Sparked Logical Models
0.0.1 - CI Build Australia (AUS)

Sparked Logical Models, published by CSIRO. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/aehrc/logical-model-web/ and changes regularly. See the Directory of published versions

Logical Model: ImplantedMedicalDeviceSummaryEREQDI - Detailed Descriptions

Draft as of 2023-09-11

Definitions for the ImplantedMedicalDeviceSummaryEREQDI logical model.

Guidance on how to interpret the contents of this table can be foundhere

0. ImplantedMedicalDeviceSummary
Definition

A summary or overview detailing the history and context of use for a specified type of implantable medical device, including details about specific implantation episodes.

ShortImplanted Medical Device Summary eReqDI
Comments

Purpose

To record a summary or overview detailing the history and context of use for a specified type of implantable medical device.

Misuse

Not 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.

Considerations

Use 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.

Control0..*
Is Modifierfalse
Must Supporttrue
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. ImplantedMedicalDeviceSummary.Protocol
Definition

@ internal @

ShortProtocol
Control0..1
TypeBackboneElement
Must Supportfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ImplantedMedicalDeviceSummary.Protocol.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
6. ImplantedMedicalDeviceSummary.Protocol.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Protocol.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. ImplantedMedicalDeviceSummary.Protocol.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    10. ImplantedMedicalDeviceSummary.Protocol.Lastupdated
    Definition

    The date this Implanted medical device summary was last updated.

    ShortLast updated
    Control0..1
    TypedateTime
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    12. ImplantedMedicalDeviceSummary.Protocol.Extension
    Definition

    Additional information required to capture local content or to align with other reference models/formalisms.

    ShortExtension
    Comments

    Considerations

    For example: local information requirements or additional metadata to align with FHIR or CIMI equivalents.

    Control0..1
    TypeReference
    Must Supporttrue
    14. ImplantedMedicalDeviceSummary.Data
    Definition

    @ internal @

    ShortData
    Control0..1
    TypeBackboneElement
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. ImplantedMedicalDeviceSummary.Data.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    Typestring
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    18. ImplantedMedicalDeviceSummary.Data.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 20. ImplantedMedicalDeviceSummary.Data.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      22. ImplantedMedicalDeviceSummary.Data.Devicetypename
      Definition

      Name of the medical device category.

      ShortDevice type name
      Comments

      Considerations

      Coding of the ‘Device name' with an external terminology is strongly recommended, if available. For example: 'cochlear implant'; 'pacemaker'; 'aneurysm clip'; 'joint replacement'; 'coronary stent'; 'bone fixation device eg screws or a plate'; or 'deep brain stimulator'.

      Control1..1
      TypeCodeableConcept
      Must Supporttrue
      24. ImplantedMedicalDeviceSummary.Data.Overallstatus
      Definition

      Assertion about the whether the device type is currently in situ.

      ShortOverall status
      Control0..1
      TypeCoding
      Must Supporttrue
      26. ImplantedMedicalDeviceSummary.Data.Overalldescription
      Definition

      A narrative description about the history or context of use for this device type over time.

      ShortOverall description
      Comments

      Considerations

      For instance: a summary or overview of any or all insertions and/or removals.

      Control0..1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      28. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails
      Definition

      Details about a specific implanted medical device.

      ShortSpecific implanted device details
      Comments

      Considerations

      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.

      Control0..1
      TypeBackboneElement
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      32. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 34. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        36. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Devicename
        Definition

        Name of the implanted medical device.

        ShortDevice name
        Comments

        Considerations

        Coding of the ‘Specific device name' with an external terminology is preferred, if available.

        Control1..1
        TypeCodeableConcept
        Must Supportfalse
        38. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Label
        Definition

        An alternative name or label to identify a specific device, when the 'Device name' is not unique.

        ShortLabel
        Comments

        Considerations

        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.

        Control0..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        40. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Status
        Definition

        Assertion about the whether the identified device is currently in situ.

        ShortStatus
        Control0..1
        TypeCoding
        Must Supportfalse
        42. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Description
        Definition

        Narrative description about the device.

        ShortDescription
        Control0..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        44. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Insertiondate
        Definition

        The Date/time when the device was implanted.

        ShortInsertion date
        Comments

        Considerations

        Partial dates are not permitted for contemporaneous recording.

