Release
4B
5
Administration
This
page
is
part
of
the
FHIR
Specification
(v4.3.0:
R4B
(v5.0.0:
R5
-
STU
).
The
This
is
the
current
published
version
which
supercedes
in
it's
permanent
home
(it
will
always
be
available
at
this
version
is
5.0.0
.
URL).
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
R5
R4B
R4
R3
R2
|
Orders
and
Observations
Work
Group
|
Maturity Level : 2 | Trial Use | Security Category : Business |
Compartments
:
|
A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.
This
resource
is
an
administrative
a
base
resource
that
tracks
individual
instances
of
a
device
and
their
location.
It
is
referenced
by
other
resources
for
recording
which
device
performed
an
action
such
as
a
procedure
or
an
observation,
referenced
which
device
was
implanted
in
or
explanted
from
a
patient,
dispensing
a
device
to
a
patient
for
their
use,
managing
inventory,
or
when
prescribing
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
dispensing
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.
'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
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.
This
category
of
devices
communicates
electronically
to
peer
information
systems
or
possibly
another
device.
In
addition
to
patient
observations
for
use
or
by
clinicians
in
providing
care
and
for
ordering
supplies,
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
is
important
to
to
collect
and
record
data
about
the
identity
and
transmit
Unique
operational
status
of
the
device
that
generated
the
observations.
The
Device
Identifier
(UDI)
resource
is
an
important
locus
for
such
information.
The
information
it
generates
for
clinical
and
other
purposes
goes
into
other
resources
such
as
the
Observation
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
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
such
as
internal
clocks,
synchronization
state,
resolution,
etc.
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 and meters for diabetics.
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.
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health.
Home
Use
Devices.
Accessed
12
May
2022
Implant
means
a
device
that
is
placed
into
a
surgically
or
naturally
formed
cavity
of
the
human
body.
A
device
is
regarded
as
an
implant
for
the
purpose
of
this
part
only
if
it
is
intended
to
remain
implanted
continuously
for
a
period
of
30
days
or
more,
unless
the
Commissioner
determines
otherwise
to
protect
human
health.
21CFR
Part
860.3
Accessed
12
May
2022
'implantable device' means any device, including those that are partially or wholly absorbed, which is intended:
by clinical intervention and which is intended to remain in place after the procedure.
Any
device
intended
to
be
partially
introduced
into
the
human
body
by
clinical
intervention
and
intended
to
remain
in
place
after
the
procedure
for
at
least
30
days
shall
also
be
deemed
to
be
an
implantable
device;
MDR
(EU)
2017/745
Accessed
12
May
2022
In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person 's overall health to help cure, treat, or prevent diseases.
In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person 's DNA to detect genomic variations.
Some
tests
are
used
in
laboratory
or
other
health
professional
settings
and
other
tests
are
for
consumers
to
use
at
home.
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health
In
Vitro
Diagnostics
and
Drug
Administration
Center
for
Devices
and
Radiological
Health
In
Vitro
Diagnostics
Accessed
12
May
2022
Patient-use,
or
home
use
devices,
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
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health.
Home
Use
Devices.
Accessed
13
March
2020.
PHDs
are
the
subset
of
patient-use
devices
that
report
their
information
to
a
peer
via
a
protocol.
One class of communicating devices is the Personal Health Device or PHD. PHDs are medical devices that can be used by patients or others who are typically not medical professions, to gather patient observations and information. These devices can often be purchased in department stores or online by anyone. They may be regulated as medical devices, or not.
PHDs include the popular fitness trackers often combined with heart rate monitors, but also blood pressure monitors, weight scales, pulse oximeters, thermometers, and, for those that require them, glucose meters. Over time more sophisticated devices such as continuous glucose monitors, insulin pumps, vital signs monitors including ECGs, and even spirometers are entering the PHD consumer market. These devices communicate measurement data and data about themselves via a digital transport protocol to some peer entity, often a mobile phone or tablet. The protocol may follow a standard but most protocols are proprietary. In either case, it is common practice for manufacturers to provide free applications that run on these mobile platforms for the purpose of communicating with their devices.
The fields populated in the Device resource by PHDs, typically via a gateway, is the information a PHD reports about itself electronically. There is no input by the patient except for information the patient may enter on the device through some UI. This device reporting capability distinguishes communicating PHDs from the general set of patient-use devices.
