Following UDI Transactions: An Overview of the Technology Behind UDI

Speakers: Sprague Ackley, Chief Scientist, Intermec Technologies, Member of AIDC 100; Paul Helmering, Enterprise Architect, Mercy Health System

This session will provide the basics of the technology behind UDI for a baseline understanding. You will be guided through bar code fundamentals (to include 1D & 2D codes); direct part marking; Radio Frequency Identification (RFID); and system design/integration. In addition this session will provide the real-world process of transactions enabled by UDI so you can learn how to prepare and communicate the UDI data.

Coffee Break

Opening Keynote – Industry Momentum & Progress

Speaker: Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, Food & Drug Administration (FDA)

Attend this session to learn what progress and activities have taken place in the last year that continues to move the UDI initiative forward. Hear about the many activities and workgroups that are evolving UDI here in the U.S. as well as gaining global traction. Understand the vision of what is coming and how best companies can embrace UDI practices to ensure day to day value and ultimate outcomes and gains.

Exhibits & Lunch in the Exhibit Hall

Exploring UDI Connections Between Manufacturers and Hospitals in Recall Processing

Speakers: Dennis P. Orthman, Senior Director, Strategic Marketplace Initiative (SMI); Steven W. Huckabaa, Network Vice President of Supply Chain Management, Retail Pharmacy Services, and Center for Innovation, Kettering Health Network; Jean Sargent, Director, Supply Chain Management, USC Health Sciences, Past President of AHRMM

These members of the SMI Product Recall Initiative Team will:
• Provide an overview of the SMI Team’s efforts
• Share key outcomes from their industry survey on product recall issues and challenges
• Review two major findings of the SMI Team:

1. Industry needs to improve the speed of recall notifications
2. Industry needs to standardize the notification format and content.

This session will also include an open discussion period for attendee Q&A and discussion of methods to improve the connections between manufacturers and providers to ensure that data is cohesive and accurate and demonstrate how data standards is the major enabler to industry success.

Practical Clinical Use Cases for UDI

Speakers: Rosalind Parkinson, Administrative Director Materiel Systems, The Ohio State University Medical Center; Rick Hampton, Wireless Communications Manager, Partners HealthCare System;Cynthia Gregg, Contract & Purchasing Specialist, Department of Veterans Affairs - VHA

Learn about practical clinical use cases for UDI from those currently involved with initiatives within their provider settings. Understand that challenges they face, uses for data and the clinical importance of UDI. During this conversation, the essential value of UDI for quality, safety and efficiency in clinical care will be evident.

Exhibits & Break (in the Exhibit Hall)

UDI Step-by-Step: Implementation Best Practices for Medical Device Manufacturers

Speaker: Tom Werthwine, Global Process Owner - Auto ID Technology and Data Standards, Johnson & Johnson Health Care Systems, Inc.; Shamiram R. Feinglass, MD, MPH, Vice President, Global Medical & Regulatory Affairs, Zimmer, Inc.

Learn from a market leader the steps they took to create a UDI project methodology, to include system design, UDI regulation impact, data considerations, and processes affected. You will understand how this project ultimately led to their large-scale distribution to market model.

Registration / Badge Pick-Up

Summary of Day One and Plans for Day Two

Speaker: Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, Food & Drug Administration (FDA)

The UDI Database: How Manufacturers Need to Develop & Maintain Master Data

Speakers: Terrie Reed, Associate Director, Informatics, FDA; Jackie Rae Elkin, Global Regulatory Affairs, Medtronic, Inc.

A key part of the development and implementation of the UDI System is the UDI Database, which will capture identifying information and other important device information. It is critical that device manufacturers develop robust, extensible processes and systems to develop, maintain and submit this “master data” to populate the UDI Database (and potentially other databases). The UDI information needs will evolve and expand over time, so the master data systems need to be designed to support this potential.

Coffee Break in the Exhibit Hall

Transforming UDI Data into Knowledge

Panelists: Corwin Hee, Director, eBusiness, Covidien; Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, Food & Drug Administration (FDA); Michael Oliver, Information Technology Manager, Claflin Company; Michael Innes, Program Director, Supply Chain Processes & Systems, Kaiser Permanente; Tom Werthwine, Global Process Owner - Auto ID Technology and Data Standards, Johnson & Johnson

Every day, unseen databases are hard at work enabling automated processes in retail and grocery. How can we use UDI to bring these advances to healthcare? This panel will explore the myths and realities of the UDI rule and its vital relationship with the underlying data. The challenges in gathering and distributing this information to help all stakeholders in the healthcare supply chain will also be discussed.

Exhibits & Lunch in the Exhibit Hall

Perfect Order and Beyond

Speakers: Dennis Black, Director of eBusiness, BD (Becton, Dickinson and Company); Alex Zimmerman, Director Information Management, Mercy Health

Learn about the process changes BD and Mercy/ROi made to achieve "Perfect Order" in the healthcare supply chain. Part of the process was implementing data standards including the GTIN (a UDI system). As a result of this collaborative effort, the UDI system is used from factory floor all the way through to the patient bedside and tied into the Electronic Health Record. This is a real-world snap shot of how UDI can work.

The Use of UDI in Clinical Information Systems

Speakers: Joe Pleasant, FHIMSS, Senior VP & CIO, Premier Inc.; Gerald Greeley, Director of Information Services, Winchester Hospital

Participate in a discussion about how the UDI will benefit the interoperability of sharing medical device information between clinical information systems. Accountable Care Organizations (ACO's), Healthcare Reform legislation and the HITECH act all point to the requirement for information to be effectively shared among providers. Why is UDI an important component of this?

Stretch Break

Panelists of Faculty to be announced

Panel of industry implementers will answer questions submitted in advance of the event as well as hold an open mic session for those that want to voice fears/challenges/questions.