NIOSH Approval Number as a Unique Device Identifier

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    • Type: Change Request
    • Resolution: Not Persuasive with Modification
    • Priority: Highest
    • Situation Awareness for Novel Epidemic Response (FHIR)
    • current
    • Public Health
    • (NA)
    • (NA)
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      NIOSH numbers are a US standard. AS this FHIR IG is universal in scope the use of a specific country's standard could be a problem for non-US implementers.

      However, change the Use of Appropriate National Models
      Many countries have developed national healthcare information models in various states of completion. This IG requires the use of national core standards or guides to localize the PublicHealthMeasure to ensure a consistent data model for automation.

      A conforming PublicHealthMeasure shall specify a jurisdiction to enable support for validation against national requirements.
      A measure defined for international use may specify an international juristiction, or multiple jurisdictions where that is feasible.
      Setting the Measure jurisdiction ensures that resources referenced by the Measure or MeasureReport conform to appropriate national standards.

      Add a discussion of why this is necessary, and some of the associated challenges that such a model needs to address, such as precision in the description of a concept such as a bed, location, ventilator or PPE device.

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      NIOSH numbers are a US standard. AS this FHIR IG is universal in scope the use of a specific country's standard could be a problem for non-US implementers. However, change the Use of Appropriate National Models Many countries have developed national healthcare information models in various states of completion. This IG requires the use of national core standards or guides to localize the PublicHealthMeasure to ensure a consistent data model for automation. A conforming PublicHealthMeasure shall specify a jurisdiction to enable support for validation against national requirements. A measure defined for international use may specify an international juristiction, or multiple jurisdictions where that is feasible. Setting the Measure jurisdiction ensures that resources referenced by the Measure or MeasureReport conform to appropriate national standards. Add a discussion of why this is necessary, and some of the associated challenges that such a model needs to address, such as precision in the description of a concept such as a bed, location, ventilator or PPE device.
    • David Pyke/Keith Boone: 22-0-0
    • Enhancement
    • Non-substantive

      As the aforementioned comment described, consistent reporting of PPE model numbers and manufacturers proved to be challenging. It is common for private labels to put their name on remarketed PPE and this can also be confusing for model number. However, the NIOSH Approval number will always be consistent and able to be located on a respirator, making its use as a UDI helpful for PPE monitoring and surveillance across the country. Unique Device Identifiers exist for a variety of medical devices. These UDIs help transmit data accurately. For PPE FFRs, the NIOSH Approval is a unique identifier that quickly denotes level of protection as well as manufacturer and potential model number.

      Existing Wording:

      None

      Proposed Wording:

      NIOSH Approval Number, which denotes NIOSH approval for a certain level of respiratory protection, shown as TC-84A-XXXX, should be incorporated as a Unique Device Identifier in 8.14.3.2.2.

            Assignee:
            Keith W. Boone
            Reporter:
            genny_luensman
            genny_luensman
            Watchers:
            2 Start watching this issue

              Created:
              Updated:
              Resolved: