<status value="draft" /> <date value="2022-10-17T09:09:13.9562003+00:00" /> <publisher value="Healthdata.be (Sciensano)" /> <contact> <name value="Service portal – healthdata.be" /> <telecom> <system value="url" /> <value value="https://sciensano.service-now.com/sp" /> <use value="work" /> </telecom> </contact> <description value="Medical devices are any internally implanted and external devices and/or aids used by the patient (in the past) to reduce the effects of functional limitations in organ systems or to facilitate the treatment of a disease." /> <copyright value="Copyright and related rights waived via CC0, https://creativecommons.org/publicdomain/zero/1.0/. This does not apply to information from third parties, for example a medical terminology system. The implementer alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize third party IP in connection with the specification or otherwise." /> <fhirVersion value="4.0.1" /> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <uri value="https://zibs.nl/wiki/MedicalDevice-v3.3.1(2020EN)" /> <name value="zib MedicalDevice-v3.3.1(2020EN)" /> </mapping> <mapping> <identity value="zib-procedure-v5.2-2020EN" /> <uri value="https://zibs.nl/wiki/Procedure-v5.2(2020EN)" /> <name value="zib Procedure-v5.2(2020EN)" /> </mapping> <mapping> <identity value="zib-functionalormentalstatus-v3.2-2020EN" /> <uri value="https://zibs.nl/wiki/FunctionalOrMentalStatus-v3.2(2020EN)" /> <name value="zib FunctionalOrMentalStatus-v3.2(2020EN)" /> </mapping> <mapping> <identity value="zib-mobility-v3.3-2020EN" /> <uri value="https://zibs.nl/wiki/Mobility-v3.3(2020EN)" /> <name value="zib Mobility-v3.3(2020EN)" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <uri value="https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-MedicalDevice" /> <name value="HdBe logical model MedicalDevice" /> </mapping> <mapping> <identity value="HdBe-Procedure" /> <uri value="https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-Procedure" /> <name value="HdBe logical model Procedure" /> </mapping> <mapping> <identity value="HdBe-FunctionalOrMentalStatus" /> <uri value="https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-FunctionalOrMentalStatus" /> <name value="HdBe logical model FunctionalOrMentalStatus" /> </mapping> <mapping> <identity value="HdBe-Mobility" /> <uri value="https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-Mobility" /> <name value="HdBe logical model Mobility" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="DeviceUseStatement" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DeviceUseStatement" /> <derivation value="constraint" /> <differential> <element id="DeviceUseStatement"> <path value="DeviceUseStatement" /> <short value="MedicalDevice" /> <alias value="MedischHulpmiddel" /> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.1" /> <comment value="MedicalDevice" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice" /> </mapping> </element> <element id="DeviceUseStatement.extension"> <path value="DeviceUseStatement.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <rules value="open" /> </slicing> <min value="0" /> </element> <element id="DeviceUseStatement.extension:healthProfessional"> <path value="DeviceUseStatement.extension" /> <sliceName value="healthProfessional" /> <min value="0" /> <type> <code value="Extension" /> <profile value="https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional" /> </type> </element> <element id="DeviceUseStatement.extension:healthProfessional.value[x]"> <path value="DeviceUseStatement.extension.value[x]" /> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.HealthProfessional" /> </mapping> </element> <element id="DeviceUseStatement.extension:location"> <path value="DeviceUseStatement.extension" /> <sliceName value="location" /> <min value="0" /> <type> <code value="Extension" /> <profile value="https://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location" /> </type> </element> <element id="DeviceUseStatement.extension:location.value[x]"> <path value="DeviceUseStatement.extension.value[x]" /> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.Location" /> </mapping> </element> <element id="DeviceUseStatement.status"> <path value="DeviceUseStatement.status" /> <comment value="This element is implictly mapped to the CBB concepts start_date and end_date. Unless the status is explicitly recorded, the following guidance applies: * When start_date is in the future, `.status` will usually be set to _intended_. * When start_date is in the past and end_date has a value and in the future or end_date has no value, `.status` will usually be set to _active_. * When end_date has a value and is in the past, `.status` will usually be set to _completed_." /> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.11" /> <comment value="StartDate (implicit, main mapping is on DeviceUseStatement.timingPeriod.start)" /> </mapping> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.14" /> <comment value="EndDate (implicit, main mapping is on DeviceUseStatement.timingPeriod.end)" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.StartDate" /> <comment value="implicit, main mapping is on DeviceUseStatement.timingPeriod.start" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.EndDate" /> <comment value="implicit, main mapping is on DeviceUseStatement.timingPeriod.end" /> </mapping> </element> <element id="DeviceUseStatement.derivedFrom"> <path value="DeviceUseStatement.derivedFrom" /> <slicing> <discriminator> <type value="profile" /> <path value="resolve()" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="DeviceUseStatement.derivedFrom:procedure"> <path value="DeviceUseStatement.derivedFrom" /> <sliceName value="procedure" /> <short value="Procedure" /> <definition value="The procedure which has the purpose if placing this product in or on the body." /> <comment value="Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed." /> <alias value="Verrichting" /> <type> <code