Three Lessons FDA Learned about Medical Device Safety Reporting

​The time has come for the U.S. Food and Drug Administration (FDA) and hospitals to work together to streamline and modernize data collection about medical devices, including medical device reports submitted by healthcare facilities, the director of FDA's Center for Devices and Radiological Health wrote in an October 24, 2016, blog post. FDA has several tools to monitor medical devices, the director wrote, but they come with inherent limitations. Because of the "rapid technological advances and iterative nature of medical device product development," as well as a product life cycle that often is measured in months instead of years, evaluation of medical device safety presents "unique challenges" for FDA. Hospitals, the director wrote, are "uniquely positioned" to identify safety issues with devices as they develop because they use the devices in real-world settings. After studying several high-profile device-related safety issues, FDA learned three lessons. First, some hospitals did not submit required reports for device-related deaths or serious injuries. Second, hospital staff often were not trained to comply with FDA reporting requirements.