FDA Releases 20 Years of “Hidden” Data Related to Medical Device Injuries and Deaths
Serious medical complications and lifelong injuries, and even death, can result from a risky or wrong medical device. But a March 8, 2019 Kaiser Health News investigative report has led to the recent Food and Drug Administration (FDA) release of two decades worth of previously hidden data containing millions of malfunctions by medical devices and allowed some manufacturers to keep potential safety issues quiet.
Some of the FDA’s public reporting of adverse device outcomes were previously filed as an “alternative summary,” and included more than 5.7 million incidents hidden from the American people. This is risk information that could have been (and now will be) helpful for device prescribing doctors, medical researchers and life-saving knowledge for consumers and patients.