ID

23502

Description

Use to record the details of a medical device used in the provision of healthcare. Use of the term 'medical device' varies depending on context. Within the Standards world, the term device tends to refer to mechanical or electronic devices that support healthcare and require rigorous documentation regarding location tracking, maintenance, calibration, software versions etc. Within the terminology context the use of device is very broad, including any medical device that can be used in direct or indirect provision of clinical care, as long as it does not act in a way that exerts a direct pharmacological, metabolic or immunological effect. Examples of medical devices range from simple devices such as urinary catheters, tongue depressors, contact lenses, artificial joint implants, breast implants and plain dressings through to advanced devices such as artificial hearts, syringe drivers, spirometers, mobile phone applications and computerised devices that capture point-of-care medical measurements. In the complex situation where a surgically implanted device is used as the means to deliver therapeutic agents such as chemotherapy directly into the body, this archetype will be used to record only the details about the medical device itself and the order for medication and details about the actual administration of the therapeutic agent will be recorded using specific medication-related INSTRUCTION and ACTION archetypes. This archetype is designed to provide the framework for structured representation of any medical device and the data elements that are contained here are not specific for any one type of device. Single use devices will commonly require data elements such as Lot Number and Date of Expiry. In contrast these are usually not relevant for durable devices which will often have a set of identifiers, including a UID, Serial Number, Model etc. Further, different types of devices will require specific information relevant to their purpose. This data can be recorded using specific CLUSTER archetypes inserted into the 'Specific properties' SLOT. For example: use of a urinary catheter may require additional details about the diameter and length of catheter, material composition, number of lumens etc. If the medical device has a number of components that require recording of details, each individual component should be recorded explicitly by using an additional CLUSTER.device archetype inserted into the 'Components' SLOT. The data field 'Software Version' allows for only a single version to be recorded. This is primarily applicable for a device which is a software application. If the device has multiple software or hardware components that need to be specified, this should be done by using an addition CLUSTER.device inserted into the 'Components' SLOT. To record additional details for durable or persistent devices that relate to ownership, physical location tracking, maintenance schedules etc, use CLUSTER.device_details archetype inserted into the 'Asset management' SLOT in this archetype. This archetype has been designed for generic use within other archetypes that need to describe a device. Examples include: OBSERVATION.blood_pressure for the sphygmomanometer; OBSERVATION.ecg for the ECG machine; OBSERVATION.urinalysis for the reactent strips and the device used for testing; ACTION.procedure; and CLUSTER.exam_tympanic_membrane to detail the otoscope used.

Keywords

  1. 7/8/17 7/8/17 - Martin Dugas
  2. 7/8/17 7/8/17 - Martin Dugas
  3. 7/30/17 7/30/17 - Martin Dugas
Uploaded on

July 8, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Medical Device

openEHR-EHR-CLUSTER.device.v1

  1. StudyEvent: openEHR-EHR-CLUSTER.device.v1
    1. openEHR-EHR-CLUSTER.device.v1
openEHR-EHR-CLUSTER.device.v1.xml
Description

openEHR-EHR-CLUSTER.device.v1.xml

Medical Device
Description

An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements.

Data type

text

Device name
Description

Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device.

Data type

text

Description
Description

Narrative description of the medical device.

Data type

text

Type
Description

The category or kind of device.

Data type

text

Manufacturer
Description

Name of manufacturer.

Data type

text

Date of manufacture
Description

Date the device was manufactured.

Data type

datetime

Batch/Lot number
Description

The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material.

Data type

text

Date of expiry
Description

Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging.

Data type

datetime

Comment
Description

Additional narrative about the device not captured in other fields.

Data type

text

Properties
Description

Further details about specific properties about the medical device.

Data type

text

Components
Description

Additional structured informations about identified components of the device.

Data type

text

Asset management
Description

Further details about management and maintenance of the device.

Data type

text

Serial number
Description

Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging.

Data type

text

Unique device identifier (UDI)
Description

A numeric or alphanumeric string that is associated with this device within a given system.

Data type

text

Catalogue number
Description

The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging.

Data type

text

Model number
Description

The exact model number assigned by the manufacturer and found on the device label or accompanying packaging.

Data type

text

Other identifier
Description

Unspecified identifier, which can be further specified in a template or at run time.

Data type

text

Software version
Description

Identification of the version of software being used in the medical device.

Data type

text

Extension
Description

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

Data type

text

Multimedia
Description

Digital representation of the device.

Data type

text

Similar models

openEHR-EHR-CLUSTER.device.v1

  1. StudyEvent: openEHR-EHR-CLUSTER.device.v1
    1. openEHR-EHR-CLUSTER.device.v1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Medical Device
Item
Medical Device
text
Device name
Item
Device name
text
Description
Item
Description
text
Type
Item
Type
text
Manufacturer
Item
Manufacturer
text
Date of manufacture
Item
Date of manufacture
datetime
Batch/Lot number
Item
Batch/Lot number
text
Date of expiry
Item
Date of expiry
datetime
Comment
Item
Comment
text
Properties
Item
Properties
text
Components
Item
Components
text
Asset management
Item
Asset management
text
Serial number
Item
Serial number
text
Unique device identifier (UDI)
Item
Unique device identifier (UDI)
text
Catalogue number
Item
Catalogue number
text
Model number
Item
Model number
text
Other identifier
Item
Other identifier
text
Software version
Item
Software version
text
Extension
Item
Extension
text
Multimedia
Item
Multimedia
text

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