ARCHETYPE Implanted medical device summary (openEHR-EHR-EVALUATION.implanted_device_summary.v0)

ARCHETYPE IDopenEHR-EHR-EVALUATION.implanted_device_summary.v0
ConceptImplanted medical device summary
DescriptionA summary or overview detailing the history and context of use for a specified type of implantable medical device, including details about specific implantation episodes.
UseUse to record a summary or overview of a single implanted medical device, or category of device. The intended scope of this archetype includes, but is not limited to: - a cochlear implant; - an intracardiac pacemaker; - one or more aneurysm clips; - a femoral head prosthesis; - a coronary stent; - bone fixation devices such as screws or plates; - deep brain electrical stimulation system lead; or - deep brain electrical stimulation system pulse generator. This archetype has been specifically designed to: - support the management of implanted medical devices over time; - assist in the identification of implanted medical devices in situ that may carry health risks for imaging and other health-related activities; and - carry critical information such as device identification that will support product recalls. The repeating 'Specific implant details' CLUSTER supports documentation about each insertion of each specific medical device, including more precise identification and summary details about the device insertion and removal. This archetype can be further developed to document medical device details such as the manufacturer, batch numbers and device identifiers by nesting the CLUSTER.device_details in the 'Structured device detail' SLOT. In practice, some clinical systems will need to record specific and detailed INSTRUCTION and ACTION archetypes to reflect the request for a medical device and subsequent activities that need to be recorded as that request is carried out. There will inevitably be some overlap between this summary and these detailed archetypes. All may be necessary in different contexts however, where possible, ideally this summary should be derived from the point of care INSTRUCTION and ACTION documentation by clinicians, to prevent the need for clinicians to duplicate data input.
MisuseNot to be used to request a medical device. Use a relevant INSTRUCTION archetype for this purpose. Not to be used to record the activities that occur in the insertion or removal of an implant. Use the ACTION.procedure archetype for this purpose.
PurposeTo record a summary or overview detailing the history and context of use for a specified type of implantable medical device.
References
Copyright© openEHR Foundation
AuthorsAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2024-04-24
Other Details LanguageAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2024-04-24
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=, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=CAB21B10A7966A4D89147018110F3AC4, build_uid=01475dc6-7f06-4a2c-8ca6-c88cfe9fdfdf, revision=0.0.1-alpha}
Keywords
Lifecyclein_development
UID18925e2d-361d-4676-b6eb-e97f9a537a3b
Language useden
Citeable Identifier1013.1.7294
Revision Number0.0.1-alpha
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  • In situ [The device type is currently inserted or implanted in the body.]
  • Removed [The device type has been removed from the body.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0006], code=at0006, itemType=ELEMENT, level=2, text=Overall description, description=A narrative description about the history or context of use for this device type over time., comment=For instance: a summary or overview of any or all insertions and/or removals., 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=/data[at0001]/items[at0007], code=at0007, itemType=CLUSTER, level=2, text=Specific implanted device details, description=Details about a specific implanted medical device., comment=This repeating group supports documentation supports documentation about each insertion of each specific medical device, including more precise identification and summary details about the medical device insertion and/or removal. This group can be further to document medical device details such as the manufacturer, batch numbers and device identifiers by nesting the 'Device details' data group in the 'Structured device detail' SLOT., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0007]/items[at0008], code=at0008, itemType=ELEMENT, level=3, text=Device name, description=Name of the implanted medical device., comment=Coding of the ‘Specific device name' with an external terminology is preferred, if available., 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=/data[at0001]/items[at0007]/items[at0009], code=at0009, itemType=ELEMENT, level=3, text=Label, description=An alternative name or label to identify a specific device, when the 'Device name' is not unique., comment=Use this field to identify a specific medical device when there are multiple devices of the same type or model implanted at the same time, such as aneurysm clips or vascular stents placed on different blood vessels or in different locations on the same blood vessel., 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=/data[at0001]/items[at0007]/items[at0010], code=at0010, itemType=ELEMENT, level=3, text=Status, description=Assertion about the whether the identified device is currently in situ., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • In situ [The specific device is currently inserted or implanted in the body.]
  • Removed [The specific device has been removed from the body.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0007]/items[at0013], code=at0013, itemType=ELEMENT, level=3, text=Description, description=Narrative description about the device., 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=/data[at0001]/items[at0007]/items[at0014], code=at0014, itemType=ELEMENT, level=3, text=Insertion date, description=The Date/time when the device was implanted., comment=Partial dates are not permitted for contemporaneous recording., 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=/data[at0001]/items[at0007]/items[at0015], code=at0015, itemType=ELEMENT, level=3, text=Implant body site, description=Identification of the area of the body where the device has been inserted., 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=/data[at0001]/items[at0007]/items[at0016], code=at0016, itemType=SLOT, level=3, text=Structured implant body site, description=Structured identification of the body site where the device has been inserted., 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.anatomical_location.v1 and specialisations or
openEHR-EHR-CLUSTER.anatomical_location_relative.v2 and specialisations or
openEHR-EHR-CLUSTER.anatomical_location_circle.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0007]/items[at0017], code=at0017, itemType=SLOT, level=3, text=Structured device detail, description=Additional structured detail about the specific implanted 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=/data[at0001]/items[at0007]/items[at0018], code=at0018, itemType=SLOT, level=3, text=Multimedia representation, description=Digital image, video or diagram related to the specific implanted 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.media_file.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0007]/items[at0019], code=at0019, itemType=ELEMENT, level=3, text=Removal date, description=The Date/time when the device was removed., comment=Partial dates are not permitted for contemporaneous recording., 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=/data[at0001]/items[at0007]/items[at0020], code=at0020, itemType=ELEMENT, level=3, text=Reason for removal, description=Description about why the implanted device was removed., 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=/data[at0001]/items[at0007]/items[at0021], code=at0021, itemType=ELEMENT, level=3, text=Next review due, description=Date on which this device should be reviewed., comment=Partial dates are not permitted., 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=/data[at0001]/items[at0007]/items[at0022], code=at0022, itemType=ELEMENT, level=3, text=Comment, description=Additional narrative about the impanted medical 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], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0023], code=at0023, itemType=ELEMENT, level=2, text=Overall comment, description=Additional narrative about the implanted medical device type, 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]]}, topLevelItems={protocol=ResourceSimplifiedHierarchyItem [path=ROOT_/protocol[at0026], code=at0026, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=0..1, cardinalityText=optional, subCardinalityFormal=0..*, subCardinalityText=Minimum of 0 items, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null], data=ResourceSimplifiedHierarchyItem [path=ROOT_/data[at0001], code=at0001, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=0..1, cardinalityText=optional, subCardinalityFormal=0..*, subCardinalityText=Minimum of 0 items, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=protocol, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/protocol[at0026]/items[at0024], code=at0024, itemType=ELEMENT, level=2, text=Last updated, description=The date this Implanted medical device summary was last updated., 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=/protocol[at0026]/items[at0025], code=at0025, itemType=SLOT, level=2, text=Extension, description=Additional information required to capture local content or to align with other reference models/formalisms., comment=For example: local information requirements or additional metadata to align with FHIR or CIMI equivalents., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
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