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	Conditions for use are located on the mainpage<!--ftConditions--> [[Bestand:list2.png\|link=HCIM_Mainpage<!--wikiMainpage-->]]<BR>		Conditions for use are located on the mainpage<!--ftConditions--> [[Bestand:list2.png\|link=HCIM_Mainpage<!--wikiMainpage-->]]<BR>
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Update bot op 27 mrt 2024 om 08:44

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	</ul>		</ul>
	Conditions for use are located on the mainpage<!--ftConditions--> [[Bestand:list2.png\|link=HCIM_Mainpage<!--wikiMainpage-->]]<BR>		Conditions for use are located on the mainpage<!--ftConditions--> [[Bestand:list2.png\|link=HCIM_Mainpage<!--wikiMainpage-->]]<BR>
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Update bot: Nieuwe pagina aangemaakt met ' {{Versions-2.16.840.1.113883.2.4.3.11.60.40.3.10.1(EN)|1|MedicalDevice-v4.0(2022EN)}} ==General information== Name: '''nl.zorg.MedicalDevice''' link=Zib of versie niet gevonden-v4.0(2022NL)
Version: '''4.0'''
HCIM Status:Final
Release: '''2...'

2024-03-26T10:47:16Z

Nieuwe pagina aangemaakt met ' {{Versions-2.16.840.1.113883.2.4.3.11.60.40.3.10.1(EN)|1|MedicalDevice-v4.0(2022EN)}}  ==General information== Name: '''nl.zorg.MedicalDevice''' link=Zib of versie niet gevonden-v4.0(2022NL) Version: '''4.0''' HCIM Status:Final Release: '''2...'

Nieuwe pagina

{{Versions-2.16.840.1.113883.2.4.3.11.60.40.3.10.1(EN)|1|MedicalDevice-v4.0(2022EN)}}

==General information==
Name: '''nl.zorg.MedicalDevice''' [[Bestand:NL.png|link=Zib of versie niet gevonden-v4.0(2022NL)]] 
Version: '''4.0''' 
HCIM Status:Final 
Release: '''2022''' 
Release status: Prepublished 
Release date: 15-10-2023

{{ErrataEN|2022|{{PAGENAME}}}}

-----
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==Metadata==
{| class="wikitable" style="font-size:90%; width: 750px"
|-
|style="width:250px; "|DCM::CoderList||Kerngroep Registratie aan de Bron
|-
|style="width:250px; "|DCM::ContactInformation.Address||*
|-
|style="width:250px; "|DCM::ContactInformation.Name||*
|-
|style="width:250px; "|DCM::ContactInformation.Telecom||*
|-
|style="width:250px; "|DCM::ContentAuthorList||Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
|-
|style="width:250px; "|DCM::CreationDate||2-1-2013
|-
|style="width:250px; "|DCM::DeprecatedDate||
|-
|style="width:250px; "|DCM::DescriptionLanguage||nl
|-
|style="width:250px; "|DCM::EndorsingAuthority.Address||
|-
|style="width:250px; "|DCM::EndorsingAuthority.Name||PM
|-
|style="width:250px; "|DCM::EndorsingAuthority.Telecom||
|-
|style="width:250px; "|DCM::Id||2.16.840.1.113883.2.4.3.11.60.40.3.10.1
|-
|style="width:250px; "|DCM::KeywordList||medisch hulpmiddel, implantaat
|-
|style="width:250px; "|DCM::LifecycleStatus||Final
|-
|style="width:250px; "|DCM::ModelerList||Kerngroep Registratie aan de Bron
|-
|style="width:250px; "|DCM::Name||nl.zorg.MedischHulpmiddel
|-
|style="width:250px; "|DCM::PublicationDate||15-10-2023
|-
|style="width:250px; "|DCM::PublicationStatus||Prepublished
|-
|style="width:250px; "|DCM::ReviewerList||Projectgroep Generieke Overdrachtsgegevens & Kerngroep Registratie aan de Bron
|-
|style="width:250px; "|DCM::RevisionDate||17-07-2023
|-
|style="width:250px; "|DCM::Supersedes||nl.zorg.MedischHulpmiddel-v3.5
|-
|style="width:250px; "|DCM::Version||4.0
|-
|style="width:250px; "|HCIM::PublicationLanguage||EN
|}

