Unique Device Identification (UDI) Implementation
Recognizing the need for a standardized system to identify medical devices, Congress included provisions in the Food and Drug Administration Amendments Act of 2007 (FDAAA), directing the U.S. Food and Drug Administration (FDA) to create a unique device identification (UDI) system that would enable tracking and identification of medical devices. In July 2012, FDA released the Proposed Rule for a Unique Device Identification System in the Federal Register. While the release of the Proposed Rule is an important step forward, its proposals, if adopted in the Final Rule, only ensure that UDIs will be developed and included on labels for relevant medical devices and that accompanying device information will be available to the public through the Global UDI Database (GUDID). The true value of a UDI system, however, lies in its broad adoption and subsequent use by manufacturers, distributors, payers, providers, patients, and other stakeholders with important roles throughout the medical device lifecycle.
To this end, the Engelberg Center for Health Care Reform at Brookings is collaborating with FDA and Chickasaw Nation Industries, Inc., to explore the potential promise of broad, stakeholder-driven UDI implementation and address the challenges it may face. Brookings will use information gathered from a number of activities, described below, to begin developing a roadmap for successful UDI implementation, which will convey the value of UDI implementation, guide relevant stakeholders in addressing key challenges, and serve as a foundation for policies supporting UDI adoption.
UDI Implementation Work Group »
Brookings has assembled a group of expert stakeholders with interests that span the medical device lifecycle to advise on issues related to the implementation of UDI, explore potential strategies for resolving them, and identify topics in need of further exploration. This UDI Implementation Work Group met for an initial meeting in July 2012 during which members identified important use cases for UDI, explored major challenges and strategies surrounding UDI implementation, and defined some of the key characteristics of a successful UDI system. Work Group members continue to be actively engaged in the UDI implementation effort through regular conference calls.
Expert Workshops »
Brookings convenes a series of full-day expert workshops on selected issues important to the success of UDI implementation. These expert workshops bring together stakeholders with relevant expertise to consider workable technical and policy approaches to achieving the full benefit of UDI implementation. Deliverables from these meetings include pre-meeting discussion guides and post-meeting summaries.
Brookings communicates to broader audiences regarding important aspects of UDI implementation by hosting webinars that are free and open to the public. During these webinars, subject matter experts and representatives from key stakeholder groups provide insight on topics related to UDI implementation, including the value of UDI implementation for particular stakeholder groups, opportunities for stakeholder involvement in shaping and driving UDI implementation, and critical strategies for achieving the promise of successful UDI implementation.