{ "description": "**Concept**\\r\\nMedical 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.\\r\\n\\r\\n\\r\\n\\r\\n**Evidence Base**\\r\\nRecording data on medically complex devices such as pacemakers is not yet common in EPD systems in the Netherlands, but is sometimes lacking: a letter from a specialist for example often does not include information on which type of pacemaker the patient has (and from which manufacturer). \\r\\nThe Dutch Ministry of Health, Welfare and Sport (VWS) will pass legislation for a national basic register of implants. Every healthcare center will have to supply a UDI (Unique Device Identification, with a link to GTIN) and a UPI (Unique Patient Identification) to the basic register. This will prevent situations in which a large group of patients have an aid or implant in which problems have been detected that cannot be traced. \\r\\n**Example Instances**", "_filename": "HdBe-MedicalDevice.json", "package_name": "healthdata.be.r4.cbb", "date": null, "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/medical_device", "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": "**Concept**\r\nMedische 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**Example Instances**\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": "0.4.1-alpha", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/resource-effectivePeriod", "valuePeriod": { "start": "2020-09-01T00:00:00+02:00" } } ], "status": "draft", "language": "en-US", "id": "109e3207-3f11-4db4-b97d-4ab3cb8ec1b2", "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": [ { "path": "medical_device", "min": 0, "definition": "Root concept of the MedicalDevice information model. This root concept contains all data elements of the MedicalDevice information model.", "short": "MedicalDevice", "_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." } ] } ] }, "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "nl-NL" }, { "url": "content", "valueMarkdown": "MedischHulpmiddel" } ] } ] }, "max": "*", "id": "medical_device", "base": { "max": "*", "min": 0, "path": "medical_device" } }, { "path": "medical_device.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": "medical_device.product", "base": { "max": "1", "min": 1, "path": "medical_device.product" } }, { "path": "medical_device.product.product_id", "min": 0, "definition": "Unique identification of the product, such as the serial number. \r\nFrequently used coding systems are HIBC and GTIN.\r\nIf the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information. \r\n\r\nThe UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).", "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": "CodeableConcept" } ], "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "nl-NL" }, { "url": "content", "valueMarkdown": "ProductID" } ] } ] }, "max": "1", "id": "medical_device.product.product_id", "base": { "max": "1", "min": 0, "path": "medical_device.product.product_id" } }, { "path": "medical_device.product.product_type", "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": "medical_device.product.product_type", "base": { "max": "1", "min": 0, "path": "medical_device.product.product_type" } }, { "path": "medical_device.product_description", "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": "medical_device.product_description", "base": { "max": "1", "min": 0, "path": "medical_device.product_description" } }, { "path": "medical_device.anatomical_location", "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": "AnatomicalLocation", "profile": [ "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": "medical_device.anatomical_location" }, { "path": "medical_device.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": "BackboneElement" } ], "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "nl-NL" }, { "url": "content", "valueMarkdown": "Indicatie" } ] } ] }, "max": "*", "id": "medical_device.indication", "base": { "max": "*", "min": 0, "path": "medical_device.indication" } }, { "path": "medical_device.indication.problem", "min": 1, "definition": "Root concept of the Problem information model.\r\nA problem describes a situation with regard to an individual’s health and/or welfare. This situation can be described by the patient himselve (in the form of a complaint) or by their healthprofessional (in the form of a diagnosis, for example).", "short": "Problem", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "nl-NL" }, { "url": "content", "valueMarkdown": "Rootconcept van de bouwsteen Probleem.\r\nEen probleem beschrijft een toestand met betrekking tot de gezondheid en/of het welzijn van een individu. Deze toestand kan zijn benoemd door de patiënt zelf (een klacht), of door zijn of haar zorgverlener (onder andere een diagnose)." } ] } ] }, "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": "Probleem" } ] } ] }, "max": "1", "id": "medical_device.indication.problem", "base": { "max": "1", "min": 1, "path": "medical_device.indication.problem" } }, { "path": "medical_device.start_date", "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": "medical_device.start_date", "base": { "max": "1", "min": 0, "path": "medical_device.start_date" } }, { "path": "medical_device.eind_datum", "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": "EindDatum", "_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" } ] } ] }, "alias": [ "EndDate" ], "max": "1", "id": "medical_device.eind_datum", "base": { "max": "1", "min": 0, "path": "medical_device.eind_datum" } }, { "path": "medical_device.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": "medical_device.comment", "base": { "max": "1", "min": 0, "path": "medical_device.comment" } }, { "path": "medical_device.location", "min": 0, "definition": "The healthcare provider at which 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": "BackboneElement" } ], "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "nl-NL" }, { "url": "content", "valueMarkdown": "Locatie" } ] } ] }, "max": "1", "id": "medical_device.location", "base": { "max": "1", "min": 0, "path": "medical_device.location" } }, { "path": "medical_device.location.healthcare_provider", "min": 1, "definition": "Root concept of the Healthcare Provider information model. This root concept contains all data elements of the Healthcare Provider information model.", "short": "HealthcareProvider", "_definition": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "nl-NL" }, { "url": "content", "valueMarkdown": "Rootconcept van de bouwsteen Zorgaanbieder. Dit rootconcept bevat alle gegevenselementen van de bouwsteen Zorgaanbieder." } ] } ] }, "type": [ { "code": "Reference", "targetProfile": [ "https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-HealthcareProvider" ] } ], "_short": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/translation", "extension": [ { "url": "lang", "valueCode": "nl-NL" }, { "url": "content", "valueMarkdown": "Zorgaanbieder" } ] } ] }, "max": "1", "id": "medical_device.location.healthcare_provider", "base": { "max": "1", "min": 1, "path": "medical_device.location.healthcare_provider" } }, { "path": "medical_device.health_professional", "min": 0, "definition": "The healthcare provider 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": "medical_device.health_professional", "base": { "max": "1", "min": 0, "path": "medical_device.health_professional" } } ] }, "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" }