Administration
This
page
is
part
of
the
Continuous
Integration
Build
of
FHIR
Specification
(v4.0.1:
R4
-
Mixed
Normative
and
STU
)
in
it's
permanent
home
(it
will
always
(will
be
available
incorrect/inconsistent
at
this
URL).
The
current
version
which
supercedes
this
version
is
5.0.0
.
For
a
full
list
of
available
versions,
see
times).
See
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
R4
R3
R2
|
Responsible
Owner:
Orders
and
Observations
Work
Group
|
|
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.
Note to Implementers: For an overview of this resource and others in the Device domain, also see the module page .
Note to Implementers: The owner has been removed from Device and is now included in DeviceAssociation as .relationship of the subject. Please comment on the revision if there are issues with removing the identification of individuals in the Device resource.
Note to Implementers: Extensions have been created and are now available to represent previously removed
Deviceelements and new concepts. These include:
device-mode,device-cycle,device-duration,device-gateway, anddevice-endpointdevice-alertDetection– describes the alert detection activation states for the overall devicedevice-conformsTo-source– represents the source of the device specificationLinks to these extensions can be found in the FHIR Extension Pack . Feedback from implementers is welcomed to inform further refinement and usage guidance.
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,
a
patient's
use.
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.
Medical
devices
may
also
include
some
types
of
software.
Non-medical devices may include items such as a machine, cellphone, computer, software application or algorithm, etc. In short, a Device can range from a tongue depressor to an MRI. The fields in the Device resource must be flexible enough to cover this range.
The
resource
may
be
used
to
record
and
transmit
document
the
Unique
Device
Identifier
(UDI)
and
information
about
a
device
where
appropriate
or
necessary
according
to
local
jurisdictions
over
time.
Additional
information
about
UDI
is
provided
in
the
Unique
Device
Identifier
(UDI)
section.
Devices may be categorized and may be associated with one or more categories. Device category examples include, but are not limited to: active, communicating, durable medical equipment, home use, implantable, InVitro diagnostics, personal health, point-of-care, single use, re-usable, and software. See DeviceDefinition for detailed descriptions of device categories.
When
referring
to
a
specific
instance,
even
without
specific
instance
details,
Device
is
to
be
used,
not
a
DeviceDefinition.
The
context
of
a
data
exchange
indicates
whether
the
data
is
representing
a
physical
instance
or
a
"kind",
not
the
presence
of
instance
data
such
as
a
patient's
implant.
lot
and
serial
numbers.
Some examples:
These areNote to Implementers: The module pages under development by Orders and Observations will further describe the variations of devicerelateduse cases across the device resources, e.g., Device, DeviceDefinition, DeviceAssociation, DeviceDispense, DeviceMetric, DeviceRequest, and Device Usage.
There are several resources that can be used to represent device related events, requests or definitions. The following Resources should be used in the following manner:
Device.property
is
used
to
capture
inherent,
essentially
fixed,
characteristics
of
the
-
The
workflow
step
to
manage
the
distribution
of
the
device.
-
The
workflow
step
to
request/order
supplies
that
would
be
needed
beyond
the
devices
in
the
DeviceRequest.
-
The
workflow
step
to
manage
the
distribution
of
supplies
that
are
ordered
beyone
the
devices
in
the
DeviceDispense.
-
To
record
the
use
of
a
device
that
is
not
In
FHIR,
the
Device
represents
either
the
device
in
total,
or
a
component
of
an
encapsulating
device
when
there
is
much
more
volatile.
The
physical
composition
a
need
for
individual
tracking
of
a
component.
A
Device
as
a
component
then
points
to
the
parent
device
it
is
represented
by
part
of.
The
top-level
Device
captures
the
Devices
pointing
to
their
"parent".
actual
data
about
the
instance
of
the
device
and
the
instances
of
all
its
children
that
either
provides
identifying
characteristics
of
the
Device
(including
applicable
UDI
–
unique
device
identification)
and
data
that
can
vary
dynamically
by
device,
e.g.,
specific
settings
at
a
particular
point
in
time.
Devices
differ
from
medications
because
they
are
not
"used
up"
-
they
remain
active
in
or
for
a
patient
in
an
ongoing
fashion.
However,
the
specific
boundary
between
medications
and
for
a
longer
duration.
They
also
may
be
re-used,
particularly
non-implanted
devices
is
defined
at
the
implementation
level
and
this
standard
does
not
enforce
those
used
for
diagnostics
and
procedures.
Frequently,
when
a
boundary
device
is
packaged
with
a
medication,
the
exception
ordering,
dispense,
and
administration
processes
typically
focus
on
the
medication
aspects
and
reference
the
device.
In
the
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
resource
should
not
be
used
to
represent
implanted
devices.
This
resource
(implanted)
devices,
rather
reference
the
relationship
where
an
actual
device
needs
to
be
tracked
in
addition
to
the
medication.
