DeviceAssociation

Introduction

Note to Balloters: To ensure the DeviceAssociation resource is ready for Normative status, we are seeking ballot comments on the substantive content. The key changes made since R5 include:

• Collapsed the DeviceAssociation.operation backbone into the other elements (e.g., DeviceAssociation.relationship now includes the operator role).
• DeviceAssociation.category was renamed DeviceAssociation.relationship and given an extensible value set.
• Added DeviceAssociation.associationStatus.
• Updated search parameters to address the changes.

Scope and Usage

Device Association records the relationship between a device and a subject and/or operator. The relationship may be as the owner, patient, operator or custodian of the device. The scope covers all devices including, but not limited to: implantables, wheelchairs, RTLS, personal health and point of care devices, diagnostic, imaging and durable medical equipment. This resource is intended to apply to any delivery environment and discipline where a device association is useful to record.

The subjects may include:

• Patient - the following are often associated with a specific patient: implantables, prosthetics, activity trackers, mobility assistance, care monitoring, etc.
• Group - some devices may be associated with a family group or treatment group. For example a weight scale or blood pressure cuff.
• Practitioner - a device that is associated with the practitioner: pager, alert monitor, cell phone, laptop/tablet
• Device - a device may be associated with another device when it is independent of the focal device. Note: this is different than the containment tree with parent element in the Device resource. For example a RFID tag used to track the location of a wheelchair.
• RelatedPerson - a device that is associated with another person related to the patient. For example, an alerting device given to a spouse while their partner is in surgery.

Boundaries and Relationships

• DeviceAssociation (this resource) - To clarify when tracking the lifecycle and traceability of a device, including assignment or dissociation with a patient, practitioner, location, or another device.
• Device - The device that is, e.g., used, placed in or on, or owned by the subject referenced in the DeviceAssociation.
• DeviceUsage when documenting a patient’s use of a device — typically clinical history or their ongoing reliance on the device.
• Procedure when the device is involved in a clinical action, such as implantation, removal, or adjustment, where details of that intervention need to be recorded.

These resources may be used together — for example, a procedure may establish or end an association, while DeviceUsage captures continued patient use.

To track changes in settings, the Observation resource can be used, where Observation.subject references the Device that the settings apply to. If, e.g., the patient that the Device is associated with needs to be identified, then the DeviceAssociation where DeviceAssociation.period includes the Observation.effective[x] would have that patient in DeviceAssociation.subject.

Background and Context

Provides additional detail on exactly how the resource is to be used

StructureDefinition

Elements (Simplified)

• DeviceAssociation [0..*]: - A record of association or dissociation of a device with a subject (e.g. patient) and/or operator
• DeviceAssociation.identifier [0..*]: Identifier Instance identifier
• DeviceAssociation.device [1..1]: Reference(Device) Reference to the device that is being associated
• DeviceAssociation.relationship [0..*]: CodeableConcept extensible:deviceassociation-relationship Describes the relationship between the device and subject
• DeviceAssociation.status [1..1]: code required:deviceassociation-status active | inactive | entered-in-error | unknown
• DeviceAssociation.statusReason [0..*]: CodeableConcept extensible:deviceassociation-status-reason The reasons given for the current association status
• DeviceAssociation.associationStatus [0..1]: CodeableConcept preferred:deviceassociation-association-status State of the device’s association
• DeviceAssociation.subject [0..1]: [Reference(BiologicallyDerivedProduct](/Reference(BiologicallyDerivedProduct), CareTeam, Device, Group, Location, Medication, NutritionProduct, Organization, Patient, Practitioner, PractitionerRole, RelatedPerson, Specimen, Substance)) The entity(ies) that the device is on or associated with
• DeviceAssociation.focus [0..1]: [Reference(BiologicallyDerivedProduct](/Reference(BiologicallyDerivedProduct), CareTeam, Device, Group, Location, Medication, NutritionProduct, Organization, Patient, Practitioner, PractitionerRole, RelatedPerson, Specimen, Substance)) The target of the association
• DeviceAssociation.bodyStructure [0..1]: Reference(BodyStructure) Current anatomical location of the device in/on subject
• DeviceAssociation.period [0..1]: Period Begin and end dates and times for the device association

Mappings

• DeviceAssociation Mappings — 1 mapping entries

Resource Packs

list-DeviceAssociation-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="DeviceAssociation-packs"/>
  <status value="current"/>
  <mode value="working"/>
</List>

Search Parameters

• device — reference — Search for products that match this code — DeviceAssociation.device
• subject — reference — The identity of the individual(s) or entity for whom to list associations — DeviceAssociation.subject
• patient — reference — The patient associated with the device — DeviceAssociation.subject.where(resolve() is Patient)
• focus — reference — The focus of an association. — DeviceAssociation.focus
• identifier — token — The identifier of the device association — DeviceAssociation.identifier
• status — token — The status of the device associations — DeviceAssociation.status
• date — date — Search for associations at or within specific times — DeviceAssociation.period
• relationship — token — Search for specific device association relationships — DeviceAssociation.relationship

Full Search Parameters

Examples

• bp-monitor-association — deviceassociation-bp-monitor-association — Blood Pressure Monitor Association During In-Patient Stay
• deviceassociation-example — deviceassociation-example
• deviceassociation-examples-header — deviceassociation-examples-header
• example — deviceassociation-example — General DeviceAssociation Example
• implant-association — deviceassociation-implant-association — Implant Device Assigned to Patient
• lab-device-association — deviceassociation-lab-device-association — Lab Device Calibration by Repair Staff
• robot-association — deviceassociation-robot-association — Surgical Robot Association
• tablet-association — deviceassociation-tablet-association — Tablet Assigned to Practitioner
• wheelchair-association — deviceassociation-wheelchair-association — Wheelchair Device Association

Full Examples