{
"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.\\r\\n#### Purpose\\r\\nData on medical devices is recorded for several reasons. Knowledge of the presence of these implants enables tracing and taking the aid or device into account in diagnostic or therapeutic procedures, care and transport. \\r\\n\\r\\nExamples include: \\r\\n\\r\\n* Consequences for transportation, toilet use, etc., in the case of a wheelchair;\\r\\n* A pacemaker can be of medical importance, but also has consequences for planning radiological exams.",
"_filename": "LogicalModel-HdBe-MedicalDevice.json",
"package_name": "healthdata.be.r4.cbb",
"date": "2022-07-07T15:04:03.2592055+00:00",
"derivation": "specialization",
"publisher": "Healthdata.be (Sciensano)",
"fhirVersion": "4.0.1",
"name": "HdBeMedicalDevice",
"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": "https://fhir.healthdata.be/StructureDefinition/LogicalModel/MedicalDevice",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "HdBe MedicalDevice",
"_description": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Medische hulpmiddelen kunnen worden omschreven als de inwendig geïmplanteerde en uitwendige apparatuur en/of hulpmiddelen die de patiënt gebruikt of heeft gebruikt om de gevolgen van functionele beperkingen van orgaansystemen te verminderen of om de behandeling van een ziekte mogelijk te maken.\r\n#### Purpose\r\nHet vastleggen van gegevens over medische hulpmiddelen heeft een aantal redenen. Kennis van aanwezigheid biedt mogelijkheid om implantaten te kunnen traceren en\r\nrekening te houden met het hulpmiddel of apparaat bij diagnostische of therapeutische procedures, verzorging en transport.\r\n\r\nVoorbeelden hier van zijn: \r\n\r\n* De consequenties voor transport, toiletgebruik, etc. indien gebruik wordt gemaakt van een rolstoel;\r\n* De aanwezigheid van een pacemaker is van medisch belang, maar heeft ook consequenties voor planning van radiologisch onderzoek.\r\n\r\n\r\n\r\n#### Evidence Base\r\nHet vastleggen van gegevens van medisch complexe apparatuur, zoals pacemakers, is in EPD systemen in Nederland nog niet gebruikelijk, maar soms wel een gemis: uit een specialistenbrief valt bv. vaak niet op te maken welke type pacemaker van welke fabrikant bij de patiënt aanwezig is.\r\nVWS zal met wetgeving komen voor een landelijk basisregister voor implantaten. Elke zorginstelling zal de UDI (Unique Device Identification, met een relatie naar GTIN) en UPI (Unique Patient Identification) moeten aanleveren aan het basisregister. Dit voorkomt de situatie dat een groot deel van de patiënten met een hulpmiddel of implantaat waar problemen mee zijn gesignaleerd, niet te traceren zijn.\r\n\r\n\r\n**References**\r\n1. Kamerbrief over het voorstel voor een register van implantaten. [Online] Beschikbaar op: http://www.rijksoverheid.nl/documenten-en-publicaties/kamerstukken/2012/11/20/kamerbrief-over-het-voorstel-voor-een-register-van-implantaten.html [Geraadpleegd: 15 september 2014].\r\n**Revision History**\r\nPublicatieversie 1.0 (15-02-2013)\r\n-\r\n\r\nPublicatieversie 1.1 (01-07-2013)\r\nBevat: [ZIB-11](https://bits.nictiz.nl/browse/ZIB-11).\r\n\r\nPublicatieversie 1.2 (01-04-2015)\r\nBevat: [ZIB-83](https://bits.nictiz.nl/browse/ZIB-83), [ZIB-88](https://bits.nictiz.nl/browse/ZIB-88), [ZIB-110](https://bits.nictiz.nl/browse/ZIB-110), [ZIB-249](https://bits.nictiz.nl/browse/ZIB-249), [ZIB-250](https://bits.nictiz.nl/browse/ZIB-250), [ZIB-251](https://bits.nictiz.nl/browse/ZIB-251), [ZIB-252](https://bits.nictiz.nl/browse/ZIB-252), [ZIB-308](https://bits.nictiz.nl/browse/ZIB-308), [ZIB-327](https://bits.nictiz.nl/browse/ZIB-327), [ZIB-353](https://bits.nictiz.nl/browse/ZIB-353).\r\n\r\nIncl. algemene wijzigingsverzoeken: \r\n[ZIB-94](https://bits.nictiz.nl/browse/ZIB-94), [ZIB-154](https://bits.nictiz.nl/browse/ZIB-154), [ZIB-200](https://bits.nictiz.nl/browse/ZIB-200), [ZIB-201](https://bits.nictiz.nl/browse/ZIB-201), [ZIB-309](https://bits.nictiz.nl/browse/ZIB-309), [ZIB-324](https://bits.nictiz.nl/browse/ZIB-324), [ZIB-326](https://bits.nictiz.nl/browse/ZIB-326).