|Authors||Wilson, Natalia A.; Drozda, Joseph Jr.|
|Link to Publication|
IN RECENT YEARS, HIGH-PROFILE CASES OF MEDICAL device failure resulting in patient harm—such as implantable cardioverter-defibrillator leads and metal-on metal hip implants—have received substantial attention both in the medical literature and popular press. These examples illustrate the need for a more effective system of monitoring device performance and protecting patient safety. The first action in the Food and Drug Administration’s (FDA’s) report on strengthening postmarket device surveillance, “establish a Unique Device Identification (UDI) System and promote its incorporation into electronic health information,” was addressed with publication of the UDI Proposed Rule.
This viewpoint article by Natalia Wilson and Joseph Drozda, published prior to publication of the Final Rule, highlights the role of UDI in supporting an effective medical device monitoring system and enhanced patient safety. The authors lay out the expected benefits of a UDI system to strengthen post market surveillance of medical devices, ensure ability to track a device across health care settings, support safe and accurate device use, standardize device documentation in health information technology (HIT) systems, enhance recall management, and support health care cost savings.