Duke University sends recs to FDA for new medical device safety evaluation system

Last year, the FDA asked Duke University's Duke-Margolis Center for Health Policy to weigh in on planning for a national medical device evaluation system (NMDES) that could better regulate medical devices. Now, Duke-Margolis has sent its suggestions to the agency about a system that would bring together the government, regulators, devicemakers and patients to improve medical device safety.

The center in a new report outlined a public-private partnership that would build on existing efforts to change the way that medical devices are tracked and evaluated. As of now, many public and private efforts from the FDA, researchers and the industry only focus on high-risk devices and come with high costs and limited technology.

"As a result, reliably and efficiently tracking the medical device safety and effectiveness outcomes of most interest to patients remains a generally unfulfilled promise," Duke-Margolis researchers said in the report.

A new system would draw on data from multiple sources such as electronic health records, claims and clinical trial data to track medical devices. Policymakers, regulators, patients and the industry would use the information to flag potential safety issues and make sure that new technology is up to muster, the researchers said in the report.

"We are entering a world with previously unimaginable amounts of medical device data and the potential for much more sophisticated understanding of health and medical issues. To reach the goal of providing better information and care for patients, a coordinated effort to establish broadly-supported processes and policies for medical device data sharing, protection, and evaluation is needed," researchers said.

The new network would also include an up-to-date registry of data on benefits and risks of medical devices, and compile information on safety updates and recalls. Improving analytics and bringing key stakeholders together under one umbrella could help reduce costs and make the system more patient-centric, researchers said.

Duke-Margolis researchers also outlined a Coordinating Center that would help manage NMDES. The center would "work closely with stakeholders across the device ecosystem to assess their needs" and build "a system focused on the reusability and interoperability of data, network linkages and tools," the researchers said.

To make sure that everyone gets a seat at the table, the center should be a public-private partnership, the researchers said. The FDA and other government agencies can take some of the reins, and nongovernmental organizations can voluntarily partner with the center to access new services and resources.

Two of the center's main objectives would be creating a more efficient data use system that gives payers, manufacturers and others better access to important device safety information. The center would also be tasked with improving post-market device safety evaluation.

Duke-Margolis' report builds on earlier efforts by the FDA to develop a better system to monitor device safety. In 2012, the FDA's Center for Devices and Radiological Health (CDRH) rolled out an action plan for a national evaluation system for medical devices.

In February 2015, an agency-backed planning board with help from the Brookings Institution released its first report about a new surveillance system. The FDA then asked Duke-Margolis to make suggestions about for its project.

Earlier this year, CDRH released a plan to create a national system for vetting medical devices. "The planning board believes that to improve high-quality, safe, effective, and timely care for patients, better information about medical devices must be a priority for the nation," Mark McClellan, director of the Duke-Margolis Center for Health Policy, said in a statement.

- read the statement
- here's the report (PDF)