\r\n\r\nPublicatieversie 3.0 (01-05-2016)\r\nBevat: [ZIB-453](https://bits.nictiz.nl/browse/ZIB-453)\r\n\r\nPublicatieversie 3.1 (04-09-2017)\r\nBevat: [ZIB-457](https://bits.nictiz.nl/browse/ZIB-457), [ZIB-461](https://bits.nictiz.nl/browse/ZIB-461), [ZIB-517](https://bits.nictiz.nl/browse/ZIB-517), [ZIB-522](https://bits.nictiz.nl/browse/ZIB-522), [ZIB-547](https://bits.nictiz.nl/browse/ZIB-547), [ZIB-549](https://bits.nictiz.nl/browse/ZIB-549), [ZIB-564](https://bits.nictiz.nl/browse/ZIB-564),. [ZIB-568](https://bits.nictiz.nl/browse/ZIB-568), [ZIB-573](https://bits.nictiz.nl/browse/ZIB-573), [ZIB-574](https://bits.nictiz.nl/browse/ZIB-574), [ZIB-578](https://bits.nictiz.nl/browse/ZIB-578), [ZIB-585](https://bits.nictiz.nl/browse/ZIB-585).\r\n\r\nPublicatieversie 3.1.1 (01-10-2018)\r\nBevat: [ZIB-673](https://bits.nictiz.nl/browse/ZIB-673).\r\n\r\nPublicatieversie 3.2 (26-02-2019)\r\nBevat: [ZIB-680](https://bits.nictiz.nl/browse/ZIB-680).\r\n\r\nPublicatieversie 3.3 (06-07-2019)\r\nBevat: [ZIB-734](https://bits.nictiz.nl/browse/ZIB-734).\r\n\r\nPublicatieversie 3.3.1 (01-09-2020)\r\nBevat: [ZIB-1116](https://bits.nictiz.nl/browse/ZIB-1116), [ZIB-1135](https://bits.nictiz.nl/browse/ZIB-1135), [ZIB-1120](https://bits.nictiz.nl/browse/ZIB-1120)."
} ]
} ]
},
"package_version": "0.10.0-beta",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/resource-effectivePeriod",
"valuePeriod": {
"start": "2020-09-01T00:00:00+02:00"
}
} ],
"status": "draft",
"language": "en-US",
"id": "f4cbbee7-ec8f-4b24-9097-e7f967e89348",
"kind": "logical",
"_name": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "HdBe-MedischHulpmiddel"
} ]
} ]
},
"url": "https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-MedicalDevice",
"version": null,
"differential": {
"element": [ {
"id": "MedicalDevice",
"max": "*",
"min": 0,
"path": "MedicalDevice",
"short": "MedicalDevice",
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "MedischHulpmiddel"
} ]
} ]
},
"definition": "Root concept of the MedicalDevice information model. This root concept contains all data elements of the MedicalDevice information model.",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Rootconcept van de bouwsteen MedischHulpmiddel. Dit rootconcept bevat alle gegevenselementen van de bouwsteen MedischHulpmiddel."
} ]
} ]
}
}, {
"path": "MedicalDevice.Product",
"min": 1,
"definition": "The medical device (internally or externally).",
"short": "Product",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Het medische hulpmiddel dat wordt gebruikt (inwendig of uitwendig)."
} ]
} ]
},
"type": [ {
"code": "BackboneElement"
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Product"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.Product"
}, {
"path": "MedicalDevice.Product.ProductId",
"min": 0,
"definition": "Unique identification code of the product. \r\nPreferably the UDI (Unique Device Identifier) is used, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)).\r\n\r\nAdditionally, other codes can be registered if needed. Such as: \r\n- a serial number\r\n- a NIHDI notification code (medical devices on the Belgian market: https://www.vas.ehealth.fgov.be/registers/sadm/web/search/public) \r\n- an identification code as indicated on the Nominative lists published by NIHDI: https://webappsa.riziv-inami.fgov.be/IRREQPublic/nl/Home/SearchNominative). Devices on these Nominative lists meet certain criteria for reimbursement.",
"short": "ProductID",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Unieke identificatie van het product, bijvoorbeeld het serienummer.\r\nVeel gebruikte coderingen zijn HIBC en GTIN.\r\nIndien de wet verplicht stelt dat deze geregistreerd wordt op basis van een UDI (Unique Device Identifier), dient de unieke identificatie opgebouwd te zijn uit een UDI-DI (Device Identifier) en een UDI-PI (Production Identifier(s)). Voor meer informatie, zie: http://www.gs1.org/healthcare/udi .\r\n\r\nDe UDI-DI dient m.b.t. GS1 GTIN (01) coderingen worden vastgelegd, waarmee o.a. een firma aan het producttype wordt gekoppeld. De UDI-PI dient te bestaan uit de volgende application identifier (AI); vervaldatum (17) en serienummer (21) en/of batch- of lotnummer (10)."
