2020 UDI Conference Agenda (as of March 12, 2020 – subject to change)
UDI Conference Registration Open
GS1 Standards for U.S. FDA UDI Workshop
(Co-located program delivered by GS1 US. Separate registration required.)
Attend this workshop for guidance on how to use GS1 Standards within the context of the U.S. FDA UDI Rule.
This workshop will cover the basics of the U.S. FDA UDI Rule and the GS1 Standards that can be used to address certain aspects of the requirements such as product identification and product labeling in both human readable and automatic information and data capture (AIDC) format.
This workshop will also cover:
• The importance of data quality and data governance as components of a UDI implementation.
• How to avoid some of the most common GTIN assignment issues.
• Standards for label quality and format.
• EU UDI requirements and global medical device updates.
Pre-Conference Workshop: The Evolving Global UDI Imperative – Working Through the Chaos to Build a Sustainable Framework
(Offered as part of your UDI Conference Registration)
Workshop Facilitators: Jay Crowley, Vice President, UDI, USDM Life Sciences; Marti Velezis, UDI Practice Lead /UDI GUDID Architect, USDM Life Sciences
As global regulators, purchasers and other 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 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, maintain and submit the ever-growing (and changing) broad set of global device attribute information to these various robust global systems, processes and stakeholders.
This session will review the current global climate, outline the trends and the direction of the international UDI activities, and break down the confusion. You will gain an understanding of why you need to work with health-care providers, researchers, patients, purchasers, insurers, and regulators 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 establishing and supporting a sustainable framework.
Note: The next two sessions run concurrently from 8:30am – 12:00pm. Please choose the session of most interest to you.
UDI BootCamp Concurrent Session
Delivered by the U.S. FDA UDI Team, this BootCamp will cover Class I UDI specifics, regulatory basics, and UDI submissions & edits. The team will be available for open discussions and answers to your questions.
The EU MDR & IVDR Workshop Concurrent Session
The EU MDR regulation applies from 26 May 2020 – with significant UDI requirements, some of which are new and different from the US regulation. We will cover these differences in the session and highlight major new challenges with ample time for audience discussion.
Luncheon & Exhibits
Speaker: Steven Luxenberg, Director, Technology & Data Services, Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration
Understanding Kits & Combination Products
Speakers from U.S. FDA UDI Team to be announced
Auto ID Technology Perspective: UDI & RAIN RFID – Transforming the Healthcare Supply Chain
Panel of RAIN Alliance Healthcare Committee Members to include: Chair, Paul M. Elizondo, Vice President of Engineering and R&D, IntelliGuard; Committee Members: Hailey Meadows, Continuum Account Executive, DeRoyal; Kristine Lohman, Marketing Communication Specialist, Terso; Brent Koeppel, Principal Research and Development Engineer, Cardinal Health
RAIN RFID is being successfully deployed, with encoded Unique Device Identifiers, to track all classes of medical devices. This session will provide you with information on case studies from acute care facilities tracking medical devices ranging from operating room towels to artificial hips; smart cabinets for tracking dental and ocular medical devices; and Cardinal Health’s experience with tracking medical devices across all classes.
The logistics and the challenges of tagging medical devices with RFID “midstream”, sterilization requirements, the barriers to source tagging, and the remaining challenges to complete source-to-patient tracking will be discussed. In addition, chain of custody, recall, charge capture, and authentication benefits will be addressed to provide a full understanding of the current RFID activities transforming the healthcare supply chain.
Exhibits & Break
Get your prize cards completed during this time
Global UDI Data Submissions: Lessons Learned (so Far)
Speakers: John Lorenc, Sr. Manager, Regulatory Solutions – Life Sciences, Reed Tech; Becky Aldhizer, Senior Manager, Regulatory Operations, Steris; Shana Harton, Senior Analyst, Unique Device Identification, J&J
Gain insights from medical device manufacturers who have implemented, and are maintaining UDI data and submissions to multiple regulatory UDI databases such as US FDA GUDID, EU EUDAMED, South Korea IMDIS, and Turkey. You will hear implementation retrospectives on what went well; what did not go as envisioned; and what adjustments need to be implemented. Approaches on global product data management strategy; communication and alignment with global stakeholders/affiliates; consistencies/differences in regional device identification business rules; and strategy plans for future global UDI compliance will be shared.
Informal Networking Gathering (cash bar)
Exhibits, Networking & Coffee – Make the most of your time by visiting with the UDI Exhibitors, networking and getting your Prize Card completed! Exhibit Hall open 8:30am – 1:30pm
Why UDI: Unlocking the Value for Patients, Partners, and YOU
Speaker: Karen Conway, Vice President, Healthcare Value, GHX
Utilizing the UDI in the Recall Process
Moderator: Mike Schiller, Senior Director, American Hospital Association, Association for Health Care Resource & Materials Management
Panelists: AHRMM Learning UDI Community Members to be announced
This session will open with a brief overview of the pain points associated with the current recall process, rapidly transitioning from presentation to innovative idea sharing session. The goal is to create an environment, through open dialogue, for idea generation and action planning which can be incorporated into the AHRMM LUC Recall Work Group’s Recommended Practices deliverable thereby bringing a comprehensive stakeholder voice to the final report.
Scanning for Interoperability: Using the FDA UDI System to Improve Implant Documentation and Recall Management
Speakers: Terrie Reed, (Former FDA Senior Advisor for UDI adoption), Manager, Reed McCullough, LLC; Joan Melendez, President, XCELRATE UDI
Luncheon & Exhibits / Networking – last chance to get your Prize Card completed!
UDI Implementation Roadmap for Providers
Speakers: Natalia Wilson, MD MPH, Clinical Associate Professor, Arizona State University | College of Health Solutions and Adjunct Assistant Professor, Mayo Clinic Alix School of Medicine; Dr. James Tcheng, Professor of Medicine, Duke University School of Medicine; Karen Conway, Vice President, Healthcare Value, GHX
This session will detail the practical and usable guidance on implementation of UDI for implantable devices at the point of clinical care. The UDI Implementation Roadmap created from leadership interviews, delineates four key areas in UDI implementation: Foundational Themes, Key Components, Key Steps, and UDI Use. It is designed to serve as a guide for hospital systems to develop their own organization-specific roadmaps.
Also discussed will be the gaps & challenges within Provider settings to include: Clinical, Information Technology, the Global Unique Device Identification Database (GUDID), Manufacturers, Support, and the Overall UDI System as well as some strategies utilized by hospital systems to address them. The session will conclude with recommendations on next steps to improve adoption of UDI, consisting of pilot projects, topics for workgroup initiatives, further stakeholder engagement, and areas of policy focus.
The Last Mile: Transmitting the UDI from the Point of Use to Insurance Claims
The Final Results and Future Direction of the UDI2Claims Project
Speakers: Joel S Weissman, PhD, Professor of Surgery (Health Policy) Harvard Medical School, Chief Science Officer and Deputy Director, Center for Surgery and Public Health, Brigham and Women’s Hospital; other speakers to be announced
UDI Community: Current Activities & Future Landscape for UDI
Moderator/Facilitator: Steven Luxenberg, Director, Technology & Data Services, Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration
Panelists: Mike Schiller, Senior Director, American Hospital Association, Association for Health Care Resource & Materials Management; Paul M. Elizondo, Chair, RAIN Alliance Healthcare Committee; David Forbes, Director, Healthcare Supply Chain Collaborative,
Health Industry Distributors Association; Eric Marshall, Executive Director, Partnership for DSCSA Governance (PDG)
Conference Wrap-Up and Prize Winners Announced (MUST be present to win!).