{
"description": "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.",
"_filename": "zib-MedicalDevice.json",
"package_name": "nictiz.fhir.nl.r4.zib2020",
"date": null,
"derivation": "constraint",
"publisher": "Nictiz",
"fhirVersion": "4.0.1",
"purpose": "This DeviceUseStatement resource represents the Dutch [zib ('Zorginformatiebouwsteen', i.e. Health and Care Information Model) MedicalDevice v3.3.1 (2020)](https://zibs.nl/wiki/MedicalDevice-v3.3.1(2020EN)).",
"name": "ZibMedicalDevice",
"mapping": [ {
"uri": "https://zibs.nl/wiki/MedicalDevice-v3.3.1(2020EN)",
"name": "zib MedicalDevice-v3.3.1(2020EN)",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
}, {
"uri": "https://zibs.nl/wiki/Procedure-v5.2(2020EN)",
"name": "zib Procedure-v5.2(2020EN)",
"identity": "zib-procedure-v5.2-2020EN"
}, {
"uri": "https://zibs.nl/wiki/FunctionalOrMentalStatus-v3.2(2020EN)",
"name": "zib FunctionalOrMentalStatus-v3.2(2020EN)",
"identity": "zib-functionalormentalstatus-v3.2-2020EN"
}, {
"uri": "https://zibs.nl/wiki/Mobility-v3.3(2020EN)",
"name": "zib Mobility-v3.3(2020EN)",
"identity": "zib-mobility-v3.3-2020EN"
} ],
"abstract": true,
"copyright": "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.",
"type": "DeviceUseStatement",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "zib MedicalDevice",
"package_version": "0.5.0-beta1",
"status": "draft",
"id": "805aab06-119c-418b-b895-3f78b6d020a0",
"kind": "resource",
"url": "http://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice",
"version": null,
"differential": {
"element": [ {
"id": "DeviceUseStatement",
"path": "DeviceUseStatement",
"alias": [ "MedischHulpmiddel" ],
"short": "MedicalDevice",
"mapping": [ {
"map": "NL-CM:10.1.1",
"comment": "MedicalDevice",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
} ]
}, {
"id": "DeviceUseStatement.extension",
"min": 0,
"path": "DeviceUseStatement.extension",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
}
}, {
"id": "DeviceUseStatement.extension:healthProfessional",
"min": 0,
"path": "DeviceUseStatement.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.HealthProfessional" ]
} ],
"sliceName": "healthProfessional"
}, {
"id": "DeviceUseStatement.extension:location",
"min": 0,
"path": "DeviceUseStatement.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://nictiz.nl/fhir/StructureDefinition/ext-MedicalDevice.Location" ]
} ],
"sliceName": "location"
}, {
"id": "DeviceUseStatement.status",
"path": "DeviceUseStatement.status",
"comment": "This element is implictly mapped to the zib concepts NL-CM:10.1.11 (StartDate) and NL-CM:10.1.14 (EndDate). Unless the status is explicitly recorded, the following guidance applies:\r\n\r\n* When StartDate is in the future, `.status` will usually be set to _intended_.\r\n* When StartDate is in the past and EndDate has a value and in the future or EndDate has no value, `.status` will usually be set to _active_.\r\n* When EndDate has a value and is in the past, `.status` will usually be set to _completed_.",
"mapping": [ {
"map": "NL-CM:10.1.11",
"comment": "StartDate (implicit, main mapping is on DeviceUseStatement.timingPeriod.start)",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
}, {
"map": "NL-CM:10.1.14",
"comment": "EndDate (implicit, main mapping is on DeviceUseStatement.timingPeriod.end)",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
} ]
}, {
"id": "DeviceUseStatement.derivedFrom",
"path": "DeviceUseStatement.derivedFrom",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "resolve()",
"type": "profile"
} ]
}
}, {
"path": "DeviceUseStatement.derivedFrom",
"definition": "The procedure which has the purpose if placing this product in or on the body.",
"short": "Procedure",
"mapping": [ {
"map": "NL-CM:14.1.7",
"comment": "Reversed reference for zib Procedure.MedicalDevice",
"identity": "zib-procedure-v5.2-2020EN"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://nictiz.nl/fhir/StructureDefinition/zib-Procedure-event", "http://nictiz.nl/fhir/StructureDefinition/zib-Procedure-request" ]
} ],
"sliceName": "procedure",
"alias": [ "Verrichting" ],
"id": "DeviceUseStatement.derivedFrom:procedure",
"comment": "Please note that on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed."
