Jan 2015 Ballot Comment #443

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    • Type: Change Request
    • Resolution: Persuasive with Modification
    • Priority: Medium
    • FHIR Core (FHIR)
    • DSTU1 [deprecated]
    • Orders & Observations
    • Device
      DeviceComponent [deprecated]
      DeviceMetric
      DeviceObservationReport [deprecated]
      DeviceRequest (was DeviceUseRequest)
      DeviceUsage (DeviceUseStatement)
    • 5.8.3.3
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      ?

      Thursday 3/26/2015 Orders and Observation call

      Change?Existing Wording:
      "Note that a GTIN (sometimes also called an EAN number) is a code for the kind of device, not an identifier for the device. The GTIN may be part of the UDI, but it may also be known separately, in which case GTINs should be carried in the type element:"

      to..

      "Note that a GTIN (sometimes also called an EAN number) is a code devekloped by GS1 for the kind of device? not an identifier for the device. A GTIN may appear on its own or it may appear in a UDI string as the DI component. The?UDIs which contain a serial number are store in the 'identifier' element while UDIs which do not contain a serial number are stored in the 'type' element."

      Eric Haas/RobHausam? Against:? 1 ?Abstain: 6 ?For:7:

      see below ?also #5849

      Show
      ? Thursday 3/26/2015 Orders and Observation call Change?Existing Wording : "Note that a GTIN (sometimes also called an EAN number) is a code for the kind of device, not an identifier for the device. The GTIN may be part of the UDI, but it may also be known separately, in which case GTINs should be carried in the type element:" to.. "Note that a GTIN (sometimes also called an EAN number) is a code devekloped by GS1 for the kind of device? not an identifier for the device. A GTIN may appear on its own or it may appear in a UDI string as the DI component. The?UDIs which contain a serial number are store in the 'identifier' element while UDIs which do not contain a serial number are stored in the 'type' element." Eric Haas/RobHausam? Against:? 1 ?Abstain: 6 ?For:7: see below ?also #5849
    • Clarification
    • Non-substantive
    • DSTU1 [deprecated]

      Existing Wording
      Note that a GTIN (sometimes also called an EAN number) is a code for the kind of device, not an identifier for the device. The GTIN may be part of the UDI, but it may also be known separately, in which case GTINs should be carried in the type element:

      Proposed Wording
      Note that a GTIN (sometimes also called an EAN number) is a code for the kind of device, not an identifier for the device. GTIN is the identifier developed by the General Specification of the GS1 Standard and can be used to represent the device identifier (DI) of the FDA UDI. The GTIN may be part of the UDI, but it may also be known separately,. For example, a GS1-formatted UDI will have a GTIN as the DI portion of the UDI; only the DI (or GTIN) will be submitted to the GUDID in a device record. In this case GTINs should be carried in the type element:

      Comments
      Providing additional background information related to GTINs and GS1.

      Also, are you using 'kind' and 'type' of device interchangably? It would be helpful to be consistent.


      Grahame's Comments
      k and agree about consistency

            Assignee:
            Unassigned
            Reporter:
            leslie_tompkins
            Watchers:
            2 Start watching this issue

              Created:
              Updated:
              Resolved: