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**' package_name: healthdata.be.r4.cbb derivation: specialization name: HdBeMedicalDevice abstract: true type: https://fhir.healthdata.be/StructureDefinition/LogicalModel/medical_device elements: eind_datum: 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: dateTime _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: EindDatum} base: {max: '1', min: 0, path: medical_device.eind_datum} index: 8 indication: short: Indication index: 5 _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: BackboneElement _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: Indicatie} array: true elements: problem: 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)." refers: ['https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-Problem'] type: Reference _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: Probleem} base: {max: '1', min: 1, path: medical_device.indication.problem} index: 6 base: {max: '*', min: 0, path: medical_device.indication} required: [problem] anatomical_location: 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: AnatomicalLocation _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: AnatomischeLocatie} index: 4 health_professional: 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.} refers: ['https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-HealthProfessional'] type: Reference _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: Zorgverlener} base: {max: '1', min: 0, path: medical_device.health_professional} index: 12 product: 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: BackboneElement _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: Product} base: {max: '1', min: 1, path: medical_device.product} index: 0 elements: product_id: 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: CodeableConcept _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: ProductID} base: {max: '1', min: 0, path: medical_device.product.product_id} index: 1 product_type: 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: 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'} base: {max: '1', min: 0, path: medical_device.product.product_type} index: 2 start_date: 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: dateTime _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: BeginDatum} base: {max: '1', min: 0, path: medical_device.start_date} index: 7 product_description: 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: string _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: ProductOmschrijving} base: {max: '1', min: 0, path: medical_device.product_description} index: 3 comment: 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: string _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: Toelichting} base: {max: '1', min: 0, path: medical_device.comment} index: 9 location: 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: BackboneElement _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: Locatie} base: {max: '1', min: 0, path: medical_device.location} index: 10 elements: healthcare_provider: 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.} refers: ['https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-HealthcareProvider'] type: Reference _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: nl-NL} - {url: content, valueMarkdown: Zorgaanbieder} base: {max: '1', min: 1, path: medical_device.location.healthcare_provider} index: 11 required: [healthcare_provider] package_version: 0.4.1-alpha class: logical kind: logical url: https://fhir.healthdata.be/StructureDefinition/LogicalModel/HdBe-MedicalDevice base: http://hl7.org/fhir/StructureDefinition/Element version: null required: [product]