MedicalDevice-v3.0(2016EN)

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General information

Name: nl.zorg.MedicalDevice
Version: 3.0
HCIM Status:Final
Release: 2016
Release status: Published
Release date: 1-5-2016


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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 1-5-2016
DCM::PublicationStatus Published
DCM::ReviewerList Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
DCM::RevisionDate 1-4-2015
DCM::Superseeds nl.nfu.MedischHulpmiddel-v1.2
DCM::Version 3.0
HCIM::PublicationLanguage EN

Revision History

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-v3.0(2016EN)HealthcareProvider-v3.0(2016EN)#9810ConcernForTransfer-v3.0(2016EN)#9806#9805#9804#9807#9803#ProductIDCodelist#AidAnatomicalLocationCodelist#ProductTypeCodelist


Type Id Concept Card. Definition DefinitionCode Reference
NL-CM:10.1.1 MedicalAid Root concept of the MedicalAid information model. This root concept contains all data elements of the MedicalAid information model.
NL-CM:10.1.2 Product 1 The medical aid used (internally or externally).
NL-CM:10.1.4 ProductID 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).

ProductIDCodelist
NL-CM:10.1.3 ProductType 0..1 The code of the type of product.
ProductTypeCodelist
NL-CM:10.1.11 StartDate 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.
NL-CM:10.1.7 Indication::Problem 0..* The medical reason for use of the medical aid.
ConcernForTransfer
NL-CM:10.1.10 Explanation 0..1 Comment about use or information on the medical aid used.
NL-CM:10.1.6 AidAnatomicalLocation 0..1 Patient’s anatomical location of the medical aid used.
AidAnatomicalLocationCodelist
NL-CM:10.1.8 Location::HealthcareProvider 0..1 The healthcare provider at which use of the medical aid was initiated or where the aid was implanted.
HealthcareProvider
NL-CM:10.1.9 HealthcareProvider 0..1 The healthcare provider involved in the indication for use of the medical aid 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 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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About this information

The information in this wikipage is based on Release summer 2016
Conditions for use are located on the mainpage
This page is generated on 21/12/2018 15:40:07 with ZibExtraction v. 3.0.6929.24609


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