MedicalDevice-v3.1(2017EN)

General information

Name: nl.zorg.MedicalDevice
Version: 3.1
HCIM Status:Final
Publication: 2017
Release status: Prepublished
Publication date: 04-09-2017

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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	04-09-2017
DCM::PublicationStatus	Prepublished
DCM::ReviewerList	Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
DCM::RevisionDate	04-09-2017
DCM::Superseeds	nl.zorg.MedischHulpmiddel-v3.0
DCM::Version	3.1
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

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

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 (physical object)
	NL-CM:10.1.2		Product					1	The medical aid used (internally or externally).	405815000 Procedure device
	NL-CM:10.1.4			ProductID				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).		HIBCProductIDCodelist ProductIDCodelist
	NL-CM:10.1.3			ProductType				0..1	The code of the type of product.		ProductTypeCodelist
	NL-CM:10.1.13		ProductDescription					0..1	Textual description of the product.
	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 device.		Problem
	NL-CM:10.1.10		Comment					0..1	Comment about use or information on the medical aid used.	48767-8 Annotation comment
	NL-CM:10.1.6		AnatomicalLocation					0..1	Patient’s anatomical location of the medical device used.	363698007 Finding site	MedicalDeviceAnatomicalLocationCodelist
	NL-CM:10.1.12		Laterality					0..1	Laterality adds information about body side to the anatomic location, e.g. left	272741003 Laterality	MedicalDeviceLateralityCodelist
	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		HealthProfessional					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		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 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

HIBCProductIDCodelist

Valueset OID 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.5

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

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

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

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

Conceptname	Codesystem name	Codesystem OID
Alle waarden	SNOMED CT	2.16.840.1.113883.6.96

More on this information model

More technical information and HL7/XML documentation you can find on the Nictiz Art-Decor page about this information model[1]
This information model is also available as pdf file or as spreadsheet

About this information

The information in this wikipage is based on Prerelease 2017 #1
Conditions for use are located on the mainpage
This page is generated on 28/09/2017 10:58:26

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