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

Overview

MeSH

  • Automatic Data Processing
  • Humans
  • Medical Record Linkage
  • Patient Identification Systems
  • United States
  • United States Food and Drug Administration
  • Workflow

MeSH Major

  • Electronic Health Records
  • Equipment and Supplies

abstract

  • 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. 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. 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. 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.

publication date

  • January 2014

has subject area

  • Automatic Data Processing
  • Electronic Health Records
  • Equipment and Supplies
  • Humans
  • Medical Record Linkage
  • Patient Identification Systems
  • United States
  • United States Food and Drug Administration
  • Workflow

Research

keywords

  • Journal Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1097/MLR.0000000000000012

PubMed ID

  • 24322986

Additional Document Info

start page

  • 26

end page

  • 31

volume

  • 52

number

  • 1