EOLDocument

COFE-MedicalDevices-Device-1

COFE-MedicalDevices-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 1..1
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 da3adcde-1449-4ac3-aa69-bb9938cfd03a
Device.type
Definition

Code or identifier to identify a kind of device.

Control 1..1
Binding

A set of codes to identify observation type used in the CDA domains.

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

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 1..1
Binding

A set of codes to identify observation type used in the CDA domains.

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

A set of codes to identify observation type used in the CDA domains.

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

Type Code
Requirements

Need to refer to a particular code in the system.

Comments
Fixed Value MDS
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
Fixed Value Medical Device Supply
Device.note
Definition

To carry information about a medical device.

Control 1..1
Type Annotation
Comments
Device.note.author[x]
Definition

The individual responsible for making the annotation.

Control 0..1
Type Choice of:
Comments
Device.note.time
Definition

Indicates when this particular annotation was made.

Control 0..1
Type DateTime
Comments
Device.note.text
Definition

The text of the annotation.

Control 1..1
Type String
Comments