Release
4
5
Snapshot
#1
Administration
This
page
is
part
of
the
FHIR
Specification
(v4.0.1:
R4
-
Mixed
Normative
and
STU
)
in
it's
permanent
home
(it
will
always
be
available
at
this
URL).
(v5.0.0-snapshot1:
R5
Snapshot
#1).
The
current
version
which
supercedes
this
version
is
5.0.0
.
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
R4
R3
R2
|
Orders
and
Observations
Work
Group
|
Maturity Level : 2 | Trial Use | Security Category : Business |
Compartments
:
|
A type 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.
This
resource
is
an
administrative
a
base
resource
that
tracks
individual
instances
of
a
device
and
their
location.
It
is
referenced
by
other
resources
for
recording
which
device
performed
an
action
such
as
a
procedure
or
an
observation,
referenced
when
prescribing
and
which
device
was
implanted
in
or
explanted
from
a
patient,
dispensing
devices
for
a
device
to
a
patient
use
for
their
use,
managing
inventory,
or
when
requesting
a
specific
device
for
ordering
supplies,
and
a
patient’s
use.
The
resource
may
be
used
to
record
and
transmit
document
the
Unique
Device
Identifier
(UDI)
and
information
about
a
device
where
appropriate
or
necessary.
Additional
information
about
UDI
is
provided
in
the
Unique
Device
Identifier
(UDI)
section.
Medical
devices
include
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
patient's
implant.
machine,
cellphone,
computer,
application,
etc.
Devices can also be subdivded as follows:
Implantable device
Accessed
13
March
2020.
Accessed
13
March
2020.
Patient-use device
Accessed
13
March
2020.
These are the device related resources
In
FHIR,
the
"Device"
is
Device
represents
either
the
"administrative"
resource
device
in
total,
or
a
component
of
a
larger
device
when
there
is
a
need
for
individual
tracking
of
a
component.
A
Device
as
a
component
then
points
to
the
parent
device
(it
does
not
change
much
and
has
manufacturer
information
etc.),
whereas
it
is
part
of.
The
Device
captures
the
DeviceComponent
actual
data
about
the
instance
of
the
device
that
either
provides
identifying
characteristics
of
the
Device
(including
applicable
UDI
–
unique
device
identification)
and
DeviceMetric
(which
is
really
data
that
can
vary
by
device,
e.g.,
specific
settings
at
a
kind
of
DeviceComponent)
particular
point
in
time.
The
DeviceDefinition
represents
the
data
that
is
applicable
to
all
devices
that
reference
that
DeviceDefinition.
The
DeviceMetric
model
the
physical
part,
dynamic
aspects
of
the
Device,
including
operation
status
of
those
aspects
and
is
consequently
much
more
volatile.
The
physical
composition
of
a
Device
is
represented
by
the
Devices
pointing
to
their
"parent".
Devices
differ
from
medications
because
they
are
not
"used
up"
-
they
remain
active
in
or
for
a
patient
in
an
ongoing
fashion.
However,
for
a
longer
duration.
They
also
may
be
re-used,
particularly
non-implanted
devices
and
those
used
for
diagnostics
and
procedures.
Frequently,
when
a
device
is
packaged
with
a
medication,
the
specific
boundary
between
medications
ordering,
dispense,
and
devices
administration
processes
typically
focus
on
the
medication
aspects
and
reference
the
device,
rather
than
that
the
Device
is
defined
at
the
implementation
level
focus
of
the
ordering,
dispense,
and
this
standard
does
not
enforce
a
boundary
with
administration
process.
In
the
exception
case
of
devices
that
an
infusion
pump,
while
some
actions
are
implanted
in
focused
on
the
device
(e.g.,
ordering
to
a
patient.
The
room
or
maintaining
the
pump),
the
focus
is
as
well
on
the
medication
while
the
device
is
used
for
administration.
However,
that
separation
is
not
always
as
clear
and
may
be
impacted
by
specific
implementations.
Regardless,
the
Medication
resource
should
not
be
used
to
represent
implanted
devices.
(implanted)
devices,
rather
reference
the
relationship
where
an
actual
device
needs
to
be
tracked
in
addition
to
the
medication.
This
resource
is
referenced
by
Signature
,
Account
,
ActivityDefinition
,
AdverseEvent
,
Appointment
,
AppointmentResponse
,
ArtifactAssessment
,
AuditEvent
,
CarePlan
,
CatalogEntry
,
ChargeItem
,
ChargeItemDefinition
,
Claim
,
ClinicalUseDefinition
,
ClinicalUseIssue
,
Communication
,
CommunicationRequest
,
Composition
,
Condition
,
Consent
,
Contract
,
DetectedIssue
,
itself,
DeviceDispense
,
DeviceMetric
,
DeviceRequest
,
DeviceUseStatement
DeviceUsage
,
DiagnosticReport
,
DocumentManifest
,
DocumentReference
,
Encounter
,
EvidenceReport
,
EvidenceVariable
,
ExplanationOfBenefit
,
Flag
,
Group
,
GuidanceResponse
,
ImagingSelection
,
ImagingStudy
,
InventoryReport
,
Invoice
,
List
,
MeasureReport
,
Media
,
MedicationAdministration
,
MedicationDispense
,
MedicationRequest
,
MessageHeader
,
MolecularSequence
,
NutritionIntake
,
Observation
,
ObservationDefinition
,
PlanDefinition
,
Procedure
,
Provenance
,
QuestionnaireResponse
,
RequestGroup
,
ResearchSubject
,
RiskAssessment
,
Schedule
,
ServiceRequest
,
Specimen
,
SupplyDelivery
,
SupplyRequest
and
Task
.
