| ARCHETYPE ID | openEHR-EHR-CLUSTER.device.v1 |
| Concept | Medical device |
| Description | 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. |
| Use | Use 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. |
| Misuse | Not 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. |
| Purpose | To record the details of a medical device used in the provision of healthcare. |
| References | HL7 FHIR Resource - Device R0.0.82 DSTU1 [Internet]. Health Level Seven International; [accessed 2015 Feb 25]. Available from: http://hl7.org/fhir/DSTU1/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 |
| Authors | Author name: Heather Leslie Organisation: Atomica Informatics Email: heather.leslie@atomicainformatics.com Date originally authored: 2010-06-29 |
| Other Details Language | Author name: Heather Leslie Organisation: Atomica Informatics Email: heather.leslie@atomicainformatics.com Date originally authored: 2010-06-29 |
| OtherDetails Language Independent | {licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=openEHR Foundation, references=HL7 FHIR Resource - Device R0.0.82 DSTU1 [Internet]. Health Level Seven International; [accessed 2015 Feb 25]. Available from: http://hl7.org/fhir/DSTU1/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, Atomica Informatics, heather.leslie@atomicainformatics.com, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=EEC8640C1336806D602A1BC344D4F733, build_uid=6f11730d-4a02-4ceb-9c00-54b899bf4a2a, revision=1.1.2} |
| Keywords | device, machine, implant, appliance, catheter, prosthesis, aid, biomedical, instrument, equipment, meter, monitor, software |
| Lifecycle | published |
| UID | dbd6f4b3-a3e6-41b1-a21e-3530ac1ca212 |
| Language used | en |
| Citeable Identifier | 1051.32.286 |
| Revision Number | 1.1.2 |
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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, 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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.media_ All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=ELEMENT, level=1, text=Unique device identifier (UDI), description=A numeric or alphanumeric string that is associated with this device within a given system., comment=Often fixed to the device as a barcode., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0004], code=at0004, itemType=ELEMENT, level=1, text=Manufacturer, description=Name of manufacturer., 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], ResourceSimplifiedHierarchyItem [path=/items[at0005], code=at0005, itemType=ELEMENT, level=1, text=Date of manufacture, description=Date the device was manufactured., comment=null, 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[at0020], code=at0020, itemType=ELEMENT, level=1, text=Serial number, description=Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging., 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], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=ELEMENT, level=1, text=Catalogue number, description=The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging., 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], ResourceSimplifiedHierarchyItem [path=/items[at0023], code=at0023, itemType=ELEMENT, level=1, text=Model number, description=The exact model number assigned by the manufacturer and found on the device label or accompanying packaging., 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], ResourceSimplifiedHierarchyItem [path=/items[at0006], code=at0006, itemType=ELEMENT, level=1, text=Batch/Lot number, description=The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material., 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], ResourceSimplifiedHierarchyItem [path=/items[at0025], code=at0025, itemType=ELEMENT, level=1, text=Software version, description=Identification of the version of software being used in the medical device., comment=When the medical device is an actual software application, record the version of the software using this data element. 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_ openEHR-EHR-CLUSTER.device_ 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.media_ |