0.3.0 - Second STU ballot

This page is part of a downloaded copy of this specification. This page is part of the Da Vinci Coverage Requirements Discovery (CRD) FHIR IG (v0.3.0: STU 1 Ballot 2) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

## StructureDefinition: DeviceSTU3 - Mappings

Mappings for the Profile.

### Mappings for Argonaut-DQ-DSTU2 (http://unknown.org/Argonaut-DQ-DSTU2)

DeviceSTU3
Device | Device
udi | Device.udi
carrierHRF | Device.udi
carrierAIDC | NA (not Supoorted)
type | Device.type
patient | Device.patient

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

DeviceSTU3
Device | Entity. Role, or Act
text | Act.text?
contained | N/A
extension | N/A
modifierExtension | N/A
identifier | .id
udi | .id and .code
id | n/a
extension | n/a
modifierExtension | N/A
deviceIdentifier | Role.id.extension
name | .displayName
jurisdiction | Role.scoper
carrierHRF | Role.id.extension
carrierAIDC | Role.id.extension
issuer | Role.id.root
entryType | NA
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
safety | NA

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

DeviceSTU3
Device | administrative.device
identifier | id
udi | id
deviceIdentifier | what
name | what
status | status
type | what
lotNumber | what
manufacturer | what
manufactureDate | what
expirationDate | what
model | what
version | what
patient | who.focus
owner | who.source
contact | who.source
location | where
url | where

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

DeviceSTU3
Device |
identifier | The serial number which is a component of 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.
udi |
deviceIdentifier | The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
name | Propietary/Trade Name of the medical Device as used in the labeling or catalog
carrierHRF | A unique device identifier (UDI) on a device label in plain text
carrierAIDC | A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
issuer | All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
type | Type description using GMDN or other code system
lotNumber | The lot or batch number within which a device was manufactured - which is a component of 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 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 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”.