EOLDocument

COFE-Device-1

COFE-Device-1

Device
Definition

This resource identifies an instance of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. Medical devices includes durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

Control 0..*
Type Device
Comments
Device.identifier
Definition

Unique instance identifiers assigned to a device by organizations like manufacturers or owners. If the identifier identifies the type of device, Device.type should be used.

Control 0..*
Type Identifier
Comments

Often fixed to the device as a barcode and may include names given to the device in local usage. Note that some of the barcodes affixed to the device identify its type, not its instance. For the FDA mandated Unique Device Identifier (UDI) use the Device.udi element.

Device.identifier.value
Definition

The portion of the identifier typically displayed to the user and which is unique within the context of the system.

Control 1..1
Type String
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.

Example dcf8d81b-832a-44ef-a294-63c99c7c5a43
Device.identifier.assigner
Definition

Organization that issued/manages the identifier.

Control 0..1
Comments

The reference may be just a text description of the assigner.

Device.identifier.assigner.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Control 0..1 ?
Type String
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Device.identifier.assigner.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Control 0..1
Type String
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Device.type
Definition

Code or identifier to identify a kind of device.

Control 1..1
Binding

Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it.

The codes SHOULD be taken from https://www.gmdnagency.org/Info.aspx?pageid=1091

; other codes may be used where these codes are not suitable
Type CodeableConcept
Comments

For the FDA mandated Unique Device Identifier (UDI) use the Device.udi element.

Device.type.coding
Definition

A reference to a code defined by a terminology system.

Control 0..1
Binding

A code from the SNOMED Clinical Terminology UK coding system that describes a type of device.

The codes SHALL be taken from http://fhir.nhs.net/ValueSet/device-type-1

Type Coding
Requirements

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labelled as UserSelected = true.

Device.type.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control 1..1
Type Uri
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Fixed Value http://snomed.info/sct
Device.type.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Control 1..1
Type Code
Requirements

Need to refer to a particular code in the system.

Comments
Device.type.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control 1..1
Type String
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Comments
Device.manufacturer
Definition

A name of the manufacturer.

Control 0..1
Type String
Comments
Device.model
Definition

The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.

Control 0..1
Type String
Comments
Example AA 1001-C
Device.version(softwareName)
Definition

The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.

Control 0..1
Type String
Comments
Example 8.15-04
Device.owner
Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Control 1..1
Comments
Device.owner.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Control 1..1 ?
Type String
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Device.owner.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Control 0..1
Type String
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.