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Section 1a: Clinical Document Architecture (CDA®)
Section 3: Implementation Guides

HL7 CDA® R2 Implementation Guide: C-CDA Supplemental Templates for Unique Device Identifier (UDI) for Implantable Medical Devices, Release 1 - US Realm

DESCRIPTION

This specification has been retired. Please see: HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes STU Companion Guide, Release 3 - US Realm for UDI related templates.

 

 

The “Harmonization Pattern for Unique Device Identifiers” was approved at the March 2016 Harmonization Meeting and outlines the representation of the UDI in HL7 standards (FHIR, CDA, v3 and v2 messages). The document also defines the individual UDI Components for all HL7 standards except for CDA.

The UDI Domain Analysis Model is currently under development in Orders and Observations and will document the use of UDI for Implantable devices.  The UDI DAM will serve as documentation of the requirements for this project.

This project will focus on the UDI requirements and any changes needed in C-CDA to exchange the individual UDI components in the healthcare system when devices are implanted in a patient.  The UDI components include the Device Identifier (DI) and the following individual production identifiers:

  • lot or batch number,
  • serial number,
  • manufacturing date,
  • expiration date, and
  • distinct identification code.

Another known missing information requirement is tracking the implant status through various events – i.e., in addition to implanting a medical device, the device may be removed, made inactive (not removed from the body), replaced and/or entered into the record in error. Therefore, the status of the device is important to capture in the patient’s device record. (refer to PHMR document for guidance).

In addition, there may be other associated clinically relevant information that will need to be documented along with the UDI – e.g., MRI Safety Information (e.g., safety status – MR Safe, MR Unsafe, MR Conditional or not included on label), or whether or not the Device is labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437).

Note: The current Product Instance Template found in C-CDA R2.1 does not currently support the individual UDI components.  There needs to be parallel work in ONC to address the deficiency in the current C-CDA release and provide technical direction when the requirements can be met.

 

This specification has been retired. Please see: HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes STU Companion Guide, Release 3 - US Realm
for UDI related templates.

 

ALTERNATIVE NAMES

HL7 CDA® R2 Implementation Guide: C-CDA Supplemental Templates for Unique Device Identifier (UDI) for Implantable Medical Devices, Release 1 - US Realm may also go by the following names or acronyms:

"CDAR2 IG: C-CDA Additional Templates (Vol 3), R1",,C-CDA Supplemental Templates, C-CDA UDI

TARGETS

  • Clinical and Public Health Laboratories
  • EHR,PHR Vendors
  • Healthcare Institutions (hospitals, long term care, home care, mental health)

BENEFITS

  • Assists EHRs in meeting electronic health record certification criteria from ONC and other national authorities' requirements for the reporting of device identifiers for implantable devices 
  • Assists in meeting FDA mandate that the labeling of devices include UDI in order to actively promote the use of UDI in the information chain to enable recalls, CDS, post-market surveillance and research in general 
  • Enables communication of UDI and its individual components in an unambiguous manner to enable downstream stakeholders to access that information for their business purposes

RELATED DOCUMENTS

HL7 CDA® R2 Implementation Guide: C-CDA Supplemental Templates for Unique Device Identifier (UDI) for Implantable Medical Devices, Release 1 - US Realm

(Download) (1.04 MB)

STU DOCUMENTS

HL7 CDA® R2 Implementation Guide: C-CDA Supplemental Templates for Unique Device Identifier (UDI) for Implantable Medical Devices, Release 1 - US Realm Expiration Nov 2020

(Download) (1.04 MB)

TOPICS

  • Medical Records
  • Patient Care

BALLOT TYPE

  • STU

STATUS DATE

2022-06-10

RESPONSIBLE WORK GROUP

Structured Documents

STAKEHOLDERS

  • Clinical and Public Health Laboratories
  • Healthcare Institutions

FAMILY

  • CDA

CURRENT STATE

  • Retired

REALM

  • US Realm