MedicalDevice-v4.0(2022EN)

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General information

Name: nl.zorg.MedicalDevice
Version: 4.0
HCIM Status:Final
Release: 2022
Release status: Prepublished
Release date: 15-10-2023

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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	15-10-2023
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

Only available in Dutch

Publicatieversie 1.0 (15-02-2013) -

Publicatieversie 1.1 (01-07-2013)

Issue summaries niet beschikbaar
Bevat: ZIB-11.

Publicatieversie 1.2 (01-04-2015) Bevat: ZIB-83, ZIB-88, ZIB-110, ZIB-249, ZIB-250, ZIB-251, ZIB-252, ZIB-308, ZIB-327, ZIB-353.

Incl. algemene wijzigingsverzoeken: ZIB-94, ZIB-154, ZIB-200, ZIB-201, ZIB-309, ZIB-324, ZIB-326.

Publicatieversie 3.0 (01-05-2016) Bevat: ZIB-453.

Publicatieversie 3.1 (04-09-2017) Bevat: ZIB-457, ZIB-461, ZIB-517, ZIB-522, ZIB-547, ZIB-549, ZIB-564,. ZIB-568, ZIB-573, ZIB-574, ZIB-578, ZIB-585.

Publicatieversie 3.1.1 (01-10-2018) Bevat: ZIB-673.

Publicatieversie 3.2 (26-02-2019) Bevat: ZIB-680.

Publicatieversie 3.3 (06-07-2019) Bevat: ZIB-734.

Publicatieversie 3.3.1 (01-09-2020) Bevat: ZIB-1116, ZIB-1135, ZIB-1120.

Publicatieversie 3.4 (01-12-2021) Bevat: ZIB-1279, ZIB-1534.

Publicatieversie 3.5 (10-06-2022) Bevat: ZIB-1535.

Publicatieversie 4.0 (15-10-2023) Bevat: ZIB-1536, ZIB-1778, ZIB-1974.

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

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

Voorbeeld file fout: Unable to find the specified file. : nl.zorg.Zib of versie niet gevonden-v4.0(NL)_Voorbeeld.docx

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

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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 Pre-release 2022-1
SNOMED CT and LOINC codes are based on:

SNOMED Clinical Terms versie: 20230930 [R] (september 2023-editie)
LOINC version 2.76

Conditions for use are located on the mainpage
This page is generated on 27/03/2024 11:10:24 with ZibExtraction v. 9.3.8851.20230

Back to HCIM list

MedicalDevice-v4.0(2022EN)

Inhoud

General information

Metadata

Revision History

Concept

Purpose

Evidence Base

Information Model

Example Instances

References