DSTU2 STU 3 Ballot
This page is part of the FHIR Specification (v1.0.2: DSTU 2). The current version which supercedes this version is

This page is part of the FHIR Specification (v1.6.0: STU 3 Ballot 4). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . For a full list of available versions, see the Directory of published versions . Page versions: . Page versions: R5 R4B R4 R3 R2

5.10.7 8.9.7 Resource Device - Mappings Resource Device - Mappings

Mappings:

RIM RIM Mapping

Mappings for the device resource.

UDI Mapping

Mappings for the device resource.

5.10.7.1 Mappings for RIM (http://hl7.org/v3) 8.9.7.1 Mappings for RIM Mapping (http://hl7.org/v3)

.code .text .statusCode .playedRole[typeCode=MANU].scoper.name .playedRole[typeCode=MANU].code .softwareName (included as part) .existenceTime.low .expirationTime .id[where root is root for UDI] .lotNumberText .playedRole[typeCode=LOCE].scoper .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] .scopedRole[typeCode=CON].player .telecom © HL7.org 2011+. FHIR DSTU2 (v1.0.2-7202) generated on Sat, Oct 24, 2015 07:43+1100. Links: Search
Device Device
    identifier     identifier .id
    type     udiCarrier .id[where root is root for UDI]
    note     status .statusCode
    status     type .code
    manufacturer     lotNumber .lotNumberText
    model     manufacturer .playedRole[typeCode=MANU].scoper.name
    version     manufactureDate .existenceTime.low
    manufactureDate     expirationDate .expirationTime
    expiry     model .playedRole[typeCode=MANU].code
    udi     version .softwareName (included as part)
    lotNumber     patient .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
    owner     owner .playedRole[typeCode=OWN].scoper
    location     contact .scopedRole[typeCode=CON].player
    patient     location .playedRole[typeCode=LOCE].scoper
    contact     url .telecom
    url     note .text
| Version History | Table of Contents | Compare to DSTU1 |

8.9.7.2 Mappings for UDI Mapping (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm) | Propose a change

UDI is a unique numeric or alphanumeric code that consists of two parts: (1) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and (2) a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: (2a) the lot or batch number within which a device was manufactured; (2b) the serial number of a specific device; (2c) the expiration date of a specific device; (2d) the date a specific device was manufactured; (2e) the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

Device N/A
    identifier The serial number which is a component of the the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
    udiCarrier 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.
    status N/A
    type The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a devicet. The system uri should be included. Possible URIs include
GS1 DIs:
http://hl7.org/fhir/NamingSystem/gs1-di
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc-di
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di
    lotNumber The lot or batch number within which a device was manufactured - which is a component of the the production identifier (PI), a conditional, variable portion of a UDI.
    manufacturer N/A
    manufactureDate The date a specific device was manufactured - which is a component of the the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
    expirationDate the expiration date of a specific device - which is a component of the the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
    model N/A
    version N/A
    patient N/A
    owner N/A
    contact N/A
    location N/A
    url N/A
    note N/A