        Control0..1
        TypedateTime
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        46. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Implantbodysite
        Definition

        Identification of the area of the body where the device has been inserted.

        ShortImplant body site
        Control0..1
        TypeCodeableConcept
        Must Supportfalse
        48. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Structuredimplantbodysite
        Definition

        Structured identification of the body site where the device has been inserted.

        ShortStructured implant body site
        Control0..1
        TypeReference
        Must Supportfalse
        50. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Structureddevicedetail
        Definition

        Additional structured detail about the specific implanted device.

        ShortStructured device detail
        Control0..1
        TypeReference
        Must Supportfalse
        52. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Multimediarepresentation
        Definition

        Digital image, video or diagram related to the specific implanted device.

        ShortMultimedia representation
        Control0..1
        TypeReference
        Must Supportfalse
        54. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Removaldate
        Definition

        The Date/time when the device was removed.

        ShortRemoval date
        Comments

        Considerations

        Partial dates are not permitted for contemporaneous recording.

        Control0..1
        TypedateTime
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        56. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Reasonforremoval
        Definition

        Description about why the implanted device was removed.

        ShortReason for removal
        Control0..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        58. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Nextreviewdue
        Definition

        Date on which this device should be reviewed.

        ShortNext review due
        Comments

        Considerations

        Partial dates are not permitted.

        Control0..1
        TypedateTime
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        60. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Comment
        Definition

        Additional narrative about the impanted medical device not captured in other fields.

        ShortComment
        Control0..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        62. ImplantedMedicalDeviceSummary.Data.Overallcomment
        Definition

        Additional narrative about the implanted medical device type, not captured in other fields.

        ShortOverall comment
        Control0..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supporttrue
        64. ImplantedMedicalDeviceSummary.Data
        Definition

        @ internal @

        ShortData
        Control0..1
        TypeBackboneElement
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        66. ImplantedMedicalDeviceSummary.Data.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        68. ImplantedMedicalDeviceSummary.Data.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 70. ImplantedMedicalDeviceSummary.Data.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          72. ImplantedMedicalDeviceSummary.Data.Devicetypename
          Definition

          Name of the medical device category.

          ShortDevice type name
          Comments

          Considerations

          Coding of the ‘Device name' with an external terminology is strongly recommended, if available. For example: 'cochlear implant'; 'pacemaker'; 'aneurysm clip'; 'joint replacement'; 'coronary stent'; 'bone fixation device eg screws or a plate'; or 'deep brain stimulator'.

          Control1..1
          TypeCodeableConcept
          Must Supporttrue
          74. ImplantedMedicalDeviceSummary.Data.Overallstatus
          Definition

          Assertion about the whether the device type is currently in situ.

          ShortOverall status
          Control0..1
          TypeCoding
          Must Supporttrue
          76. ImplantedMedicalDeviceSummary.Data.Overalldescription
          Definition

          A narrative description about the history or context of use for this device type over time.

          ShortOverall description
          Comments

          Considerations

          For instance: a summary or overview of any or all insertions and/or removals.

          Control0..1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          78. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails
          Definition

          Details about a specific implanted medical device.

          ShortSpecific implanted device details
          Comments

          Considerations

          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.

          Control0..*
          TypeBackboneElement
          Must Supportfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          80. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          82. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 84. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            86. ImplantedMedicalDeviceSummary.Data.Overallcomment
            Definition

            Additional narrative about the implanted medical device type, not captured in other fields.

            ShortOverall comment
            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue

            Guidance on how to interpret the contents of this table can be foundhere

            0. ImplantedMedicalDeviceSummary
            Definition

            A summary or overview detailing the history and context of use for a specified type of implantable medical device, including details about specific implantation episodes.

            ShortImplanted Medical Device Summary eReqDI
            Comments

            Purpose

            To record a summary or overview detailing the history and context of use for a specified type of implantable medical device.

            Misuse

            Not 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.

            Considerations

            Use 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.

            Control0..*
            Must Supporttrue
            Logical ModelInstances of this logical model are not marked to be the target of a Reference
            2. ImplantedMedicalDeviceSummary.Data
            Definition

            @ internal @

            ShortData
            Control0..1
            TypeBackboneElement
            Must Supportfalse
            4. ImplantedMedicalDeviceSummary.Data.Devicetypename
            Definition

            Name of the medical device category.

            ShortDevice type name
            Comments

            Considerations

            Coding of the ‘Device name' with an external terminology is strongly recommended, if available. For example: 'cochlear implant'; 'pacemaker'; 'aneurysm clip'; 'joint replacement'; 'coronary stent'; 'bone fixation device eg screws or a plate'; or 'deep brain stimulator'.

            Control1..1
            TypeCodeableConcept
            Must Supporttrue
            6. ImplantedMedicalDeviceSummary.Data.Overallstatus
            Definition

            Assertion about the whether the device type is currently in situ.

            ShortOverall status
            Control0..1
            TypeCoding
            Must Supporttrue
            8. ImplantedMedicalDeviceSummary.Data.Overalldescription
            Definition

            A narrative description about the history or context of use for this device type over time.

            ShortOverall description
            Comments

            Considerations

            For instance: a summary or overview of any or all insertions and/or removals.

            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            10. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails
            Definition

            Details about a specific implanted medical device.

            ShortSpecific implanted device details
            Comments

            Considerations

            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.

            Control0..*
            TypeBackboneElement
            Must Supportfalse
            12. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Devicename
            Definition

            Name of the implanted medical device.

            ShortDevice name
            Comments

            Considerations

            Coding of the ‘Specific device name' with an external terminology is preferred, if available.

            Control1..1
            TypeCodeableConcept
            Must Supportfalse
            14. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Label
            Definition

            An alternative name or label to identify a specific device, when the 'Device name' is not unique.

            ShortLabel
            Comments

            Considerations

            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.

            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            16. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Status
            Definition

            Assertion about the whether the identified device is currently in situ.

            ShortStatus
            Control0..1
            TypeCoding
            Must Supportfalse
            18. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Description
            Definition

            Narrative description about the device.

            ShortDescription
            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            20. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Insertiondate
            Definition

            The Date/time when the device was implanted.

            ShortInsertion date
            Comments

            Considerations

            Partial dates are not permitted for contemporaneous recording.

            Control0..1
            TypedateTime
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            22. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Implantbodysite
            Definition

            Identification of the area of the body where the device has been inserted.

            ShortImplant body site
            Control0..1
            TypeCodeableConcept
            Must Supportfalse
            24. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Structuredimplantbodysite
            Definition

            Structured identification of the body site where the device has been inserted.

            ShortStructured implant body site
            Control0..1
            TypeReference
            Must Supportfalse
            26. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Structureddevicedetail
            Definition

            Additional structured detail about the specific implanted device.

            ShortStructured device detail
            Control0..1
            TypeReference
            Must Supportfalse
            28. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Multimediarepresentation
            Definition

            Digital image, video or diagram related to the specific implanted device.

            ShortMultimedia representation
            Control0..1
            TypeReference
            Must Supportfalse
            30. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Removaldate
            Definition

            The Date/time when the device was removed.

            ShortRemoval date
            Comments

            Considerations

            Partial dates are not permitted for contemporaneous recording.

            Control0..1
            TypedateTime
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            32. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Reasonforremoval
            Definition

            Description about why the implanted device was removed.

            ShortReason for removal
            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            34. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Nextreviewdue
            Definition

            Date on which this device should be reviewed.

            ShortNext review due
            Comments

            Considerations

            Partial dates are not permitted.

            Control0..1
            TypedateTime
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            36. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Comment
            Definition

            Additional narrative about the impanted medical device not captured in other fields.

            ShortComment
            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            38. ImplantedMedicalDeviceSummary.Data.Overallcomment
            Definition

            Additional narrative about the implanted medical device type, not captured in other fields.

            ShortOverall comment
            Control0..1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            40. ImplantedMedicalDeviceSummary.Protocol
            Definition

            @ internal @

            ShortProtocol
            Control0..1
            TypeBackboneElement
            Must Supportfalse
            42. ImplantedMedicalDeviceSummary.Protocol.Lastupdated
            Definition

            The date this Implanted medical device summary was last updated.

            ShortLast updated
            Control0..1
            TypedateTime
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue

            Guidance on how to interpret the contents of this table can be foundhere

            0. ImplantedMedicalDeviceSummary
            Definition

            A summary or overview detailing the history and context of use for a specified type of implantable medical device, including details about specific implantation episodes.

