STU 2 Ballot

This page is part of the Data Access Framework (v1.6.0: STU 2 Ballot 1) based on FHIR v1.6.0. . For a full list of available versions, see the Directory of published versions

D.4.1.4 StructureDefinition: DAF-Device-UDI - Mappings

Mappings for the daf-core-device Profile.

Mappings for UDI Mapping (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm)

Profile daf-core-device
DeviceDAFCoreDeviceN/A
   id
   meta
   implicitRules
   language
   text
   contained
   extension
   modifierExtension
   identifierThe 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.
   udiCarrierThe 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.
   statusN/A
   typeThe 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
   lotNumberThe 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.
   manufacturerN/A
   manufactureDateThe 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”.
   expirationDatethe 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”.
   modelN/A
   versionN/A
   patientN/A
   ownerN/A
   contactN/A
   locationN/A
   urlN/A
   noteN/A

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

Profile daf-core-device
DeviceDAFCoreDeviceEntity. Role, or Act
   id
   meta
   implicitRules
   language
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   identifier.id
   udiCarrier.id[where root is root for UDI]
   status.statusCode
   type.code
   lotNumber.lotNumberText
   manufacturer.playedRole[typeCode=MANU].scoper.name
   manufactureDate.existenceTime.low
   expirationDate.expirationTime
   model.playedRole[typeCode=MANU].code
   version.softwareName (included as part)
   patient.playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
   owner.playedRole[typeCode=OWN].scoper
   contact.scopedRole[typeCode=CON].player
   location.playedRole[typeCode=LOCE].scoper
   url.telecom
   note.text

Mappings for W5 Mapping (http://hl7.org/fhir/w5)

Profile daf-core-device
DeviceDAFCoreDeviceadministrative.device
   id
   meta
   implicitRules
   language
   text
   contained
   extension
   modifierExtension
   identifierid
   udiCarrierid
   statusstatus
   typewhat
   lotNumberwhat
   manufacturerwhat
   manufactureDatewhat
   expirationDatewhat
   modelwhat
   versionwhat
   patientwho.focus
   ownerwho.source
   contactwho.source
   locationwhere
   urlwhere
   note