In
some
sense
the
Medication
is
referenced
analogous
to
the
Observation
generated
by
Signature
,
a
Blood
Pressure
personal
health
device.
The
Observation
resource
contains
the
blood
pressure
values,
units
and
the
time
stamp
while
the
Device
resource
contains
the
manufacturer
name,
model
number,
serial
number,
firmware
and
hardware
versions,
exchange
protocol
information,
any
clock
capabilities,
etc.
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
Filter:
|
|---|---|---|---|---|
Device
|
TU | DomainResource |
Item
used
in
healthcare
+ Rule: only one Device.name.display SHALL be true when there is more than one Device.name Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
identifier
|
0..* | Identifier |
Instance
identifier
|
|
definition
|
0..1 |
|
The
reference
to
the
definition
for
the
device
|
|
udiCarrier
|
Σ | 0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
|
deviceIdentifier
|
Σ | 1..1 | string |
Mandatory
fixed
portion
of
UDI
|
|
|
0..1 | uri |
The
namespace
for
the
device
identifier
value
|
|
|
issuer
| Σ | 1..1 | uri |
UDI
Issuing
Organization
|
|
jurisdiction
|
0..1 | uri |
Regional
UDI
authority
|
|
|
carrierAIDC
|
Σ | 0..1 | base64Binary |
UDI
Machine
Readable
|
|
carrierHRF
|
Σ | 0..1 | string |
UDI
Human
Readable
|
entryType
|
0..1 | code |
barcode
|
rfid
|
manual
|
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
|
unknown
|
|
availabilityStatus
|
0..1 | CodeableConcept |
lost
|
|
|
|
biologicalSourceEvent
|
0..1 |
|
A
production
identifier
of
the
donation,
collection,
or
pooling
event
from
which
biological
material
in
this
device
was
derived
|
|
|
manufacturer
|
0..1 | string |
Name
of
device
manufacturer
|
|
|
manufactureDate
|
0..1 | dateTime |
A
production
identifier
that
indicates
the
date
when
the
device
was
made
|
|
|
expirationDate
|
0..1 | dateTime |
A
production
identifier
that
indicates
the
date
and
time
of
expiry
of
this
device
(if
applicable)
|
|
|
lotNumber
|
0..1 | string |
A
production
identifier
that
indicates
the
Lot
number
of
manufacture
|
|
|
serialNumber
|
0..1 | string |
A
production
identifier
that
indicates
the
Serial
number
assigned
by
the
manufacturer
|
|
|
name
|
C | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
|
|
value
|
Σ | 1..1 | string |
The
|
|
type
|
Σ | 1..1 |
|
registered-name
|
user-friendly-name
|
patient-reported-name
|
|
display
| ?! Σ C | 0..1 | boolean |
The
preferred
device
name
|
|
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
|
|
|
|
0..* | CodeableConcept |
Indicates
a
high-level
grouping
of
the
device
Binding: FHIR Device Category ( Example ) |
|
|
type
|
0..* | CodeableConcept |
The
kind
or
type
of
device
Binding: Device Type ( Example ) |
|
|
deviceVersion
|
0..* | BackboneElement |
The
|
|
|
type
|
0..1 | CodeableConcept |
The
type
of
the
device
version,
e.g.
manufacturer,
approved,
internal
Binding: Device Version Type ( Example ) |
|
|
component
|
0..1 | Identifier |
The
|
|
|
|
0..1 | dateTime |
The
date
the
version
was
installed
on
the
device
|
|
|
value
| 1..1 | string |
The
version
|
|
|
conformsTo
|
0..* | BackboneElement |
Identifies
the
|
|
|
category
|
0..1 | CodeableConcept |
Describes
the
common
type
of
the
Binding: Device Specification Category ( Example ) |
|
|
specification
|
1..1 |
|
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
Binding: Device Specification Type ( Example ) |
|
|
version
|
0..1 | string |
Specific
form
or
variant
of
the
standard
|
|
|
property
|
0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
|
|
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
Binding: Device Property Type (Example only) ( Example ) |
|
value[x]
|
1..1 |
Value
of
the
property
|
||
valueQuantity
| Quantity | |||
|
valueCodeableConcept
|
|
CodeableConcept | ||
|
valueString
|
string | |||
|
valueBoolean
|
|
|
|
|
|
valueInteger
|
integer | |||
|
valueRange
|
|
|
|
|
|
|
Attachment | |||
|
additive
|
0..* |
|
Material
added
to
a
container
device
|
|
|
type
|
1..1 | CodeableReference ( SubstanceDefinition ) |
The
additive
substance
Binding: Substance Code ( Example ) |
|
|
quantity
|
0..1 | SimpleQuantity |
Quantity
of
additive
substance
within
container
|
|
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
location
|
|
0..1 | Reference ( Location ) |
Where
the
device
is
found
|
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
|
|
safety
|
Σ | 0..* | CodeableConcept |
Safety
Characteristics
of
Device
Binding: Device Safety ( Example ) |
|
parent
|
0..1 | Reference ( Device ) |
The
|
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
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> < < <<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"> < < < <<definition><!-- 0..1 canonical(DeviceDefinition) The reference to the definition for the device --></definition> <udiCarrier> <!-- 0..* Unique Device Identifier (UDI) value --> <deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI --> <deviceIdentifierSystem value="[uri]"/><!-- 0..1 The namespace for the device identifier value --> <issuer value="[uri]"/><!-- 1..1 UDI Issuing Organization --> <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority --> <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable value --> <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable value --> <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown --> </udiCarrier>< <</statusReason> < < < < < < < < <<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict"> </deviceName> < < <</type> < <</systemType> < </specialization> < <</type> <</component> < </version> < <</type> <</valueQuantity> <</valueCode><status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown --> <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus> <biologicalSourceEvent><!-- 0..1 Identifier A production identifier of the donation, collection, or pooling event from which biological material in this device was derived --></biologicalSourceEvent> <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer --> <manufactureDate value="[dateTime]"/><!-- 0..1 A production identifier that indicates the date when the device was made --> <expirationDate value="[dateTime]"/><!-- 0..1 A production identifier that indicates the date and time of expiry of this device (if applicable) --> <lotNumber value="[string]"/><!-- 0..1 A production identifier that indicates the Lot number of manufacture --> <serialNumber value="[string]"/><!-- 0..1 A production identifier that indicates the Serial number assigned by the manufacturer --> <name> <!-- I 0..* The name or names of the device as known to the manufacturer and/or patient --> <value value="[string]"/><!-- 1..1 The term that names the device --> <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type> <display value="[boolean]"/><!-- I 0..1 The preferred device name --> </name> <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 --> <category><!-- 0..* CodeableConcept Indicates a high-level grouping of the device --></category> <type><!-- 0..* CodeableConcept The kind or type of device --></type> <deviceVersion> <!-- 0..* The actual design of the device or software version running on the device --> <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> <installDate value="[dateTime]"/><!-- 0..1 The date the version was installed on the device --> <value value="[string]"/><!-- 1..1 The version text --> </deviceVersion> <conformsTo> <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device --> <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement --></category> <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to --></specification> <version value="[string]"/><!-- 0..1 Specific form or variant of the standard --> </conformsTo> <property> <!-- 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. --> <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Value of the property --></value[x]> </property><</patient> <</owner><additive> <!-- 0..* Material added to a container device --> <type><!-- 1..1 CodeableReference(SubstanceDefinition) The additive substance --></type> <quantity><!-- 0..1 Quantity(SimpleQuantity) Quantity of additive substance within container --></quantity> </additive> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <location><!-- 0..1 Reference(Location) Where the device is found --></location><<note><!-- 0..* Annotation Device notes and comments --></note><</safety> <</parent><safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety> <parent><!-- 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of --></parent> </Device>
JSON Template
{
"resourceType" : "",
"resourceType" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"
"
"<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
"
"
"
"
"definition" : "<canonical(DeviceDefinition)>", // The reference to the definition for the device
"udiCarrier" : [{ // Unique Device Identifier (UDI) value
"deviceIdentifier" : "<string>", // R! Mandatory fixed portion of UDI
"deviceIdentifierSystem" : "<uri>", // The namespace for the device identifier value
"issuer" : "<uri>", // R! UDI Issuing Organization
"jurisdiction" : "<uri>", // Regional UDI authority
"carrierAIDC" : "<base64Binary>", // UDI Machine Readable value
"carrierHRF" : "<string>", // UDI Human Readable value
"entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
}],
"
"
"
"
"
"
"
"
"
"
"<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">type
"status" : "<code>", // active | inactive | entered-in-error | unknown
"availabilityStatus" : { CodeableConcept }, // lost | damaged | destroyed | available
"biologicalSourceEvent" : { Identifier }, // A production identifier of the donation, collection, or pooling event from which biological material in this device was derived
"manufacturer" : "<string>", // Name of device manufacturer
"manufactureDate" : "<dateTime>", // A production identifier that indicates the date when the device was made
"expirationDate" : "<dateTime>", // A production identifier that indicates the date and time of expiry of this device (if applicable)
"lotNumber" : "<string>", // A production identifier that indicates the Lot number of manufacture
"serialNumber" : "<string>", // A production identifier that indicates the Serial number assigned by the manufacturer
"name" : [{ // I The name or names of the device as known to the manufacturer and/or patient
"value" : "<string>", // R! The term that names the device
"type" : { CodeableConcept }, // R! registered-name | user-friendly-name | patient-reported-name
"display" : <boolean> // I The preferred device name
}],
"
"
"
"
"
"
"modelNumber" : "<string>", // The manufacturer's model number for the device
"partNumber" : "<string>", // The part number or catalog number of the device
"category" : [{ CodeableConcept }], // Indicates a high-level grouping of the device
"type" : [{ CodeableConcept }], // The kind or type of device
"deviceVersion" : [{ // 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
"installDate" : "<dateTime>", // The date the version was installed on the device
"value" : "<string>" // R! The version text
}],
"
"
"
"
"conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
"category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement
"specification" : { CodeableConcept }, // R! Identifies the standard, specification, or formal guidance that the device adheres to
"version" : "<string>" // Specific form or variant of the standard
}],
"
"
"
"
"property" : [{ // Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
