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  1. FHIR Specification Feedback
  2. FHIR-31750

Complement Valueset-identifier-type for Device identifiers

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    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R4
    • FHIR Infrastructure
    • ValueSet
    • 4.4.1.501.1
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      Code Display Definition
      UDI-
      -      		 Universal Device Identifier An identifier assigned to a device using the Unique Device Identification framework as defined by IMDRF (http://imdrf.org). This value is deprecated and Distribution Identifier should be used instead.
      DISTID Distribution Identifier An identifier appearing on the packaging of a marketed product used to track it through its lifecycle (e.g., transport, inventory, use, and disposal).
      DIRECT-MARKING Identifier directly marked on the identified item An identifier physically marked on the item that it identifies.
      SINGLE-ITEM Identifier for any single item of a homogeneous collection  An identifier pre-defined by the assigner used for identifying an individual item in a homogeneous collection. An example would be a box of syringes where a SINGLE-ITEM identifier would refer to any arbitrary single syringe in the box.  Another example of use of this value is the "Unit of use DI" as defined in the regulatory medical device databases (e.g. GUDID for US and EUDAMED for EU).  
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      Code Display Definition UDI - - Universal Device Identifier An identifier assigned to a device using the Unique Device Identification framework as defined by IMDRF ( http://imdrf.org ).  This value is deprecated and Distribution Identifier should be used instead. DISTID Distribution Identifier An identifier appearing on the packaging of a marketed product used to track it through its lifecycle (e.g., transport, inventory, use, and disposal). DIRECT-MARKING Identifier directly marked on the identified item An identifier physically marked on the item that it identifies. SINGLE-ITEM Identifier for any single item of a homogeneous collection  An identifier pre-defined by the assigner used for identifying an individual item in a homogeneous collection. An example would be a box of syringes where a SINGLE-ITEM identifier would refer to any arbitrary single syringe in the box.  Another example of use of this value is the "Unit of use DI" as defined in the regulatory medical device databases (e.g. GUDID for US and EUDAMED for EU).  
    • Marti Velezis / Lloyd McKenzie : 4-0-0
    • Enhancement
    • Compatible, substantive

    Description

      The description below has been rewritten post discussion with MnM on October 27.
      This tracker is also linked to UP-232, which will be updated once the current tracker is approved by MnM.

      The jurisdictional databases of medical devices (GUDID for US, EUDAMED for EU) define 3 complimentary UDI identifiers for medical devices, that need to be recorded in resources DeviceDefinition and Device for representing devices in catalogs, using the identifier 0..* Identifier element. These 3 complimentary UDI identifiers are the "Secondary UDI-DI", the "Direct marking UDI-DI" and the "Unit of use DI". Their intended representation with the Identifier data type is depicted as follows: 

        use type system value assigner
      Secondary UDI-DI secondary UDI http://terminology.hl7.org/CodeSystem/v2-0203 the identifier reference to the issuer (e.g. GS1, HIBCC ...)
      Direct marking UDI-DI official DIRECT-MARKING http://terminology.hl7.org/CodeSystem/v2-0203 the identifier reference to the issuer
      Unit of use DI official SINGLE-ITEM http://terminology.hl7.org/CodeSystem/v2-0203 the identifier reference to the issuer

      Types DIRECT-MARKING and SINGLE-ITEM are new values proposed by this tracker for addition to ValueSet identifier-type and to CodeSystem v2-0203. They are defined in the table below, which also proposes an addition (text in bold) to the definition of type UDI:

      Code Display Definition
      UDI Universal Device Identifier An identifier assigned to a device using the Unique Device Identification framework as defined by IMDRF (http://imdrf.org). This value is intended to be used exclusively for the Secondary UDI-DI.
      DIRECT-MARKING Identifier directly marked on the identified item An identifier physically marked on the item that it identifies.
      SINGLE-ITEM Identifier for any single item of a homogeneous collection  An identifier pre-defined by the assigner used for identifying an individual item in a homogeneous collection. An example of use of this value is the "Unit of use DI" as defined in the regulatory medical device databases (e.g. GUDID for US and EUDAMED for EU)

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            costateixeira Jose Costa-Teixeira
            fmacary Francois Macary
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              Updated:
              Resolved: