TEMPLATE NES_TS Medical Devices Data Hub.v0 (NES_TS Medical Devices Data Hub.v0)

TEMPLATE IDNES_TS Medical Devices Data Hub.v0
ConceptNES_TS Medical Devices Data Hub.v0
DescriptionThis template is designed to be used as the data definition for compositions reflecting data items necessary to track the details of implantable medical devices. Specifically the definition is for the Medical Devices Data Hub (MDDH) programme in NHS Scotland managed by NHS National Services Scotland, as part of the wider 'Scan for Safety' programme. Data will often be populated via integrations with external systems, but will also be needed to support applications and user interfaces for user interaction and maintenance.
UseThe data will be used to provide contextual information to clinical and non-clinical users including patients, for example allowing clinicians to view which devices have been implanted in a patient or to allow patients to see which devices have been implanted in them. The data may subsequently be used for reporting purposes across the programme of work. Data could potentially be used for decision support systems in specific contexts. Data may be linked into other national data sources such as Scottish Morbidity Records (SMR) to provide additional analysis, for example the surveillance of key outcomes for a medical device.
MisuseThe scope does not extend to other purposes or projects for medical devices at this time. It should not be employed as a proxy for recording procedures on their own, i.e. without any associated medical device data. It is not intended to support the full process of procedure planning, ordering and completion as only the final outcome of any procedure is recorded. The data is concerned only with implantable medical devices at this time.
PurposeThis template is designed to be used as the data definition for compositions reflecting data items necessary to track the details of implantable medical devices. Specifically the definition is for the Medical Devices Data Hub (MDDH) programme in NHS Scotland managed by NHS National Services Scotland, as part of the wider 'Scan for Safety' programme. Data will often be populated via integrations with external systems, but will also be needed to support applications and user interfaces for user interaction and maintenance.
References
Authorsdate: 2023-01-04; name: Dr Paul Miller; organisation: NHS Education for Scotland Technology Service; email: paul.miller@nhs.scot
Other Details Languagedate: 2023-01-04; name: Dr Paul Miller; organisation: NHS Education for Scotland Technology Service; email: paul.miller@nhs.scot
OtherDetails Language Independent{custodian_organisation=NHS Education for Scotland Technology Service, PARENT:MD5-CAM-1.0.1=2A789520F48E91960C4825733C8BA68F, original_language=ISO_639-1::en, MD5-CAM-1.0.1=38618e567d88ded0cd31af0fd41b6070, sem_ver=0.0.9, build_uid=75f1ebce-78bd-4898-99b6-c888938e81cb}
Keywordsmedical devices, implant, implants, mesh, nail, pacemaker, replacement, screw, joint replacement, stent, DES, drug eluting stent, tape, lens, graft, device, artificial joints, breast implants, cochlear implants, intraocular lenses, intrauterine device, IUD
Language useden
Citeable Identifier1051.57.301
AllOperationalTemplate [rootArchetypeId=openEHR-EHR-COMPOSITION.report-procedure.v1, otherContributors=Austin Mitchell austin.mitchell2@nhs.scot; Ruth Alison ruth.alison@nhs.scot; Susannah Mclean susannah.mclean2@nhs.scot; Iain Robertson iain.robertson@gov.scot; Jonathan Waldheim-Ross jonathan.waldheim-ross@nhs.scot, tshis=[ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1], code=at0000.1, itemType=COMPOSITION, level=0, text=NES_TS Medical Devices Data Hub, description=Document to communicate information to others about any stand-alone procedure or operation performed., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=COMPOSITION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=null, code=null, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=1, text=Other Context, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.xds_metadata.v0], code=at0000, itemType=CLUSTER, level=2, text=XDS Metadata, description=Additional composition metadata aligned with IHE-XDS which is not already available from the Reference Model COMPOSITION class., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/context/other_context[at0001]/items[openEHR-EHR-CLUSTER.xds_metadata.v0]/items[at0003], code=at0003, itemType=ELEMENT, level=3, text=Document type, description=The code specifying the precise type of document from the user perspective. Normally selected from a valueset provided by the local IHE-XDS Affinity Domain or national standard., comment=for example: Pulmonary History and Physical, Discharge Summary, Ultrasound Report. These codes are specific to an XDS Affinity Domain., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.service.v1], code=at0000, itemType=ACTION, level=1, text=Operation, description=A simple health-related service or activity delivered by a clinician, organisation or agency., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ACTION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.service.v1]/description[at0001], code=at0001, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=2, text=Description, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.service.v1]/description[at0001]/items[at0011], code=at0011, itemType=ELEMENT, level=3, text=Operation name, description=Identification of the clinical service carried out., comment=For example: 'Sarcoma MDT meeting' or 'Physiotherapy referral'. Coding of the specific service name with a terminology is preferred, where possible., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.service.v1]/protocol[at0015], code=at0015, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=2, text=Protocol, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.service.v1]/protocol[at0015]/items[at0018], code=at0018, itemType=ELEMENT, level=3, text=Operation identifier, description=The ID assigned to the order by the provider fulfilling the service., comment=This is equivalent to Filler Identifier in FHIR., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=
  •  Identifier
