BALTIMORE – More than 200 global industry leaders involved in the implementation of the Unique Device Identification rule gathered here for the annual UDI conference on June 11 12, to discuss and learn ways to hasten progress. This year the conference included manufacturers and numerous international representatives interested in growing use of UDI with comparable structured rules in their countries as well as personnel from different medical device manufacturers and providers and government entities interested in how best to use UDI data for master item database integrity.
While UDI use and compliance has been underway in the United States for some time, UDIs are now spreading to the rest of the world for medical devices. Speakers at this year’s annual conference highlighted growing awareness of clinical integration with supply chain management (SCM) and electronic health record (EHR) systems.
The initial structure and discussion of concepts that led to the UDI rule were presented at a conference program in 2006 in Gaithersburg, MD. The UDI rule was finalized Sept. 24, 2013, by the U.S. Food and Drug Administration establishing requirements for manufacturers to mark devices or packaging in both human readable and automatic identification (bar-code) formats. Although it has only been six years since the rule was finalized in 2013, the inaugural UDI annual conference was held years earlier as the rule was being formulated to meet congressionally mandated requirements passed in 2007.
Two preconference sessions took place on June 10 with one focused on GS1 UDI support and the other program co-hosted by GHX and USDM on the globalization of the UDI initiatives. The GS1 program was titled, “GS1 Standards for U.S. FDA UDI Workshop” and the GHX and USDM program, “Expanding and Evolving Global UDI Imperative: Understanding the Future Nexus of Regulatory, Commercial, and Patient-Safety Information.”
The GS1 workshop focused on GS1 standards and systems used within the context of the UDI Rule. Presentations covered UDI basics and requirements for product identification, labeling and submitting data into the FDA Global Unique Device Identification Database (GUDID). The presentations included perspectives on data quality and data governance as central needs for successfully meeting UDI rule requirements.
The GHX USDM program focused on expanding UDI use globally. Issues discussed included regulations and use of “shared” data elements in different regions, countries, and healthcare systems. Highlights of international activities include the European UDI requirements published in 2017 as well as UDI activities in developing similar regulations in Japan, China, Taiwan, South Korea and Saudi Arabia and Singapore, among other areas. Examples of programs outside the U.S. include the Dutch Implant Registry and Scan4Safety launched in 2018 in the United Kingdom National Health System.
Uniting the digital divide
A central focus was costs and benefits derived from UDI use, and the growing recognition of UDI needs to achieve interoperability and ONC requirements for certification of electronic health records. Jay Crowley, Vice President, Unique Device Identification Services and Solutions, USDM Life Sciences, and GHX’s Karen Conway, Vice President, Healthcare Value, GHX, noted the impacts of UDI Production Identifier (PI) and Device Identifier (DI) to facilitate recalls as a key clinical strategy to promote patient safety and enhance quality of care. An overarching part of the discussion was the need for data integrity as a key portion of achieving benefits and trust across systems and trading partners noting, “the information on the label incorporating the UDI is the source of truth for the item and is reflected in the database and recorded in the patient record.” Conway stressed that UDIs are a primary driver for master item data and essential to achieving value for healthcare providers. Marti Velezis, USDM Life Science’s UDI Practice Lead, echoed Conway’s comments that as UDI goes global, the need is managing business processes and handling complex bus rules.
The FDA’s Terrie Reed, Senior Advisor for UDI Adoption, and the FDA’s Erin Quencer, Regulatory Health
Scientist, provided the conference keynote on Tuesday morning, June 11. They discussed progress and expansion of UDI use and provided summary statistics and FDA UDI helpdesk activities to ensure UDI accuracy in real world applications. In discussing global expansion in the use of UDIs, Terrie noted that the International Medical Device Regulators Forum (IMDRF) (http://imdrf.org) has some excellent guides, including UDI System Application Guides N54 and N48. Some of these have just been finalized and build on UDI foundations for achieving consensus worldwide with World Health Organization and many countries. The overarching theme was globally acceptance and growth in use of UDI.
USDM Life Science’s Crowley joined Reed following the opening keynote. They talked about the
patient-safety information needs and the growing impacts of UDI use. Crowley reflected on the first UDI conference in 2006 in Gaithersburg, when GAO Healthcare Director Marcia Crosse noted, “Our preliminary analysis found that firms initiated about 700 recalls per year. However, we found that firms were unable to correct or remove all recalled devices even though subject to the highest risk or Class I recalls….” This was part of the emphasis for the creation of the UDI rule that enables supply chain participants to work together in achieving improved device effectiveness and reducing risks and costs.
