ARCHETYPE Medical Device (openEHR-EHR-CLUSTER.device.v1)

ARCHETYPE IDopenEHR-EHR-CLUSTER.device.v1
ConceptMedical Device
DescriptionAn instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements.
UseUse to record the details of a medical device used in the provision of healthcare. Use of the term 'medical device' varies depending on context. Within the Standards world, the term device tends to refer to mechanical or electronic devices that support healthcare and require rigorous documentation regarding location tracking, maintenance, calibration, software versions etc. Within the terminology context the use of device is very broad, including any medical device that can be used in direct or indirect provision of clinical care, as long as it does not act in a way that exerts a direct pharmacological, metabolic or immunological effect. Examples of medical devices range from simple devices such as urinary catheters, tongue depressors, contact lenses, artificial joint implants, breast implants and plain dressings through to advanced devices such as artificial hearts, syringe drivers, spirometers, mobile phone applications and computerised devices that capture point-of-care medical measurements. In the complex situation where a surgically implanted device is used as the means to deliver therapeutic agents such as chemotherapy directly into the body, this archetype will be used to record only the details about the medical device itself and the order for medication and details about the actual administration of the therapeutic agent will be recorded using specific medication-related INSTRUCTION and ACTION archetypes. This archetype is designed to provide the framework for structured representation of any medical device and the data elements that are contained here are not specific for any one type of device. Single use devices will commonly require data elements such as Lot Number and Date of Expiry. In contrast these are usually not relevant for durable devices which will often have a set of identifiers, including a UID, Serial Number, Model etc. Further, different types of devices will require specific information relevant to their purpose. This data can be recorded using specific CLUSTER archetypes inserted into the 'Specific properties' SLOT. For example: use of a urinary catheter may require additional details about the diameter and length of catheter, material composition, number of lumens etc. If the medical device has a number of components that require recording of details, each individual component should be recorded explicitly by using an additional CLUSTER.device archetype inserted into the 'Components' SLOT. The data field 'Software Version' allows for only a single version to be recorded. This is primarily applicable for a device which is a software application. If the device has multiple software or hardware components that need to be specified, this should be done by using an addition CLUSTER.device inserted into the 'Components' SLOT. To record additional details for durable or persistent devices that relate to ownership, physical location tracking, maintenance schedules etc, use CLUSTER.device_details archetype inserted into the 'Asset management' SLOT in this archetype. This archetype has been designed for generic use within other archetypes that need to describe a device. Examples include: OBSERVATION.blood_pressure for the sphygmomanometer; OBSERVATION.ecg for the ECG machine; OBSERVATION.urinalysis for the reactent strips and the device used for testing; ACTION.procedure; and CLUSTER.exam_tympanic_membrane to detail the otoscope used.
MisuseNot to be used to record data about medicinal products that exert a direct pharmacological, metabolic or immunologic effect. For example: a medicine impregnated dressing that requires a prescription should be recorded using the INSTRUCTION.medication_order archetype, focused on the active ingredients, dosage etc.
PurposeTo record the details of a medical device used in the provision of healthcare.
ReferencesResource Device [Internet]. HL7 International, FHIR Specification first DSTU version (v 0.0.82) [cited: 2015-02-25]. Available from: http://www.hl7.org/implement/standards/fhir/device.html.

Guidelines for 64-bit Global Identifier (EUI-64) [Internet]. IEEE Standards Association [cited: 2015-02-25]. Available from: http://standards.ieee.org/regauth/oui/tutorials/EUI64.html.
