Report on device safety recommends unique device identifiers (UDI)

Read the full senate report from the Health, Education, Labor, and Pensions Committee.

Recommendation #1: Congress should require and promote that unique device identifiers (UDIs) be included in insurance claims, electronic health records, and device registries.”
Additional news coverage:

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.

Medical Device Research at a Regional Health System

Journal Asian Hospital and Healthcare Management
Authors Joseph P Drozda and Timothy R Smith
Year Published 2014
Link to Publication – (PDF)

Abstract

In 2009, Mercy made the decision to embark on a research programme involving implanted medical devices by employing Unique Device Identifiers (UDIs). Mercy is a four-state regional health system headquartered in St. Louis, Missouri that serves communities in Arkansas, Kansas, Missouri, and Oklahoma through 40 hospitals ranging from small, critical access facilities to large tertiary medical centres. In addition, Mercy employs over 2,000 physicians specialised in multiple disciplines and generates in excess of US$4 billion annually.

Mercy’s Information Journey

In 2006, Mercy began implementing EpicCare (Epic, Verona, WI) Electronic Health Record (EHR) in all of the system’s hospitals and employed physician practices – a process that took over six years to complete which resulted in a ‘fully connected’ health system generating a significant amount of clinical data across the healthcare spectrum. Despite this success, Mercy continues to face challenges in turning these data into actionable information due in part to free-standing clinical and administrative databases such as those contained in the cardiac catheterisation laboratory (Cath Lab) software and the Enterprise Resource Planning (ERP) solution. These ‘data islands’ make it difficult to establish a comprehensive view of administrative, clinical processes and of patient outcomes necessary for Mercy leaders to manage in the changing healthcare environment created by US Affordable Care Act (ACA).

New Business Environment and Need for Actionable Information

As healthcare reforms proceed, Mercy must learn to deal with US Centers for Medicare and Medicaid Services (CMS) programmes such as value-based purchasing, and public reporting of hospital and physician performance, along with different delivery models, such as patient centered medical homes and Accountable Care Organisations (ACOs). Mercy’s Springfield ( Missouri), network is participating in CMS’s ACO programme building on experience gained from the network’s successes as part of the earlier CMS Physician Group Practice demonstration. Finally, CMS is also working on new reimbursement strategies meant ultimately to replace fee for service. These include shared savings; bundled payments; and, potentially, monthly payments per assigned beneficiary (capitation). All of these changes will require an in-depth understanding of both the clinical and administrative aspects of the business and how the two interrelate.

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.