Jan 2015 Ballot Comment #444

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    • Type: Change Request
    • Resolution: Not Persuasive with Modification
    • Priority: Medium
    • FHIR Core (FHIR)
    • DSTU1 [deprecated]
    • Orders & Observations
    • Device
    • 5.8.5
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      AS far as I know Neither AIDC nor HRF contain 'executable' functions. However During the Fall 2015 Atlanta WGM we re-affirmed the need to be able to at least communicate the HRF (human readable format of the barcode) as printed under the barcode (which contains the available UDI components plus potentially other data of interest) and strongly encourage the sending of the UDI components as individual fields as well. Consequently the Device.udi field must be renamed (field, description, etc.) as it does not only contain the UDI components of the HRF. Additionally we should accommodate that in the future one may want to also send the AIDC as it may contain more information than the HRF (specifically for GS1 barcodes), so the description should not preclude such future use. Tracker 7254 and 8925 addresses these issues.

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      AS far as I know Neither AIDC nor HRF contain 'executable' functions. However During the Fall 2015 Atlanta WGM we re-affirmed the need to be able to at least communicate the HRF (human readable format of the barcode) as printed under the barcode (which contains the available UDI components plus potentially other data of interest) and strongly encourage the sending of the UDI components as individual fields as well. Consequently the Device.udi field must be renamed (field, description, etc.) as it does not only contain the UDI components of the HRF. Additionally we should accommodate that in the future one may want to also send the AIDC as it may contain more information than the HRF (specifically for GS1 barcodes), so the description should not preclude such future use. Tracker 7254 and 8925 addresses these issues.
    • Eric Haas/Rob Hausam: 8-0-6
    • Enhancement
    • Non-substantive

      Existing Wording
      FDA Mandated Unique Device Identifier. Use the human readable information (the content that the user sees, which is sometimes different to the exact syntax represented in the barcode)

      Comments
      If using ONLY the human-readable interpretation of the UDI, any executable functions found in the barcode syntax will be lost.
      FDA has recommended maintaining a copy of the barcode syntax of the UDI, on the backend, as the transactable form; the form that should be shared with other sources and applications and can be parsed into its constituent parts.
      The human-readable interpretation (HRI) of the UDI can and should be rendered to the user, but maintaining the original barcode syntax of the UDI preserves the functionality for downstream users of the UDI data.

      Grahame's Comments
      need further discussion of this; is there a syntax for the executable functions? I haven't seen one. Has FDA published one and it's trasnform to a human readable portion?

            Assignee:
            Jose Costa-Teixeira
            Reporter:
            leslie_tompkins
            Watchers:
            3 Start watching this issue

              Created:
              Updated:
              Resolved: