Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers

Abstract

Background

The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption.

Methods

Semi-structured interviews were performed with health system personnel involved in UDI implementation in their cardiac catheterization labs or operating rooms. Interviews were transcribed and analyzed using the framework methodology of Ritchie and Spencer. An expert panel evaluated findings and informed barriers, strategies, and next steps.

Results

Twenty-four interviews at ten health systems were performed. Identified barriers were internal (lack of organizational support, information technology gaps, clinical resistance) and external (information technology vendor resistance, limitations in manufacturer support, gaps in reference data, lack of an overall UDI system). Identified strategies included relationship building, education, engagement, and communication. Next steps to advance UDI adoption focus on education, research, support, and policy.

Conclusions and Implications

Delineation of UDI implementation barriers and strategies provides guidance and support for health systems to adopt the UDI standard and electronically document UDIs during clinical care. Next steps illuminate critical areas for attention to advance UDI adoption and achieve a comprehensive UDI system in health care to strengthen patient care and safety.

Keywords:

• unique device identifier
• FDA
• implementation barriers
• implementation strategies
• information technology systems
• device manufacturer responsibilities

Acknowledgments

This project would not have been possible without significant multi-stakeholder work and support. We thank the BUILD Consortium members for their engagement and support of the project: Dennis Black, Becton, Dickinson and Company; Kevin Capatch, M.S., Geisinger; Jeff Dressler, MBA, Abbott Laboratories; Curtis Dudley, Mercy; Jo Carol Hiatt, M.D. MBA, previously Kaiser Permanente; Theodore Heise, Ph.D., RAC, MED Institute; Kay Hysell, Mayo Clinic; Tom Maughan, DePuySynthes; Bart Phillips, M.S., Medtronic; Terrie Reed, M.S., previously US FDA; Angela Silvestri, RAC, Stryker; Cynthia Shumway, Intermountain Healthcare; Brad Steger, Zimmer Biomet; Paul Varosy, M.D., FACC, FAHA, FHRS, Department of Veterans Affairs Eastern Colorado Health Care System; Kirk Wiedmeier, previously Duke University Health System (Ended involvement before project end: Lesley Kelly Hall, previously Healthwise; Michael Schiller, CMRP, AHRMM). We thank Melina Cox-Ferrera, M.S. and Lara Salvo, M.S. for their project support.

Disclosure

Natalia A Wilson reports Advisory Committee involvement in the AIM North America UDI Advisory Committee, Association for Health Care Resource & Materials Management Learning UDI Community Steering Committee; Consulting for Arizona State University’s Center for Healthcare Delivery and Policy, Mass General Brigham; Research funding from the National Evaluation System for health Technology Coordinating Center, Patient-Centered Outcomes Research Institute; Purchased stock options in Vitreos Health. James E Tcheng reports being on the Board of Directors of the Regenstrief Foundation, Member of the HL7 Advisory Council, Co-chair of the HL7 Clinical Interoperability Council, Consultant for Lumedx. Jove Graham reports Research funding from Astra Zeneca, Medtronic Inc., Purdue Pharma LP, Patient-Centered Outcomes Research Institute, Pfizer Inc. The authors report no other conflicts of interest in this work.

Additional information

Funding

This work was supported by HHS-FDA 1U01FD005476-01 REVISED, 02 REVISED, and 03 as well as grants from Johnson & Johnson and Medtronic, Inc. The funds were received by Mercy.