ID

24341

Beschrijving

Derived from www.openehr.org 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.

Link

www.openehr.org

Trefwoorden

  1. 08-07-17 08-07-17 - Martin Dugas
  2. 08-07-17 08-07-17 - Martin Dugas
  3. 30-07-17 30-07-17 - Martin Dugas
Geüploaded op

30 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0

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Medical Device (EHR Archetype)

openEHR-EHR-CLUSTER.device.v1

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

openEHR-EHR-CLUSTER.device.v1.xml

Medical Device
Beschrijving

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.

Datatype

text

Alias
UMLS CUI [1]
C3177146
Device name
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C2825207
Description
Beschrijving

Narrative description of the medical device.

Datatype

text

Alias
UMLS CUI [1]
C0678257
Type
Beschrijving

The category or kind of device.

Datatype

text

Manufacturer
Beschrijving

Name of manufacturer.

Datatype

text

Alias
UMLS CUI [1]
C0947322
Date of manufacture
Beschrijving

Date the device was manufactured.

Datatype

datetime

Batch/Lot number
Beschrijving

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.

Datatype

text

Date of expiry
Beschrijving

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

Datatype

datetime

Comment
Beschrijving

Additional narrative about the device not captured in other fields.

Datatype

text

Properties
Beschrijving

Further details about specific properties about the medical device.

Datatype

text

Components
Beschrijving

Additional structured informations about identified components of the device.

Datatype

text

Asset management
Beschrijving

Further details about management and maintenance of the device.

Datatype

text

Serial number
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C2348188
Unique device identifier
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C3833473
Catalogue number
Beschrijving

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

Datatype

text

Model number
Beschrijving

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

Datatype

text

Other identifier
Beschrijving

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

Datatype

text

Software version
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C3827995
Extension
Beschrijving

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

Datatype

text

Multimedia
Beschrijving

Digital representation of the device.

Datatype

text

Alias
UMLS CUI [1]
C0376478

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)
Datatype
Alias
Medical Device
Item
Medical Device
text
C3177146 (UMLS CUI [1])
Device name
Item
Device name
text
C2825207 (UMLS CUI [1])
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Type
Item
Type
text
Manufacturer
Item
Manufacturer
text
C0947322 (UMLS CUI [1])
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
C2348188 (UMLS CUI [1])
UDI
Item
Unique device identifier
text
C3833473 (UMLS CUI [1])
Catalogue number
Item
Catalogue number
text
Model number
Item
Model number
text
Other identifier
Item
Other identifier
text
Software version
Item
Software version
text
C3827995 (UMLS CUI [1])
Extension
Item
Extension
text
Multimedia
Item
Multimedia
text
C0376478 (UMLS CUI [1])

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