==Revision History==
<div class="mw-collapsible mw-collapsed">
'' 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.
</div>

==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: 
<ul>
<li>Consequences for transportation, toilet use, etc., in the case of a wheelchair;</li>
<li>A pacemaker can be of medical importance, but also has consequences for planning radiological exams.</li>
</ul>

==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==
 
<imagemap> Bestand:MedicalDevice-v4.0Model(2022EN).png | center
rect 425 360 539 430 [[#381]]
rect 825 194 987 239 [[#ProductTypeCodelist]]
rect 159 269 273 339 [[#1203]]
rect 508 91 622 161 [[HealthProfessional-v3.5.2(2022EN)]]
rect 334 91 458 161 [[HealthcareProvider-v3.5(2022EN)]]
rect 699 158 789 228 [[#387]]
rect 159 180 273 250 [[Problem-v4.6(2022EN)]]
rect 699 254 789 324 [[#1198]]
rect 508 181 622 251 [[#1200]]
rect 159 91 273 161 [[#383]]
rect 344 198 448 278 [[#1199]]
rect 508 271 622 341 [[#1708]]
rect 269 360 383 430 [[AnatomicalLocation-v1.0.2(2022EN)]]
rect 825 267 987 312 [[#ProductTypeImplantsCodelist]]
rect 825 340 987 390 [[#ProductTypeGeenCodelist]]
desc none
</imagemap>
 
{| border= "1" width="1500px" style = "font-size: 9.5pt; border: solid 1px silver; border-collapse:collapse;" cellpadding = "3px" cellspacing ="0px"
|-style="background-color: #1F497D; color: white; font-weight: bold; font-variant: small-caps; "
|style="width:30px;"|Type||style="width:100px;"|Id||colspan="6 " style="width:140px;"|Concept||Card.||style="width: 600px;"|Definition||style="width:200px;"|DefinitionCode||style="width:200px;"|Reference
|-style="vertical-align:top; background-color: #E3E3E3; "
|style = "text-align:center" |[[Bestand: block.png| 20px | link=]]
||NL-CM:10.1.1
|colspan ="6" style ="padding-left: 0px"|[[Bestand: arrowdown.png | 10px | link=]]MedicalDevice
|
|Root concept of the MedicalDevice information model. This root concept contains all data elements of the MedicalDevice information model.
|
{|
|-
|[https://terminologie.nictiz.nl/art-decor/snomed-ct?conceptId=49062001 49062001] Device
|}
|
|-style="vertical-align:top; background-color: #E8D7BE; "
|style = "text-align:center" |[[Bestand: folder.png| 16px | link=]]
||NL-CM:10.1.2
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowdown.png | 10px | link=]]Product
|1
|The medical device (internally or externally).
|
{|
|-
|[https://terminologie.nictiz.nl/art-decor/snomed-ct?conceptId=405815000 405815000] Procedure device
|}
|
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: CD.png| 16px | link=]]
||NL-CM:10.1.3
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: none;" |
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="4" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]ProductType
|0..1
|The code of the type of product.
|
|
{|
|-
|[[Bestand: List2.png | link=#ProductTypeCodelist]]||[[#ProductTypeCodelist|ProductTypeCodelist]]
|-
|[[Bestand: List2.png | link=#ProductTypeGeenCodelist]]||[[#ProductTypeGeenCodelist|ProductTypeGeenCodelist]]
|-
|[[Bestand: List2.png | link=#ProductTypeImplantsCodelist]]||[[#ProductTypeImplantsCodelist|ProductTypeImplantsCodelist]]
|}
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: ST.png| 16px | link=]]
||NL-CM:10.1.16
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: none;" |
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="4" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]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.
|
|
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: ST.png| 16px | link=]]
||NL-CM:10.1.13
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]ProductDescription
|0..1
|Textual description of the product.
|
|
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: Verwijzing.png| 20px | link=]]
||NL-CM:10.1.15
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]AnatomicalLocation
|0..1
|Patient’s anatomical location of the medical device used.
|
{|
|-
|[https://terminologie.nictiz.nl/art-decor/snomed-ct?conceptId=363698007 363698007] Finding site
|}
|
{|
|-
|[[Bestand: block.png | link=AnatomicalLocation-v1.0.2(2022EN)]]||[[AnatomicalLocation-v1.0.2(2022EN) |AnatomicalLocation]]
|}
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: Verwijzing.png| 20px | link=]]
||NL-CM:10.1.7
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]Indication::Problem
|0..*
|The medical reason for use of the medical device.
|
|
{|
|-
|[[Bestand: block.png | link=Problem-v4.6(2022EN)]]||[[Problem-v4.6(2022EN) |Problem]]
|}
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: TS.png| 16px | link=]]
||NL-CM:10.1.11
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]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.
|
|
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: TS.png| 16px | link=]]
||NL-CM:10.1.14
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]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.
|
|
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: ST.png| 16px | link=]]
||NL-CM:10.1.10
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]Comment
|0..1
|Comment about use or information on the medical device used.
|
{|
|-
|[https://terminologie.nictiz.nl/art-decor/loinc?conceptId=48767-8 48767-8] Annotation comment [Interpretation] Narrative
|}
|
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: Verwijzing.png| 20px | link=]]
||NL-CM:10.1.8
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]Location::HealthcareProvider
|0..1
|The healthcare provider where use of the medical device was initiated or where the aid was implanted.
|
|
{|
|-
|[[Bestand: block.png | link=HealthcareProvider-v3.5(2022EN)]]||[[HealthcareProvider-v3.5(2022EN) |HealthcareProvider]]
|}
|-style="vertical-align:top; background-color: transparent; "
|style = "text-align:center" |[[Bestand: Verwijzing.png| 20px | link=]]
||NL-CM:10.1.9
|style = "width: 7px; padding-left: 0px; padding-right: 0px; border-left: none; border-right: 1px dotted silver;" |
|colspan ="5" style ="padding-left: 0px"|[[Bestand: arrowright.png | 10px | link=]]HealthProfessional
|0..1
|The health professional involved in the indication for use of the medical device implant.
|
|
{|
|-
|[[Bestand: block.png | link=HealthProfessional-v3.5.2(2022EN)]]||[[HealthProfessional-v3.5.2(2022EN) |HealthProfessional]]
|}
|}
Columns Concept and DefinitionCode: hover over the values for more information 
For explanation of the symbols, please see the legend page [[Bestand:list2.png|link=Legend]]