This resource implements the Participant pattern.
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
Device
|
TU | DomainResource |
Item
used
in
healthcare
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
identifier
|
0..* | Identifier |
Instance
identifier
|
|
displayName
|
0..1 |
| The name used to display by default when the device is referenced | |
definition
| 0..1 | CodeableReference ( DeviceDefinition ) | The reference to the definition for the device | |
udiCarrier
|
Σ | 0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
deviceIdentifier
|
Σ | 1..1 | string | Mandatory fixed portion of UDI |
|
issuer
|
0..1 | uri | UDI Issuing Organization | |
|
jurisdiction
|
0..1 | uri | Regional UDI authority | |
|
carrierAIDC
|
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String |
|
carrierHRF
|
Σ | 0..1 | string | UDI Human Readable Barcode String |
entryType
|
0..1 | code |
barcode
|
rfid
|
manual
UDIEntryType ( Required ) |
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
|
unknown
FHIRDeviceStatus ( Required ) |
|
statusReason
|
0..* | CodeableConcept |
discarded
|
FHIRDeviceStatusReason ( Extensible ) |
|
|
biologicalSource
|
0..1 |
|
An identifier that supports traceability to the biological entity that is the source of biological material in the product | |
|
manufacturer
|
0..1 | string | Name of device manufacturer | |
|
manufactureDate
|
0..1 | dateTime | Date when the device was made | |
|
expirationDate
|
0..1 | dateTime | Date and time of expiry of this device (if applicable) | |
|
lotNumber
|
0..1 | string | Lot number of manufacture | |
|
serialNumber
|
0..1 | string | Serial number assigned by the manufacturer | |
|
deviceName
|
0..* | BackboneElement |
The
name
or
names
of
the
device
as
|
|
|
name
|
1..1 | string |
The
name
|
|
|
type
|
1..1 | code |
registered-name
|
user-friendly-name
|
patient-reported-name
DeviceNameType ( Required ) |
|
|
modelNumber
|
0..1 | string | The manufacturer's model number for the device | |
|
partNumber
|
0..1 | string | The part number or catalog number of the device | |
|
type
|
0..* | CodeableConcept |
The
kind
or
type
of
device
Device Type ( Example ) |
|
|
version
|
0..* | BackboneElement |
The
|
|
|
type
| 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal | |
|
|
|
|
The
|
|
|
|
|
string |
The
version
|
|
|
|
0..* | BackboneElement |
The
actual
|
|
|
type
|
|
CodeableConcept |
|
|
value[x]
|
0..1 |
|
|
|
valueQuantity
| Quantity | |||
|
valueCodeableConcept
| CodeableConcept | |||
|
valueString
|
|
string |
|
|
|
valueBoolean
| boolean | |||
|
valueInteger
| integer | |||
|
valueRange
|
|
|
|
|
|
| Attachment | |||
|
subject
| 0..1 | Reference ( Patient | Practitioner | Person ) | Patient to whom Device is affixed | |
|
operationalStatus
|
|
|
|
|
|
|
|
|
FHIRDeviceOperationalStatus ( Example ) |
|
|
|
0..* | CodeableConcept |
|
|
|
associationStatus
|
0..1 |
| The state of the usage or application of the device | |
|
value
| 1..1 | CodeableConcept |
implanted|explanted|attached
FHIRDeviceAssociationStatus ( |
|
|
reason
|
|
0..* | CodeableConcept |
The
reasons
given
for
the
current
association
status
|
|
owner
|
0..1 | Reference ( Organization ) | Organization responsible for device | |
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
location
|
0..1 | Reference ( Location ) | Where the device is found | |
|
url
|
0..1 | uri | Network address to contact device | |
|
endpoint
| 0..* | Reference ( Endpoint ) |
Technical
endpoints
providing
access
to
electronic
services
provided
by
the
device
| |
|
link
| 0..* | BackboneElement |
An
associated
device,
attached
to,
used
with,
communicating
with
or
linking
a
previous
or
new
device
model
to
the
focal
device
| |
|
relation
| 1..1 | Coding |
The
type
indicates
the
relationship
of
the
related
device
to
the
device
instance
DeviceRelationType ( Extensible ) | |
|
relatedDevice
| 1..1 | CodeableReference ( Device ) | A reference to the linked device | |
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
|
|
safety
|
Σ | 0..* | CodeableConcept |
Safety
Characteristics
of
Device
|
|
parent
|
0..1 | Reference ( Device ) |
The
|
|
|
Documentation
for
this
format
|
||||
UML Diagram ( Legend )
XML Template
<Device xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Instance identifier --></identifier>
<</definition><displayName value="[string]"/><!-- 0..1 The name used to display by default when the device is referenced --> <definition><!-- 0..1 CodeableReference(DeviceDefinition) The reference to the definition for the device --></definition> <udiCarrier> <!-- 0..* Unique Device Identifier (UDI) Barcode string -->< <<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict"> <<deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI --> <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization --> <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority --> <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String --> <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String --><<entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown --> </udiCarrier>< <</statusReason> < <<status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown --> <statusReason><!-- 0..* CodeableConcept discarded | obsolete | removed --></statusReason> <biologicalSource><!-- 0..1 Identifier An identifier that supports traceability to the biological entity that is the source of biological material in the product --></biologicalSource> <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer --> <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made --> <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) --> <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture --> <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->< < <<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict"><deviceName> <!-- 0..* The name or names of the device as known to the manufacturer and/or patient --> <name value="[string]"/><!-- 1..1 The name that identifies the device --> <type value="[code]"/><!-- 1..1 registered-name | user-friendly-name | patient-reported-name --> </deviceName>< < <</type> < <</systemType> < </specialization><modelNumber value="[string]"/><!-- 0..1 The manufacturer's model number for the device --> <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device --> <type><!-- 0..* CodeableConcept The kind or type of device --></type> <version> <!-- 0..* The actual design of the device or software version running on the device --><</type> <</component><type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <value value="[string]"/><!-- 1..1 The version text --> </version> <property> <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties --><</type> <</valueQuantity> <</valueCode><type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 0..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Property value - as a code, quantity, boolean, string or attachmment --></value[x]> </property><</patient><subject><!-- 0..1 Reference(Patient|Person|Practitioner) Patient to whom Device is affixed --></subject> <operationalStatus> <!-- 0..1 The status of the device itself - whether it is switched on, or activated, etc --> <value><!-- 1..1 CodeableConcept on |off | standby --></value> <reason><!-- 0..* CodeableConcept The reasons given for the current operational status --></reason> </operationalStatus> <associationStatus> <!-- 0..1 The state of the usage or application of the device --> <value><!-- 1..1 CodeableConcept implanted|explanted|attached --></value> <reason><!-- 0..* CodeableConcept The reasons given for the current association status --></reason> </associationStatus> <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <location><!-- 0..1 Reference(Location) Where the device is found --></location> <url value="[uri]"/><!-- 0..1 Network address to contact device --> <endpoint><!-- 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device --></endpoint> <link> <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device --> <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation> <relatedDevice><!-- 1..1 CodeableReference(Device) A reference to the linked device --></relatedDevice> </link> <note><!-- 0..* Annotation Device notes and comments --></note> <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety><</parent><parent><!-- 0..1 Reference(Device) The device that this device is attached to or is part of --></parent> </Device>
JSON Template
{
"resourceType" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"displayName" : "<string>", // The name used to display by default when the device is referenced
"definition" : { CodeableReference(DeviceDefinition) }, // The reference to the definition for the device
"udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
"
"<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
1) GS1:
http://hl7.org/fhir/NamingSystem/gs1-di,
2) HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI,
3) ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
4) ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">issuer
"
"deviceIdentifier" : "<string>", // R! Mandatory fixed portion of UDI
"issuer" : "<uri>", // UDI Issuing Organization
"jurisdiction" : "<uri>", // Regional UDI authority
"carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
"carrierHRF" : "<string>", // UDI Human Readable Barcode String
"
"entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
}],
"
"
"
"
"status" : "<code>", // active | inactive | entered-in-error | unknown
"statusReason" : [{ CodeableConcept }], // discarded | obsolete | removed
"biologicalSource" : { Identifier }, // An identifier that supports traceability to the biological entity that is the source of biological material in the product
"manufacturer" : "<string>", // Name of device manufacturer
"manufactureDate" : "<dateTime>", // Date when the device was made
"expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
"lotNumber" : "<string>", // Lot number of manufacture
"serialNumber" : "<string>", // Serial number assigned by the manufacturer
"
"
"<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">type
}],
"
"
"
"
"
"
"deviceName" : [{ // The name or names of the device as known to the manufacturer and/or patient
"name" : "<string>", // R! The name that identifies the device
"type" : "<code>" // R! registered-name | user-friendly-name | patient-reported-name
}],
"modelNumber" : "<string>", // The manufacturer's model number for the device
"partNumber" : "<string>", // The part number or catalog number of the device
"type" : [{ CodeableConcept }], // The kind or type of device
"version" : [{ // The actual design of the device or software version running on the device
"
"
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"value" : "<string>" // R! The version text
}],
"property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
"
"
"
"type" : { CodeableConcept }, // R! Code that specifies the property being represented
// value[x]: Property value - as a code, quantity, boolean, string or attachmment. One of these 7:
"valueQuantity" : { Quantity }
"valueCodeableConcept" : { CodeableConcept }
"valueString" : "<string>"
"valueBoolean" : <boolean>
"valueInteger" : <integer>
"valueRange" : { Range }
"valueAttachment" : { Attachment }
}],
"
"subject" : { Reference(Patient|Person|Practitioner) }, // Patient to whom Device is affixed
"operationalStatus" : { // The status of the device itself - whether it is switched on, or activated, etc
"value" : { CodeableConcept }, // R! on |off | standby
"reason" : [{ CodeableConcept }] // The reasons given for the current operational status
},
"associationStatus" : { // The state of the usage or application of the device
"value" : { CodeableConcept }, // R! implanted|explanted|attached
"reason" : [{ CodeableConcept }] // The reasons given for the current association status
},
"owner" : { Reference(Organization) }, // Organization responsible for device
"contact" : [{ ContactPoint }], // Details for human/organization for support
"location" : { Reference(Location) }, // Where the device is found
