DocumentHeader

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 DXH12345
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 http://fhir.nhs.net/ValueSet/device-type-1

; 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 SHOULD be taken from http://fhir.nhs.net/ValueSet/device-type-1

; other codes may be used where these codes are not suitable
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.type.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control 0..1
Type Boolean
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Device.note
Definition

Descriptive information, usage information or implantation information that is not captured in an existing element.

Control 0..*
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
Device.status
Definition

Status of the Device availability.

Control 0..1
Binding

The availability status of the device.

The codes SHALL be taken from http://hl7.org/fhir/ValueSet/devicestatus

Type Code
Is Modifier True
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
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.manufactureDate
Definition

The date and time when the device was manufactured.

Control 0..1
Type DateTime
Comments
Device.expiry
Definition

The date and time beyond which this device is no longer valid or should not be used (if applicable).

Control 0..1
Type DateTime
Comments
Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Control 0..1
Type String
Comments

Alphanumeric Maximum 20.

Device.owner
Definition

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

Control 0..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.

Device.location
Definition

The place where the device can be found.

Control 0..1
Comments
Device.location.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.location.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.patient
Definition

Patient information, if the resource is affixed to a person.

Control 0..1
Comments
Device.patient.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.patient.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.contact
Definition

Contact details for an organization or a particular human that is responsible for the device.

Control 0..*
Type ContactPoint
Comments

used for troubleshooting etc.

Device.contact.system
Definition

Telecommunications form for contact point - what communications system is required to make use of the contact.

Control 1..1 ?
Binding

Telecommunications form for contact point

The codes SHALL be taken from http://hl7.org/fhir/ValueSet/contact-point-system

Type Code
Comments
Example phone
Device.contact.value
Definition

The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

Control 1..1
Type String
Requirements

Need to support legacy numbers that are not in a tightly controlled format.

Comments

Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

Example 0191 4021111
Device.contact.use
Definition

Identifies the purpose for the contact point.

Control 0..1
Binding

Use of contact point

The codes SHALL be taken from http://hl7.org/fhir/ValueSet/contact-point-use

Type Code
Is Modifier True
Requirements

Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

Comments

This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one. Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

Example work
Device.contact.rank
Definition

Specifies a preferred order in which to use a set of contacts. Contacts are ranked with lower values coming before higher values.

Control 0..1
Type PositiveInt
Comments

Note that rank does not necessarily follow the order in which the contacts are represented in the instance.

Example 1
Device.contact.period
Definition

Time period when the contact point was/is in use.

Control 0..1
Type Period
Comments
Device.contact.period.start
Definition

The start of the period. The boundary is inclusive.

Control 0..1 ?
Type DateTime
Comments

If the low element is missing, the meaning is that the low boundary is not known.

Device.contact.period.end
Definition

The end of the period. If the end of the period is missing, it means that the period is ongoing. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

Control 0..1 ?
Type DateTime
Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has a end value of 2012-02-03.

Device.url
Definition

A network address on which the device may be contacted directly.

Control 0..1
Type Uri
Comments

If the device is running a FHIR server, the network address should be the root URL from which a conformance statement may be retrieved.