Summary: The Food and Drug Administration (FDA) is responsible for protecting the American public from unsafe and ineffective medical devices, which range from simple household items, such as thermometers, to implanted heart valves. During the past 15 years, the U.S. medical device industry has grown from 5,900 to 16,900 firms; more than $40 billion was spent on such devices in the United States in 1994. Medical device manufacturers have been required since 1984 to report malfunctions, along with resulting injuries and deaths, to FDA. Hospitals and other facilities, however, were not required to report these cases and rarely did so. As a result, Congress passed the Safe Medical Devices Act of 1990, which expanded the reporting requirements to include user facilities, such as hospitals and nursing homes, and medical device distributors. GAO found that although FDA collects reports from users, hospitals, nursing homes, manufacturers, and others about problems with medical devices, FDA does not act systematically to ensure that reported problems are resolved promptly, thus defeating the system's usefulness as an early warning about defective medical devices.
