UDI Adoption

UDIs are unique identifiers for medical devices that are required on the device label and packaging in both human and machine readable (e.g. barcode) forms. An UDI is also required on the actual medical device for devices that are intended for more than one use and intended to be reprocessed before each use. The U.S. FDA mandated the UDI system in September 2013. (UDI Rule).

 

​Use of UDIs benefits clinical care, medical device evaluation, research, regulatory oversight, and health care operations. For instance, UDI provides a standard for documentation of medical devices implanted in patients in the electronic health record (EHR). UDI also supports improved aggregation of post-market device data from EHRs, claims, and clinical registries. A broad UDI system augments FDA’s focus on RWD and RWE to inform risks and benefits of device usage.

 

UDI-Focused Research

  1. The BUILD Initiative (Building UDI into Longitudinal Data for Medical Device Evaluation) 

Principal Investigator: Joseph P. Drozda, Jr., M.D.

Co-Investigators: Jove Graham, PhD, Brent Muhlestein, MD, FACC, FAHA, James Tcheng, MD, Natalia Wilson, MD MPH

 

Brief Description

The aims of the BUILD Initiative were to 1) extend UDI capture and documentation of implantable devices in the cardiac catheterization lab (cath lab) from Mercy to three two additional hospital systems; 2) build a distributed data network with data from implant-requiring procedures in the cardiac cath lab from the three hospital systems; and 3) create an UDI implementation roadmap informed by interviews of US hospital system leaders in UDI implementation. This work supports MDEpiNet by developing the infrastructure and methodology for robust post-market surveillance, research, and innovation through a system of automated capture of clinical data from EHRs and UDI associated device data, all of which can be linked to national registries.

In BUILD’s Extension of the UDI Implementation Pilot (Extension) the Mercy Health coronary stent UDI demonstration project was extended to production status at Geisinger and Intermountain Healthcare.

In BUILD’s Medical Device Data Capture and Exchange: Leading Practices and Future Directions (Leading Practices) leadership interviews in hospital systems that had implemented UDI for implantable devices were performed and informed development of the UDI Implementation Roadmap. A multi-stakeholder consortium of hospital system and manufacturer UDI leaders, the BUILD Consortium, was assembled in order to advise the project and actively participate in creation of the Roadmap. (BUILD Consortium Charter)

Project Partners

The project team included researchers from Mercy, Geisinger, Intermountain Healthcare, Duke, and Arizona State University. Members of the BUILD Consortium included hospital system, manufacturer, FDA, and advocacy group UDI leaders (BUILD Consortium Member Biographies)

 

Source of Funding

This work was funded by HHS-FDA 1U01FD005476-01 as well as funding from Johnson and Johnson and Medtronic.

 

Project Outcomes

The major products of this initiative include the BUILD common data model (CDM), an augmented UDI database (AUDI) containing UDI-linked coronary stent clinically significant attributes, coronary stent research databases at each of the 3 hospital systems constructed on the CDM and containing EHR clinical data and UDI-linked AUDI attributes, a distributed data network of the hospital system databases, and studies using distributed analytics that illustrate the utility of the network data in evaluating stent effectiveness and safety. Another product of the initiative is a Roadmap for UDI Implementation for implantable devices at the point of care that includes an exposition of gaps and challenges with strategies used by hospital systems to address them and of next step areas to advance UDI adoption and use.

 

Reports​

  • Leading Practices Final Summary Report & Roadmap

Wilson NA. Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD) Point of Care Capture of UDI for Implantable Devices Final Summary Report & Roadmap. U.S. Food and Drug Administration. 2019. 

