MedicalDevice-v1.2(2015EN)

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General information

Name: nl.nfu.MedicalDevice NL.png
Version: 1.2
HCIM Status:Final
Release: 2015
Release status: Published
Release date: 1-4-2015


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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 NFU
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.nfu.MedischHulpmiddel
DCM::PublicationDate 1-4-2015
DCM::PublicationStatus Published
DCM::ReviewerList Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
DCM::RevisionDate 1-4-2015
DCM::Superseeds
DCM::Version 1.2
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

Concept

Medical aids 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 aids 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 NFU opts for GS1 standards to increase patient safety and improve logistic efficiency.

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


#9809HealthProfessional-v1.2.1(2015EN)HealthcareProvider-v1.2(2015EN)#9810ConcernForTransfer-v1.2(2015EN)#9806#9805#9804#9807#9803#ProductIDCodelist#AidAnatomicalLocationCodelist#ProductTypeCodelistMedicalDevice-v1.2Model(2015EN).png


Type Id Concept Card. Definition DefinitionCode Reference
Block.png NL-CM:10.1.1 Arrowdown.pngMedicalAid Root concept of the MedicalAid building block. This root concept contains all data elements of the MedicalAid building block.
Folder.png NL-CM:10.1.2 Arrowdown.pngProduct 1 The medical aid used (internally or externally).
CD.png NL-CM:10.1.4 Arrowright.pngProductID 0..1 Unique identification of the product, such as the serial number.

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 ProductIDCodelist
CD.png NL-CM:10.1.3 Arrowright.pngProductType 0..1 The code of the type of product.
List2.png ProductTypeCodelist
TS.png NL-CM:10.1.11 Arrowright.pngStartDate 0..1 The start date of the first use or implant of the medical aid. 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 aid.
Block.png ConcernForTransfer
ST.png NL-CM:10.1.10 Arrowright.pngExplanation 0..1 Comment about use or information on the medical aid used.
CD.png NL-CM:10.1.6 Arrowright.pngAidAnatomicalLocation 0..1 Patient’s anatomical location of the medical aid used.
List2.png AidAnatomicalLocationCodelist
Verwijzing.png NL-CM:10.1.8 Arrowright.pngLocation::HealthcareProvider 0..1 The healthcare provider at which use of the medical aid was initiated or where the aid was implanted.
Block.png HealthcareProvider
Verwijzing.png NL-CM:10.1.9 Arrowright.pngHealthcareProvider 0..1 The healthcare provider involved in the indication for use of the medical aid 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 Hulpmiddel Anatomische Locatie Indicatie Locatie Toelichting
ProductID ProductType ProbleemNaam Organisatie
Naam
Afdeling
Specialisme
08-03-2012 42192210 Rolstoel Multiple sclerose Kan korte afstanden lopen
Begin
Datum
Product Hulpmiddel Anatomische Locatie Indicatie Locatie Toelichting
ProductID ProductType ProbleemNaam Organisatie
Naam
Afdeling
Specialisme
2007 42144000 Gehoorapparaat R oor Presbyacusis St. Franciscus Gasthuis Audiologie Apparaat niet zichtbaar (diep in de gehooringang)
Begin
Datum
Product Hulpmiddel Anatomische Locatie Indicatie Locatie Toelichting
ProductID ProductType ProbleemNaam Organisatie
Naam
Afdeling
Specialisme
10-02-2004 422033500 VVI Pacemaker L subclavian pouch 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 aid 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

AidAnatomicalLocationCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.2 Binding:
Conceptname Codesystem name Codesystem OID
SNOMED CT: <<91723000|anatomical structure| SNOMED CT 2.16.840.1.113883.6.96

ProductIDCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.3 Binding:
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:
Conceptname Codesystem name Codesystem OID
Alle waarden UNSPSC 2.16.840.1.113883.6.302

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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 Registratie aan de bron publication 2015 including errata dd. 16-07-2015
Conditions for use are located on the mainpage List2.png
This page is generated on 24/12/2018 12:30:37 with ZibExtraction v. 3.0.6932.1989


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