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
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). |
| ||||||||
|
|
NL-CM:10.1.3 | ProductType
|
0..1 | The code of the type of 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 aid. |
| ||||||||
|
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. |
| ||||||||
|
|
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. |
| ||||||||
|
|
NL-CM:10.1.9 | HealthcareProvider
|
0..1 | The healthcare provider involved in the indication for use of the medical aid implant. |
| ||||||||
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
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