PoCDs
are
of
another
level
of
complexity
compared
to
PHDs:
they
include
devices
like
multi-parameter
physiological
patient
monitors,
anesthesia
workstations,
infusion
pumps
and
numerous
other
kinds
of
devices
that
provide
near-real-time
information
about
patient
condition
or
therapy,
potentially
including
dozens
or
hundreds
of
variables
coming
from
a
single
device
system.
They
may
be
structurally
complex,
involving
multiple
subsystems
that
are
themselves
complex,
such
as
a
patient's
implant.
ventilator
or
gas
analyzer
functioning
within
an
anesthesia
workstation,
or
pluggable
modules
in
a
patient
monitor
controlling
invasive
blood
pressure
or
gathering
EEG
data.
Information systems using such data need to be able to understand the structure and dynamic state of the devices originating them, generally requiring access to what is in effect a dynamically changing model of the device and its subsystems and measuring capabilities. This requires more than a single Device resource - a hierarchy of Device resources is constructed carrying data about the top-level containing device (for example a monitor), and a hierarchy of contained Device resources representing subsystems (in the monitor, builtin and attached modular measurement capabilities), channels, and DeviceMetric resources representing individual measurements or computations.
A
device
that
is
intended
to
be
used
on
one
individual
during
a
single
procedure;
MDR
(EU)
2017/745
Accessed
12
May
2022
Reusable
medical
devices
are
devices
that
health
care
providers
can
reuse
to
diagnose
and
treat
one
or
multiple
patients.
Examples
of
reusable
medical
devices
include
surgical
forceps,
endoscopes
and
laryngoscopes.
US
Food
and
Drug
Administration
Center
for
Devices
and
Radiological
Health
Reusable
Medical
Devices
A software item like a data transformer or converter, or a clinical support algorithm, may be an independently deployed, managed and configured entity that contributes to patient care and needs to be documented just a surely as, say, a physical cardiac monitor. The FHIR Device resource can contain instance data such as version information and operational attributes. It can also represent the relationship of the software item to other device and information system components through reference linkages. This category includes software regardless of whether or not is regulated. Device resource instances documenting software items are important to traceability of data and analyzing adverse events, and so have important patient safety roles.
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 are the device related resources
In
FHIR,
the
physical
part,
including
operation
status
and
Device
represents
either
the
device
in
total,
or
a
component
of
an
encapsulating
device
when
there
is
much
more
volatile.
The
physical
composition
a
need
for
individual
tracking
of
a
component.
A
Device
as
a
component
then
points
to
the
parent
device
it
is
represented
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
Devices
pointing
to
their
"parent".
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
in
an
ongoing
fashion.
However,
the
specific
boundary
between
medications
and
for
a
longer
duration.
They
also
may
be
re-used,
particularly
non-implanted
devices
is
defined
at
the
implementation
level
and
this
standard
does
not
enforce
those
used
for
diagnostics
and
procedures.
Frequently,
when
a
boundary
device
is
packaged
with
a
medication,
the
exception
ordering,
dispense,
and
administration
processes
typically
focus
on
the
medication
aspects
and
reference
the
device.
In
the
case
of
devices
that
an
infusion
pump,
while
some
actions
are
implanted
in
focused
on
the
device
(e.g.,
ordering
to
a
patient.
The
room
or
maintaining
the
pump),
the
focus
is
as
well
on
the
medication
while
the
device
is
used
for
administration.
However,
that
separation
is
not
always
as
clear
and
may
be
impacted
by
specific
implementations.
Regardless,
the
Medication
resource
resource
should
not
be
used
to
represent
implanted
devices.
