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Past Event

Unique Device Identification (UDI) Implementation Work Group Kick-Off

On July 16, 2012, the Engelberg Center convened a small work group of experts representing key stakeholder groups, including device manufacturers, payers, electronic health record vendors, academics, clinicians, and others with a vested interest in UDI implementation. This Work Group convened for an initial in-person meeting at Brookings where the group delved into the major use cases that should be the focus of initial UDI implementation efforts, explored major challenges to implementation, and identified those that could benefit from greater attention during subsequent expert workshops.

 

Recently, the U.S. Food and Drug and Administration (FDA) released its Proposed Rule outlining a system of unique device identifiers (UDIs). The Engelberg Center for Health Care Reform at Brookings is beginning work to support the implementation and full adoption of UDIs across the medical device lifecycle. Initiated in cooperation with FDA and Chickasaw Nation Industries, Inc. as part of the Medical Device Epidemiology Network (MDEpiNet) program, this work will help identify, prioritize, and explore the most pressing issues pertaining to UDI implementation.

Agenda

History and Future Directions of FDA’s UDI Initiatives

Charge to the UDI Implementation Work Group

Session IV: How Can We Harness Expert Workshops and Webinars to Inform the UDI Implementation Roadmap?

Welcome, Overview, and Meeting Objectives

Session I: What are the Major UDI Use Cases that Would Benefit from an Implementation Roadmap?

Session II: What are the Major Challenges to Adoption and Implementation of UDIs?

Session III: How Will We Define Successful Implementation and What is Needed to Get There?

R

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Closing Remarks

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