"type" : { CodeableConcept }, // R! Code that specifies the property being represented
// value[x]: Value of the property. One of these 7:
"valueQuantity" : { Quantity },
"valueCodeableConcept" : { CodeableConcept },
"valueString" : "<string>",
"valueBoolean" : <boolean>,
"valueInteger" : <integer>,
"valueRange" : { Range },
"valueAttachment" : { Attachment }
}],
"additive" : [{ // Material added to a container device
"type" : { CodeableReference(SubstanceDefinition) }, // R! The additive substance
"quantity" : { Quantity(SimpleQuantity) } // Quantity of additive substance within container
}],
"
"
"contact" : [{ ContactPoint }], // Details for human/organization for support
"location" : { Reference(Location) }, // Where the device is found
"
"note" : [{ Annotation }], // Device notes and comments
"
"
"safety" : [{ CodeableConcept }], // Safety Characteristics of Device
"parent" : { Reference(Device) } // The higher level or encompassing device that this device is a logical part of
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:;[ a fhir:Device; fhir:nodeRole fhir:treeRoot; # if this is the parser root# from # from fhir: fhir: fhir: fhir: 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: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: 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: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:# from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension fhir:identifier ( [ Identifier ] ... ) ; # 0..* Instance identifier fhir:definition [ canonical(DeviceDefinition) ] ; # 0..1 The reference to the definition for the device fhir:udiCarrier ( [ # 0..* Unique Device Identifier (UDI) value fhir:deviceIdentifier [ string ] ; # 1..1 Mandatory fixed portion of UDI fhir:deviceIdentifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value fhir:issuer [ uri ] ; # 1..1 UDI Issuing Organization fhir:jurisdiction [ uri ] ; # 0..1 Regional UDI authority fhir:carrierAIDC [ base64Binary ] ; # 0..1 UDI Machine Readable value fhir:carrierHRF [ string ] ; # 0..1 UDI Human Readable value fhir:entryType [ code ] ; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown ] ... ) ; fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error | unknown fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | available fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 A production identifier of the donation, collection, or pooling event from which biological material in this device was derived fhir:manufacturer [ string ] ; # 0..1 Name of device manufacturer fhir:manufactureDate [ dateTime ] ; # 0..1 A production identifier that indicates the date when the device was made fhir:expirationDate [ dateTime ] ; # 0..1 A production identifier that indicates the date and time of expiry of this device (if applicable) fhir:lotNumber [ string ] ; # 0..1 A production identifier that indicates the Lot number of manufacture fhir:serialNumber [ string ] ; # 0..1 A production identifier that indicates the Serial number assigned by the manufacturer fhir:name ( [ # 0..* I The name or names of the device as known to the manufacturer and/or patient fhir:value [ string ] ; # 1..1 The term that names the device fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name fhir:display [ boolean ] ; # 0..1 I The preferred device name ] ... ) ; fhir:modelNumber [ string ] ; # 0..1 The manufacturer's model number for the device fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device fhir:category ( [ CodeableConcept ] ... ) ; # 0..* Indicates a high-level grouping of the device fhir:type ( [ CodeableConcept ] ... ) ; # 0..* The kind or type of device fhir:deviceVersion ( [ # 0..* The actual design of the device or software version running on the device fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies fhir:installDate [ dateTime ] ; # 0..1 The date the version was installed on the device fhir:value [ string ] ; # 1..1 The version text ] ... ) ; fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to fhir:version [ string ] ; # 0..1 Specific form or variant of the standard ] ... ) ; fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented # value[x] : 1..1 Value of the property. One of these 7 fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:String ; string ] fhir:value [ a fhir:Boolean ; boolean ] fhir:value [ a fhir:Integer ; integer ] fhir:value [ a fhir:Range ; Range ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:additive ( [ # 0..* Material added to a container device fhir:type [ CodeableReference(SubstanceDefinition) ] ; # 1..1 The additive substance fhir:quantity [ Quantity(SimpleQuantity) ] ; # 0..1 Quantity of additive substance within container ] ... ) ; fhir:contact ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support fhir:location [ Reference(Location) ] ; # 0..1 Where the device is found fhir:note ( [ Annotation ] ... ) ; # 0..* Device notes and comments fhir:safety ( [ CodeableConcept ] ... ) ; # 0..* Safety Characteristics of Device fhir:parent [ Reference(Device) ] ; # 0..1 The higher level or encompassing device that this device is a logical part of ]
Changes
since
R3
from
both
R4
and
R4B
| Device | |
| Device.definition |
|
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| Device.udiCarrier.issuer |
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| Device.name |
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|
|
|
|
|
| Device.distinctIdentifier |
|
| Device.deviceName.name |
|
| Device.specialization.systemType |
|
| Device.version |
|
| Device.property.valueQuantity |
|
| Device.property.valueCode |
|
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|
See the Full Difference for further information
This
analysis
is
available
for
R4
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).
