2015May core #881 - Require GMDN as device kind

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Medium
    • FHIR Core (FHIR)
    • DSTU1 [deprecated]
    • Orders & Observations
    • Device
    • Hide

      Can't require binding here : Change DEVICEKIND binding to GMDN(Global Medical Device Nomenclature) and provide link to codes: https://www.gmdnagency.org/ wtih binding strength of "Preferred".

      Change notes section

      ~5.10.3.2.1 Device Types
      There are many sources of possible codes for device type. The example uses device codes from GMDN (Global Medical Device Nomenclature). Another source which may be appropriate is RTM (Rosetta Terminology Mapping). The local UDI repository (in the US this is the GUDID database) is another source as well, however, the full UDI string is placed in the Device.udi element. Alternatively, many jurisdictions have their own supply chain arrangements which define many useful codes.

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      Can't require binding here : Change DEVICEKIND binding to GMDN(Global Medical Device Nomenclature) and provide link to codes: https://www.gmdnagency.org/ wtih binding strength of "Preferred". Change notes section ~5.10.3.2.1 Device Types There are many sources of possible codes for device type. The example uses device codes from GMDN (Global Medical Device Nomenclature). Another source which may be appropriate is RTM (Rosetta Terminology Mapping). The local UDI repository (in the US this is the GUDID database) is another source as well, however, the full UDI string is placed in the Device.udi element. Alternatively, many jurisdictions have their own supply chain arrangements which define many useful codes.
    • Austin Kreisler/Ken McCaslin:3-0-10
    • Enhancement
    • Non-substantive
    • Yes
    • DSTU1 [deprecated]

      Existing Wording: Binding DeviceKind: Example: RTM Management Service (Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it)

      Type CodeableConcept

      Comments

      For the FDA Mandated Unique Device Identifier (UDI) use the Device.udi element

      Proposed Wording: Binding DeviceKind: Required: GMDN (Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it)

      Type CodeableConcept

      Comments

      For the FDA Mandated Unique Device Identifier (UDI) use the Device.udi element

      Comment:

      The FDA require GMDN for its Global UDI Database. RTMMS references IEEE 11073 10101 codes. Those are not mandated by FDA, GMDN is: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

      http://helpdesk.gs1.org/ArticleDetails.aspx?UDI%20%28Unique%20Device%20Identification%29&id=0ac8aa0b-f690-e311-ac70-00155d644649

      https://www.gmdnagency.org/Info.aspx?pageid=1091

            Assignee:
            Unassigned
            Reporter:
            Ioana Singureanu
            Watchers:
            3 Start watching this issue

              Created:
              Updated:
              Resolved: