Administration
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R5
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|
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 is 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, which device was implanted in or explanted from a patient, dispensing a device to a patient for their use, managing inventory, or when requesting a specific device for 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 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.
8.15.1.0.1
Active
device
See
DeviceDefinition
'Active
device'
means
any
device,
the
operation
of
which
depends
on
a
source
of
energy
other
than
that
generated
by
the
human
body
for
that
purpose,
or
by
gravity,
and
which
acts
by
changing
the
density
detailed
descriptions
of
or
converting
that
energy.
Devices
intended
to
transmit
energy,
substances
or
other
elements
between
an
active
device
and
the
patient,
without
any
significant
change,
shall
not
be
deemed
to
be
active
devices.
Software
shall
also
be
deemed
to
be
an
active
device.
MDR
(EU)
2017/745
Active
Implantable
Medical
Devices
include
the
definition
for
both
active
devices
and
implantable
devices
(see
below).
Examples
include:
Implantable
cardiac
pacemakers;
Implantable
defibrillator;
Implantable
neurostimulator
systems;
Leads,
electrodes,
adaptors
for
implantable
pulse
generators;
Brachytherapy
systems;
Ventricular
Assist
Devices
(VADs);
Cochlear
implants;
Implantable
infusion
pumps;
Implantable
glucose
monitors;
Micro
Electro-Mechanical
Systems
(MEMS);
and
their
accessories
where
applicable.
categories.
This
category
of
devices
communicates
electronically
to
peer
information
systems
or
possibly
another
device.
In
addition
When
referring
to
patient
observations
for
use
by
clinicians
in
providing
care
and
for
building
a
health
record,
the
device
communicates
metadata
about
its
own
state
and
the
protocol
used
to
transfer
that
information.
To
support
the
use
and
evaluate
the
reliability
of
the
patient
data,
it
specific
instance,
even
without
specific
instance
details,
Device
is
important
to
to
collect
and
record
data
about
the
identity
and
operational
status
be
used,
not
a
DeviceDefinition.
The
context
of
a
data
exchange
indicates
whether
the
device
that
generated
the
observations.
The
Device
resource
data
is
an
important
locus
for
such
information.
The
information
it
generates
for
clinical
and
other
purposes
goes
into
other
resources
such
as
the
Observation
representing
a
physical
instance
or
Medication
resource
depending
upon
what
the
device
does.
To
support
device-related
information
about
Communicating
Medical
Devices
the
Device
resource
needs
to
have
elements
that
describe
a
"kind",
not
only
the
basic
information
like
the
serial
number,
manufacturer
name
and
model
number,
but
information
about
the
protocol,
its
version,
its
certification,
the
properties
it
has
to
perform
its
purposed
tasks
presence
of
instance
data
such
as
internal
clocks,
synchronization
state,
resolution,
etc.
8.15.1.0.3
Durable
Medical
Equipment
Equipment
and
supplies
that
provides
therapeutic
benefits
to
a
patient
in
need
because
of
certain
medical
conditions
and/or
illnesses,
and
which
are
ordered
by
a
health
care
provider
for
everyday
or
extended
use.
Examples
include:
oxygen
equipment,
suction
pumps,
traction
equipment,
home
infusion
services,
continuous
positive
airway
pressure
(CPAP)
devices,
hospital
beds,
wheelchairs,
crutches
walkers,
canes,
or
blood
testing
strips
lot
and
meters
for
diabetics.
serial
numbers.
A
home
use
medical
device
is
a
medical
device
intended
for
users
in
any
environment
outside
of
a
professional
healthcare
facility.
This
includes
devices
intended
for
use
in
both
professional
healthcare
facilities
and
homes.
Some
examples:
Note to Implementers: The module pages under development by Orders and Observations will further describe the variations of device use cases across the device resources, e.g., Device, DeviceDefinition, DeviceAssociation, DeviceDispense, DeviceMetric, DeviceRequest, and Device Usage.
These
There
are
the
several
resources
that
can
be
used
to
represent
device
related
resources
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
device,
such
as
a
"large"
blood
pressure
cuff,
the
bore
size
of
an
MRI,
the
color
of
a
lead.
(Such
static
characteristics
may
also
be
recorded
in
-
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
covered
by
a
procedure
-
i.e.,
patient
reported
use
of
a
device.
In FHIR, the Device represents either the device in total, or a component of an encapsulating device when there is a need for individual tracking of a component. A Device as a component then points to the parent device it is part of. The top-level Device captures the 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.
The
DeviceMetric
models
the
properties
of
the
Observations
generated
by
the
device,
such
as
whether
or
not
the
Observation
is
a
setting.