            ShortImplanted Medical Device Summary eReqDI
            Comments

            Purpose

            To record a summary or overview detailing the history and context of use for a specified type of implantable medical device.

            Misuse

            Not 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.

            Considerations

            Use 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.

            Control0..*
            Is Modifierfalse
            Must Supporttrue
            Logical ModelInstances of this logical model are not marked to be the target of a Reference
            2. ImplantedMedicalDeviceSummary.Protocol
            Definition

            @ internal @

            ShortProtocol
            Control0..1
            TypeBackboneElement
            Must Supportfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            4. ImplantedMedicalDeviceSummary.Protocol.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            Typestring
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            6. ImplantedMedicalDeviceSummary.Protocol.extension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortAdditional content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Protocol.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 8. ImplantedMedicalDeviceSummary.Protocol.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              10. ImplantedMedicalDeviceSummary.Protocol.Lastupdated
              Definition

              The date this Implanted medical device summary was last updated.

              ShortLast updated
              Control0..1
              TypedateTime
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              12. ImplantedMedicalDeviceSummary.Protocol.Extension
              Definition

              Additional information required to capture local content or to align with other reference models/formalisms.

              ShortExtension
              Comments

              Considerations

              For example: local information requirements or additional metadata to align with FHIR or CIMI equivalents.

              Control0..1
              TypeReference
              Must Supporttrue
              14. ImplantedMedicalDeviceSummary.Data
              Definition

              @ internal @

              ShortData
              Control0..1
              TypeBackboneElement
              Must Supporttrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              16. ImplantedMedicalDeviceSummary.Data.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              18. ImplantedMedicalDeviceSummary.Data.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 20. ImplantedMedicalDeviceSummary.Data.modifierExtension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                Summarytrue
                Requirements

                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                Alternate Namesextensions, user content, modifiers
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                22. ImplantedMedicalDeviceSummary.Data.Devicetypename
                Definition

                Name of the medical device category.

                ShortDevice type name
                Comments

                Considerations

                Coding of the ‘Device name' with an external terminology is strongly recommended, if available. For example: 'cochlear implant'; 'pacemaker'; 'aneurysm clip'; 'joint replacement'; 'coronary stent'; 'bone fixation device eg screws or a plate'; or 'deep brain stimulator'.

                Control1..1
                TypeCodeableConcept
                Must Supporttrue
                24. ImplantedMedicalDeviceSummary.Data.Overallstatus
                Definition

                Assertion about the whether the device type is currently in situ.

                ShortOverall status
                Control0..1
                TypeCoding
                Must Supporttrue
                26. ImplantedMedicalDeviceSummary.Data.Overalldescription
                Definition

                A narrative description about the history or context of use for this device type over time.

                ShortOverall description
                Comments

                Considerations

                For instance: a summary or overview of any or all insertions and/or removals.

                Control0..1
                Typestring
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supporttrue
                28. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails
                Definition

                Details about a specific implanted medical device.

                ShortSpecific implanted device details
                Comments

                Considerations

                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.

                Control0..1
                TypeBackboneElement
                Must Supporttrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                30. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                32. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension
                Definition

                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 34. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.modifierExtension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  Requirements

                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  36. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Devicename
                  Definition

                  Name of the implanted medical device.

                  ShortDevice name
                  Comments

                  Considerations

                  Coding of the ‘Specific device name' with an external terminology is preferred, if available.

                  Control1..1
                  TypeCodeableConcept
                  Must Supportfalse
                  38. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Label
                  Definition

                  An alternative name or label to identify a specific device, when the 'Device name' is not unique.

                  ShortLabel
                  Comments

                  Considerations

                  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.

                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  40. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Status
                  Definition

                  Assertion about the whether the identified device is currently in situ.

                  ShortStatus
                  Control0..1
                  TypeCoding
                  Must Supportfalse
                  42. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Description
                  Definition

                  Narrative description about the device.

                  ShortDescription
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  44. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Insertiondate
                  Definition

                  The Date/time when the device was implanted.

                  ShortInsertion date
                  Comments

                  Considerations

                  Partial dates are not permitted for contemporaneous recording.

