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Type:
Change Request
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Resolution: Not Persuasive with Modification
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Priority:
Highest
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Situation Awareness for Novel Epidemic Response (FHIR)
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current
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Public Health
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(NA)
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(NA)
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David Pyke/Keith Boone: 22-0-0
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Enhancement
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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.
- is voted on by
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BALLOT-14365 Affirmative - Genevieve Luensman : 2021-Jan-FHIR IG SANER R1 STU
- Balloted