2019 UDI Conference Agenda (as of May 28, 2019 – subject to change)
This program has been approved for Continuing Professional Education (CPE) credits by the Association for Health Care Resource & Materials Management (AHRMM). Attendees of this program may earn up to 17.5 CPE Contact Hours.
UDI Conference Registration Open
GS1 Standards for U.S. FDA UDI Workshop – 5.0 CPEs
(Co-located program delivered by GS1 US. Separate registration required.)
This 5-hour workshop introduces you to the GS1 System and focuses on the GS1 Standards used within the context of the U.S. FDA Unique Device Identification (UDI) Rule.*
Attendees will be introduced to the basics of the U.S. FDA UDI Rule and to those GS1 Standards that can be used to address certain aspects of the requirements for product identification, product labeling, and submission of information to the Global Unique Device Identification Database (GUDID). The workshop will also discuss the importance of data quality and data governance as components of a UDI implementation. Additionally, attendees receive a brief update on how to avoid some of the most common GUDID data issues.
Audience Takeaways:
CLICK TO REGISTER FOR THE GS1 WORKSHOP
Note: for full information about the UDI rule, please see the link to the U.S. FDA Unique Device Identification System website on the bottom of this page.
Pre-Conference Workshop: The Expanding and Evolving Global UDI Imperative – Understanding the Future Nexus of Regulatory, Commercial, & Patient-Safety Information – 3 CPEs
(Offered as part of your UDI Conference Registration)
Workshop Facilitators:
Karen Conway, Vice President, Healthcare Value, GHX
Jay Crowley, Vice President, UDI, USDM Life Sciences
Marti Velezis, UDI Practice Lead /UDI GUDID Architect, USDM Life Sciences
To promote global harmonization, the International Medical Device Regulators Forum (IMDRF) set-out basic UDI requirements, including recommended “shared” data elements, in their guidance document “Unique Device Identification (UDI) of Medical Devices”. However, as regulators, purchasers and other global stakeholders begin to develop and implement country or regulator-specific UDI or UDI-like systems – they are not only trying to address device identification – but also support the resolution of particular national or local concerns (e.g., counterfeits, traceability, cost-control/reimbursement).
These new regulatory, commercial, and patient-safety use-cases create novel and complex challenges for device manufacturers, who now must establish and maintain robust global systems and processes that allow them to associate a broad set of global device attribute information, with real-world clinical information to support its indications, the continuous receipt and analysis of quality, performance and safety data, as well as information related to its distribution and costs.
Device manufacturers must work cross-functionally internally and with external stakeholders to manage growing information demands. Understanding what is happening globally – and why – will help prepare manufacturers to meet these global demands. This requires manufacturers to upend traditional siloed approaches to data and information – where regulatory, quality, clinical, supply chain, marketing, and product owners all create and maintain their data separately. In the future, every part of the organization must have access to and use the same information about a device, over the entire lifecycle, across the entire organization, and in all external communications about that device. This workshop will address how manufacturers can develop sustainable structures to manage the multitude and magnitude of regulatory, commercial, and patient-safety information.
Registration Open
Opening Keynote Address: UDI Expansion & Progress – .5 CPE
Speakers: Terrie Reed, Senior Advisor for UDI Adoption and Erin Quencer, Regulatory Health Scientist, U.S. Food & Drug Administration
Ms. Reed and Ms. Quencer will share an update on the current progress and expansion of the UDI initiative to include the current stats and status of implementation (including manual vs 3rd party vs HL7 submissions). Learn about the critical knowledge that the FDA has gained through the UDI Helpdesk as well as the UDI community stakeholders and how they have responded to ensure the accuracy of UDI medical device information in real world applications. 
The Worldwide Melding of Regulatory, Commercial, & Patient Safety Information Needs – 1.0 CPE
Speakers: Jay Crowley, Vice President, UDI, USDM Life Sciences; Terrie Reed, Senior Advisor for UDI Adoption, U.S. Food & Drug Administration
This session will discuss the melding of the regulatory, commercial, and patient-safety information needs and ways in which device manufacturers, health-care providers, researchers, patients, purchasers, insurers, and regulators can work together to achieve the shared goals of improving device safety, effectiveness, healthcare quality and patient safety, and reducing risks and healthcare costs. The appropriate initial development, maintenance and re-use of information is central to the supporting these global use-cases. 
Coffee Break
UDI Data Enrichment & Innovation: Leveraging UDI to Provide Extended Value – 1.0 CPE
Speakers: Patrick Lupinetti, J.D., Senior Vice President for Legal Services and Medical Device, First Databank; Dr. James Tcheng, Professor of Medicine, Duke University School of Medicine; Dr. Joseph Drozda, Director of Outcomes Research, Mercy Health
This session will describe potential applications of UDI-based data sources that can provide highly useful information to clinical users and achieve workflow efficiencies throughout a healthcare provider’s operations. UDIs are more than regulatory markers, but keys that can unlock additional relevant product attributes, facilitate recall management, improve EHR documentation, and simplify inventory management, and this presentation will identify these opportunities and how they might be achieved.
Luncheon & Exhibits
Tips & Tricks Roundtables
In addition to all the solutions in the Exhibit Hall, take advantage of the Roundtables during this time. Topics will include:
Case Studies: Med Device Manufacturer’s Perspectives on Merging Global Requirements – 1.0 CPE
Speakers: Steve Roan, Sr. Director, Portfolio Data & Standards Compliance, Smith & Nephew; Dennis Black, Director of eBusiness, BD; Dawn Fowler, Director, UDI/Master Data Management, Masimo
With global recognition and development of international requirements, UDI is no longer a “One and Done” but an ongoing process. There is a growing demand for medical device manufacturers to share product data with regulators, registries, and trading partners. In order to meet these demands, manufactures must develop robust master data discipline within their organizations to ensure their data is complete, accurate, and available throughout the product lifecycle.
Hear the details and lessons learned through US UDI, UK Scan4Safety, EU’s EUDAMED, and other global regulations that are shaping a broader approach to UDI/Master Data Management (MDM) processes, systems and standardization to ensure a scalable, sustainable MDM program to support emerging global requirements.
International Standards & Quality Management Systems: The Framework for Incorporating Sustainable UDI Processes Within Your Organization – 1.0 CPE
Speaker: Lena Cordie, President, Qualitas Professional Services, LLC.
Whether you are a manufacturer, distributor or healthcare facility, UDI has likely entered your daily vernacular. But what does it take to incorporate it into your organization’s daily operations in a way that allows for the addition of different requirements from new jurisdictions? Change is inevitable but the pains associated with change can be reduced and/or eliminated if you develop sustainable UDI processes that incorporate commonly shared principles and best practices. This session with explore how international standards and quality management systems can be used to build the framework to UDI processes that are not only compliant, but also adaptable.
Exhibits & Networking Reception
Sponsored by 
Multiple prizes will be given away during the Reception – must be present to win!
Registration Open
Exhibits, Networking & Coffee – Make the most of your time by visiting with the UDI Exhibitors and networking! Exhibit Hall open 8:30am – 2:30pm
EU MDR & IVDR Intensive: What We Know Today; Challenges Defined; and Action Steps You Need to Take – 1.5 CPEs
Speaker: Jay Crowley, Vice President, UDI, USDM Life Sciences; others to be announced
The new European medical device regulations (the MDR and IVDR) are to start implementing in less than 1 year (MDR DoA is 26 May 2020; IVDR is 2022). This session will compare the US UDI to the EU requirements and provide a guide as to what device manufacturers and other economic operators need to be aware of and action they should be taking today in order to be prepared for the imminent changes. This is also a time for you to share your questions with the expert panelists and gain clarity on issues you are facing.
Exhibits & Coffee Break
UDI Beyond Regulations and Compliance: In the Trenches Treating Patients – 1.0 CPE
Speakers: Nancy LeMaster, Interim Director, Learning UDI Communities (LUC) AHRMM; Trent Pierce, Implant Coordinator, Shock Trauma Operating Room, University of Maryland Medical Center; Wendy Watson, OR Supply Chain Manager, University Health Network; David A. Rapp, CIO, VP Supply Chain, Wheeling Hospital, Inc.