                  Control0..1
                  TypedateTime
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  46. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Implantbodysite
                  Definition

                  Identification of the area of the body where the device has been inserted.

                  ShortImplant body site
                  Control0..1
                  TypeCodeableConcept
                  Must Supportfalse
                  48. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Structuredimplantbodysite
                  Definition

                  Structured identification of the body site where the device has been inserted.

                  ShortStructured implant body site
                  Control0..1
                  TypeReference
                  Must Supportfalse
                  50. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Structureddevicedetail
                  Definition

                  Additional structured detail about the specific implanted device.

                  ShortStructured device detail
                  Control0..1
                  TypeReference
                  Must Supportfalse
                  52. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Multimediarepresentation
                  Definition

                  Digital image, video or diagram related to the specific implanted device.

                  ShortMultimedia representation
                  Control0..1
                  TypeReference
                  Must Supportfalse
                  54. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Removaldate
                  Definition

                  The Date/time when the device was removed.

                  ShortRemoval date
                  Comments

                  Considerations

                  Partial dates are not permitted for contemporaneous recording.

                  Control0..1
                  TypedateTime
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  56. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Reasonforremoval
                  Definition

                  Description about why the implanted device was removed.

                  ShortReason for removal
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  58. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Nextreviewdue
                  Definition

                  Date on which this device should be reviewed.

                  ShortNext review due
                  Comments

                  Considerations

                  Partial dates are not permitted.

                  Control0..1
                  TypedateTime
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  60. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.Comment
                  Definition

                  Additional narrative about the impanted medical device not captured in other fields.

                  ShortComment
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  62. ImplantedMedicalDeviceSummary.Data.Overallcomment
                  Definition

                  Additional narrative about the implanted medical device type, not captured in other fields.

                  ShortOverall comment
                  Control0..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  64. ImplantedMedicalDeviceSummary.Data
                  Definition

                  @ internal @

                  ShortData
                  Control0..1
                  TypeBackboneElement
                  Must Supportfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  66. ImplantedMedicalDeviceSummary.Data.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  XML FormatIn the XML format, this property is represented as an attribute.
                  Summaryfalse
                  68. ImplantedMedicalDeviceSummary.Data.extension
                  Definition

                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 70. ImplantedMedicalDeviceSummary.Data.modifierExtension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                    ShortExtensions that cannot be ignored even if unrecognized
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                    Summarytrue
                    Requirements

                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                    Alternate Namesextensions, user content, modifiers
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    72. ImplantedMedicalDeviceSummary.Data.Devicetypename
                    Definition

                    Name of the medical device category.

                    ShortDevice type name
                    Comments

                    Considerations

                    Coding of the ‘Device name' with an external terminology is strongly recommended, if available. For example: 'cochlear implant'; 'pacemaker'; 'aneurysm clip'; 'joint replacement'; 'coronary stent'; 'bone fixation device eg screws or a plate'; or 'deep brain stimulator'.

                    Control1..1
                    TypeCodeableConcept
                    Must Supporttrue
                    74. ImplantedMedicalDeviceSummary.Data.Overallstatus
                    Definition

                    Assertion about the whether the device type is currently in situ.

                    ShortOverall status
                    Control0..1
                    TypeCoding
                    Must Supporttrue
                    76. ImplantedMedicalDeviceSummary.Data.Overalldescription
                    Definition

                    A narrative description about the history or context of use for this device type over time.

                    ShortOverall description
                    Comments

                    Considerations

                    For instance: a summary or overview of any or all insertions and/or removals.

                    Control0..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supportfalse
                    78. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails
                    Definition

                    Details about a specific implanted medical device.

                    ShortSpecific implanted device details
                    Comments

                    Considerations

                    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.

                    Control0..*
                    TypeBackboneElement
                    Must Supportfalse
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    80. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.id
                    Definition

                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                    ShortUnique id for inter-element referencing
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    82. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    SlicingThis element introduces a set of slices on ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 84. ImplantedMedicalDeviceSummary.Data.Specificimplanteddevicedetails.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      86. ImplantedMedicalDeviceSummary.Data.Overallcomment
                      Definition

                      Additional narrative about the implanted medical device type, not captured in other fields.

                      ShortOverall comment
                      Control0..1
                      Typestring
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue