N RECENT YEARS, HIGH-PROFILE CASES OF MEDICAL DE- vice failure resulting in patient harm-such as implant-able 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. The Final Rule, expected in June 2013, will mandate that manufacturers assign unique identifiers to their marketed devices. In addition to enhancing postmarket surveillance, use of UDI should ensure the ability to track a device across health care settings; support safe and accurate device use; create a standard for device documentation in health information technology (HIT) systems; enhance recall management; improve efficiency; and support health care cost savings. A human-readable and automated identification and data capture form of UDI will be required per the proposed rule, the latter to allow automated capture of UDI in HIT systems. The rule will pertain to all 3 classes of medical devices.4
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