The Food and Drug Administration’s Unique Device Identification System Better Postmarket Data on the Safety and Effectiveness of Medical Devices.

Journal JAMA
Authors Rising J, Moscovitch B.
Year Published 2014
Link to article

Summary

This viewpoint article from the Pew Charitable Trust discusses the benefits of UDI use. Indicated is that inclusion of UDI in patient electronic health records, claims, and medical device registries is necessary to achieve benefit of the UDI system. A call to action is put forth for government agencies, specialty medical societies, and health care organizations to collaborate in order to achieve the potential of UDI use.

National projections of time, cost and failure in implantable device identification: Consideration of unique device identification use.

Journal Healthcare
Authors Wilson N, Broatch J, Jehn M, Davis C.
Year Published 2015
Link to article

Summary

The authors of this article developed national projections of time, cost, and failure in implant identification prior to revision total hip and knee arthroplasty (THA/TKA). Projections were significant, including projections for failure in implant identification prior to revision THA/TKA as greater than 50,000 preoperatively and 25,000 intraoperatively by 2030. Authors conclude that findings support the need for improved implant documentation and identification, highlighting the need for a UDI system that would set the standard for device documentation and identification.

The mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system

Journal Healthcare
Authors Joseph P. Drozda Jr., Curtis Dudley, Paul Helmering, James Roach, Lisa Hutchison
Year Published 2016
Link to article

Summary

This article examines results of the FDA-sponsored UDI demonstration where prototype UDIs of coronary stents were scanned and captured in Mercy’s electronic information system. The demonstration revealed improved inventory management and cardiac catheterization laboratory supply tracking. The resulting benefits of incorporating UDIs into the electronic information system included preventing procedure delays, lowering cost, and increasing revenue. Challenges with the demonstration ranged from technology integration to inventory management application and data limitations. The authors conclude the UDI system can be extended to all medical devices and implemented in most hospitals.

Implementing unique device identification in electronic health record systems: organizational, workflow, and technological challenges

Journal Medical Care
Authors Campion, Thomas R JR; Johnson, Stephen; Paxton, Elizabeth; Mushlin, Alvin; Sedrakyan, Art
Year Published 2015
Link to article

Abstract

Provided from the perspective of the MDEpiNet Science and Infrastructure Center at Weill Cornell Medical College, authors discuss the organizational, workflow, and technological challenges associated with UDI implementation. Recommendations to address UDI implementation challenges from regulatory, peer organization and specialty society perspectives are included. The authors propose that in order to achieve the benefits of the UDI system envisioned by the FDA, there must be integration among involved people, processes, and technology.

BACKGROUND: The United States Food and Drug Administration (FDA) has proposed creating a unique device identification (UDI) system for medical devices to facilitate postmarket surveillance, quality improvement, and other applications. Although a small number of health care institutions have implemented initiatives comparable with the proposed UDI system by capturing data in electronic health record (EHR) systems, it is unknown whether institutions with fewer resources will be able to similarly implement UDI.

OBJECTIVE AND METHODS: This paper calls attention to organizational, workflow, and technological challenges in UDI system implementation by drawing from the literature on EHR and clinical research systems implementation.

FINDINGS: Organizational challenges for UDI system implementation include coordinating multiple stakeholders to define UDI attributes and characteristics for use in EHRs, guiding organizational change within individual institutions for integrating UDI with EHRs, and guiding organizational change for reusing UDI data captured in EHRs. Workflow challenges include capturing UDI data in EHRs using keyboard entry and barcode scanning. Technological challenges involve interfacing UDI data between EHRs and surgical information systems, transforming UDI and related patient data from EHRs for research, and applying data standards to UDI within and beyond EHRs.

DISCUSSION AND CONCLUSIONS: We provide recommendations for regulations, organizational sharing, and professional society engagement to raise awareness of and overcome UDI system implementation challenges. Implementation of the UDI system will require integration of people, process, and technology to achieve benefits envisioned by FDA, including improved postmarket device surveillance and quality of care.

Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration.

Journal The American Heart Journal
Authors Tcheng, James; Crowley, Jay; Tomes, Madris; Reed, Terrie; Dudas, Joseph; Thompson, Kweli; Garratt, Kirk; Drozda, Joseph Jr.;  on behalf of the MDEpiNet UDI Demonstration Expert Workgroup
Year Published 2014
Link to publication

Abstract
BACKGROUND: Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration.

METHODS: An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data.

RESULTS: Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management.

CONCLUSIONS: This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information.