Copyright© openEHR Foundation
AuthorsAuthor name: Heather Leslie
Organisation: Ocean Informatics
Email: heather.leslie@oceaninformatics.com
Date originally authored: 2010-06-29
Other Details LanguageAuthor name: Heather Leslie
Organisation: Ocean Informatics
Email: heather.leslie@oceaninformatics.com
Date originally authored: 2010-06-29
OtherDetails Language Independent{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 3.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/., custodian_organisation=openEHR Foundation, references=Resource Device [Internet]. HL7 International, FHIR Specification first DSTU version (v 0.0.82) [cited: 2015-02-25]. Available from: http://www.hl7.org/implement/standards/fhir/device.html. Guidelines for 64-bit Global Identifier (EUI-64) [Internet]. IEEE Standards Association [cited: 2015-02-25]. Available from: http://standards.ieee.org/regauth/oui/tutorials/EUI64.html., current_contact=Heather Leslie, Ocean Informatics, heather.leslie@oceaninformatics.com, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=E4E11C034E29C626B3B3A8448D2CB86C, build_uid=2a8b319e-fe20-490b-9b6e-728c0f87858e, revision=1.0.1}
Keywordsdevice, machine, implant, appliance, catheter, prosthesis, aid, biomedical, instrument, equipment, meter, monitor, software
Lifecyclepublished
UIDdbd6f4b3-a3e6-41b1-a21e-3530ac1ca212
Language useden
Citeable Identifier1013.1.17
Revision Number1.0.1
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements., archetypeConceptComment=null, otherContributors=Tomas Alme, DIPS, Norway
Koray Atalag, University of Auckland, New Zealand
Silje Ljosland Bakke, Bergen Hospital Trust, Norway
Mate Bestek, Ministry of Health of the Republic of Slovenia, Slovenia
Lars Bitsch-Larsen, Haukeland University hospital, Norway
Diego Bosca, IBIME group, Spain
Margaret Campbell, Queensland Health, Australia
Rong Chen, Cambio Healthcare Systems, Sweden
Stephen Chu, Queensland Health, Australia
Samo Drnovsek, Marand ltd, Slovenia
Ivan Drvaric, NIJZ- National institute for public health of Slovenia, Slovenia
Shahla Foozonkhah, Ocean Informatics, Australia
Einar Fosse, National Centre for Integrated Care and Telemedicine, Norway
Heather Grain, Llewelyn Grain Informatics, Australia
Grahame Grieve, Australia
Sam Heard, Ocean Informatics, Australia
Gorazd Kalan, University Medical Centre Ljubljana, Slovenia
Lars Karlsen, DIPS ASA, Norway
Daniel Karlsson, Linköping University, Sweden
Russell Leftwich, Russell B Leftwich MD, United States
Sabine Leh, Haukeland University Hospital, Department of Pathology, Norway
Heather Leslie, Ocean Informatics, Australia (Editor)
Vesna Levasic, Orthopaedic Hospital Valdoltra, Slovenia
Luis Marco Ruiz, Norwegian Center for Integrated Care and Telemedicine, Norway
Ian McNicoll, freshEHR Clinical Informatics, United Kingdom (Editor)
Bjoern Naess, DIPS ASA, Norway
Dave Nurse, Allocate Software, United Kingdom
Živa Rant, National Instittute of Public Health, Slovenia
Anoop Shah, University College London, United Kingdom
Micaela Thierley, Helse Bergen, Norway, originalLanguage=en, translators=Spanish (Argentina): Alan March, Hospital Universitario Austral, Buenos Aires, Argentina, amarch@cas.austral.edu.ar, MD
Norwegian Bokmål: Lars Bitsch-Larsen, Haukeland University Hospital, lbla@helse-bergen.no
Portuguese (Brazil): Osmeire Chamelette Sanzovo, Hospital Sírio Libanês - SP, osmeire.acsanzovo@hsl.org.br
Arabic (Syria): Mona Saleh
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openEHR-EHR-CLUSTER.dimensions.v1 and specialisations Or
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When the medical device has multiple software applications embedded within it, record each software component in a separate CLUSTER archetype within the Components SLOT - either as a nested instance of another CLUSTER.device archetype or using a CLUSTER archetype designed specifically for recording software details (but not yet available at time of this archetype development)., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Date of expiry, description=Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging., comment=This date usually applies only to single use or disposable devices., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0024], code=at0024, itemType=ELEMENT, level=1, text=Other identifier, description=Unspecified identifier, which can be further specified in a template or at run time., comment=Coding of the name of the identifier with a coding system is desirable, if available., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0019], code=at0019, itemType=SLOT, level=1, text=Asset management, description=Further details about management and maintenance of the device., comment=For example: Owner, Contact details, Location, Network address, Date due for replacement, Calibration details etc., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.device_details.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0018], code=at0018, itemType=SLOT, level=1, text=Components, description=Additional structured informations about identified components of the device., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.device.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0026], code=at0026, itemType=SLOT, level=1, text=Extension, description=Additional information required to capture local context or to align with other reference models/formalisms., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0027], code=at0027, itemType=SLOT, level=1, text=Multimedia, description=Digital representation of the device., comment=For example: a technical diagram of a device, or a digital image., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
openEHR-EHR-CLUSTER.multimedia.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Comment, description=Additional narrative about the device not captured in other fields., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]