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.

Journal of Bone and Joint Surgery, Vol 96, Issue Supplement 1

Journal Journal of Bone & Joint Surgery, Vol 96. Supplement 1 – International Consortium of Orthopedic Registries
Authors Multiple
Year Published 2014
Link to Publication

List of 14 Articles

  • National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative
  • A Distributed Health Data Network Analysis of Survival Outcomes: The International Consortium of Orthopaedic Registries Perspective
  • Effect of Femoral Head Size on Metal-on-HXLPE Hip Arthroplasty Outcome in a Combined Analysis of Six National and Regional Registries
  • Risk of Revision Following Total Hip Arthroplasty: Metal-on-Conventional Polyethylene Compared with Metal-on-Highly Cross-Linked Polyethylene Bearing Surfaces: International Results from Six Registries
  • Distributed Analysis of Hip Implants Using Six National and Regional Registries: Comparing Metal-on-Metal with Metal-on-Highly Cross-Linked Polyethylene Bearings in Cementless Total Hip Arthroplasty in Young Patients
  • Comparative Effectiveness of Ceramic-on-Ceramic Implants in Stemmed Hip Replacement: A Multinational Study of Six National and Regional Registries
  • Multinational Comprehensive Evaluation of the Fixation Method Used in Hip Replacement: Interaction with Age in Context
  • International Comparative Evaluation of Knee Replacement with Fixed or Mobile Non-Posterior-Stabilized Implants
  • International Comparative Evaluation of Knee Replacement with Fixed or Mobile-Bearing Posterior-Stabilized Prostheses
  • International Comparative Evaluation of Fixed-Bearing Non-Posterior-Stabilized and Posterior-Stabilized Total Knee Replacements
  • Survivorship of Hip and Knee Implants in Pediatric and Young Adult Populations
  • Which Implant Should We Use for Primary Total Hip Replacement?: A Systematic Review and Meta-Analysis
  • Review of Clinical Outcomes-Based Anchors of Minimum Clinically Important Differences in Hip and Knee Registry-Based Reports and Publications
  • Implementation of Patient-Reported Outcome Measures in U.S. Total Joint Replacement Registries: Rationale, Status, and Plans

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.

Value of Unique Device Identification in the Digital Health Infrastructure

Journal JAMA
Authors Wilson, Natalia A.; Drozda, Joseph Jr.
Year Published 2013
Link to Publication

IN RECENT YEARS, HIGH-PROFILE CASES OF MEDICAL device failure resulting in patient harm—such as implantable cardioverter-defibrillator leads and metal-on metal hip implants—have received substantial attention both in the medical literature and popular press. These examples illustrate the need for a more effective system of monitoring device performance and protecting patient safety. The first action in the Food and Drug Administration’s (FDA’s) report on strengthening postmarket device surveillance, “establish a Unique Device Identification (UDI) System and promote its incorporation into electronic health information,” was addressed with publication of the UDI Proposed Rule.

This viewpoint article by Natalia Wilson and Joseph Drozda, published prior to publication of the Final Rule, highlights the role of UDI in supporting an effective medical device monitoring system and enhanced patient safety. The authors lay out the expected benefits of a UDI system to strengthen post market surveillance of medical devices, ensure ability to track a device across health care settings, support safe and accurate device use, standardize device documentation in health information technology (HIT) systems, enhance recall management, and support health care cost savings.

Postmarket surveillance for medical devices: America’s new strategy

Journal BMJ
Authors Normand, Sharon-Lise T.; Hatfield, Laura; Drozda, Joseph; Resnic, Fred
Year Published 2012
Link to Publication

Abstract

The FDA’s plan is a big ask but will be well worth the effort

In September 2012, the US Food and Drug Administration (FDA) released its vision for a postmarket surveillance system for medical devices, describing four key strategies to protect public health. But why this initiative now? Firstly, several concerns about the safety of specific devices, such as the Medtronic Fidelis defibrillator lead and the DePuy ASR hip implant, have garnered substantial press coverage. Secondly, the Institute of Medicine recently called for a substantial overhaul of processes for the approval and postmarket safety surveillance of medical devices. Thirdly, the FDA has undertaken several premarket initiatives to improve the efficiency of the regulatory review for innovative devices. With the number and complexity of medical devices growing rapidly, it is timely to complement the new premarket initiatives with a strong postmarket surveillance program.

Regulation of the entry into use of medical devices in the United States was introduced after that for drugs table, and it quickly became apparent that the public health assessment of devices would need to be different from that of drugs. Unlike drugs, medical devices are assembled from many components, may affect patients long after the initial exposure, and have rapid product development cycles, which lead to frequent incremental improvements. Medical devices also pose unique challenges to studying …