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Section 1h: Cross-paradigm/Domain Analysis Models
Section 3: Implementation Guides

HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2

DESCRIPTION

The Unique Device Identifier (UDI) Pattern provides the guidelines for exchanging UDI information associated with medical devices, initially implantable devices in patients.  This document will not give implementation guidance for specific use cases and worfklows, but will set the overarching guidelines for all working groups that need to exchange the unique device identification on the fields and format intended for expressing UDI related data using V2, V3, and FHIR.  The goal of the UDI Pattern is to enable semantic interoperability for recording UDI information on medical devices used on or implanted in patients regardless of the information exchange standard used to move the information across (e.g., HL7 Version 2.x, HL7 v3 messages or CDA, HL7 FHIR).

 

ALTERNATIVE NAMES

HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2 may also go by the following names or acronyms:

"Reaffirmation of HL7 Implementation Guide: UDI Pattern, R2",HL7 IG UDI R2,"HL7 XParadigm IG: UDI Pattern, R1",Unique Device Identifier, UDI, Pattern, "HL7 Version 3 Cross Paradigm Implementation Guide: Medical Devices and Unique Device Identification (UDI) Pattern, Release 1"

TARGETS

  • Clinical and Public Health Laboratories
  • Quality Reporting Agencies
  • Standards Development Organizations (SDOs)
  • Regulatory Agency
  • Payors
  • EHR, PHR Vendors
  • Equipment Vendors
  • Health Care IT Vendors
  • Clinical Decision Support Systems Vendors
  • Lab Vendors
  • HIS Vendors
  • Emergency Services Providers
  • Local and State Departments of Health
  • Medical Imaging Service Providers
  • Healthcare Institutions (hospitals, long term care, home care, mental health)

 

BENEFITS

  • Creates clarity on where and how to document UDI related information in the base standards
  • Enables implementation guides that require access and/or exchange of UDI related information to consistently define how to communicate it

 

IMPLEMENTATIONS/CASE STUDIES

  • EHRs Certified to ONC’s 2015 Certification Edition 
  • US FDA GUDID 
  • IHE Patient Care Device Technical Framework

 

DEVELOPMENT BACKGROUND

The UDI Pattern was initially defined as a harmonization document.  As the definitions solidified in the respective standard, the guidance was put in normative, cross-paradigm specification to ensure a higher degree of conformance.

With Release 2, updates resulting from HL7 v2.9 and HL7 FHIR R4 were included.

RELATED DOCUMENTS

HL7 Cross Paradigm Implementation Guide: UDI Pattern, Release 2

(Download)

TOPICS

  • Attachments
  • Cardiology
  • Care Provision
  • Clinical Statement
  • Healthcare Devices
  • Laboratory
  • Materials Management
  • Patient Care
  • Regulated Products
  • Regulated Studies
  • Scheduling

BALLOT TYPE

  • Normative

STATUS DATE

2024-04-16

RESPONSIBLE WORK GROUP

Orders and Observations

STAKEHOLDERS

  • Clinical and Public Health Laboratories
  • Clinical Decision Support Systems Vendors
  • EHR, PHR Vendors
  • Emergency Services Providers
  • Equipment Vendors
  • Health Care IT Vendors
  • Healthcare Institutions
  • HIS Vendors
  • Lab Vendors
  • Local and State Departments of Health
  • Medical Imaging Service Providers
  • Payors
  • Quality Reporting Agencies
  • Regulatory Agency
  • Standards Development Organizations (SDOs)

FAMILY

  • Cross-paradigm

CURRENT STATE

  • Active

REALM

  • Universal