Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation December 2014 The Brookings Institution l Washington, DC www.brookings.edu Authors Gregory Daniel Mark McClellan Managing Director, Engelberg Center Director, Health Care Innovation for Health Care Reform and Value Initiative Fellow, The Brookings Institution Senior Fellow, The Brookings Institution Siromi Gardina Dalia Deak Research Director Research Assistant Engelberg Center for Health Care Reform Engelberg Center for Health Care Reform The Brookings Institution The Brookings Institution Jonathan Bryan Craig Streit Research Assistant Research Assistant Engelberg Center for Health Care Reform Engelberg Center for Health Care Reform The Brookings Institution The Brookings Institution This roadmap was developed under a cooperative agreement with the U.S. Food and Drug Administration (FDA) and Chickasaw Nation Industries, Inc. (CNI) LLC About the Engelberg Center for Health Care Reform at Brookings Established in 2007, the Engelberg Center for Health Care Reform at Brookings is dedicated to providing practical solutions to achieve high-quality, innovative, affordable health care. To achieve its mission, the Center conducts research, develops policy recommendations, and provides technical expertise to test and evaluate innovative health care solutions. Acknowledgements The Engelberg Center for Health Care Reform (ECHCR) at the Brookings Institution wishes to thank several individuals that contributed to the research, development and preparation of this roadmap. Roadmap Contributors provided active and ongoing feedback throughout the draft process as well as substantial editorial input. Their involvement was extensive and their contributions are reflected throughout. ECHCR held a kick-off meeting of the UDI Implementation Work Group to begin the conversation around opportunities and challenges associated with UDI implementation, on July 16, 2012. This meeting brought together representatives from key groups, including device manufacturers, payers, electronic health record vendors, academics, clinicians, and others with a vested interest in UDI implementation. With the Work Group’s guidance, ECHR convened three expert workshops on exploring the following topics: exploring the opportunities and challenges associated with capturing UDI in claims, identifying steps for implementation and integration of UDI within electronic data infrastructure of care delivery sites, and utilizing UDIs as a tool for improved patient and provider connectivity. ECHCR used the knowledge harnessed through these expert workshops as a launching pad for developing the roadmap for UDI implementation across the healthcare ecosystem. Finally, the Acknowledgements section recognizes numerous individuals that provided valuable information for case studies, strategies, and recommendations. Although all of these individuals have been involved in the roadmap’s development, neither they nor their organizations necessarily endorse the roadmap’s recommendations or conclusions. Roadmap Contributors Joseph Drozda Terrie Reed Director, Outcomes Research Senior Project Leader, Clinical Informatics Sisters of Mercy Health System Duke Clinical Research Institute Curtis Dudley Walter Suarez Vice President, Integrated Technology Solutions Executive Director, Health IT Strategy and Policy Sisters of Mercy Health System Kaiser Permanente Thomas Gross Margaret Weiker Director, Office of Surveillance and Biometrics Chair, Center for Devices and Radiological Health Accredited Standards Committee X12N U.S. Food and Drug Administration Natalia Wilson Leslie Kelly Hall Associate Director, School for the Science of Senior Vice President, Health care Delivery, College of Health Solutions, Healthwise Arizona State University UDI Implementation Work Group Kristine Martin Anderson Joseph Drozda Senior Vice President, Director, Outcomes Research Booz Allen Hamilton Sisters of Mercy Health System Amy Compton-Phillips Matthew Emons Associate Executive Director, Quality Physician Executive and Senior Director, The Permanente Federation, LLC Cerner 2 Shamiram Feinglass Frederic Resnic VP Global and Regulatory Affairs, CMO, Danaher Chairman, Department of Cardiovascular Corporation Medicine, Lahey Clinic Louis Jacques Kate Ryan Senior Vice President and Chief Clinical Officer, Policy Representative, ADVI NARAL Pro-Choice America Richard Kuntz Art Sedrakyan Senior Vice President and Chief Scientific, Clinical, Associate Professor, Departments of Public Health and Regulatory Officer and Cardiac Surgery, Medtronic Weill Cornell Medical College David S. Muntz Paul Varosy Senior Vice President, Chief Information Officer Director of Cardiac Electrophysiology GetWellNetwork Veterans Affairs Eastern Colorado Health System