MedicalDevice-v1.2(2015EN)

General information

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

---

Back to HCIM list

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

Type	Id	Concept						Card.	Definition	DefinitionCode	Reference
	NL-CM:10.1.1	MedicalAid							Root concept of the MedicalAid building block. This root concept contains all data elements of the MedicalAid building block.
	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

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

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	UNSPSC	2.16.840.1.113883.6.302

This information model in other releases

• Release 2016, (Version 3.0)
• Release 2017, (Version 3.1)

More on this information model

To exchange information based on health and care information models, additional, more technical specifications are required.
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

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

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
This page is generated on 24/01/2018 17:13:11

---

Back to HCIM list