(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
|
|---|---|---|---|---|
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
|
|
displayName
|
0..1 | string |
The
name
used
to
display
by
default
when
the
device
is
referenced
| |
definition
| 0..1 |
|
The
reference
to
the
definition
for
the
device
|
|
udiCarrier
|
Σ | 0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
deviceIdentifier
|
Σ | 1..1 | string |
Mandatory
fixed
portion
of
UDI
|
|
issuer
|
Σ | 1..1 | uri |
UDI
Issuing
Organization
|
|
jurisdiction
|
0..1 | uri |
Regional
UDI
authority
|
|
|
carrierAIDC
|
Σ | 0..1 | base64Binary |
UDI
Machine
Readable
Barcode
String
|
|
carrierHRF
|
Σ | 0..1 | string |
UDI
Human
Readable
Barcode
String
|
entryType
|
0..1 | code |
barcode
|
rfid
|
manual
Binding: |
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
Binding: |
|
availabilityStatus
|
0..1 | CodeableConcept |
lost
|
|
|
|
biologicalSourceEvent
|
0..1 |
|
An
identifier
that
supports
traceability
to
the
event
during
which
material
in
this
product
from
one
or
more
biological
entities
was
obtained
or
pooled
|
|
|
manufacturer
|
0..1 | string |
Name
of
device
manufacturer
|
|
|
manufactureDate
|
0..1 | dateTime |
Date
when
the
device
was
made
|
|
|
expirationDate
|
0..1 | dateTime |
Date
and
time
of
expiry
of
this
device
(if
applicable)
|
|
|
lotNumber
|
0..1 | string |
Lot
number
of
manufacture
|
|
|
serialNumber
|
0..1 | string |
Serial
number
assigned
by
the
manufacturer
|
|
|
name
|
C | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
|
|
value
|
Σ | 1..1 | string |
The
|
|
type
|
Σ | 1..1 | code |
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: |
|
display
| ?! Σ C | 0..1 | boolean |
The
preferred
device
name
|
|
modelNumber
|
0..1 | string |
The
manufacturer's
model
number
for
the
device
|
|
|
partNumber
|
0..1 | string |
The
part
number
or
catalog
number
of
the
device
|
|
|
|
0..* |
|
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 ) |
|
|
version
|
0..* | BackboneElement |
The
actual
design
of
the
device
or
software
version
running
on
the
device
| |
|
type
|
|
|
The
Binding: Device Version Type ( Example ) |
|
|
|
|
|
The
|
|
|
|
0..1 |
|
The
date
the
version
|
|
|
value
|
|
|
The
|
|
|
conformsTo
|
|
|
|
|
|
|
0..1 |
|
Binding: Device Specification Category ( Example ) |
|
|
specification
|
1..1 |
|
Binding: Device Specification Type ( Example ) |
|
|
version
|
0..1 | string |
Specific
form
or
variant
of
the
standard
| |
|
property
| 0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
|
|
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
Binding: Device Property Type ( Example ) |
|
value[x]
| 1..1 |
Value
of
the
property
| ||
valueQuantity
|
Quantity | |||
|
valueCodeableConcept
| CodeableConcept | |||
|
valueString
|
|
| ||
|
valueBoolean
| boolean | |||
|
valueInteger
|
|
integer | ||
|
| Range | |||
|
valueAttachment
| Attachment | |||
|
mode
|
|
CodeableConcept |
Binding: FHIR Device Operation Mode ( Example ) |
|
|
cycle
|
0..1 |
|
|
|
|
duration
|
0..1 | Duration |
A
measurement
of
time
during
the
device's
operation
(e.g.,
days,
hours,
mins,
etc.)
| |
|
owner
| 0..1 | Reference ( Organization ) |
Organization
responsible
for
device
|
|
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
location
|
0..1 | Reference ( Location ) |
Where
the
device
is
found
|
|
|
url
|
0..1 | uri |
Network
address
to
contact
device
|
|
|
endpoint
| 0..* | Reference ( Endpoint ) |
Technical
endpoints
providing
access
to
electronic
services
provided
by
the
device
| |
|
gateway
|
0..* | CodeableReference ( Device ) |
Linked
device
acting
as
a
communication/data
collector,
translator
or
controller
| |
|
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
|
|
|
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><displayName value="[string]"/><!-- 0..1 The name used to display by default when the device is referenced --> <definition><!-- 0..1 CodeableReference(DeviceDefinition) The reference to the definition for the device --></definition> <udiCarrier> <!-- 0..* Unique Device Identifier (UDI) Barcode string -->< <<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict"> <<deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI --> <issuer value="[uri]"/><!-- 1..1 UDI Issuing Organization --> <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority --> <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String --> <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String --><<entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown --> </udiCarrier>< <</statusReason> < <<status value="[code]"/><!-- 0..1 active | inactive | entered-in-error --> <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus> <biologicalSourceEvent><!-- 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled --></biologicalSourceEvent> <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer --> <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made --> <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) --> <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture --> <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->< < <<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict"> </deviceName><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 value="[code]"/><!