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

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Logical Model: Implanted Medical Device Summary EREQDI

Official URL: https://aehrc.csiro.au/fhir/logical-models/ImplantedMedicalDeviceSummaryEREQDI				Version: 0.0.1
Draft as of 2023-09-11				Computable Name: ImplantedMedicalDeviceSummaryEREQDI

The Implanted Medical Device Summary EREQDI Logical Model Mindmap is shown below.

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.

Roadmap

Usage:

• This Logical Model Profile is not used by any profiles in this Implementation Guide

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