Existing Wording: The full UDI carrier - The Human Readable Form (HRF) representation of the barcode string as printed on the packaging of the device. The 'type' component should be set to UDI and the 'system' component to the the appropriate repository url. the additional URL is needed to identify the authoritative source for UDI generation within the jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. This allows a recipient of a UDI to know which database will contain the UDI-associated metadata. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC identifiers cannot be conveyed in FHIR.

Proposed Wording: The means to convey the UDI and any non-UDI elements by using easily readable plain-text and AIDC formats.

The 'type' component should be set to UDI and the 'system' component to the the appropriate repository url. the additional URL is needed to identify the authoritative source for UDI generation within the jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. This allows a recipient of a UDI to know which database will contain the UDI-associated metadata. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC identifiers cannot be conveyed in FHIR.

Based on FDA Draft Guidance, "For purposes of this draft guidance we define UDI carrier as the means to convey the UDI and any non-UDI elements

by using easily readable plain-text and AIDC forms. In the UDI carrier, the UDI should precede any

non-UDI elements. The easily readable plain-text form of the UDI should be ordered to specify the DI first, followed by the PIs. If there

are any non-UDI elements in the UDI carrier, the non-UDI elements should follow the PIs that are part of the UDI."

Comment:

How does the sending system know the system just from the UDI string? The jurisdiction may not be represented in the barcode(s) or rfid. What happens if this value is not populated - how does the receiving system interpret the value sent for the udiCarrier? The description needs to be updated to reflect the need to convey both the jurisdiction (e.g. US vs other countries) and the URI of the assigning authority (see type in UDI mappiing)

Summary:

How does the sending system know the jurisdiction from the string?