-- 1..1 registered-name | user-friendly-name | patient-reported-name --> <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 --><</type> < <</systemType> < </specialization><category><!-- 0..* CodeableConcept Indicates a high-level grouping of the device --></category> <type><!-- 0..* CodeableConcept The kind or type of device --></type> <version> <!-- 0..* The actual design of the device or software version running on the device --><</type> <</component><type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <installDate value="[dateTime]"/><!-- 0..1 The date the version was installed on the device --> <value value="[string]"/><!-- 1..1 The version text --> </version>< <</type> <</valueQuantity> <</valueCode><conformsTo> <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device --> <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement --></category> <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to --></specification> <version value="[string]"/><!-- 0..1 Specific form or variant of the standard --> </conformsTo> <property> <!-- 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. --> <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Value of the property --></value[x]> </property><</patient><mode><!-- 0..1 CodeableConcept The designated condition for performing a task --></mode> <cycle><!-- 0..1 Count The series of occurrences that repeats during the operation of the device --></cycle> <duration><!-- 0..1 Duration A measurement of time during the device's operation (e.g., days, hours, mins, etc.) --></duration> <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <location><!-- 0..1 Reference(Location) Where the device is found --></location> <url value="[uri]"/><!-- 0..1 Network address to contact device --> <endpoint><!-- 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device --></endpoint> <gateway><!-- 0..* CodeableReference(Device) Linked device acting as a communication/data collector, translator or controller --></gateway> <note><!-- 0..* Annotation Device notes and comments --></note><</safety> <</parent><safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety> <parent><!-- 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of --></parent> </Device>
JSON Template
{
"resourceType" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"displayName" : "<string>", // The name used to display by default when the device is referenced
"definition" : { CodeableReference(DeviceDefinition) }, // The reference to the definition for the device
"udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
"
"<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
1) GS1:
http://hl7.org/fhir/NamingSystem/gs1-di,
2) HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI,
3) ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
4) ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">issuer
"
"deviceIdentifier" : "<string>", // R! Mandatory fixed portion of UDI
"issuer" : "<uri>", // R! UDI Issuing Organization
"jurisdiction" : "<uri>", // Regional UDI authority
"carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
"carrierHRF" : "<string>", // UDI Human Readable Barcode String
"
"entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
}],
"
"
"
"
"status" : "<code>", // active | inactive | entered-in-error
"availabilityStatus" : { CodeableConcept }, // lost | damaged | destroyed | available
"biologicalSourceEvent" : { Identifier }, // An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
"manufacturer" : "<string>", // Name of device manufacturer
"manufactureDate" : "<dateTime>", // Date when the device was made
"expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
"lotNumber" : "<string>", // Lot number of manufacture
"serialNumber" : "<string>", // Serial number assigned by the manufacturer
"
"
"<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">type
"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" : "<code>", // 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
"version" : [{ // The actual design of the device or software version running on the device
"
"
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"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 }
}],
"mode" : { CodeableConcept }, // The designated condition for performing a task
"cycle" : { Count }, // The series of occurrences that repeats during the operation of the device
"duration" : { Duration }, // A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
"owner" : { Reference(Organization) }, // Organization responsible for device
"contact" : [{ ContactPoint }], // Details for human/organization for support
"location" : { Reference(Location) }, // Where the device is found
"url" : "<uri>", // Network address to contact device
"endpoint" : [{ Reference(Endpoint) }], // Technical endpoints providing access to electronic services provided by the device