==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===
{| class="wikitable" width="60%"
|-style='vertical-align:top; background-color: #E8D7BE;'
|Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.1
|Binding: Required
|}
{| class="wikitable" width="60% "
|-style="background-color: #1F497D; color: white; font-weight: bold; "
|Conceptname
|Codesystem name||Codesystem OID
|-style="vertical-align:top; "
|SNOMED CT: <[https://terminologie.nictiz.nl/art-decor/snomed-ct?conceptId=260787004 260787004]<noWiki>|</noWiki>Physical object<noWiki>|</noWiki>
|SNOMED CT
|2.16.840.1.113883.6.96
|}
=== ProductTypeGeenCodelist===
{| class="wikitable" width="60%"
|-style='vertical-align:top; background-color: #E8D7BE;'
|Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.7
|Binding: Required
|}
{| class="wikitable" width="60% "
|-style="background-color: #1F497D; color: white; font-weight: bold; "
|Conceptname
|Conceptcode
|Codesystem name||Codesystem OID
|Description
|-style="vertical-align:top; "
|Geen
|0
|Hulpmiddelen gehoor
|2.16.840.1.113883.2.4.3.11.22.211
|geen gehoorapparaat
|-style="vertical-align:top; "
|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===
{| class="wikitable" width="60%"
|-style='vertical-align:top; background-color: #E8D7BE;'
|Valueset OID: 2.16.840.1.113883.2.4.3.11.60.40.2.10.1.6
|Binding: Required
|}
{| class="wikitable" width="60% "
|-style="background-color: #1F497D; color: white; font-weight: bold; "
|Conceptname
|Codesystem name||Codesystem OID
|-style="vertical-align:top; "
|SNOMED CT: ^[https://terminologie.nictiz.nl/terminology/snomed/viewRefset?id=52801000146101 52801000146101]<noWiki>|</noWiki>Dutch implant registry simple reference set<noWiki>|</noWiki>
|SNOMED CT
|2.16.840.1.113883.6.96
|}

==This information model in other releases==

{{Versions-2.16.840.1.113883.2.4.3.11.60.40.3.10.1(EN)|2|2022}}

==Information model references==
====This information model refers to====
*[[AnatomicalLocation-v1.0.2(2022EN)|AnatomicalLocation-v1.0.2]]
*[[HealthcareProvider-v3.5(2022EN)|HealthcareProvider-v3.5]]
*[[HealthProfessional-v3.5.2(2022EN)|HealthProfessional-v3.5.2]]
*[[Problem-v4.6(2022EN)|Problem-v4.6]]
====This information model is used in====
*[[AbilityToPerformMouthcareActivities-v3.1(2022EN)|AbilityToPerformMouthcareActivities-v3.1]]
*[[BladderFunction-v4.0(2022EN)|BladderFunction-v4.0]]
*[[BowelFunction-v4.0(2022EN)|BowelFunction-v4.0]]
*[[FeedingTubeSystem-v3.4(2022EN)|FeedingTubeSystem-v3.4]]
*[[FunctionalOrMentalStatus-v3.2.1(2022EN)|FunctionalOrMentalStatus-v3.2.1]]
*[[HearingFunction-v3.3(2022EN)|HearingFunction-v3.3]]
*[[Infusion-v3.4(2022EN)|Infusion-v3.4]]
*[[Mobility-v3.3.1(2022EN)|Mobility-v3.3.1]]
*[[NursingIntervention-v4.0(2022EN)|NursingIntervention-v4.0]]
*[[Procedure-v5.4(2022EN)|Procedure-v5.4]]
*[[Respiration-v3.2(2022EN)|Respiration-v3.2]]
*[[Stoma-v3.4(2022EN)|Stoma-v3.4]]
*[[VisualFunction-v3.3(2022EN)|VisualFunction-v3.3]]
*[[Wound-v3.4(2022EN)|Wound-v3.4]]
==Technical specifications in HL7v3 CDA and HL7 FHIR==
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:
<ul>
<li>HL7® version 3 CDA compatible specifications, available through the Nictiz ART-DECOR® environment {{ArtDecorLinks|2022|10.1}}</li>
<li>HL7® FHIR® compatible specifications, available through the Nictiz environment on the Simplifier FHIR {{SimplefierLinks|2022|MedischHulpmiddel}}</li>
</ul>
==Downloads==
This information model is also available as [[Media:nl.zorg.MedicalDevice-v4.0(2022EN).pdf|pdf file]] [[File:PDF.png|link=]] or as [[Media:nl.zorg.MedicalDevice-v4.0(2022EN).xlsx|spreadsheet]] [[File:xlsx.png|link=]]
==About this information==
The information in this wikipage is based on Pre-release 2022-1 
SNOMED CT and LOINC codes are based on:
<ul>
<li>SNOMED Clinical Terms versie: 20230930 [R] (september 2023-editie)</li>
<li>LOINC version 2.76</li>
</ul>
Conditions for use are located on the mainpage [[Bestand:list2.png|link=HCIM_Mainpage]] 
This page is generated on 26/03/2024 11:42:26 with ZibExtraction v. 9.3.8851.20230 
-----
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MedicalDevice-v4.0(2022EN) - Bewerkingsoverzicht

Update bot op 27 mrt 2024 om 10:25

Update bot op 27 mrt 2024 om 08:44

Update bot: Nieuwe pagina aangemaakt met ' {{Versions-2.16.840.1.113883.2.4.3.11.60.40.3.10.1(EN)|1|MedicalDevice-v4.0(2022EN)}} ==General information== Name: '''nl.zorg.MedicalDevice''' link=Zib of versie niet gevonden-v4.0(2022NL) Version: '''4.0''' HCIM Status:Final Release: '''2...'

Update bot: Nieuwe pagina aangemaakt met ' {{Versions-2.16.840.1.113883.2.4.3.11.60.40.3.10.1(EN)|1|MedicalDevice-v4.0(2022EN)}} ==General information== Name: '''nl.zorg.MedicalDevice''' link=Zib of versie niet gevonden-v4.0(2022NL)
Version: '''4.0'''
HCIM Status:Final
Release: '''2...'