"url" : "<uri>", // Network address to contact device
"endpoint" : [{ Reference(Endpoint) }], // Technical endpoints providing access to electronic services provided by the device
"link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
"relation" : { Coding }, // R! The type indicates the relationship of the related device to the device instance
"relatedDevice" : { CodeableReference(Device) } // R! A reference to the linked device
}],
"note" : [{ Annotation }], // Device notes and comments
"safety" : [{ CodeableConcept }], // Safety Characteristics of Device
"
"parent" : { Reference(Device) } // The device that this device is attached to or is part of
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .fhir:fhir:Device.displayName [ string ]; # 0..1 The name used to display by default when the device is referenced fhir:Device.definition [ CodeableReference(DeviceDefinition) ]; # 0..1 The reference to the definition for the device fhir:Device.udiCarrier [ # 0..* Unique Device Identifier (UDI) Barcode stringfhir: fhir:<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">Device.udiCarrier.issuer fhir:fhir:Device.udiCarrier.deviceIdentifier [ string ]; # 1..1 Mandatory fixed portion of UDI fhir:Device.udiCarrier.issuer [ uri ]; # 0..1 UDI Issuing Organization fhir:Device.udiCarrier.jurisdiction [ uri ]; # 0..1 Regional UDI authority fhir:Device.udiCarrier.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String fhir:Device.udiCarrier.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode Stringfhir:fhir:Device.udiCarrier.entryType [ code ]; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown ], ...;fhir: fhir: fhir: fhir:fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown fhir:Device.statusReason [ CodeableConcept ], ... ; # 0..* discarded | obsolete | removed fhir:Device.biologicalSource [ Identifier ]; # 0..1 An identifier that supports traceability to the biological entity that is the source of biological material in the product fhir:Device.manufacturer [ string ]; # 0..1 Name of device manufacturer fhir:Device.manufactureDate [ dateTime ]; # 0..1 Date when the device was made fhir:Device.expirationDate [ dateTime ]; # 0..1 Date and time of expiry of this device (if applicable) fhir:Device.lotNumber [ string ]; # 0..1 Lot number of manufacture fhir:Device.serialNumber [ string ]; # 0..1 Serial number assigned by the manufacturerfhir: fhir: fhir:<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">Device.deviceName.type ], ...; fhir: fhir: fhir: fhir: fhir: fhir:fhir:Device.deviceName [ # 0..* The name or names of the device as known to the manufacturer and/or patient fhir:Device.deviceName.name [ string ]; # 1..1 The name that identifies the device fhir:Device.deviceName.type [ code ]; # 1..1 registered-name | user-friendly-name | patient-reported-name ], ...; fhir:Device.modelNumber [ string ]; # 0..1 The manufacturer's model number for the device fhir:Device.partNumber [ string ]; # 0..1 The part number or catalog number of the device fhir:Device.type [ CodeableConcept ], ... ; # 0..* The kind or type of device fhir:Device.version [ # 0..* The actual design of the device or software version running on the devicefhir: fhir:fhir:Device.version.type [ CodeableConcept ]; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:Device.version.component [ Identifier ]; # 0..1 The hardware or software module of the device to which the version applies fhir:Device.version.value [ string ]; # 1..1 The version text ], ...; fhir:Device.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesfhir: fhir: fhir:fhir:Device.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property being represented # Device.property.value[x] : 0..1 Property value - as a code, quantity, boolean, string or attachmment. One of these 7 fhir:Device.property.valueQuantity [ Quantity ] fhir:Device.property.valueCodeableConcept [ CodeableConcept ] fhir:Device.property.valueString [ string ] fhir:Device.property.valueBoolean [ boolean ] fhir:Device.property.valueInteger [ integer ] fhir:Device.property.valueRange [ Range ] fhir:Device.property.valueAttachment [ Attachment ] ], ...;fhir:fhir:Device.subject [ Reference(Patient|Person|Practitioner) ]; # 0..1 Patient to whom Device is affixed fhir:Device.operationalStatus [ # 0..1 The status of the device itself - whether it is switched on, or activated, etc fhir:Device.operationalStatus.value [ CodeableConcept ]; # 1..1 on |off | standby fhir:Device.operationalStatus.reason [ CodeableConcept ], ... ; # 0..* The reasons given for the current operational status ]; fhir:Device.associationStatus [ # 0..1 The state of the usage or application of the device fhir:Device.associationStatus.value [ CodeableConcept ]; # 1..1 implanted|explanted|attached fhir:Device.associationStatus.reason [ CodeableConcept ], ... ; # 0..* The reasons given for the current association status ]; fhir:Device.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device fhir:Device.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support fhir:Device.location [ Reference(Location) ]; # 0..1 Where the device is found fhir:Device.url [ uri ]; # 0..1 Network address to contact device fhir:Device.endpoint [ Reference(Endpoint) ], ... ; # 0..* Technical endpoints providing access to electronic services provided by the device fhir:Device.link [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device fhir:Device.link.relation [ Coding ]; # 1..1 The type indicates the relationship of the related device to the device instance fhir:Device.link.relatedDevice [ CodeableReference(Device) ]; # 1..1 A reference to the linked device ], ...; fhir:Device.note [ Annotation ], ... ; # 0..* Device notes and comments fhir:Device.safety [ CodeableConcept ], ... ; # 0..* Safety Characteristics of Devicefhir:fhir:Device.parent [ Reference(Device) ]; # 0..1 The device that this device is attached to or is part of ]
Changes since R3
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See the Full Difference for further information
This analysis is available as XML or JSON .