)
for
R4B
as
XML
or
JSON
.
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
Filter:
|
|---|---|---|---|---|
|
Device
|
TU | DomainResource |
Item
used
in
healthcare
+ Rule: only one Device.name.display SHALL be true when there is more than one Device.name Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
|
identifier
|
0..* | Identifier |
Instance
identifier
|
|
|
definition
|
0..1 |
|
The
reference
to
the
definition
for
the
device
|
|
|
udiCarrier
|
Σ | 0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
|
|
deviceIdentifier
|
Σ | 1..1 | string |
Mandatory
fixed
portion
of
UDI
|
|
|
0..1 | uri |
The
namespace
for
the
device
identifier
value
|
|
|
issuer
| Σ | 1..1 | uri |
UDI
Issuing
Organization
|
|
jurisdiction
|
0..1 | uri |
Regional
UDI
authority
|
|
|
carrierAIDC
|
Σ | 0..1 | base64Binary |
UDI
Machine
Readable
|
|
carrierHRF
|
Σ | 0..1 | string |
UDI
Human
Readable
|
|
entryType
|
0..1 | code |
barcode
|
rfid
|
manual
|
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
|
unknown
|
|
availabilityStatus
|
0..1 | CodeableConcept |
lost
|
|
|
|
biologicalSourceEvent
|
0..1 |
|
A
production
identifier
of
the
donation,
collection,
or
pooling
event
from
which
biological
material
in
this
device
was
derived
|
|
|
manufacturer
|
0..1 | string |
Name
of
device
manufacturer
|
|
|
manufactureDate
|
0..1 | dateTime |
A
production
identifier
that
indicates
the
date
when
the
device
was
made
|
|
|
expirationDate
|
0..1 | dateTime |
A
production
identifier
that
indicates
the
date
and
time
of
expiry
of
this
device
(if
applicable)
|
|
|
lotNumber
|
0..1 | string |
A
production
identifier
that
indicates
the
Lot
number
of
manufacture
|
|
|
serialNumber
|
0..1 | string |
A
production
identifier
that
indicates
the
Serial
number
assigned
by
the
manufacturer
|
|
|
name
|
C | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
|
|
value
|
Σ | 1..1 | string |
The
|
|
type
|
Σ | 1..1 |
|
registered-name
|
user-friendly-name
|
patient-reported-name
|
|
display
| ?! Σ C | 0..1 | boolean |
The
preferred
device
name
|
|
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
|
|
|
|
0..* | CodeableConcept |
Indicates
a
high-level
grouping
of
the
device
Binding: FHIR Device Category ( Example ) |
|
|
type
|
0..* | CodeableConcept |
The
kind
or
type
of
device
Binding: Device Type ( Example ) |
|
|
deviceVersion
|
0..* | BackboneElement |
The
|
|
|
type
|
0..1 | CodeableConcept |
The
type
of
the
device
version,
e.g.
manufacturer,
approved,
internal
Binding: Device Version Type ( Example ) |
|
|
component
|
0..1 | Identifier |
The
|
|
|
|
0..1 | dateTime |
The
date
the
version
was
installed
on
the
device
|
|
|
value
| 1..1 | string |
The
version
|
|
|
conformsTo
|
0..* | BackboneElement |
Identifies
the
|
|
|
category
|
0..1 | CodeableConcept |
Describes
the
common
type
of
the
Binding: Device Specification Category ( Example ) |
|
|
specification
|
1..1 |
|
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
Binding: Device Specification Type ( Example ) |
|
|
version
|
0..1 | string |
Specific
form
or
variant
of
the
standard
|
|
|
property
|
0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
|
|
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
Binding: Device Property Type (Example only) ( Example ) |
|
|
value[x]
|
1..1 |
Value
of
the
property
|
||
|
valueQuantity
| Quantity | |||
|
valueCodeableConcept
|
|
CodeableConcept | ||
|
valueString
|
string | |||
|
valueBoolean
|
|
|
|
|
|
valueInteger
|
integer | |||
|
valueRange
|
|
|
|
|
|
|
Attachment | |||
|
additive
|
0..* |
|
Material
added
to
a
container
device
|
|
|
type
|
1..1 | CodeableReference ( SubstanceDefinition ) |
The
additive
substance
Binding: Substance Code ( Example ) |
|
|
quantity
|
0..1 | SimpleQuantity |
Quantity
of
additive
substance
within
container
|
|
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
location
|
|
0..1 | Reference ( Location ) |
Where
the
device
is
found
|
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
|
|
safety
|
Σ | 0..* | CodeableConcept |
Safety
Characteristics
of
Device
Binding: Device Safety ( Example ) |
|
parent
|
0..1 | Reference ( Device ) |
The
|
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
XML Template
<<Device xmlns="http://hl7.org/fhir"><</definition> < < <<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"> < < < <<definition><!-- 0..1 canonical(DeviceDefinition) The reference to the definition for the device --></definition> <udiCarrier> <!-- 0..* Unique Device Identifier (UDI) value --> <deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI --> <deviceIdentifierSystem value="[uri]"/><!-- 0..1 The namespace for the device identifier value --> <issuer value="[uri]"/><!-- 1..1 UDI Issuing Organization --> <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority --> <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable value --> <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable value --> <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown --> </udiCarrier>< <</statusReason> < < < < < < < < <<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict"> </deviceName> < < <</type> < <</systemType> < </specialization> < <</type> <</component> < </version> < <</type> <</valueQuantity> <</valueCode><status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown --> <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus> <biologicalSourceEvent><!-- 0..1 Identifier A production identifier of the donation, collection, or pooling event from which biological material in this device was derived --></biologicalSourceEvent> <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer --> <manufactureDate value="[dateTime]"/><!