<status value="draft" /> <date value="2026-01-09" /> <publisher value="HL7 Canada - FHIR Implementation Work Group" /> <contact> <telecom> <system value="url" /> <value value="https://infocentral.infoway-inforoute.ca/en/collaboration/wg/fhir-implementations" /> </telecom> </contact> <description value="Proposed constraints on the Device resource for the minimal set of data to query and retrieve a patient's implantable device." /> <jurisdiction> <coding> <system value="urn:iso:std:iso:3166" /> <code value="CA" /> </coding> </jurisdiction> <fhirVersion value="4.0.1" /> <mapping> <identity value="rim" /> <uri value="http://hl7.org/v3" /> <name value="RIM Mapping" /> </mapping> <mapping> <identity value="w5" /> <uri value="http://hl7.org/fhir/fivews" /> <name value="FiveWs Pattern Mapping" /> </mapping> <mapping> <identity value="udi" /> <uri value="http://fda.gov/UDI" /> <name value="UDI Mapping" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="Device" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Device" /> <derivation value="constraint" /> <differential> <element id="Device"> <path value="Device" /> <short value="Device Profile" /> <definition value="The Device Profile is based upon the core FHIR Device Resource" /> <constraint> <key value="ca-device-1" /> <severity value="warning" /> <human value="Implantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF." /> <expression value="udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())" /> <xpath value="not(f:udiCarrier) or (f:carrierHRF or f:carrierAIDC)" /> </constraint> <constraint> <key value="ca-device-2" /> <severity value="warning" /> <human value="For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present." /> <expression value="udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())" /> <xpath value="not(f:udiCarrier) or (f:manufactureDate or f:expirationDate or f:lotNumber or f:serialNumber or f:distinctIdentifier)" /> </constraint> </element> <element id="Device.udiCarrier"> <path value="Device.udiCarrier" /> <min value="1" /> <max value="1" /> </element> <element id="Device.udiCarrier.deviceIdentifier"> <path value="Device.udiCarrier.deviceIdentifier" /> <min value="1" /> <max value="1" /> </element> <element id="Device.distinctIdentifier"> <path value="Device.distinctIdentifier" /> <min value="0" /> <max value="1" /> </element> <element id="Device.expirationDate"> <path value="Device.expirationDate" /> <min value="0" /> <max value="1" /> </element> <element id="Device.lotNumber"> <path value="Device.lotNumber" /> <min value="0" /> <max value="1" /> </element> <element id="Device.serialNumber"> <path value="Device.serialNumber" /> <min value="0" /> <max value="1" /> </element> <element id="Device.type"> <path value="Device.type" /> <comment value="The device-kind and device-type valueSets used in HL7 are identical. This profile currently mainatins the binding on device-kind because it is currently hosted in THO and is therefor expected to be updated more frequently" /> <min value="1" /> <binding> <strength value="extensible" /> <description value="Codes to identify medical devices" /> <valueSet value="http://terminology.hl7.org/ValueSet/device-kind" /> </binding> </element> <element id="Device.patient"> <path value="Device.patient" /> <min value="1" /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-patient" /> </type> </element> <element id="Device.parent"> <path value="Device.parent" /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-device" /> </type> </element> </differential> </StructureDefinition>