure patient data is protected
- Building capabilities to provide value to a broad group of stakeholders
In December, Brookings published a roadmap for implementing a Unique Device Identifier (UDI) system.
And in September, a report from the Pew Charitable Trusts and others called for a national system of registries to track safety and effectiveness in medical devices.