See R3 <--> R4 Conversion Maps (status = 9 tests that all execute ok. All tests pass round-trip testing and 1 r3 resources are invalid (0 errors). )
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
|
Device
|
TU | DomainResource |
Item
used
in
healthcare
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
|
identifier
|
0..* | Identifier |
Instance
identifier
|
|
|
displayName
|
0..1 |
| The name used to display by default when the device is referenced | |
|
definition
| 0..1 | CodeableReference ( DeviceDefinition ) | The reference to the definition for the device | |
|
udiCarrier
|
Σ | 0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
|
deviceIdentifier
|
Σ | 1..1 | string | Mandatory fixed portion of UDI |
|
issuer
|
0..1 | uri | UDI Issuing Organization | |
|
jurisdiction
|
0..1 | uri | Regional UDI authority | |
|
carrierAIDC
|
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String |
|
carrierHRF
|
Σ | 0..1 | string | UDI Human Readable Barcode String |
|
entryType
|
0..1 | code |
barcode
|
rfid
|
manual
UDIEntryType ( Required ) |
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
|
unknown
FHIRDeviceStatus ( Required ) |
|
statusReason
|
0..* | CodeableConcept |
discarded
|
FHIRDeviceStatusReason ( Extensible ) |
|
|
biologicalSource
|
0..1 |
|
An identifier that supports traceability to the biological entity that is the source of biological material in the product | |
|
manufacturer
|
0..1 | string | Name of device manufacturer | |
|
manufactureDate
|
0..1 | dateTime | Date when the device was made | |
|
expirationDate
|
0..1 | dateTime | Date and time of expiry of this device (if applicable) | |
|
lotNumber
|
0..1 | string | Lot number of manufacture | |
|
serialNumber
|
0..1 | string | Serial number assigned by the manufacturer | |
|
deviceName
|
0..* | BackboneElement |
The
name
or
names
of
the
device
as
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name
|
1..1 | string |
The
name
|
|
|
type
|
1..1 | code |
registered-name
|
user-friendly-name
|
patient-reported-name
DeviceNameType ( Required ) |
|
|
modelNumber
|
0..1 | string | The manufacturer's model number for the device | |
|
partNumber
|
0..1 | string | The part number or catalog number of the device | |
|
type
|
0..* | CodeableConcept |
The
kind
or
type
of
device
Device Type ( Example ) |
|
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version
|
0..* | BackboneElement |
The
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type
| 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal | |
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The
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string |
The
version
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0..* | BackboneElement |
The
actual
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type
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CodeableConcept |
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value[x]
|
0..1 |
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valueQuantity
| Quantity | |||
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valueCodeableConcept
| CodeableConcept | |||
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valueString
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string |
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valueBoolean
| boolean | |||
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valueInteger
| integer | |||
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valueRange
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| Attachment | |||
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subject
| 0..1 | Reference ( Patient | Practitioner | Person ) | Patient to whom Device is affixed | |
|
operationalStatus
|
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|
FHIRDeviceOperationalStatus ( Example ) |
|
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|
0..* | CodeableConcept |
|
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|
associationStatus
|
0..1 |
| The state of the usage or application of the device | |
|
value
| 1..1 | CodeableConcept |
implanted|explanted|attached
FHIRDeviceAssociationStatus ( |
|
|
reason
|
|
0..* | CodeableConcept |
The
reasons
given
for
the
current
association
status
|
|
owner
|
0..1 | Reference ( Organization ) | Organization responsible for device | |
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
location
|
0..1 | Reference ( Location ) | Where the device is found | |
|
url
|
0..1 | uri | Network address to contact device | |
|
endpoint
| 0..* | Reference ( Endpoint ) |
Technical
endpoints
providing
access
to
electronic
services
provided
by
the
device
| |
|
link
| 0..* | BackboneElement |
An
associated
device,
attached
to,
used
with,
communicating
with
or
linking
a
previous
or
new
device
model
to
the
focal
device
| |
|
relation
| 1..1 | Coding |
The
type
indicates
the
relationship
of
the
related
device
to
the
device
instance
DeviceRelationType ( Extensible ) | |
|
relatedDevice
| 1..1 | CodeableReference ( Device ) | A reference to the linked device | |
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
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|
safety
|
Σ | 0..* | CodeableConcept |
Safety
Characteristics
of
Device
|
|
parent
|
0..1 | Reference ( Device ) |
The
|
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|
Documentation
for
this
format
|
||||
XML Template
<Device xmlns="http://hl7.org/fhir"><</definition><displayName value="[string]"/><!-- 0..1 The name used to display by default when the device is referenced --> <definition><!-- 0..1 CodeableReference(DeviceDefinition) The reference to the definition for the device --></definition> <udiCarrier> <!-- 0..* Unique Device Identifier (UDI) Barcode string -->< <<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict"> <<deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI --> <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization --> <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority --> <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String --> <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String --><<entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown --> </udiCarrier>< <</statusReason> < <<status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown --> <statusReason><!-- 0..* CodeableConcept discarded | obsolete | removed --></statusReason> <biologicalSource><!-- 0..1 Identifier An identifier that supports traceability to the biological entity that is the source of biological material in the product --></biologicalSource> <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer --> <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made --> <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) --> <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture --> <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->< < <<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict"><deviceName> <!