Agenda

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.

CLICK TO REGISTER FOR THE GS1 WORKSHOP

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.

Registration Open

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.

Welcome Address

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.

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)

Registration Open

Why UDI: Unlocking the Value for Patients, Partners, and YOU

Speaker: Karen Conway, Vice President, Healthcare Value, GHX

This level-setting, thought-inspiring session will explore how UDI regulations fit in the global movement toward value-based healthcare. Understanding the bigger picture helps answer questions around WHY, HOW and WHAT to do to leverage your investments in UDI compliance and adoption to meet evolving market demands, and position your organization for success in a healthcare system that rewards the delivery of outcomes that matter to patients relative to the cost to achieve them. 

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 detail the value of using the UDI in the recall process for each industry stakeholder (suppliers, providers, patients, regulatory, etc.), discuss the current level of usage of UDIs in the recall management process, and share the recommended practices for each stakeholder group to gain the most value going forward.

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

In 2013 the US FDA published a rule establishing the UDI system, intended to identify a medical device through distribution and use. Over the past six years, UDI has increasingly appeared as the unique standard, scannable identifier on millions of medical devices not only in the US but around the world. In the US, AccessGUDID, a free FDA-sponsored publicly available database, enhances the value of UDI through searchable, downloadable and API ready access to over 2.4 million records, each associated with a single device identifier on a device label. Hospitals and their health system vendors are beginning to take advantage of these public resources by developing and using IT systems that scan the UDI and pull data from AccessGUDID to better document implants and other devices as part of health information. This session will go into detail on the work of a case study of a hospital using UDI to improve documentation of implants which reduces the exposure of patients to expired and recalled products. You will hear how they arrived at the decision to use UDIs as part of their efforts to improve OR operations, and describe how UDIs are routinely being scanned and documented, and the efforts being taken to improve the UDI system. Each speaker will offer insights from their own perspective on the impact of UDI today and opportunities for the future.

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

Although there is a national system using health insurance claims for post-market surveillance of drugs (FDA’s Sentinel), no such system exists for monitoring the safety and effectiveness of implantable devices. In advance of expected 2024 regulations that would allow UDI-DIs to be reported in claims, Partners HealthCare, Blue Cross Blue Shield of Massachusetts, Geisinger, and Geisinger Health Plan collaborated to demonstrate the feasibility of transmitting DIs from the point of care (POC) to insurance claims, and analyzed the resulting claims (UDI2Claims Project). The investigators of this federally-funded demonstration and research project will report on their final results. Two stakeholders from the policy / payer/ and stakeholder community will react to the findings and suggest possible ways forward, in particular on the likelihood of adoption by the Centers for Medicare and Medicaid (CMS). Time for discussion at the end of the session will allow for audience questions and feedback.

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

This session will provide industry reports from the leading trade organizations on the current work being conducted on UDI-related activities covering multiple stakeholder positions. 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. Understand how these organizations are supporting each other in a cooperative community fashion, and how you, too, can become involved.

Conference Wrap-Up and Prize Winners Announced (MUST be present to win!).