Administration
This
page
is
part
of
the
FHIR
Specification
v6.0.0-ballot3:
Release
6
Ballot
(3rd
Draft)
(see
Ballot
Notes
).
The
current
version
is
5.0.0
.
For
a
full
list
Continuous
Integration
Build
of
available
versions,
see
FHIR
(will
be
incorrect/inconsistent
at
times).
See
the
Directory
of
published
versions
|
Responsible
Owner:
Orders
and
Observations
Work
Group
|
|
Security Category : Business |
Compartments
:
|
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:
The following extensions will be added to a future Extension Pack releaseExtensions have been created and are now available tocoverrepresent previously removedDeviceelementsincluding: mode, cycle, duration, gatewayandendpoint. In addition, the followingnewextensions will be added: 1. For device alerts called device-alertDetection, whichconcepts. These include:
device-mode,device-cycle,device-duration,device-gateway, anddevice-endpointdevice-alertDetection– describes the alert detection activation states for the overalldevice. 2. Fordevicedevice-conformsTo-source– represents the source of thespecification, device-conformsTo-source.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.
See
DeviceDefinition
for
detailed
descriptions
of
devce
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 lot and serial numbers.
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.
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
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
DeviceDefinition.).
-
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.
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)
value
|
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
value
|
|
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
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
known
to
the
manufacturer
and/or
patient
|
|
value
|
Σ | 1..1 | string |
The
term
that
names
the
device
|
|
type
|
Σ | 1..1 | CodeableConcept |
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( Extensible ) |
|
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 ) |
|
|
deviceVersion
|
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..* | BackboneElement |
Material
added
to
a
container
device
|
|
|
type
|
1..1 |
CodeableReference
(
|
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
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><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 -->< <<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,<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><!-- 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> <additive> <!-- 0..* Material added to a container device --><</type><type><!-- 1..1 CodeableReference(SubstanceDefinition) The additive substance --></type> <quantity><!-- 0..1 Quantity(SimpleQuantity) Quantity of additive substance within container --></quantity><| </performer> <</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><!-- 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" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"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
"
"<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,
"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/> .# 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: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 UDIfhir: 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: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 | 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 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 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: ] 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:additive ( [ # 0..* Material added to a container devicefhir:fhir:type [ CodeableReference(SubstanceDefinition) ] ; # 1..1 The additive substance fhir:quantity [ Quantity(SimpleQuantity) ] ; # 0..1 Quantity of additive substance within containerfhir: fhir:] ... ) ; 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 from both R4 and R4B
| Device | |
| Device.definition |
|
| Device.udiCarrier.deviceIdentifier |
|
| Device.udiCarrier.deviceIdentifierSystem |
|
| Device.udiCarrier.issuer |
|
| Device.udiCarrier.entryType |
|
| Device.availabilityStatus |
|
| Device.biologicalSourceEvent |
|
| Device.name |
|
| Device.name.value |
|
| Device.name.type |
|
| Device.name.display |
|
| Device.category |
|
| Device.type |
|
| Device.deviceVersion |
|
| Device.deviceVersion.type |
|
| Device.deviceVersion.component |
|
| Device.deviceVersion.installDate |
|
| Device.deviceVersion.value |
|
| Device.conformsTo |
|
| Device.conformsTo.category |
|
| Device.conformsTo.specification |
|
| Device.conformsTo.version |
|
| Device.property.value[x] |
|
| Device.additive |
|
| Device.additive.type |
|
| Device.additive.quantity |
|
| 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)
value
|
|
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
value
|
|
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
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
known
to
the
manufacturer
and/or
patient
|
|
value
|
Σ | 1..1 | string |
The
term
that
names
the
device
|
|
type
|
Σ | 1..1 | CodeableConcept |
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( Extensible ) |
|
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 ) |
|
|
deviceVersion
|
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..* | BackboneElement |
Material
added
to
a
container
device
|
|
|
type
|
1..1 |
CodeableReference
(
|
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
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><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 -->< <<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,<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><!-- 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> <additive> <!-- 0..* Material added to a container device --><</type><type><!-- 1..1 CodeableReference(SubstanceDefinition) The additive substance --></type> <quantity><!-- 0..1 Quantity(SimpleQuantity) Quantity of additive substance within container --></quantity><| </performer> <</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><!-- 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" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"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
"
"<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,
"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/> .# 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: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 UDIfhir: 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: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 | 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 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 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: ] 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:additive ( [ # 0..* Material added to a container devicefhir:fhir:type [ CodeableReference(SubstanceDefinition) ] ; # 1..1 The additive substance fhir:quantity [ Quantity(SimpleQuantity) ] ; # 0..1 Quantity of additive substance within containerfhir: fhir:] ... ) ; 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 from both R4 and R4B
| Device | |
| Device.definition |
|
| Device.udiCarrier.deviceIdentifier |
|
| Device.udiCarrier.deviceIdentifierSystem |
|
| Device.udiCarrier.issuer |
|
| Device.udiCarrier.entryType |
|
| Device.availabilityStatus |
|
| Device.biologicalSourceEvent |
|
| Device.name |
|
| Device.name.value |
|
| Device.name.type |
|
| Device.name.display |
|
| Device.category |
|
| Device.type |
|
| Device.deviceVersion |
|
| Device.deviceVersion.type |
|
| Device.deviceVersion.component |
|
| Device.deviceVersion.installDate |
|
| Device.deviceVersion.value |
|
| Device.conformsTo |
|
| Device.conformsTo.category |
|
| Device.conformsTo.specification |
|
| Device.conformsTo.version |
|
| Device.property.value[x] |
|
| Device.additive |
|
| Device.additive.type |
|
| Device.additive.quantity |
|
| 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 | Extensible |
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. |
| Device.deviceVersion.type | 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 | 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
.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 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
|
|
| udi-carrier-hrf | 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 | |
| version | string | The specific version of the device | Device.deviceVersion.value | |
| version-type | composite | Value and type of version |
On
Device.deviceVersion:
type: type value: value |
FHIR
®©
HL7.org
2011+.
FHIR
R6
hl7.fhir.core#6.0.0-ballot3
generated
on
Tue,
Apr
1,
Mon,
Nov
10,
2025
12:24+1100.
04:55+0000.
Links:
Search
|
Version
History
|
Contents
|
Glossary
|
QA
|
Compare
to
R4
|
Compare
to
R5
|
Compare
to
Last
Ballot
|
|
Propose
a
change