Devices
differ
from
medications
because
they
are
not
"used
up"
-
they
remain
active
in
or
for
a
patient
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
ordering,
dispense,
and
administration
processes
typically
focus
on
the
medication
aspects
and
reference
the
device.
In the case of an infusion pump, while some actions are focused on the device (e.g., ordering to a 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, rather reference the relationship where an actual device needs to be tracked in addition to the medication. In some sense the Medication is analogous to the Observation generated by 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
|
|
deviceIdentifierSystem
| 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
|
card
|
self-reported
|
electronic-transmission
|
unknown
Binding: UDI Entry Type ( Required ) |
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
|
unknown
Binding: FHIR Device Status ( Required ) |
|
availabilityStatus
|
0..1 | CodeableConcept |
lost
|
damaged
|
destroyed
|
available
Binding: FHIR Device Availability Status ( Extensible ) |
|
|
biologicalSourceEvent
|
0..1 | Identifier |
A
production
identifier
|
|
|
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
known
to
the
manufacturer
and/or
patient
|
|
value
|
Σ | 1..1 | string |
The
term
that
names
the
device
|
|
type
|
Σ | 1..1 |
|
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( |
|
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
|
|
|
category
|
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 ) |
|
|
|
0..* | BackboneElement |
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
Binding: Device Version Type ( Example ) |
|
|
component
|
0..1 | Identifier |
The
hardware
or
software
module
of
the
device
to
which
the
version
applies
|
|
|
installDate
|
0..1 | dateTime |
The
date
the
version
was
installed
on
the
device
|
|
|
value
|
1..1 | string |
The
version
text
|
|
|
conformsTo
|
0..* | BackboneElement |
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
Binding: Device Specification Category ( Example ) |
|
|
specification
|
1..1 | CodeableConcept |
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
adheres
to
Binding: Device Specification Type ( Example ) |
|
|
version
|
0..1 | string |
Specific
form
or
variant
of
the
standard
|
|
|
property
|
0..* | BackboneElement |
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
Binding: Device Property Type (Example only) ( Example ) |
|
value[x]
|
1..1 |
Value
of
the
property
|
||
valueQuantity
|
Quantity | |||
|
valueCodeableConcept
|
CodeableConcept | |||
|
valueString
|
string | |||
|
valueBoolean
|
boolean | |||
|
valueInteger
|
integer | |||
|
valueRange
|
Range | |||
|
valueAttachment
|
Attachment | |||
|
additive
|
|
0..* |
|
Material
added
to
a
|
|
type
|
|
1..1 |
|
The
|
|
quantity
|
0..1 |
|
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
higher
level
or
encompassing
device
that
this
device
is
a
logical
part
of
|
|
|
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-diI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,<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><<status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown --> <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus><</biologicalSourceEvent><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>< <</type> <</component> < < </version><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><</mode> <</cycle> <</duration> <</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>< <</endpoint> <</gateway><note><!-- 0..* Annotation Device notes and comments --></note> <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-diI,
3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
"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
}],
"
"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# 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 identifierfhir: 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-diI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,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 authorityfhir: fhir: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:fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error | unknown fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | availablefhir: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 manufacturerfhir: fhir: fhir: fhir: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 devicefhir: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 devicefhir: fhir: fhir: fhir: fhir: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: ] fhir: ] fhir: ]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: fhir: fhir: fhir: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 foundfhir: fhir: fhir: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 from both R4 and R4B
| Device |
|
| Device.definition |
|
| Device.udiCarrier.deviceIdentifier |
|
|
|
|
|
|
|
|
|
|
| Device.availabilityStatus |
|
| Device.biologicalSourceEvent |
|
| Device.name |
|
| Device.name.value |
|
| Device.name.type |
|
| Device.name.display |
|
| Device.category |
|
| Device.type |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Device.deviceVersion.value |
|
|
|
|
|
|
|
| Device.conformsTo.specification |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Device.statusReason |
|
| Device.distinctIdentifier |
|
| Device.deviceName.name |
|
| Device.specialization.systemType |
|
| Device.version |
|
| Device.property.valueQuantity |
|
| Device.property.valueCode |
|
| Device.patient |
|
| Device.owner |
|
| Device.url |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and 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
|
|
deviceIdentifierSystem
| 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
|
card
|
self-reported
|
electronic-transmission
|
unknown
Binding: UDI Entry Type ( Required ) |
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
|
unknown
Binding: FHIR Device Status ( Required ) |
|
availabilityStatus
|
0..1 | CodeableConcept |
lost
|
damaged
|
destroyed
|
available
Binding: FHIR Device Availability Status ( Extensible ) |
|
|
biologicalSourceEvent
|
0..1 | Identifier |
A
production
identifier
|
|
|
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
known
to
the
manufacturer
and/or
patient
|
|
