The Role of Postmarket Surveillance in the Medical Device Risk Management System

The primary vehicles of medical device risk management are the threat and actuality of product liability plus federal regulation by FDA’s Center for Devices and Radiological Health (CDRH). CDRH regulates devices using varying degrees of stringency, including premarket approval. Even after premarket approval, subsequent failures of several devices have led to widespread litigation. This litigation often results in gag orders on risk-related information. Case studies are used to elucidate these pluralistic risk management issues, focusing explicitly on the use of postmarket surveillance as a risk management tool. No device has received more attention in the regulatory and liability arenas than the Bjork-Shiley convexo-concave (cc) tilting disc heart valve. This device, which received premarket approval in 1979, was designed to decrease the rate of thromboembolism associated with its predecessor valve, which was introduced in 1969 and dominated the market in the 1970’s. Among the changes to this new valve were a change in the position of the outlet-strut weld and the angular orientation of the outle