FDA Plans ID-Tag System to Detect Faulty Devices
BY THOMAS M. BURTON , The Wall Street Journal
The Food and Drug Administration is devising a new system for detecting malfunctions in medical devices that will tap medical and billing records from hospitals and insurance companies.
The system is designed to catch malfunctioning devices like the St. Jude Medical Inc. heart defibrillator wires recently linked to at least 20 deaths. The agency wants to assign a new bar-code-like identification number to medical devices.
It would use that number to search large databases of records that could include veterans' and other hospitals, as well as large insurance companies. That could potentially allow the agency to know more precisely the ...