value
|
Σ | 1..1 | string |
The
term
that
names
the
device
|
|
type
|
Σ | 1..1 |
|
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( |
|
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
|
|
|
category
|
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 ) |
|
|
|
0..* | BackboneElement |
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
Binding: Device Version Type ( Example ) |
|
|
component
|
0..1 | Identifier |
The
hardware
or
software
module
of
the
device
to
which
the
version
applies
|
|
|
installDate
|
0..1 | dateTime |
The
date
the
version
was
installed
on
the
device
|
|
|
value
|
1..1 | string |
The
version
text
|
|
|
conformsTo
|
0..* | BackboneElement |
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
Binding: Device Specification Category ( Example ) |
|
|
specification
|
1..1 | CodeableConcept |
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
adheres
to
Binding: Device Specification Type ( Example ) |
|
|
version
|
0..1 | string |
Specific
form
or
variant
of
the
standard
|
|
|
property
|
0..* | BackboneElement |
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
Binding: Device Property Type (Example only) ( Example ) |
|
|
value[x]
|
1..1 |
Value
of
the
property
|
||
|
valueQuantity
|
Quantity | |||
|
valueCodeableConcept
|
CodeableConcept | |||
|
valueString
|
string | |||
|
valueBoolean
|
boolean | |||
|
valueInteger
|
integer | |||
|
valueRange
|
Range | |||
|
valueAttachment
|
Attachment | |||
|
additive
|
|
0..* |
|
Material
added
to
a
|
|
type
|
|
1..1 |
|
The
|
|
quantity
|
0..1 |
|
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
higher
level
or
encompassing
device
that
this
device
is
a
logical
part
of
|
|
|
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-diI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,<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><<status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown --> <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus><</biologicalSourceEvent><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>< <</type> <</component> < < </version><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><</mode> <</cycle> <</duration> <</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>< <</endpoint> <</gateway><note><!-- 0..* Annotation Device notes and comments --></note> <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-diI,
3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
"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
}],
"
"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# 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 identifierfhir: 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-diI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,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 authorityfhir: fhir: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:fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error | unknown fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | availablefhir: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 manufacturerfhir: fhir: fhir: fhir: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 devicefhir: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 devicefhir: fhir: fhir: fhir: fhir: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: ] fhir: ] fhir: ]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: fhir: fhir: fhir: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 foundfhir: fhir: fhir: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 from both R4 and R4B
| Device |
|
| Device.definition |
|
| Device.udiCarrier.deviceIdentifier |
|
|
|
|
|
|
|
|
|
|
| Device.availabilityStatus |
|
| Device.biologicalSourceEvent |
|
| Device.name |
|
| Device.name.value |
|
| Device.name.type |
|
| Device.name.display |
|
| Device.category |
|
| Device.type |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Device.deviceVersion.value |
|
|
|
|
|
|
|
| Device.conformsTo.specification |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Device.statusReason |
|
| Device.distinctIdentifier |
|
| Device.deviceName.name |
|
| Device.specialization.systemType |
|
| Device.version |
|
| Device.property.valueQuantity |
|
| Device.property.valueCode |
|
| Device.patient |
|
| Device.owner |
|
| Device.url |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .
Additional definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis
| Path | ValueSet | Type | Documentation |
|---|---|---|---|
| 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 association state of the device. |
| Device.type | DeviceType | Example |
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. |
|
|
DeviceVersionType | Example |
Describes the type of version |
| Device.conformsTo.category | DeviceSpecificationCategory (a valid code from FHIR Device Specialization Category ) | Example |
The kind of standards used by the device. |
| Device.conformsTo.specification | DeviceSpecificationType | Example |
The type or specification of a standard that devices can adhere to |
| Device.property.type |
|
Example |
|
| Device.additive.type |
|
Example |
|
| 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.
Devices.status
Device.status
is
about
the
record,
while
operationalStatus
and
associationStatus
are
.availabilityStatus
is
about
other
aspects
of
the
device.
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) |
|
|
| 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 |
( DeviceDefinition ) |
|
| device-name | string | A server defined search that may match any of the string fields in Device.name or Device.type. | Device.name.value | Device.type.coding.display | Device.type.text | |
| 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 parent device |
Device.parent
( Device ) |
|
| serial-number | string | The serial number of the device | Device.serialNumber | Device.identifier.where(type='SNO') | |
| specification | 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 | |
|
|
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 | |
|
|
|
|
|
|
|
|
|
|
type: type value: value |
FHIR
®©
HL7.org
2011+.
FHIR
R5
hl7.fhir.core#5.0.0
R6
hl7.fhir.core#6.0.0-ballot3
generated
on
Sun,
Mar
26,
2023
15:24+1100.
Nov
9,
2025
23:54+0000.
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