MedicalDevice-v4.0(2024EN)

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General information

Name: nl.zorg.MedicalDevice
Version: 4.0
HCIM Status:Final
Release: 2024
Release status: Prepublished
Release date: 15-04-2024

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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 15-04-2024
DCM::PublicationStatus Prepublished
DCM::ReviewerList Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
DCM::RevisionDate 17-07-2023
DCM::Supersedes nl.zorg.MedischHulpmiddel-v3.5
DCM::Version 4.0
HCIM::PublicationLanguage EN

Revision History

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


#381#ProductTypeCodelist#1203HealthProfessional-v4.0(2024EN)HealthcareProvider-v3.6(2024EN)#387Problem-v4.7(2024EN)#1198#1200#383#1199#1708AnatomicalLocation-v1.0.3(2024EN)#ProductTypeImplantsCodelist#ProductTypeGeenCodelist


Type Id Concept Card. Definition DefinitionCode Reference
NL-CM:10.1.1 MedicalDevice Root concept of the MedicalDevice information model. This root concept contains all data elements of the MedicalDevice information model.
49062001 Device
NL-CM:10.1.2 Product 1 The medical device (internally or externally).
405815000 Procedure device
NL-CM:10.1.3 ProductType 0..1 The code of the type of product.
ProductTypeCodelist
ProductTypeGeenCodelist
ProductTypeImplantsCodelist
NL-CM:10.1.16 ProductID 0..1 Globally unique identification of the product, for example the serial number or a UDI (unique device identifier). For some products, the law requires the use of a UDI. Commonly used coding systems are HIBC and GS1/GTIN.

A UDI often contains more information than just an ID, but also, for example, an expiration date. If a UDI is used, the entire code can be included as text in ProductID, so that no important information is lost.

NL-CM:10.1.13 ProductDescription 0..1 Textual description of the product.
NL-CM:10.1.15 AnatomicalLocation 0..1 Patient’s anatomical location of the medical device used.
363698007 Finding site
AnatomicalLocation
NL-CM:10.1.7 Indication::Problem 0..* The medical reason for use of the medical device.
Problem
NL-CM:10.1.11 StartDate 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.
NL-CM:10.1.14 EndDate 0..1 The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted.
NL-CM:10.1.10 Comment 0..1 Comment about use or information on the medical device used.
48767-8 Annotation comment [Interpretation] Narrative
NL-CM:10.1.8 Location::HealthcareProvider 0..1 The healthcare provider where use of the medical device was initiated or where the aid was implanted.
HealthcareProvider
NL-CM:10.1.9 HealthProfessional 0..1 The health professional involved in the indication for use of the medical device implant.
HealthProfessional

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

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

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

ProductTypeCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1 Binding: Required
Conceptname Codesystem name Codesystem OID
SNOMED CT: <260787004|Physical object| SNOMED CT 2.16.840.1.113883.6.96

ProductTypeGeenCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.7 Binding: Required
Conceptname Conceptcode Codesystem name Codesystem OID Description
Geen 0 Hulpmiddelen gehoor 2.16.840.1.113883.2.4.3.11.22.211 geen gehoorapparaat
Geen 0 eCare codes 2.16.840.1.113883.2.4.3.11.22.218 geen visuele hulpmiddelen

Note: Intended to be used with VisualFunction and HearingFunction.

ProductTypeImplantsCodelist

Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.6 Binding: Required
Conceptname Codesystem name Codesystem OID
SNOMED CT: ^52801000146101|Dutch implant registry simple reference set| SNOMED CT 2.16.840.1.113883.6.96

This information model in other releases

Information model references

This information model refers to

This information model is used in

Technical specifications in HL7v3 CDA and HL7 FHIR

To exchange information based on health and care information models, additional, more technical specifications are required.<BR> Not every environment can handle the same technical specifications. For this reason, there are several types of technical specifications:

  • HL7® version 3 CDA compatible specifications, available through the Nictiz ART-DECOR® environment
  • HL7® FHIR® compatible specifications, available through the Nictiz environment on the Simplifier FHIR

Downloads

This information model is also available as pdf file or as spreadsheet

About this information

The information in this wikipage is based on Prerelease 2024-1
SNOMED CT and LOINC codes are based on:

  • SNOMED Clinical Terms versie: 20240331 [R] (maart 2024-editie)
  • LOINC version 2.77

Conditions for use are located on the mainpage
This page is generated on 25/04/2024 12:41:46 with ZibExtraction v. 9.3.8880.19756

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