}, {
"id": "DeviceUseStatement.timing[x]",
"path": "DeviceUseStatement.timing[x]",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "$this",
"type": "type"
} ]
}
}, {
"id": "DeviceUseStatement.timing[x]:timingPeriod",
"path": "DeviceUseStatement.timing[x]",
"type": [ {
"code": "Period"
} ],
"sliceName": "timingPeriod"
}, {
"id": "DeviceUseStatement.timing[x]:timingPeriod.start",
"path": "DeviceUseStatement.timing[x].start",
"alias": [ "BeginDatum" ],
"short": "StartDate",
"mapping": [ {
"map": "NL-CM:10.1.11",
"comment": "StartDate",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
} ],
"definition": "The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted."
}, {
"id": "DeviceUseStatement.timing[x]:timingPeriod.end",
"path": "DeviceUseStatement.timing[x].end",
"alias": [ "EindDatum" ],
"short": "EndDate",
"mapping": [ {
"map": "NL-CM:10.1.14",
"comment": "EndDate",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
} ],
"definition": "The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted."
}, {
"id": "DeviceUseStatement.device",
"path": "DeviceUseStatement.device",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Device", "http://nictiz.nl/fhir/StructureDefinition/zib-MedicalDevice.Product" ]
} ]
}, {
"id": "DeviceUseStatement.reasonReference",
"path": "DeviceUseStatement.reasonReference",
"slicing": {
"rules": "open",
"discriminator": [ {
"path": "resolve()",
"type": "profile"
} ]
}
}, {
"id": "DeviceUseStatement.reasonReference:indication",
"path": "DeviceUseStatement.reasonReference",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://nictiz.nl/fhir/StructureDefinition/zib-Problem" ]
} ],
"alias": [ "Indicatie" ],
"short": "Indication",
"mapping": [ {
"map": "NL-CM:10.1.7",
"comment": "Indication",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
} ],
"sliceName": "indication",
"definition": "The medical reason for use of the medical device."
}, {
"path": "DeviceUseStatement.reasonReference",
"definition": "The association between a zib MedicalDevice and another zib or other functional model.",
"short": "zib MedicalDevice reference",
"mapping": [ {
"map": "NL-CM:4.26.5",
"comment": "Reversed reference for zib FunctionalOrMentalStatus.MedicalDevice",
"identity": "zib-functionalormentalstatus-v3.2-2020EN"
}, {
"map": "NL-CM:4.3.4",
"comment": "Reversed reference for zib Mobility.MedicalDevice",
"identity": "zib-mobility-v3.3-2020EN"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://nictiz.nl/fhir/StructureDefinition/zib-FunctionalOrMentalStatus", "http://nictiz.nl/fhir/StructureDefinition/zib-Mobility" ]
} ],
"sliceName": "zibMedicalDeviceReference",
"alias": [ "FunctioneleOfMentaleStatus", "Mobiliteit" ],
"id": "DeviceUseStatement.reasonReference:zibMedicalDeviceReference",
"comment": "There are several zibs that reference zib 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. \r\n\r\nNote that some zibs 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 zibs 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."
}, {
"id": "DeviceUseStatement.bodySite",
"path": "DeviceUseStatement.bodySite",
"type": [ {
"code": "CodeableConcept",
"profile": [ "http://nictiz.nl/fhir/StructureDefinition/zib-AnatomicalLocation" ]
} ],
"alias": [ "AnatomischeLocatie" ],
"short": "Location / AnatomicalLocation",
"binding": {
"strength": "required",
"valueSet": "http://decor.nictiz.nl/fhir/ValueSet/2.16.840.1.113883.2.4.3.11.60.121.11.11--20200901000000"
},
"mapping": [ {
"map": "NL-CM:10.1.15",
"comment": "AnatomicalLocation",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
} ],
"definition": "Patient’s anatomical location of the medical device used."
}, {
"id": "DeviceUseStatement.note",
"max": "1",
"path": "DeviceUseStatement.note"
}, {
"id": "DeviceUseStatement.note.text",
"path": "DeviceUseStatement.note.text",
"alias": [ "Toelichting" ],
"short": "Comment",
"mapping": [ {
"map": "NL-CM:10.1.10",
"comment": "Comment",
"identity": "zib-medicaldevice-v3.3.1-2020EN"
} ],
"definition": "Comment about use or information on the medical device used."
} ]
},
"contact": [ {
"name": "Nictiz",
"telecom": [ {
"use": "work",
"value": "https://www.nictiz.nl",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/DeviceUseStatement"
}