J. Marc Overhage Natalia Wilson Chief Medical Informatics Officer, Health Services, Associate Director, School for the Science of Siemens Medical Solutions, Inc Health Care Delivery, College of Health Solutions Arizona State University Richard Platt Professor and Chair, Department of Population Medicine, Harvard Medical School Acknowledgments George Arges (American Hospital Association) Joshua Rising (Pew Charitable Trusts) Dennis Black (Becton Dickinson) Sara Rivera (Hubbert Systems Consulting) Karen Conway (GHX) Erin Rubens (Department of Health and Human Jay Crowley (FDA) Services) Joe Dudas (Mayo Clinic) Patricia Shrader (Medtronic, Inc.) Kenny Jackelen (EPIC) Linda Sigg (FDA) Aaron Kaplan (Dartmouth University) Julia Skapik (Office of the National Coordinator) Behnaz Minaei (FDA) Pansy Watson (California Department of Health Elizabeth Paxton (Kaiser Permanente) Care Services) Anita Rayner (FDA) Tess Webre (FDA) Jacob Reider (Office of the National Coordinator) The authors also thank additional Brookings staff members, including Heather Colvin, Adam Aten and Pranav Aurora for their research and editorial support. 3 TABLE OF CONTENTS EXECUTIVE SUMMARY ………………………………………………………………..….………………………………. 5 Part 1: Background and Value of UDI Implementation SECTION 1 Introduction ……………………………….…………………………………………..…………………….………..……………… 7 SECTION 2 Benefits of Achieving Successful UDI Implementation …………………………………………………………….. 12 Part 2: Strategies for UDI Implementation SECTION 3 Integrate UDIs into Provider Systems ……………………..……………………………………………………….……. 28 SECTION 4 Integrate UDIs into Administrative Transactions...……………..….…………………………………………….… 45 SECTION 5 Integrate UDIs into Patient-Directed Tools………………………………………………..……………….………….. 58 Part 3: Conclusion SECTION 6 Conclusion………………………………………………………………………………………………………………........…… 69 APPENDICES Appendix A: Unique Device Identifier Basics .……………………………………..……………………………….... 73 Appendix B: Global Unique Device Identification Database (GUDID) .………………….………………….. 74 Appendix C: Mercy Health Case Study..………………………………………………………………………………..… 75 Appendix D: Glossary of Key Terms ...….………………………………………………………………………………… 83 ENDNOTES ….……………….……………………………………………………………………….…………………….......88 4 UDI Implementation Roadmap © The Brookings Institution, 2014 Executive Summary The U.S. Food and Drug Administration (FDA) is transparency, and more accurate and efficient establishing a national unique device supply chain processes. These activities are more identification system to adequately identify readily conducted for pharmaceuticals because of medical devices through their distribution and the widespread use of National Drug Codes use. When the system is fully implemented, the (NDCs) as the standard mechanism for label of most devices will include a unique device communicating specific pharmaceutical identifier (UDI) in human- and machine-readable information across the health care system. form. Device labelers must also submit certain The benefits of UDI implementation across the information about each device to the FDA- health care system are significant and, while the administered Global Unique Device Identification path to full implementation is complex, there are Database (GUDID). The database, which will serve relatively straightforward steps that can be done as a reference catalog of information about every now to begin realizing many of them. For device with an identifier, will be publicly example, two high priority steps that can be taken accessible to allow all stakeholders— provider in the near term include enabling providers to systems, payers, clinicians, patients, industry, FDA scan and record UDIs into EHRs at the POC and and others— to search, download, and use motivating patients who receive device implants information in the GUDID. The UDI system, which or use other major devices to demand the UDIs will be phased in over several years, represents a from their providers. A national “Know Your UDI” landmark step towards improving patient safety, campaign can be an effective way to increase modernizing device postmarket surveillance, and awareness of the importance of UDIs to patients facilitating device innovation. These promised and consumers. benefits will only be fully realized with the adoption and integration of UDIs into the health Additional strategies include integrating UDIs into care delivery system. hospital inventory management and billing systems, and incorporating UDIs into Adoption and use of UDIs across the health care administrative transactions. Further, integrating system by provider systems, patients, payers, UDIs into easily accessible patient and consumer health information technology (HIT) developers, tools, such as personal health records (PHR) and and many others can