In an effort to develop enhanced methods to evaluate the safety of medical devices, the U.S. Food and Drug Administration (FDA) has established a five-year cooperative agreement with Yale University, in partnership with Medtronic, Inc.
Yale and partners will develop a general framework for and key methodologies, best practices, and strategies that are essential to the success of an effective U.S. medical device surveillance registry network. This project will bring together critical stakeholders who will help define problem areas and develop solutions for medical device surveillance that is responsive to societal needs.
“There is a great need to develop methods and initiatives to ensure that the devices that are approved are truly safe and effective when they are adopted into practice,” said Harlan Krumholz, M.D., the Harold H. Hines, Jr. Professor of Medicine (cardiology) and professor of investigative medicine and of public health (health policy); director of the Clinical Scholars Program; and director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation.
“We need systems that provide early warning of problems and provide the information to ensure these devices are providing the benefits that we expect,” Krumholz added.