Defining a Globally Unique Device Identifier

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Type Standard / Implementation Specification Standards Process Maturity Implementation Maturity Adoption Level Federally required Cost Test Tool Availability
Standard
Final
Production
Rating 1
Yes
Free
N/A
Implementation Specification
In Development
Pilot
Rating 1
No
Free
N/A
Limitations, Dependencies, and Preconditions for Consideration Applicable Value Set(s) and Starter Set(s)
  • Per the FDA, Unique Device Identification system will be phased in over several years, with the final compliance date of September, 2020.
  • Compliance date for UDI of implantable, life supporting and life sustaining devices was 9/24/2015.  These data are available at http://accessgudid.nlm.nih.gov.
  • The HL7 Harmonization Pattern for UDIs is currently in development, with the next revision release anticipated in February 2018.
  • See UDI projects in the Interoperability Proving Ground.
  •  Feedback requested

Comment

NCPDP - Comment

Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP Product Identifiers Standard Implementation Guide Version 1.4

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 3

Federally Required – No

Cost – $

Test Tool Availability – No

New Comment -Section I – U Defining a Globally Unique Device

Please make the following changes:

1.Please add row for  “Implementation” and add “IEEE 11073 PHD Harmonization Pattern for Unique Device Identifiers”. The remaining fields are the same as for HL7 Harmonization…

NCPDP Response

The NCPDP Product Identifiers Standard Implementation Guide is intended to define, clarify, and ensure continuity of the Product Identification Codes for drugs and other items used in the healthcare marketplace to meet the needs within the healthcare industry including but not limited to payers, providers and patients. You must be an NCPDP member to access the standards.

NCPDP Comment

Support of the UDI-DI will be available in the NCPDP SCRIPT Standard Version 2017071 and the NCPDP Telecommunication Standard Version F2. Today, these numbers are reformatted to support the field size limitations.