MedicalDevice-v3.1.1(2018EN)

Uit Zorginformatiebouwstenen
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General information

Name: nl.zorg.MedicalDevice NL.png
Version: 3.1.1
HCIM Status:Final
Release: 2018
Release status: Prepublished
Release date: 01-10-2018

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Metadata

DCM::CoderList Kerngroep Registratie aan de Bron
DCM::ContactInformation.Address *
DCM::ContactInformation.Name *
DCM::ContactInformation.Telecom *
DCM::ContentAuthorList Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
DCM::CreationDate 2-1-2013
DCM::DeprecatedDate
DCM::DescriptionLanguage nl
DCM::EndorsingAuthority.Address
DCM::EndorsingAuthority.Name PM
DCM::EndorsingAuthority.Telecom
DCM::Id 2.16.840.1.113883.2.4.3.11.60.40.3.10.1
DCM::KeywordList medisch hulpmiddel, implantaat
DCM::LifecycleStatus Final
DCM::ModelerList Kerngroep Registratie aan de Bron
DCM::Name nl.zorg.MedischHulpmiddel
DCM::PublicationDate 01-10-2018
DCM::PublicationStatus Prepublished
DCM::ReviewerList Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
DCM::RevisionDate 31-12-2017
DCM::Superseeds nl.zorg.MedischHulpmiddel-v3.1
DCM::Version 3.1.1
HCIM::PublicationLanguage EN

Revision History

Only available in Dutch

Publicatieversie 1.0 (15-02-2013) -

Publicatieversie 1.1 (01-07-2013)

ZIB-11 Gebruik van de GS1 standaard

Publicatieversie 1.2 (01-04-2015)

ZIB-83 Wijzigingsvoorstel OverdrachtMedischHulpmiddel
ZIB-88 OverdrachtMedischHulpmiddel
ZIB-110 Example of the instrument van OverdrachtMedischHulpmiddel bevat kolom Zorgverlener, definities binnen deze kolom moeten duidelijker
ZIB-249 In de klinische bouwsteen OverdrachtMedischHulpmiddel DCM::ValueSet SNOMED CT aangepast van concept AnatomischeLocalisatie naar tagged value DCM::ContentExpression.
ZIB-250 In klinische bouwsteen OverdrachtMedischHulpmiddel de waarde van DCM::Name aanpassen van OverdrachtMedischHulpmiddel naar nl.nfu.OverdrachtMedischHulpmiddel.
ZIB-251 Tagged value DCM::ValueSet van concept ProductType aangepast naar DCM::CodeSystem.
ZIB-252 Tagged value DCM::ValueSet GTIN aangepast naar DCM::AssigningAuthority GTIN.
ZIB-308 Prefix Overdracht weggehaald bij de generieke bouwstenen
ZIB-327 AnatomischeLocalisatie wijzigen in AnatomischeLocatie
ZIB-353 Tagged values DCM::CodeSystem aanpassen naar DCM::ValueSet incl. gekoppelde codelijst.

Incl. algemene wijzigingsverzoeken:

ZIB-94 Aanpassen tekst van Disclaimer, Terms of Use & Copyrights
ZIB-154 Consequenties opsplitsing Medicatie bouwstenen voor overige bouwstenen.
ZIB-200 Naamgeving SNOMED CT in tagged values klinische bouwstenen gelijk getrokken.
ZIB-201 Naamgeving OID: in tagged value notes van klinische bouwstenen gelijk getrokken.
ZIB-309 EOI aangepast
ZIB-324 Codelijsten Name en Description beginnen met een Hoofdletter
ZIB-326 Tekstuele aanpassingen conform de kwaliteitsreview kerngroep 2015

Publicatieversie 3.0 (01-05-2016)

Publicatieversie 3.1 (04-09-2017)

ZIB-457 Uitbreiding AnatomischeLocatieCodelijst met Snomed qualifiers
ZIB-461 Uitbreiding ProductIDCodelijst met HIBC
ZIB-517 Onduidelijk hoe ProductTypeCodelijst gebruikt moet worden.
ZIB-522 Codestelsel veranderen voor producttype
ZIB-547 Toevoegen SNOMED CT als mogelijk codestelsel voor het coderen van producttype
ZIB-549 De Engelse naam van de bouwsteen en het rootconcept zijn niet correct
ZIB-564 Aanpassing/harmonisatie Engelse conceptnamen
ZIB-568 Example Instances niet correct
ZIB-573 Toevoegen van de mogelijkheid om dimensies van het hulpmiddel aan te geven
ZIB-574 Alleen verwijzen naar het rootconcept van de ZIB.
ZIB-578 Aan het concept anatomische locatie moet een concept Laterariteit toegevoegd worden.
ZIB-585 Toevoegen concept Lateraliteit aan het concept Anatomische Locatie

Publicatieversie 3.1.1 (01-10-2018)

ZIB-673 Tekstueel wijzigen 'medical aid' naar 'medical device'.

Concept

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.

Purpose

Data 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.

Examples include:

  • Consequences for transportation, toilet use, etc., in the case of a wheelchair;
  • A pacemaker can be of medical importance, but also has consequences for planning radiological exams.

Evidence Base

Recording 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).
The 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.

