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CASE STUDY PARTICIPANTS: Lawrence Gossman, AVP, Supply Chain, Fran Sercer, MSN RN, Associate Director of Interventional Services, Anita Sears, Director of Supply Chain, Eskenazi Health

WORK GROUP TITLE:UDI Capture Work GroupCASE STUDY PARTICIPANTS:Sandi Michel, MPMP, ITIL, CLSSBB, Director of Supply Chain Systems and Quality, the Office of Data Standards & Interoperability for Franciscan Missionaries of Our Lady Health System (FMOLHS)CASE STUDY ORGANIZATION:

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A UDI Capture Work Group Case Study at the Baptist Health.

In part one, we explore the reasons why the FDA created the (UOU) Unit of Use.

In the third part of the the FDA Unique Device Identification (UDI) “Unit of Use” (UOU) webcast series, we cover several potential use cases for the FDA UDI UOU identifier.

In part two of the FDA Unique Device Identification (UDI) Unit of Use (UOU) webcast series, we cover the FDA definition of the term, Unit of Use.

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: Wendy Watson, OR Supply Chain Manager at University Health Network CASE STUDY ORGANIZATION: University Health Network (UHN) serves the residents of Toronto, Ontario, Canada’s largest city, and the surrounding communities. UHN is comprised of 10 program areas spread across four hospitals and eight sites. It has $2B in revenues, 1,200 patient beds and its surgeons perform 24,000 surgical procedures each year.

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: Becky Ashin, Vice President, Advanced Orthopaedic Center, University of Tennessee Medical Center Beth Kaylor, RN Clinical Director, Innovation, DeRoyal Industries CASE STUDY ORGANIZATION:

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: James Phillips, Consulting Manager, DSI, the Office of Data Standards and Interoperability, Franciscan Missionaries of Our Lady Health System (FMOLHS) CASE STUDY ORGANIZATION:

A UDI Capture Work Group Case Study at the Beaver Dam Community Hospitals, Inc.

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: Jim Booker, Manager of Master Data Management, Supply Chain, Stanford Health Care CASE STUDY ORGANIZATION:

This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.

The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner. Below is the FDA press release:

On November 21, 2013, AHRMM submitted electronically