"gateway" : [{ CodeableReference(Device) }], // Linked device acting as a communication/data collector, translator or controller
"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/> .fhir: fhir: fhir: fhir: fhir:<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">Device.udiCarrier.issuer fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">Device.deviceName.type ], ...; fhir: fhir: fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:fhir:identifier ( [ Identifier ] ... ) ; # 0..* Instance identifier fhir:displayName [ string ] ; # 0..1 The name used to display by default when the device is referenced fhir:definition [ CodeableReference(DeviceDefinition) ] ; # 0..1 The reference to the definition for the device fhir:udiCarrier ( [ # 0..* Unique Device Identifier (UDI) Barcode string fhir:deviceIdentifier [ string ] ; # 1..1 Mandatory fixed portion of UDI fhir:issuer [ uri ] ; # 1..1 UDI Issuing Organization fhir:jurisdiction [ uri ] ; # 0..1 Regional UDI authority fhir:carrierAIDC [ base64Binary ] ; # 0..1 UDI Machine Readable Barcode String fhir:carrierHRF [ string ] ; # 0..1 UDI Human Readable Barcode String fhir:entryType [ code ] ; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown ] ... ) ; fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | available fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled fhir:manufacturer [ string ] ; # 0..1 Name of device manufacturer fhir:manufactureDate [ dateTime ] ; # 0..1 Date when the device was made fhir:expirationDate [ dateTime ] ; # 0..1 Date and time of expiry of this device (if applicable) fhir:lotNumber [ string ] ; # 0..1 Lot number of manufacture fhir:serialNumber [ string ] ; # 0..1 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 [ code ] ; # 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:version ( [ # 0..* The actual design of the device or software version running on the device fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies fhir:installDate [ dateTime ] ; # 0..1 The date the version was installed on the device fhir:value [ string ] ; # 1..1 The version text ] ... ) ; fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to fhir:version [ string ] ; # 0..1 Specific form or variant of the standard ] ... ) ; fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented # value[x] : 1..1 Value of the property. One of these 7 fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:string ; string ] fhir:value [ a fhir:boolean ; boolean ] fhir:value [ a fhir:integer ; integer ] fhir:value [ a fhir:Range ; Range ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:mode [ CodeableConcept ] ; # 0..1 The designated condition for performing a task fhir:cycle [ Count ] ; # 0..1 The series of occurrences that repeats during the operation of the device fhir:duration [ Duration ] ; # 0..1 A measurement of time during the device's operation (e.g., days, hours, mins, etc.) fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device fhir:contact ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support fhir:location [ Reference(Location) ] ; # 0..1 Where the device is found fhir:url [ uri ] ; # 0..1 Network address to contact device fhir:endpoint ( [ Reference(Endpoint) ] ... ) ; # 0..* Technical endpoints providing access to electronic services provided by the device fhir:gateway ( [ CodeableReference(Device) ] ... ) ; # 0..* Linked device acting as a communication/data collector, translator or controller fhir:note ( [ Annotation ] ... ) ; # 0..* Device notes and comments fhir:safety ( [ CodeableConcept ] ... ) ; # 0..* Safety Characteristics of Device fhir:parent [ Reference(Device) ] ; # 0..1 The higher level or encompassing device that this device is a logical part of ]
Changes
since
from
both
R4
and
R4B
| Device | |
| Device.displayName |
|
| Device.definition |
|
| Device.udiCarrier.deviceIdentifier |
|
| Device.udiCarrier.issuer |
|
| Device.udiCarrier.entryType |
|
| Device.status |
|
| Device.availabilityStatus |
|
| Device.biologicalSourceEvent |
|
| Device.name |
|
| Device.name.value |
|
| Device.name.type |
|
| Device.name.display |
|
| Device.category |
|
| Device.type |
|
| Device.version.installDate |
|
| Device.conformsTo |
|
| Device.conformsTo.category |
|
| Device.conformsTo.specification |
|
| Device.conformsTo.version |
|
| Device.property.value[x] |
|
| Device.mode |
|
| Device.cycle |
|
| Device.duration |
|
| Device.endpoint |
|
| Device.gateway |
|
| Device.statusReason |
|
| Device.distinctIdentifier |
|
| Device.deviceName.name |
|
| Device.specialization.systemType |
|
| Device.property.valueQuantity |
|
| Device.property.valueCode |
|
| Device.patient |
|
See the Full Difference for further information
This
analysis
is
available
for
R4
as
XML
or
JSON
.
Conversions
between
R3
and
R4
for
R4B
as
XML
or
JSON
.
See
R3
<-->
R4
<-->
R5
Conversion
Maps
(status
=
9
tests
that
all
execute
ok.
All
tests
pass
round-trip
testing
and
1
r3
resources
are
invalid
(0
errors).
)
See
Conversions
Summary
.)