Information Model


#12921#HIBCProductIDCodelist#MedicalDeviceLateralityCodelist#12934#MedicalDeviceAnatomicalLocationCodelist#ProductIDCodelist#ProductTypeCodelist#12935HealthProfessional-v3.2(2018EN)HealthcareProvider-v3.2(2018EN)#12933Problem-v4.1.1(2018EN)#12928#12929#12932#12923#12931MedicalDevice-v3.1.1Model(EN).png


Type Id Concept Card. Definition DefinitionCode Reference
Block.png NL-CM:10.1.1 Arrowdown.pngMedicalDevice Root concept of the MedicalDevice information model. This root concept contains all data elements of the MedicalDevice information model.
49062001 Device
Folder.png NL-CM:10.1.2 Arrowdown.pngProduct 1 The medical device (internally or externally).
405815000 Procedure device
CD.png NL-CM:10.1.4 Arrowright.pngProductID 0..1 Unique identification of the product, such as the serial number.

Frequently used coding systems are HIBC and GTIN. If 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.

The 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).

List2.png HIBCProductIDCodelist
List2.png ProductIDCodelist
CD.png NL-CM:10.1.3 Arrowright.pngProductType 0..1 The code of the type of product.
List2.png ProductTypeCodelist
ST.png NL-CM:10.1.13 Arrowright.pngProductDescription 0..1 Textual description of the product.
TS.png NL-CM:10.1.11 Arrowright.pngStartDate 0..1 The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted.
Verwijzing.png NL-CM:10.1.7 Arrowright.pngIndication::Problem 0..* The medical reason for use of the medical device.
Block.png Problem
ST.png NL-CM:10.1.10 Arrowright.pngComment 0..1 Comment about use or information on the medical device used.
48767-8 Annotation comment [Interpretation] Narrative
CD.png NL-CM:10.1.6 Arrowright.pngAnatomicalLocation 0..1 Patient’s anatomical location of the medical device used.
363698007 Finding site
List2.png MedicalDeviceAnatomicalLocationCodelist
CD.png NL-CM:10.1.12 Arrowright.pngLaterality 0..1 Laterality adds information about body side to the anatomic location, e.g. left
272741003 Laterality
List2.png MedicalDeviceLateralityCodelist
Verwijzing.png NL-CM:10.1.8 Arrowright.pngLocation::HealthcareProvider 0..1 The healthcare provider at which use of the medical device was initiated or where the aid was implanted.
Block.png HealthcareProvider
Verwijzing.png NL-CM:10.1.9 Arrowright.pngHealthProfessional 0..1 The healthcare provider involved in the indication for use of the medical device implant.
Block.png HealthProfessional

Columns Concept and DefinitionCode: hover over the values for more information
For explanation of the symbols, please see the legend page List2.png

Example Instances

Only available in Dutch

Begin
Datum 		Product Anatomische Locatie Lateraliteit Indicatie Locatie Toelichting
ProductID ProductType ProbleemNaam Organisatie
Naam 		Afdeling
Specialisme
08-03-2012 GTIN/HIBC code Rolstoel Multiple sclerose Kan korte afstanden lopen
Begin
Datum 		Product Anatomische Locatie Lateraliteit Lateraliteit Locatie Toelichting
ProductID ProductType ProbleemNaam Organisatie
Naam 		Afdeling
Specialisme
2007 GTIN/HIBC code Gehoorapparaat Oor Rechts Presbyacusis St. Franciscus Gasthuis Audiologie Apparaat niet zichtbaar (diep in de gehooringang)
Begin
Datum 		Product Anatomische Locatie Lateraliteit Indicatie Locatie Toelichting
ProductID ProductType ProbleemNaam Organisatie
Naam 		Afdeling
Specialisme
10-02-2004 GTIN/HIBC code Pacemaker Subclavian pouch Links Paroxymaal boezemfibrilleren Academisch Medisch Centrum Cardiologie Laatst doorgemeten in 2011

Issues

The UNSPSC code system has a great many products (including non-medical products). That is why a Dutch set and/or subcollection of this code system is required to indicate the type of product. We have currently opted to consider all values in the UNPSPSC for documenting the type of medical device product in the absence of such a set.

References

1. 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].

Valuesets

HIBCProductIDCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.5 Binding: Extensible
Conceptname Codesystem name Codesystem OID
Alle waarden Health Industry Bar Code (HIBC) 2.16.840.1.113883.6.40

MedicalDeviceAnatomicalLocationCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.2 Binding: Extensible
Conceptname Codesystem name Codesystem OID
SNOMED CT: < 442083009|Anatomical or acquired body structure| SNOMED CT 2.16.840.1.113883.6.96

MedicalDeviceLateralityCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.4 Binding: Extensible
Conceptname Conceptcode Codesystem name Codesystem OID Description
Left 7771000 SNOMED CT 2.16.840.1.113883.6.96 Links
Right 24028007 SNOMED CT 2.16.840.1.113883.6.96 Rechts
Right and left 51440002 SNOMED CT 2.16.840.1.113883.6.96 Rechts en links

ProductIDCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.3 Binding: Extensible
Conceptname Codesystem name Codesystem OID
Alle waarden Global Trade Item Number (GTIN) 1.3.160

ProductTypeCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1 Binding: Extensible
Conceptname Codesystem name Codesystem OID
Alle waarden SNOMED CT 2.16.840.1.113883.6.96

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This information model is also available as pdf file PDF.png or as spreadsheet Xlsx.png

About this information

The information in this wikipage is based on Prerelease 2018 #1
SNOMED CT and LOINC codes are based on:

  • SNOMED Clinical Terms version: 20180731 [R] (July 2018 Release)
  • LOINC version 2.64

Conditions for use are located on the mainpage List2.png
This page is generated on 01/11/2018 17:36:41 with ZibExtraction v. 2.0.6879.31307

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