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Type:
Change Request
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Resolution: Persuasive with Modification
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Priority:
Medium
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FHIR Core (FHIR)
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DSTU1 [deprecated]
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Orders & Observations
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Device
DeviceComponent [deprecated]
DeviceMetric
DeviceObservationReport [deprecated]
DeviceRequest (was DeviceUseRequest)
DeviceUsage (DeviceUseStatement) -
5.8.3.3
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Clarification
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Non-substantive
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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
- is voted on by
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BALLOT-391 Affirmative - Leslie Tompkins : 2015-Jan-FHIR R1
- Closed