} ]
} ]
},
"type": [ {
"code": "string",
"profile": [ "http://hl7.org/fhir/StructureDefinition/string" ]
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "ProductID"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.Product.ProductId"
}, {
"path": "MedicalDevice.Product.ProductType",
"min": 0,
"definition": "The code of the type of product.",
"short": "ProductType",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "De code van het type product."
} ]
} ]
},
"type": [ {
"code": "CodeableConcept"
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "ProductType"
} ]
} ]
},
"binding": {
"strength": "required",
"valueSet": "https://fhir.healthdata.be/ValueSet/ProductType",
"description": "ProductType codes"
},
"max": "1",
"id": "MedicalDevice.Product.ProductType"
}, {
"path": "MedicalDevice.ProductDescription",
"min": 0,
"definition": "Textual description of the product.",
"short": "ProductDescription",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Tekstuele beschrijving van het product."
} ]
} ]
},
"type": [ {
"code": "string"
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "ProductOmschrijving"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.ProductDescription"
}, {
"path": "MedicalDevice.AnatomicalLocation",
"min": 0,
"definition": "Patient’s anatomical location of the medical device used.",
"short": "AnatomicalLocation",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Anatomische locatie van het gebruikte hulpmiddel bij de patiënt."
} ]
} ]
},
"type": [ {
"code": "Reference",
"targetProfile": [ "https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-AnatomicalLocation" ]
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "AnatomischeLocatie"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.AnatomicalLocation"
}, {
"path": "MedicalDevice.Indication",
"min": 0,
"definition": "The medical reason for use of the medical device.",
"short": "Indication",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "De medische reden voor het gebruik van het medisch hulpmiddel."
} ]
} ]
},
"type": [ {
"code": "Reference",
"targetProfile": [ "https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-Problem" ]
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Indicatie"
} ]
} ]
},
"max": "*",
"id": "MedicalDevice.Indication"
}, {
"path": "MedicalDevice.StartDate",
"min": 0,
"definition": "The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted.",
"short": "StartDate",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "De startdatum van eerste toepassing of implantatie het medische hulpmiddel. Een vage datum, bijv. alleen een jaartal, is toegestaan."
} ]
} ]
},
"type": [ {
"code": "dateTime"
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "BeginDatum"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.StartDate"
}, {
"path": "MedicalDevice.EndDate",
"min": 0,
"definition": "The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted.",
"short": "EndDate",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "De einddatum van de laatste toepassing of explantatie van het medische hulpmiddel. Een vage datum, bijv. alleen een jaartal, is toegestaan."
} ]
} ]
},
"type": [ {
"code": "dateTime"
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "EindDatum"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.EndDate"
}, {
"path": "MedicalDevice.Comment",
"min": 0,
"definition": "Comment about use or information on the medical device used.",
"short": "Comment",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Opmerking bij de toepassing of informatie over het gebruikte hulpmiddel."
} ]
} ]
},
"type": [ {
"code": "string"
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Toelichting"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.Comment"
}, {
"path": "MedicalDevice.Location",
"min": 0,
"definition": "The healthcare organization where the use of the medical device was initiated or where the aid was implanted.",
"short": "Location",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "De zorgaanbieder waar het gebruik van het hulpmiddel geïnitieerd werd of waar het hulpmiddel geïmplanteerd werd."
} ]
} ]
},
"type": [ {
"code": "Reference",
"targetProfile": [ "https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-HealthcareOrganization" ]
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Locatie"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.Location"
}, {
"path": "MedicalDevice.HealthProfessional",
"min": 0,
"definition": "The health professional involved in the indication for use of the medical device implant.",
"short": "HealthProfessional",
"_definition": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "De zorgverlener betrokken bij de indicatiestelling voor het gebruik of de implantatie van het hulpmiddel."
} ]
} ]
},
"type": [ {
"code": "Reference",
"targetProfile": [ "https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-HealthProfessional" ]
} ],
"_short": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "nl-NL"
}, {
"url": "content",
"valueMarkdown": "Zorgverlener"
} ]
} ]
},
"max": "1",
"id": "MedicalDevice.HealthProfessional"
} ]
},
"contact": [ {
"name": "Service portal – healthdata.be",
"telecom": [ {
"use": "work",
"value": "https://sciensano.service-now.com/sp",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Element"
}