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.

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.

@ internal @

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

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.

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.

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).

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.

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.

The date this Implanted medical device summary was last updated.

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

Considerations

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

@ internal @

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

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.

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.

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).

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.

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.

Name of the medical device category.

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'.

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

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

Considerations

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

Details about a specific implanted medical device.

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.

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

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.

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.

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).

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.

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.

Name of the implanted medical device.

Considerations

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

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

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.

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

Narrative description about the device.

The Date/time when the device was implanted.

Considerations

Partial dates are not permitted for contemporaneous recording.

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

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

Additional structured detail about the specific implanted device.

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

The Date/time when the device was removed.

Considerations

Partial dates are not permitted for contemporaneous recording.

Description about why the implanted device was removed.

Date on which this device should be reviewed.

Considerations

Partial dates are not permitted.

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

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

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.

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.

@ internal @

The date this Implanted medical device summary was last updated.

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

Considerations

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

@ internal @

Name of the medical device category.

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'.

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

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

Considerations

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

Details about a specific implanted medical device.

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.

Name of the implanted medical device.

Considerations

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

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

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.

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

Narrative description about the device.

The Date/time when the device was implanted.

Considerations

Partial dates are not permitted for contemporaneous recording.

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

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

Additional structured detail about the specific implanted device.

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

The Date/time when the device was removed.

Considerations

Partial dates are not permitted for contemporaneous recording.

Description about why the implanted device was removed.

Date on which this device should be reviewed.

Considerations

Partial dates are not permitted.

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

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

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.

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.

@ internal @

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

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.

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.

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).

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.

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.

The date this Implanted medical device summary was last updated.

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

Considerations

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

@ internal @

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

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.

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.

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).

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.

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.

Name of the medical device category.

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'.

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

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

Considerations

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

Details about a specific implanted medical device.

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.

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

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.

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.

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).

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.

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.

Name of the implanted medical device.

Considerations

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

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

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.

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

Narrative description about the device.

The Date/time when the device was implanted.

Considerations

Partial dates are not permitted for contemporaneous recording.

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

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

Additional structured detail about the specific implanted device.

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

The Date/time when the device was removed.

Considerations

Partial dates are not permitted for contemporaneous recording.

Description about why the implanted device was removed.

Date on which this device should be reviewed.

Considerations

Partial dates are not permitted.

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

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