NEW DEVICE SURVEILLANCE SYSTEM PROPOSED (Orthopedics This Week)
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 theMinneapolis 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, p...