With all the talk about data, regulations and compliance it’s easy to lose track of the fact that the UDI was created to enhance patient safety, improve outcomes, and expand the efficiency of the supply chain. This session will humanize UDI and drive home the importance of the data within the GUDID. Hear directly from people on the hospital front lines that interact daily with clinicians and patients. What are the consequences when they encounter multiple device identifiers or bar codes won’t scan? Learn what is working, what needs to be improved, how UDI is critical for streamlining EHR efforts, and the many enhanced benefits realized for patient safety.
Luncheon & Exhibits / Networking
Tips & Tricks Roundtables
In addition to all the solutions in the Exhibit Hall, take advantage of the Roundtables during this time. Topics will include:
The Implant Imperative: Capturing the UDI in the Perioperative Setting at the Point of Use – .5 CPE
Speakers: Mike Schiller, Vice President Healthcare Engagement, MatrixIT; Brad Steger, Global Project Manager for UDI Systems, Zimmer Biomet; David A. Rapp, CIO, VP Supply Chain, Wheeling Hospital, Inc.; Lisa Erlinger, Ph.D., CRNA, Director of Surgical Services and Director of Anesthesia at Wickenburg Community Hospital; Walter Pistor, Healthcare Solutions Specialist, Ping Identity
The need to capture UDI data at the point of use is driving a host of changes to the way implants are packaged and scanned. Join our panelists who will tell the implant story from their perspectives; manufacturer, health IT, perioperative nurse, and downstream analytics. The panel will detail the current climate, challenges, cooperative efforts underway and benefits based on data from case studies and observations gained through pilot programs to scan and capture the UDI in the procedural sterile field setting.
Real World Evidence: Research Driving Better Device Design – 1.0 CPE
Speakers: Dr. James Tcheng, Professor of Medicine, Duke University School of Medicine; JaWanna L. Henry, Public Health Analyst, Office of Technology- Technical Strategies and Analysis- Strategic Initiatives, Office of the National Coordinator for Health Information Technology; Colleen Skau, Ph.D., Quality and Research Programs Manager, American Urogynecologic Society; Terrie Reed, Senior Advisor for UDI Adoption, U.S. Food & Drug Administration
Much of the focus of the UDI regulations in both the U.S. and Europe is designed to garner real world evidence on how products perform in the real world. Research findings will be highlighted from bringing together leadership, expertise, and resources from health care professionals, industry, patient groups, payers, academia, and government to build and operate a national medical device evaluation system. Details on outcomes, impacts and findings will be shared. This panel explores how organizations are changing systems and processes to leverage this data, how it will impact your organization, and how to use the collected data to improve medical device development. This will be highlighted through the sharing of two specific Pilot programs.
Stretch Break
UDI Community Collaboration – Join the Conversation! – 1.0 CPE
Brought to you by Learning UDI Communities (LUC), AHRMM
Moderator/Facilitator: Nancy LeMaster, Interim Director, Learning UDI Communities (LUC) AHRMM
Panelists: Terrie Reed, Senior Advisor for UDI Adoption, U.S. Food & Drug Administration; EllenMary Martin, Chief Strategy Officer and & Vice President of Product Management, DUKAL Corporation, and a board member of the Healthcare Manufacturers Management Council (HMMC); Zach Rothstein, Vice President, Technology & Regulatory Affairs, Advanced Medical Technology Association (AdvaMed); Joan Meléndez,Co-Founder & Partner, TeamEHR
This session will highlight the role of AHRMM’s Learning UDI Community (LUC) group and how it has created a platform for Industry organizations/stakeholders to come together to engage and cooperate in the UDI adoption efforts to ensure that expected UDI benefits are achieved. You will hear what industry organizations are teaching and learning about UDI adoption, and programs being implementation through their member constituents representing the healthcare providers, medical device manufacturers, distributor organizations, and others. Gain an understanding of the strategic UDI priorities creating the collaborative communities both here in the United States as well as other countries for the benefit of global trade and device evaluation.
Conference Wrap-Up and Prize Winners Announced (MUST be present to win!).
