New Device Surveillance System Proposed

The health care arm of the Brookings Institution in Washington, D.C. prepared a proposal for a national device surveillance system for medical devices. The purpose of the proposal is to do for devices what the FDA Sentinel system does in tracking drugs and vaccines. The Brookings Institution produced the report at the request of the Food and Drug Administration’s device-safety division.

One reason medical device surveillance has not already taken place, according to Joe Carlson writing in the Minneapolis Star Tribune, is that while Congress’ mandate to include devices under the FDA’s supervision is now three years old, the agency has been held up by the fact that medical devices lack a universal system for product numbering, as exists for automobiles.

The report, titled “Strengthening Patient Care, ” lays out a seven-year, $250 million program to launch the National Medical Device Postmarket Surveillance System. The report notes that there is no lack of data on patient experience. The goal of the proposed surveillance system would be to harness the potential of the existing mass of data on patients through a voluntary, public/private partnership with input from device makers, physicians, insurance companies and patients.

Carlson quotes Harlan Krumholz, M.D, Yale cardiologist and health care outcomes expert, who said, “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.”

Carlson wrote, “The system would track each medical device through its life cycle with patients on a mass scale, offering insights not possible with clinical trials that might only track a few thousand patients over the course of one or two years.”

Industry groups appear to be on board. Carlson quotes Janet Trunzo, senior executive vice president with the trade group AdvaMed, who said device makers agree that input from stakeholders can be harnessed to promote public health. She added that companies also support using unique device identifiers in a national device-safety surveillance system.