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1], code=at0000, itemType=ACTION, level=1, text=Procedure, description=A clinical activity carried out for screening, investigative, diagnostic, curative, therapeutic, evaluative or palliative purposes., comment=null, uncommonOntologyItems=null, occurencesFormal=1..*, occurencesText=Mandatory, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=ACTION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001], code=at0001, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=2, text=Description, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=3, text=Procedure name, description=Identification of the procedure by name., comment=Coding of the specific procedure with a terminology is preferred, where possible., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1], code=at0000, itemType=CLUSTER, level=3, text=Device Details, 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., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[at0001], code=at0001, itemType=ELEMENT, level=4, text=Product description, description=Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device., comment=This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[at0021], code=at0021, itemType=ELEMENT, level=4, 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=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[at0020], code=at0020, itemType=ELEMENT, level=4, text=Device 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=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[at0006], code=at0006, itemType=ELEMENT, level=4, text=Device Lot or Batch 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=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[openEHR-EHR-CLUSTER.anatomical_location.v1], code=at0000, itemType=CLUSTER, level=4, text=Anatomical location, description=A physical site on or within the human body., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[openEHR-EHR-CLUSTER.anatomical_location.v1]/items[at0001], code=at0001, itemType=ELEMENT, level=5, text=Body site name, description=Identification of a single physical site either on, or within, the human body., comment=This data element is the only mandated data point in this archetype and should be used as the primary data point to record an anatomical location with a commonly used name. It is strongly recommended that 'Body site name' be recorded as specifically as is anatomically possible. For example: record 'upper eyelid' rather than recording 'eyelid' with 'upper' as a qualifier; 'fifth rib' rather than 'rib' with a numeric qualifier. Use the other data elements for laterality, aspect, region and anatomical line to provide more detail. This data element should be coded with a terminology capable of triggering decision support, where possible - an appropriate termset for use here could comprise individual concepts or a list of precoordinated terms. Free text should be used only if there is no appropriate terminology available. If body site name is already identified in the parent archetype, then this data element may be redundant. Alternatively, a use case has been identified where the value may be duplicated into this element to support semantic querying using this archetype, rather than the data element within the parent., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=Default value: Body Site, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[openEHR-EHR-CLUSTER.anatomical_location.v1]/items[at0002], code=at0002, itemType=ELEMENT, level=5, text=Laterality, description=The side of the body on which the identified body site is located., comment=If the identified body site has no laterality, this data element should not have a value. If the 'Body site name' data element uses pre-coordinated terms that include laterality, then this data element is redundant., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Left 
  • Right 
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[openEHR-EHR-CLUSTER.nes_ts-medical-device-regulatory-details.v0], code=at0000, itemType=CLUSTER, level=4, text=nes_ts-medical-device-regulatory-details, description=NES_TS UK_MHRA Medical Device, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[openEHR-EHR-CLUSTER.device.v1]/items[openEHR-EHR-CLUSTER.nes_ts-medical-device-regulatory-details.v0]/items[at0001], code=at0001, itemType=ELEMENT, level=5, text=Class, description=The Class of device as defined by the associated regulatory body or policy, comment=For example, Class I, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Class I
  • Class IIa
  • Class IIb
  • Class III
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/description[at0001]/items[at0067], code=at0067, itemType=ELEMENT, level=3, text=Procedure type, description=The type of procedure., comment=This pragmatic data element may be used to support organisation within the user interface., uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=
  • Device implantation
  • Device removal
  • Other
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/protocol[at0053], code=at0053, itemType=UNSUPPORTEDTOPLEVELATTRIBUTE, level=2, text=Protocol, description=, comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=UNSUPPORTEDTOPLEVELATTRIBUTE, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/protocol[at0053]/items[openEHR-EHR-CLUSTER.organisation_cc.v0], code=at0000, itemType=CLUSTER, level=3, text=Organisation, description=Organisation details aligned with FHIR resource., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/protocol[at0053]/items[openEHR-EHR-CLUSTER.organisation_cc.v0]/items[openEHR-EHR-CLUSTER.identifier_cc.v0], code=at0000, itemType=CLUSTER, level=4, text=Health Board, description=Identifier details aligned with FHIR resources or data types., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/protocol[at0053]/items[openEHR-EHR-CLUSTER.organisation_cc.v0]/items[openEHR-EHR-CLUSTER.identifier_cc.v0]/items[at0001], code=at0001, itemType=ELEMENT, level=5, text=Value, description=The identifier value., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_IDENTIFIER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/protocol[at0053]/items[openEHR-EHR-CLUSTER.organisation_cc.v0]/items[at0011], code=at0011, itemType=ELEMENT, level=4, text=Type, description=The kind(s) of organization that this is., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=Default value: Health Board, extendedValues=null], ResourceSimplifiedHierarchyItem [path=[openEHR-EHR-COMPOSITION.report-procedure.v1]/content[openEHR-EHR-ACTION.procedure.v1]/protocol[at0053]/items[openEHR-EHR-CLUSTER.organisation_cc.v0]/items[at0012], code=at0012, itemType=ELEMENT, level=4, text=Name, description=Name associated with the organisation., comment=null, uncommonOntologyItems=null, occurencesFormal=null, occurencesText=null, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], templateType=normal]