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

Journal Medical Care
Authors Campion Jr, Thomas R., Stephen B. Johnson, Elizabeth W. Paxton, Alvin I. Mushlin, and Art Sedrakyan.
Year Published 2014
Link to Publication

Abstract

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.

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.