-- 0..* The name or names of the device as known to the manufacturer and/or patient --> <name value="[string]"/><!-- 1..1 The name that identifies the device --> <type value="[code]"/><!-- 1..1 registered-name | user-friendly-name | patient-reported-name --> </deviceName>< < <</type> < <</systemType> < </specialization><modelNumber value="[string]"/><!-- 0..1 The manufacturer's model number for the device --> <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device --> <type><!-- 0..* CodeableConcept The kind or type of device --></type> <version> <!-- 0..* The actual design of the device or software version running on the device --><</type> <</component><type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <value value="[string]"/><!-- 1..1 The version text --> </version> <property> <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties --><</type> <</valueQuantity> <</valueCode><type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 0..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Property value - as a code, quantity, boolean, string or attachmment --></value[x]> </property><</patient><subject><!-- 0..1 Reference(Patient|Person|Practitioner) Patient to whom Device is affixed --></subject> <operationalStatus> <!-- 0..1 The status of the device itself - whether it is switched on, or activated, etc --> <value><!-- 1..1 CodeableConcept on |off | standby --></value> <reason><!-- 0..* CodeableConcept The reasons given for the current operational status --></reason> </operationalStatus> <associationStatus> <!-- 0..1 The state of the usage or application of the device --> <value><!-- 1..1 CodeableConcept implanted|explanted|attached --></value> <reason><!-- 0..* CodeableConcept The reasons given for the current association status --></reason> </associationStatus> <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <location><!-- 0..1 Reference(Location) Where the device is found --></location> <url value="[uri]"/><!-- 0..1 Network address to contact device --> <endpoint><!-- 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device --></endpoint> <link> <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device --> <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation> <relatedDevice><!-- 1..1 CodeableReference(Device) A reference to the linked device --></relatedDevice> </link> <note><!-- 0..* Annotation Device notes and comments --></note> <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety><</parent><parent><!-- 0..1 Reference(Device) The device that this device is attached to or is part of --></parent> </Device>
JSON Template
{
"resourceType" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"displayName" : "<string>", // The name used to display by default when the device is referenced
"definition" : { CodeableReference(DeviceDefinition) }, // The reference to the definition for the device
"udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
"
"<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
1) GS1:
http://hl7.org/fhir/NamingSystem/gs1-di,
2) HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI,
3) ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
4) ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">issuer
"
"deviceIdentifier" : "<string>", // R! Mandatory fixed portion of UDI
"issuer" : "<uri>", // UDI Issuing Organization
"jurisdiction" : "<uri>", // Regional UDI authority
"carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
"carrierHRF" : "<string>", // UDI Human Readable Barcode String
"
"entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
}],
"
"
"
"
"status" : "<code>", // active | inactive | entered-in-error | unknown
"statusReason" : [{ CodeableConcept }], // discarded | obsolete | removed
"biologicalSource" : { Identifier }, // An identifier that supports traceability to the biological entity that is the source of biological material in the product
"manufacturer" : "<string>", // Name of device manufacturer
"manufactureDate" : "<dateTime>", // Date when the device was made
"expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
"lotNumber" : "<string>", // Lot number of manufacture
"serialNumber" : "<string>", // Serial number assigned by the manufacturer
"
"
"<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">type
}],
"
"
"
"
"
"
"deviceName" : [{ // The name or names of the device as known to the manufacturer and/or patient
"name" : "<string>", // R! The name that identifies the device
"type" : "<code>" // R! registered-name | user-friendly-name | patient-reported-name
}],
"modelNumber" : "<string>", // The manufacturer's model number for the device
"partNumber" : "<string>", // The part number or catalog number of the device
"type" : [{ CodeableConcept }], // The kind or type of device
"version" : [{ // The actual design of the device or software version running on the device
"
"
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"value" : "<string>" // R! The version text
}],
"property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
"
"
"
"type" : { CodeableConcept }, // R! Code that specifies the property being represented
// value[x]: Property value - as a code, quantity, boolean, string or attachmment. One of these 7:
"valueQuantity" : { Quantity }
"valueCodeableConcept" : { CodeableConcept }
"valueString" : "<string>"
"valueBoolean" : <boolean>
"valueInteger" : <integer>
"valueRange" : { Range }
"valueAttachment" : { Attachment }
}],
"
"subject" : { Reference(Patient|Person|Practitioner) }, // Patient to whom Device is affixed
"operationalStatus" : { // The status of the device itself - whether it is switched on, or activated, etc
"value" : { CodeableConcept }, // R! on |off | standby
"reason" : [{ CodeableConcept }] // The reasons given for the current operational status
},
"associationStatus" : { // The state of the usage or application of the device
"value" : { CodeableConcept }, // R! implanted|explanted|attached
"reason" : [{ CodeableConcept }] // The reasons given for the current association status
},
"owner" : { Reference(Organization) }, // Organization responsible for device
"contact" : [{ ContactPoint }], // Details for human/organization for support
"location" : { Reference(Location) }, // Where the device is found
"url" : "<uri>", // Network address to contact device
"endpoint" : [{ Reference(Endpoint) }], // Technical endpoints providing access to electronic services provided by the device
"link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
"relation" : { Coding }, // R! The type indicates the relationship of the related device to the device instance
"relatedDevice" : { CodeableReference(Device) } // R! A reference to the linked device
}],
"note" : [{ Annotation }], // Device notes and comments
"safety" : [{ CodeableConcept }], // Safety Characteristics of Device
"
"parent" : { Reference(Device) } // The device that this device is attached to or is part of