-- 0..1 A production identifier that indicates the date when the device was made --> <expirationDate value="[dateTime]"/><!-- 0..1 A production identifier that indicates the date and time of expiry of this device (if applicable) --> <lotNumber value="[string]"/><!-- 0..1 A production identifier that indicates the Lot number of manufacture --> <serialNumber value="[string]"/><!-- 0..1 A production identifier that indicates the Serial number assigned by the manufacturer --> <name> <!-- I 0..* The name or names of the device as known to the manufacturer and/or patient --> <value value="[string]"/><!-- 1..1 The term that names the device --> <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type> <display value="[boolean]"/><!-- I 0..1 The preferred device name --> </name> <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 --> <category><!-- 0..* CodeableConcept Indicates a high-level grouping of the device --></category> <type><!-- 0..* CodeableConcept The kind or type of device --></type> <deviceVersion> <!-- 0..* The actual design of the device or software version running on the device --> <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> <installDate value="[dateTime]"/><!-- 0..1 The date the version was installed on the device --> <value value="[string]"/><!-- 1..1 The version text --> </deviceVersion> <conformsTo> <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device --> <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement --></category> <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to --></specification> <version value="[string]"/><!-- 0..1 Specific form or variant of the standard --> </conformsTo> <property> <!-- 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. --> <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Value of the property --></value[x]> </property><</patient> <</owner><additive> <!-- 0..* Material added to a container device --> <type><!-- 1..1 CodeableReference(SubstanceDefinition) The additive substance --></type> <quantity><!-- 0..1 Quantity(SimpleQuantity) Quantity of additive substance within container --></quantity> </additive> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <location><!-- 0..1 Reference(Location) Where the device is found --></location><<note><!-- 0..* Annotation Device notes and comments --></note><</safety> <</parent><safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety> <parent><!-- 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of --></parent> </Device>
JSON Template
{
"resourceType" : "",
"resourceType" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"
"
"<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
"
"
"
"
"definition" : "<canonical(DeviceDefinition)>", // The reference to the definition for the device
"udiCarrier" : [{ // Unique Device Identifier (UDI) value
"deviceIdentifier" : "<string>", // R! Mandatory fixed portion of UDI
"deviceIdentifierSystem" : "<uri>", // The namespace for the device identifier value
"issuer" : "<uri>", // R! UDI Issuing Organization
"jurisdiction" : "<uri>", // Regional UDI authority
"carrierAIDC" : "<base64Binary>", // UDI Machine Readable value
"carrierHRF" : "<string>", // UDI Human Readable value
"entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
}],
"
"
"
"
"
"
"
"
"
"
"<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">type
"status" : "<code>", // active | inactive | entered-in-error | unknown
"availabilityStatus" : { CodeableConcept }, // lost | damaged | destroyed | available
"biologicalSourceEvent" : { Identifier }, // A production identifier of the donation, collection, or pooling event from which biological material in this device was derived
"manufacturer" : "<string>", // Name of device manufacturer
"manufactureDate" : "<dateTime>", // A production identifier that indicates the date when the device was made
"expirationDate" : "<dateTime>", // A production identifier that indicates the date and time of expiry of this device (if applicable)
"lotNumber" : "<string>", // A production identifier that indicates the Lot number of manufacture
"serialNumber" : "<string>", // A production identifier that indicates the Serial number assigned by the manufacturer
"name" : [{ // I The name or names of the device as known to the manufacturer and/or patient
"value" : "<string>", // R! The term that names the device
"type" : { CodeableConcept }, // R! registered-name | user-friendly-name | patient-reported-name
"display" : <boolean> // I The preferred device name
}],
"
"
"
"
"
"
"modelNumber" : "<string>", // The manufacturer's model number for the device
"partNumber" : "<string>", // The part number or catalog number of the device
"category" : [{ CodeableConcept }], // Indicates a high-level grouping of the device
"type" : [{ CodeableConcept }], // The kind or type of device
"deviceVersion" : [{ // 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
"installDate" : "<dateTime>", // The date the version was installed on the device
"value" : "<string>" // R! The version text
}],
"
"
"
"
"conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
"category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement
"specification" : { CodeableConcept }, // R! Identifies the standard, specification, or formal guidance that the device adheres to
"version" : "<string>" // Specific form or variant of the standard
}],
"
"
"
"
"property" : [{ // Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
"type" : { CodeableConcept }, // R! Code that specifies the property being represented
// value[x]: Value of the property. One of these 7:
"valueQuantity" : { Quantity },
"valueCodeableConcept" : { CodeableConcept },
"valueString" : "<string>",
"valueBoolean" : <boolean>,
"valueInteger" : <integer>,
"valueRange" : { Range },