The program then shifted to UDI use for healthcare quality and clinical patient safety impacts.
Dr. James Tcheng, Duke University School of Medicine, and Dr. Joseph Drozda, Mercy Health, responded to questions about UDI issues raised by attorney Patrick Lupinetti, Senior Vice President, First Databank. They described how UDl information can be extremely useful to clinicians in achieving efficiencies throughout provider organizations. They noted UDls can provide links to relevant product attributes and can be used to improve EHR documentation, simplify inventory management and facilitate recall management.
A panel featuring Steve Roan, Senior Director, Portfolio Data & Standards Compliance, Smith & Nephew; Dennis Black, Director, eBusiness, BD; and Dawn Fowler, Director, UDI/Master Data Management, Masimo; highlighted their shared vision needs commitment to global harmonization and standardization, and a focus on establishing priorities for use-cases (what are we solving for) based on understanding what data are truly critical to the patient care process. They further indicated the need to enable systems for data consumption and to invest in provider education and technology.
Global, clinical UDI connections
In addition to the emphasis on UDI clinical care impacts, program presentations continued to highlight the growing global use of UDIs with development of international requirements
as part of an ongoing process. As use of UDIs continues to grow, medical device manufacturers require robust master data information procedures within their organizations to ensure UDI data is complete, accurate, and available throughout the product lifecycle.
The following morning, the emphasis on clinical integration of UDI to SCM and EHR systems continued with a program titled, “UDI Beyond Regulations and Compliance: In the Trenches Treating Patients.” Nancy LeMaster, Interim Director, Learning UDI Communities (LUC) AHRMM, led the panel, which also included Trent Pierce, Shock Trauma Implant Coordinator at University of Maryland Medical Center; Wendy Watson, OR Supply Chain Manager, University Health Network, Toronto; and David Rapp, CIO and Vice President, Supply Chain, Wheeling Hospital Inc. Their discussions about UDI use in the perioperative environment drove home the importance of the Global Unique Device Identification Database (GUDID) as a means to supporting clinical care on the hospital front lines for clinicians and patients.
One of the biggest – and most familiar – challenges discussed at this program was the difficulty for nurses in ORs or other areas knowing which bar code to scan. The issues on label scanning are formats of different labels and need for clinicians to know what bar code to scan to capture UDI information for the EHR. Reviewing your organization’s procedures to understand what works and what needs to be improved, including how UDI is critical for streamlining EHR efforts, will lead to enhanced benefits being realized for patient safety. Also important is the association of the bar code in middleware solutions, including notes on implant sites. The group suggested the need to develop training for the use of products and recording of UDIs in the perioperative environment.
The panel reflected on the difficulties of processing recalls prior to the UDI rule in 2013. Since the UDI rule was initially implemented, scanning of data – while still difficult – has made it much simpler to process recalls than previously. One related issue was the request for the FDA to incorporate the DI information on FDA-Issued Recall notices. This request in process change is under review by the FDA.
Mike Schiller, Vice President,Healthcare Engagement, SteriTrack, continued the focus on UDI use in the perioperative environment with Brad Steger, Global Project Manager for UDI Systems, Zimmer Biomet; David A. Rapp, CIO and Vice President, Supply Chain, Wheeling Hospital Inc.; Lisa Erlinger, Ph.D., CRNA, Director of Surgical Services and Director of Anesthesia, Wickenburg Community Hospital; and Walter Pistor, Healthcare Solutions Specialist, Ping Identity. The group reviewed the capture of UDIs at the point of use in the ORs as a driver of changes affecting how implants are packaged and scanned, again homing in on the need to review current processes and provide training to those responsible for capture and entry of UDI data into EHRs in OR sterile field environments.
One notable opportunity provided at the UDI Annual conference was “Tips & Tricks Roundtables.” The roundtables had experts on each topic available to discuss individual needs during lunch breaks with topics covering different UDI issues ranging from technical/data quality, policy/regulatory and adoption, UDI LUM (Lowest Unit of Measure) to the AHRMM Learning UDI Communities (LUC). The roundtables had active participation as attendees sought clarification on the topics and concepts presented.
The 2019 UDI Annual Conference successfully explored the growing trends in the global use of UDIs as well as the impacts and benefits on clinical care with integration to SCM and EHR systems. For those interested in additional information, major suggestions include the AHRMM LUC whitepapers and case studies, the FDA site specifically for the UDI information and recall notices, and the IMDRF site noted. While much progress has been achieved in a few short years, clearly there is more work to be done as participants across the healthcare supply chain seek to enhance the support of quality patient care outcomes.