  • Key Roadmap Sections

Implementation Roadmap

Gaps, Challenges & Strategies

Abstract

  • Graham J, Muhlestein J, Tcheng J, McKinnon A, Knight S, May H, Bair T, Capatch K, Drozda J.  Building medical device identifiers into longitudinal data: the BUILD distributed data network.  Abstracts from the 26th annual Health Care Systems Research Network Conference, April 8-10, 2020. J Patient Cent Res Rev. 2020;7:64-137. doi: 10.17294/2330-0698.1762

 

Presentations

  • International Forum on Quality & Safety in Healthcare (virtual). Patient Safety, Implantable Devices, and Unique Device Identification (poster). November 2020

  • 12th Annual Conference on the Science of Dissemination and Implementation. UDI System Implementation for Patient Care and Safety in U.S. Hospital Systems (poster). December 2019

  • HTG Summit 2019. BUILD: Leading Practices Point of Care Capture of UDI for Implantable Devices. October 2019

  • 2019 Academy Health Annual Research Meeting. Building a Unique Device Identification System for Implantable Devices in US Hospital Systems (poster). June 2019

  1. Unique Device Identifier (UDI) Implementation in the Electronic Information of a Single Health System: An MDEpiNet Demonstration

Principal Investigator: Joseph P. Drozda, Jr., M.D.

Brief Description

The U.S. Food and Drug Administration (FDA) envisions strengthening the system of medical device postmarket surveillance through the use of electronic health information gathered in the course of care and sees unique device identifiers (UDIs) as keys enabling linking of disparate systems. To this end, the FDA supported a demonstration performed by Mercy Health (a 4-state regional health system headquartered in St. Louis, Missouri) that had 3 aims:

  • To implement a coronary stent surveillance system in its electronic health record (EHR)

  • To identify the obstacles for creating such a system along with potential solutions

  • To assess the usefulness of the EHR data in device safety surveillance.

 

Mercy designed and implemented a system for capturing prototype coronary stent UDIs by means of barcode scanning in its cardiac catheterization laboratories (cath labs) and incorporating them in its supply chain management, inventory management, billing, and cath lab clinical systems. The UDI was used to link the specific coronary stent with the patient in whom it was implanted. This resulted in creation of a database that included pertinent UDI-related device information and clinical data obtained from the EHR thus enabling assessment of coronary stent safety and effectiveness over time.

Project Partners

Mercy along with Healthcare Transformation Group (HTG) partners (an alliance of Mercy, Geisinger, Intermountain Healthcare, Kaiser Permanente, and Mayo Clinic) assembled an expert panel of interventional cardiologists to help in refining the project design and to select meaningful coronary stent attributes for inclusion in the surveillance database. The expert panel worked with a group of stakeholders that included representatives of HTG health systems, professional societies (American College of Cardiology and Society for Cardiovascular Angiography and Interventions), and industry (Abbott, Boston Scientific, and Medtronic) as well as FDA.

 

The Mercy team was multidisciplinary, led by a senior health services researcher, and was a combined effort of a number of departments: cath lab, research, information technology, supply chain, and operational optimization.

Source of Funding

This work was a part of the MDEpiNet Methodology Center of Harvard Medical School. This work was supported by contract DHHS/FDA-22320172C from the Center for Devices and Radiological Health, USA Food and Drug Administration.

Project Outcomes

This “proof of concept” pilot demonstrated that EHR data can be useful in evaluating implanted medical devices in the postmarket setting. The next step would be to work with a national device registry to obtain this same information in de-identified format from multiple health systems in order to assess large numbers of devices nationally and create a clearer picture of device performance and safety in the real world.

 

The major product of this initiative was a dynamic database, the UDI Research database (UDIR) that is a dataset generated from Mercy’s data warehouse, that contains UDI-associated coronary stent attribute data and clinical data, and that receives clinical data extracted from the EHR on a weekly basis to enable long term patient follow up. The UDIR, then, provides information that can be used in assessment of device safety and effectiveness.

Reports

  • Drozda JP, Helmering P, Moore V, Smith TR. Implementation of Unique Device Identification Demonstration Projects Final Report

Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance.

 

Publications

  • Drozda J, Zeringue A, Dummitt B, Yount B, Resnic F. How real-world evidence can really deliver: a case study of data source development and use.  BMJ Surgery, Interventions, & Health Technologies 2020;2:e000024. doi: 10.1136/bmjsit-2019-000024

  • Drozda JP Jr, Roach J, Forsyth T, Helmering P, Dummitt B, Tcheng JE. Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration. J Am Med Inform Assoc 2018;25:111-120. Originally published on-line May 3, 2017.  Available at https://doi.org/10.1093/jamia/ocx041.