"valueAttachment" : { Attachment }
}],
"additive" : [{ // Material added to a container device
"type" : { CodeableReference(SubstanceDefinition) }, // R! The additive substance
"quantity" : { Quantity(SimpleQuantity) } // Quantity of additive substance within container
}],
"
"
"contact" : [{ ContactPoint }], // Details for human/organization for support
"location" : { Reference(Location) }, // Where the device is found
"
"note" : [{ Annotation }], // Device notes and comments
"
"
"safety" : [{ CodeableConcept }], // Safety Characteristics of Device
"parent" : { Reference(Device) } // The higher level or encompassing device that this device is a logical part of
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:;[ a fhir:Device; fhir:nodeRole fhir:treeRoot; # if this is the parser root# from # from fhir: fhir: fhir: fhir: 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: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: 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: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:# from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension fhir:identifier ( [ Identifier ] ... ) ; # 0..* Instance identifier fhir:definition [ canonical(DeviceDefinition) ] ; # 0..1 The reference to the definition for the device fhir:udiCarrier ( [ # 0..* Unique Device Identifier (UDI) value fhir:deviceIdentifier [ string ] ; # 1..1 Mandatory fixed portion of UDI fhir:deviceIdentifierSystem [ uri ] ; # 0..1 The namespace for the device identifier value fhir:issuer [ uri ] ; # 1..1 UDI Issuing Organization fhir:jurisdiction [ uri ] ; # 0..1 Regional UDI authority fhir:carrierAIDC [ base64Binary ] ; # 0..1 UDI Machine Readable value fhir:carrierHRF [ string ] ; # 0..1 UDI Human Readable value fhir:entryType [ code ] ; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown ] ... ) ; fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error | unknown fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | available fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 A production identifier of the donation, collection, or pooling event from which biological material in this device was derived fhir:manufacturer [ string ] ; # 0..1 Name of device manufacturer fhir:manufactureDate [ dateTime ] ; # 0..1 A production identifier that indicates the date when the device was made fhir:expirationDate [ dateTime ] ; # 0..1 A production identifier that indicates the date and time of expiry of this device (if applicable) fhir:lotNumber [ string ] ; # 0..1 A production identifier that indicates the Lot number of manufacture fhir:serialNumber [ string ] ; # 0..1 A production identifier that indicates the Serial number assigned by the manufacturer fhir:name ( [ # 0..* I The name or names of the device as known to the manufacturer and/or patient fhir:value [ string ] ; # 1..1 The term that names the device fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name fhir:display [ boolean ] ; # 0..1 I The preferred device name ] ... ) ; fhir:modelNumber [ string ] ; # 0..1 The manufacturer's model number for the device fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device fhir:category ( [ CodeableConcept ] ... ) ; # 0..* Indicates a high-level grouping of the device fhir:type ( [ CodeableConcept ] ... ) ; # 0..* The kind or type of device fhir:deviceVersion ( [ # 0..* The actual design of the device or software version running on the device fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies fhir:installDate [ dateTime ] ; # 0..1 The date the version was installed on the device fhir:value [ string ] ; # 1..1 The version text ] ... ) ; fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to fhir:version [ string ] ; # 0..1 Specific form or variant of the standard ] ... ) ; fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented # value[x] : 1..1 Value of the property. One of these 7 fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:String ; string ] fhir:value [ a fhir:Boolean ; boolean ] fhir:value [ a fhir:Integer ; integer ] fhir:value [ a fhir:Range ; Range ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:additive ( [ # 0..* Material added to a container device fhir:type [ CodeableReference(SubstanceDefinition) ] ; # 1..1 The additive substance fhir:quantity [ Quantity(SimpleQuantity) ] ; # 0..1 Quantity of additive substance within container ] ... ) ; fhir:contact ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support fhir:location [ Reference(Location) ] ; # 0..1 Where the device is found fhir:note ( [ Annotation ] ... ) ; # 0..* Device notes and comments fhir:safety ( [ CodeableConcept ] ... ) ; # 0..* Safety Characteristics of Device fhir:parent [ Reference(Device) ] ; # 0..1 The higher level or encompassing device that this device is a logical part of ]
Changes
since
Release
3
from
both
R4
and
R4B
| Device | |
| Device.definition |
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| Device.udiCarrier.issuer |
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| Device.name |
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| Device.distinctIdentifier |
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| Device.deviceName.name |
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| Device.specialization.systemType |
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| Device.version |
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| Device.property.valueQuantity |
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| Device.property.valueCode |
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See the Full Difference for further information
This
analysis
is
available
for
R4
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).