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .fhir:fhir:Device.displayName [ string ]; # 0..1 The name used to display by default when the device is referenced fhir:Device.definition [ CodeableReference(DeviceDefinition) ]; # 0..1 The reference to the definition for the device fhir:Device.udiCarrier [ # 0..* Unique Device Identifier (UDI) Barcode stringfhir: fhir:<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">Device.udiCarrier.issuer fhir:fhir:Device.udiCarrier.deviceIdentifier [ string ]; # 1..1 Mandatory fixed portion of UDI fhir:Device.udiCarrier.issuer [ uri ]; # 0..1 UDI Issuing Organization fhir:Device.udiCarrier.jurisdiction [ uri ]; # 0..1 Regional UDI authority fhir:Device.udiCarrier.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String fhir:Device.udiCarrier.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode Stringfhir:fhir:Device.udiCarrier.entryType [ code ]; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown ], ...;fhir: fhir: fhir: fhir:fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown fhir:Device.statusReason [ CodeableConcept ], ... ; # 0..* discarded | obsolete | removed fhir:Device.biologicalSource [ Identifier ]; # 0..1 An identifier that supports traceability to the biological entity that is the source of biological material in the product fhir:Device.manufacturer [ string ]; # 0..1 Name of device manufacturer fhir:Device.manufactureDate [ dateTime ]; # 0..1 Date when the device was made fhir:Device.expirationDate [ dateTime ]; # 0..1 Date and time of expiry of this device (if applicable) fhir:Device.lotNumber [ string ]; # 0..1 Lot number of manufacture fhir:Device.serialNumber [ string ]; # 0..1 Serial number assigned by the manufacturerfhir: fhir: fhir:<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">Device.deviceName.type ], ...; fhir: fhir: fhir: fhir: fhir: fhir:fhir:Device.deviceName [ # 0..* The name or names of the device as known to the manufacturer and/or patient fhir:Device.deviceName.name [ string ]; # 1..1 The name that identifies the device fhir:Device.deviceName.type [ code ]; # 1..1 registered-name | user-friendly-name | patient-reported-name ], ...; fhir:Device.modelNumber [ string ]; # 0..1 The manufacturer's model number for the device fhir:Device.partNumber [ string ]; # 0..1 The part number or catalog number of the device fhir:Device.type [ CodeableConcept ], ... ; # 0..* The kind or type of device fhir:Device.version [ # 0..* The actual design of the device or software version running on the devicefhir: fhir:fhir:Device.version.type [ CodeableConcept ]; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:Device.version.component [ Identifier ]; # 0..1 The hardware or software module of the device to which the version applies fhir:Device.version.value [ string ]; # 1..1 The version text ], ...; fhir:Device.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesfhir: fhir: fhir:fhir:Device.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property being represented # Device.property.value[x] : 0..1 Property value - as a code, quantity, boolean, string or attachmment. One of these 7 fhir:Device.property.valueQuantity [ Quantity ] fhir:Device.property.valueCodeableConcept [ CodeableConcept ] fhir:Device.property.valueString [ string ] fhir:Device.property.valueBoolean [ boolean ] fhir:Device.property.valueInteger [ integer ] fhir:Device.property.valueRange [ Range ] fhir:Device.property.valueAttachment [ Attachment ] ], ...;fhir:fhir:Device.subject [ Reference(Patient|Person|Practitioner) ]; # 0..1 Patient to whom Device is affixed fhir:Device.operationalStatus [ # 0..1 The status of the device itself - whether it is switched on, or activated, etc fhir:Device.operationalStatus.value [ CodeableConcept ]; # 1..1 on |off | standby fhir:Device.operationalStatus.reason [ CodeableConcept ], ... ; # 0..* The reasons given for the current operational status ]; fhir:Device.associationStatus [ # 0..1 The state of the usage or application of the device fhir:Device.associationStatus.value [ CodeableConcept ]; # 1..1 implanted|explanted|attached fhir:Device.associationStatus.reason [ CodeableConcept ], ... ; # 0..* The reasons given for the current association status ]; fhir:Device.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device fhir:Device.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support fhir:Device.location [ Reference(Location) ]; # 0..1 Where the device is found fhir:Device.url [ uri ]; # 0..1 Network address to contact device fhir:Device.endpoint [ Reference(Endpoint) ], ... ; # 0..* Technical endpoints providing access to electronic services provided by the device fhir:Device.link [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device fhir:Device.link.relation [ Coding ]; # 1..1 The type indicates the relationship of the related device to the device instance fhir:Device.link.relatedDevice [ CodeableReference(Device) ]; # 1..1 A reference to the linked device ], ...; fhir:Device.note [ Annotation ], ... ; # 0..* Device notes and comments fhir:Device.safety [ CodeableConcept ], ... ; # 0..* Safety Characteristics of Devicefhir:fhir:Device.parent [ Reference(Device) ]; # 0..1 The device that this device is attached to or is part of ]
Changes since Release 3
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See the Full Difference for further information
This analysis is available as XML or JSON .
See R3 <--> R4 Conversion Maps (status = 9 tests that all execute ok. All tests pass round-trip testing and 1 r3 resources are invalid (0 errors). )
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis a
| Path | Definition | Type | Reference |
|---|---|---|---|
| Device.udiCarrier.entryType |
|
Required | UDIEntryType |
| Device.status |
|
Required | FHIRDeviceStatus |
| Device.statusReason |
|
Extensible | FHIRDeviceStatusReason |
| Device.deviceName.type |
|
Required | DeviceNameType |
| Device.type |
|
Example | DeviceType |
| Device.operationalStatus.value | Example | FHIRDeviceOperationalStatus | |
| Device.associationStatus.value | Example | FHIRDeviceAssociationStatus | |
| Device.link.relation | Extensible | DeviceRelationType |
Nearly all devices are assigned a string of characters to represent one or more identifiers or codes, which are usually printed or affixed to the device using either barcodes or RFIDs. The identifier or code can come from the manufacturer (for example, a 'serial number', 'reference number', or 'catalog number'), various institution and registries. Any of these identifiers or codes assigned to the device can and should be recorded in the device resource. However, there can there can be confusion where to represent them in the resource because codes and identifiers are represented in FHIR as semantically distinct elements and because organizations may conflate the term 'code' for an identifier or 'identifier' for a code in their names.