  • Drozda JP, Dudley C, Helmering P, Roach J, Hutchison J. The Mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system. Healtc (Amst.). 2016;4(2):116-9. DOI: 10.1016/j.hjdsi.2015.07.002

  • Tcheng JE, Crowley J, Tomes M, Reed TL, Dudas JM, Thompson KP, Garratt KN, Drozda Jr. JP. Unique device identifiers (udis) for coronary stent post-market surveillance and research: A report from the FDA’s Medical Device Epidemiology Network (MDEpiNet) udi demonstration, American Heart Journal. 2014;168(4);405-13,e2., doi: 10.1016/j.ahj.2014.07.001  

  • Drozda JP, Smith TR. Medical device research at a regional health system: the Mercy experience. Asian Hospital & Healthcare Management. 2014;30

http://www.asianhhm.com/equipment_devices/medical-device-research.html

 

Abstract

  • Slayton R, Roach J, Smith P, Helmering P, Reed T, Resnic F, Normand S-L, Drozda JP Jr. Leveraging health information technology in a large health system: barriers to designing and implementing a unique device identifier research database. Academy Health Health Information Technology Interest Group Meeting, June 7, 2014.

Presentations

  • Unique Device Identifiers in Electronic Health Records. U.S. Food and Drug Administration Unique Device Identification (UDI) for Postmarket Surveillance and Compliance Public Workshop, Bethesda, MD, September 12, 2011.

  • Results of the FDA Unique Device Identifier Demonstration. GS1 Connect 2013 Conference, San Antonio, TX, June 13, 2013.

  • Food and Drug Administration UDI Demonstration. Global GS1 Healthcare Conference, San Francisco, CA, October 3, 2013.

  • Implementation of Unique Device Identification Demonstration Project – A Report from MDEpiNet. Food and Drug Administration Center for Device and Radiologic Health Epidemiology Grand Rounds, Silver Spring, MD, February 20, 2014.

  • Food and Drug Administration UDI Demonstration. HIMSS 2014, Intelligent Hospital Pavilion, Orlando FL, February 25, 2014

  • Update on Mercy’s UDI Demonstration: What’s Next? GS1 Connect Conference, San Diego, CA, June 11, 2014.

  • Device Specific Surveillance: The UDI Demonstration and Beyond. MDEpiNet Annual Meeting. Bethesda, MD, October 14, 2014.

  • FDA UDI Demonstration. HIMSS webinar: UDI at the Heart of the Triple Aim. November 19, 2014.

  • Evaluate how UDI capture in patients’ medical records and other data systems used by providers and clinicians can improve care and affect workflow, and identify standards revisions that are needed to obtain benefits. Part of a panel. Realizing the Benefits of the Unique Device Identifier in Health Care. An event co-hosted by the U.S. Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and The Pew Charitable Trusts, Washington, DC, December 9, 2014.

  • Mercy’s UDI Journey. GS1 Canada Carenet Healthcare Sector Board Meeting Conference Call and Webinar. March 4, 2015.

  • Mercy’s Unique Device Identification Journey. GS1 Canada Healthcare Advisory Council Meeting, Conference Call, and Webinar, April 9, 2015.

  • Medical Devices and the Triple Aim. GHX Supply Chain Summit, Scottsdale, AZ, May 6, 2015.

  • Mercy Unique Device Identification Project.  Part of Transforming Canada and U.S. Health Systems by Leveraging Cross-Border Supply Chains.  Canada-U.S. Health Summit 2015, The Wilson Center, Washington, D.C., November 2-3, 2015. 

  • Mercy Unique Device Identification Pilots.  Health Business Insights Supply Chain Academy webinar, November 24, 2015.

Coordinators

Joseph Drozda, MD, FACC

Natalia Wilson, MD, MPH

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