)
for
R4B
as
XML
or
JSON
.
See
the
Profiles
&
Extensions
and
the
alternate
Additional
definitions:
Master
Definition
XML
+
JSON
,
XML
Schema
/
Schematron
+
JSON
Schema
,
ShEx
(for
Turtle
)
+
see
the
extensions
,
the
spreadsheet
version
&
the
dependency
analysis
| Path |
|
Type |
|
|---|---|---|---|
| Device.udiCarrier.entryType | UDIEntryType | Required |
Codes to identify how UDI data was entered. |
| Device.status | FHIRDeviceStatus | Required |
The status of the Device record. |
| Device.availabilityStatus | FHIRDeviceAvailabilityStatus | Extensible |
The availability status of the device. |
| Device.name.type | DeviceNameType |
|
The type of name the device is referred by. |
| Device.category | FHIRDeviceCategory | Example |
The
|
| Device.type | DeviceType |
|
Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example. |
| Device.deviceVersion.type |
|
Example | Describes the type of version |
| Device.conformsTo.category | DeviceSpecificationCategory (a valid code from FHIR Device Specialization Category ) | Example |
The
|
| Device.conformsTo.specification | DeviceSpecificationType |
|
The type or specification of a standard that devices can adhere to |
| Device.property.type |
| Example | The fixed characteristics or conditions of the device. These codes are for example purposes only. |
| Device.additive.type | SubstanceCode | Example |
This
value
set
contains
concept
codes
for
specific
substances.
It
includes
codes
from
SNOMED
|
| Device.safety | DeviceSafety | Example |
Codes
used
to
identify
medical
devices
safety
characteristics.
These
codes
are
taken
from
the
NCI
Thesaurus
|
| UniqueKey | Level | Location | Description | Expression |
dev-1
| Rule | (base) | only one Device.name.display SHALL be true when there is more than one Device.name | name.where(display=true).count() <= 1 |
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:
(Also
see:
https://terminology.hl7.org/6.5.0/MDC.html
for
more
information
about
using
ISO/IEEE
11073
Medical
Device
Communication
(MDC)
Nomenclature)
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
.
Device.type
relates
DeviceDefinition.classification.type
using
the
same
binding
enabling
referencing.
Please
see
the
Search
Parameters
for
details
on
how
to
search
for
devices
by
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*:
components(1):
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.
Device.status
is
about
the
record,
while
.availabilityStatus
is
about
the
device
itself.
Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to 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-event | token | The biological source for the device | Device.biologicalSourceEvent | |
| code | token | The definition / type of the device (code) | Device.type | Device.definition.resolve().classification.type | |
| code-value-concept | composite | Code and value parameter pair |
On
Device:
specification: specification.ofType(CodeableConcept) version: version.ofType(string) | |
| definition | reference | The definition / type of the device |
Device.definition
( DeviceDefinition ) | |
| device-name | string |
A
server
defined
search
that
may
match
any
of
the
string
fields
in
|
|
|
| expiration-date | 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 | string | The lot number of the device | Device.lotNumber | |
| manufacture-date | date | The manufacture date of the device | Device.manufactureDate | |
| manufacturer | string | The manufacturer of the device | Device.manufacturer | |
| model | string | The model of the device | Device.modelNumber | |
|
parent
|
reference |
The
|
( |
|
|
serial-number
|
|
|
| |
|
|
token | The standards, specifications, or formal guidances. | Device.conformsTo.specification | |
| specification-version | composite | A composite of both specification and version |
On
Device.conformsTo:
specification: specification version: version | |
| status | token | active | inactive | entered-in-error | unknown | Device.status | |
| type | token | The type of the device | Device.type | |
|
udi-carrier-hrf
|
string |
UDI
Barcode
(RFID
or
other
technology)
string
in
|
Device.udiCarrier.carrierHRF | |
| udi-di | string | The udi Device Identifier (DI) | Device.udiCarrier.deviceIdentifier | |
|
version
|
|
|
|
|
| version-type | composite | Value and type of version |
On
Device.deviceVersion:
type: type value: value |
FHIR
®©
HL7.org
2011+.
FHIR
Release
4
(Technical
Correction
#1)
(v4.0.1)
R6
hl7.fhir.core#6.0.0-ballot3
generated
on
Fri,
Mon,
Nov
1,
2019
09:34+1100.
QA
Page
10,
2025
15:21+0000.
Links:
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|
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|
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