The
identifier
element
is
only
intended
for
use
when
it's
an
actual
identifier
for
a
specific
instance
of
a
device.
That
would
mean
that
each
device
would
have
a
separate
serial
number
and
would
be
represented
using
this
element
-
devices
without
serial
numbers
(for
example,
a
box
of
syringes)
would
not.
Concepts
such
as
a
reference
number
or
catalog
number
or
GTIN
describe
a
code
which
represents
a
kind
of
device
and
are
conveyed
using
the
type
element.
Some
sources
of
standard
codes
for
devices
and
translations
within
type
are
listed
below:
For
systems
that
do
have
a
system
URI
for
device
types
(indicating
the
model
number
or
part
number),
they
can
and
should
appear
as
codings
in
Device.type
.
The
International
Medical
Device
Regulators
Forum
IMDRF
UDI
Working
Group
published
UDI
System
for
Medical
Devices
(Version
2.0)
,
the
base
specification
for
Unique
Device
Identifiers
(UDI).
The
United
States
Food
and
Drug
Administration
has
produced
an
implementation
guide
for
Unique
Device
Identifiers
(UDI)
which
implements
the
IMDRF
specification
and
other
jurisdictions
may
produce
similar
IMDRF
implementation
guides
as
well.
The
full
UDI
string
that
represents
the
barcode
as
printed
on
the
packaging
of
the
device
or
Automatic
Identification
and
Data
Capture
(AIDC)
representation
is
called
the
"UDI
carrier".
The
UDI
has
2
components*:
*non-UDI
elements
may
also
appear
within
the
UDI
carrier.
**a
"GTIN"
(sometimes
also
called
an
EAN
number)
is
a
code
developed
by
GS1
for
the
kind
of
device
not
an
identifier
for
the
device.
A
GTIN
may
appear
on
its
own
or
it
may
appear
in
a
UDI
string
as
the
DI
component.
The
DI
of
the
UDI
may
be
stored
in
a
jurisdictional
repository
and
used
as
the
primary
key
to
access
other
device
information.
For
example,
in
the
United
States,
the
DI
of
the
UDI
is
submitted
in
a
device
record
to
the
Global
Unique
Device
Identification
Database
(GUDID)
.
The
UDI
may
identify
an
instance
of
a
device
uniquely
(when
the
PI
includes
a
serial
number),
or
it
may
just
identify
the
type
of
the
device.
The
UDI
is
parsed
into
its
constituent
parts
(DI,
PI
and
other
elements)
by
parsing
rules
developed
by
each
Issuing
Agency
standard.
Where
the
device
has
an
assigned
UDI,
the
other
details
carried
in
the
resource
(e.g.,
lot,
expiration
date,
etc.)
SHALL
be
consistent
with
the
information
encoded
in
the
UDI
string
or
registered
in
the
local
repository.
Best practice guidelines for transmitting UDI data using the Device resource dictate transmitting both the UDI Carrier and all components found within the UDI as described in Device UDI Mapping . Several examples are provided for further guidance.
Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
| Name | Type | Description | Expression | In Common |
| biological-source | token | The biological source for the device | Device.biologicalSource | |
| definition | reference | The definition / type of the device | Device.definition.reference | |
| device-name | string | A server defined search that may match any of the string fields in Device.deviceName or Device.type. | Device.deviceName.name | Device.type.coding.display | Device.type.text | |
| expiration-date N | date | The expiration date of the device | Device.expirationDate | |
| identifier | token | Instance id from manufacturer, owner, and others | Device.identifier | |
| location | reference | A location, where the resource is found |
Device.location
( Location ) |
|
| lot-number N | string | The lot number of the device | Device.lotNumber | |
| manufacture-date N | date | The manufacture date of the device | Device.manufactureDate | |
| manufacturer N | string | The manufacturer of the device | Device.manufacturer | |
| model N | string | The model of the device | Device.modelNumber | |
| organization | reference | The organization responsible for the device |
Device.owner
( Organization ) |
|
| parent | reference | The parent device |
Device.parent
( Device ) | |
| patient | reference | Patient information, if the resource is affixed to a person |
( Practitioner , Patient , Person ) |
|
| serial-number N | string | The serial number of the device | Device.serialNumber | |
| status N | token | active | inactive | entered-in-error | unknown | Device.status | |
| subject | reference | Subject information, to which the device is associated of affixed |
Device.subject
( Practitioner , Patient , Person ) | |
| type | token | The type of the device | Device.type | |
| udi-carrier | string | UDI Barcode (RFID or other technology) string in *HRF* format. | Device.udiCarrier.carrierHRF | |
| udi-di | string | The udi Device Identifier (DI) | Device.udiCarrier.deviceIdentifier | |
| url N | uri | Network address to contact device | Device.url | |
| version N | string | The specific version of the device | Device.version.value |
FHIR
®©
HL7.org
2011+.
FHIR
Release
4
(Technical
Correction
#1)
(v4.0.1)
R5
Draft
Ballot
hl7.fhir.core#5.0.0-snapshot1
generated
on
Fri,
Nov
1,
2019
09:34+1100.
QA
Page
Sun,
Dec
19,
2021
08:19+1100.
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