value="Reference" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-Procedure-event" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-Procedure-request" /> </type> <mapping> <identity value="zib-procedure-v5.2-2020EN" /> <map value="NL-CM:14.1.7" /> <comment value="Reversed reference for zib Procedure.MedicalDevice" /> </mapping> <mapping> <identity value="HdBe-Procedure" /> <map value="MedicalDevice" /> <comment value="Reversed reference for CBB Procedure.medical_device" /> </mapping> </element> <element id="DeviceUseStatement.timing[x]"> <path value="DeviceUseStatement.timing[x]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="DeviceUseStatement.timing[x]:timingPeriod"> <path value="DeviceUseStatement.timing[x]" /> <sliceName value="timingPeriod" /> <type> <code value="Period" /> </type> </element> <element id="DeviceUseStatement.timing[x]:timingPeriod.start"> <path value="DeviceUseStatement.timing[x].start" /> <short value="StartDate" /> <definition value="The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted." /> <alias value="BeginDatum" /> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.11" /> <comment value="StartDate" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.StartDate" /> </mapping> </element> <element id="DeviceUseStatement.timing[x]:timingPeriod.end"> <path value="DeviceUseStatement.timing[x].end" /> <short value="EndDate" /> <definition value="The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted." /> <alias value="EindDatum" /> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.14" /> <comment value="EndDate" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.EndDate" /> </mapping> </element> <element id="DeviceUseStatement.device"> <path value="DeviceUseStatement.device" /> <type> <code value="Reference" /> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-MedicalDevice.Product" /> </type> </element> <element id="DeviceUseStatement.reasonReference"> <path value="DeviceUseStatement.reasonReference" /> <slicing> <discriminator> <type value="profile" /> <path value="resolve()" /> </discriminator> <rules value="open" /> </slicing> </element> <element id="DeviceUseStatement.reasonReference:indication"> <path value="DeviceUseStatement.reasonReference" /> <sliceName value="indication" /> <short value="Indication" /> <definition value="The medical reason for use of the medical device." /> <alias value="Indicatie" /> <type> <code value="Reference" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-Problem" /> </type> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.7" /> <comment value="Indication" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.Indication" /> </mapping> </element> <element id="DeviceUseStatement.reasonReference:HdBe-MedicalDeviceReference"> <path value="DeviceUseStatement.reasonReference" /> <sliceName value="HdBe-MedicalDeviceReference" /> <short value="CBB MedicalDevice reference" /> <definition value="The association between a CBB MedicalDevice and another zib or other functional model." /> <comment value="There are several CBBs that reference CBB MedicalDevice on a functional level, but for which the direction of the reference in FHIR is reversed. Consult the mappings on this element for an overview of which zib concepts are mapped to this element. Note that some CBBs have a reference to MedicalDevice that is further constrained (e.g. with additional constraints on ProductType or AnatomicalLocation), such as HearingFunction and VisualFunction. For these CBBs separate DeviceUseStatement profiles have been created (based on this profile) which also include a specific slice on which their respective MedicalDevice concept mapping is present." /> <alias value="FunctioneleOfMentaleStatus" /> <alias value="Mobiliteit" /> <type> <code value="Reference" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-FunctionalOrMentalStatus" /> <targetProfile value="https://fhir.healthdata.be/StructureDefinition/HdBe-Mobility" /> </type> <mapping> <identity value="zib-functionalormentalstatus-v3.2-2020EN" /> <map value="NL-CM:4.26.5" /> <comment value="Reversed reference for zib FunctionalOrMentalStatus.MedicalDevice" /> </mapping> <mapping> <identity value="zib-mobility-v3.3-2020EN" /> <map value="NL-CM:4.3.4" /> <comment value="Reversed reference for zib Mobility.MedicalDevice" /> </mapping> <mapping> <identity value="HdBe-FunctionalOrMentalStatus" /> <map value="MedicalDevice" /> <comment value="Reversed reference for CBB FunctionalOrMentalStatus.medical_device" /> </mapping> <mapping> <identity value="HdBe-Mobility" /> <map value="MedicalDevice" /> <comment value="Reversed reference for CBB Mobility.medical_device" /> </mapping> </element> <element id="DeviceUseStatement.bodySite"> <path value="DeviceUseStatement.bodySite" /> <short value="Location / AnatomicalLocation" /> <definition value="Patient’s anatomical location of the medical device used." /> <alias value="AnatomischeLocatie" /> <type> <code value="CodeableConcept" /> <profile value="https://fhir.healthdata.be/StructureDefinition/HdBe-AnatomicalLocation" /> </type> <binding> <strength value="required" /> <valueSet value="https://fhir.healthdata.be/ValueSet/Location" /> </binding> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.15" /> <comment value="AnatomicalLocation" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.AnatomicalLocation" /> </mapping> </element> <element id="DeviceUseStatement.note"> <path value="DeviceUseStatement.note" /> <max value="1" /> </element> <element id="DeviceUseStatement.note.text"> <path value="DeviceUseStatement.note.text" /> <short value="Comment" /> <definition value="Comment about use or information on the medical device used." /> <alias value="Toelichting" /> <mapping> <identity value="zib-medicaldevice-v3.3.1-2020EN" /> <map value="NL-CM:10.1.10" /> <comment value="Comment" /> </mapping> <mapping> <identity value="HdBe-MedicalDevice" /> <map value="MedicalDevice.Comment" /> </mapping> </element> </differential> </StructureDefinition>