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
|
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
|
|
|
displayName
|
0..1 | string |
The
name
used
to
display
by
default
when
the
device
is
referenced
| |
|
definition
| 0..1 |
|
The
reference
to
the
definition
for
the
device
|
|
|
udiCarrier
|
Σ | 0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
|
deviceIdentifier
|
Σ | 1..1 | string |
Mandatory
fixed
portion
of
UDI
|
|
issuer
|
Σ | 1..1 | uri |
UDI
Issuing
Organization
|
|
jurisdiction
|
0..1 | uri |
Regional
UDI
authority
|
|
|
carrierAIDC
|
Σ | 0..1 | base64Binary |
UDI
Machine
Readable
Barcode
String
|
|
carrierHRF
|
Σ | 0..1 | string |
UDI
Human
Readable
Barcode
String
|
|
entryType
|
0..1 | code |
barcode
|
rfid
|
manual
Binding: |
|
|
status
|
?! Σ | 0..1 | code |
active
|
inactive
|
entered-in-error
Binding: |
|
availabilityStatus
|
0..1 | CodeableConcept |
lost
|
|
|
|
biologicalSourceEvent
|
0..1 |
|
An
identifier
that
supports
traceability
to
the
event
during
which
material
in
this
product
from
one
or
more
biological
entities
was
obtained
or
pooled
|
|
|
manufacturer
|
0..1 | string |
Name
of
device
manufacturer
|
|
|
manufactureDate
|
0..1 | dateTime |
Date
when
the
device
was
made
|
|
|
expirationDate
|
0..1 | dateTime |
Date
and
time
of
expiry
of
this
device
(if
applicable)
|
|
|
lotNumber
|
0..1 | string |
Lot
number
of
manufacture
|
|
|
serialNumber
|
0..1 | string |
Serial
number
assigned
by
the
manufacturer
|
|
|
name
|
C | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
|
|
value
|
Σ | 1..1 | string |
The
|
|
type
|
Σ | 1..1 | code |
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: |
|
display
| ?! Σ C | 0..1 | boolean |
The
preferred
device
name
|
|
modelNumber
|
0..1 | string |
The
manufacturer's
model
number
for
the
device
|
|
|
partNumber
|
0..1 | string |
The
part
number
or
catalog
number
of
the
device
|
|
|
|
0..* |
|
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 ) |
|
|
version
|
0..* | BackboneElement |
The
actual
design
of
the
device
or
software
version
running
on
the
device
| |
|
type
|
|
|
The
Binding: Device Version Type ( Example ) |
|
|
|
|
|
The
|
|
|
|
0..1 |
|
The
date
the
version
|
|
|
value
|
|
|
The
|
|
|
conformsTo
|
|
|
|
|
|
|
0..1 |
|
Binding: Device Specification Category ( Example ) |
|
|
specification
|
1..1 |
|
Binding: Device Specification Type ( Example ) |
|
|
version
|
0..1 | string |
Specific
form
or
variant
of
the
standard
| |
|
property
| 0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
|
|
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
Binding: Device Property Type ( Example ) |
|
|
value[x]
| 1..1 |
Value
of
the
property
| ||
|
valueQuantity
|
Quantity | |||
|
valueCodeableConcept
| CodeableConcept | |||
|
valueString
|
|
| ||
|
valueBoolean
| boolean | |||
|
valueInteger
|
|
integer | ||
|
| Range | |||
|
valueAttachment
| Attachment | |||
|
mode
|
|
CodeableConcept |
Binding: FHIR Device Operation Mode ( Example ) |
|
|
cycle
|
0..1 |
|
|
|
|
duration
|
0..1 | Duration |
A
measurement
of
time
during
the
device's
operation
(e.g.,
days,
hours,
mins,
etc.)
| |
|
owner
| 0..1 | Reference ( Organization ) |
Organization
responsible
for
device
|
|
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
location
|
0..1 | Reference ( Location ) |
Where
the
device
is
found
|
|
|
url
|
0..1 | uri |
Network
address
to
contact
device
|
|
|
endpoint
| 0..* | Reference ( Endpoint ) |
Technical
endpoints
providing
access
to
electronic
services
provided
by
the
device
| |
|
gateway
|
0..* | CodeableReference ( Device ) |
Linked
device
acting
as
a
communication/data
collector,
translator
or
controller
| |
|
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
|
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
XML Template
<Device xmlns="http://hl7.org/fhir"><</definition><displayName value="[string]"/><!-- 0..1 The name used to display by default when the device is referenced --> <definition><!-- 0..1 CodeableReference(DeviceDefinition) The reference to the definition for the device --></definition> <udiCarrier> <!-- 0..* Unique Device Identifier (UDI) Barcode string -->< <<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict"> <<deviceIdentifier value="[string]"/><!-- 1..1 Mandatory fixed portion of UDI --> <issuer value="[uri]"/><!-- 1..1 UDI Issuing Organization --> <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority --> <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String --> <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String --><<entryType value="[code]"/><!-- 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown --> </udiCarrier>< <</statusReason> < <<status value="[code]"/><!-- 0..1 active | inactive | entered-in-error --> <availabilityStatus><!-- 0..1 CodeableConcept lost | damaged | destroyed | available --></availabilityStatus> <biologicalSourceEvent><!-- 0..1 Identifier An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled --></biologicalSourceEvent> <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer --> <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made --> <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) --> <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture --> <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->< < <<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict"> </deviceName><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 value="[code]"/><!-- 1..1 registered-name | user-friendly-name | patient-reported-name --> <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 --><</type> < <</systemType> < </specialization><category><!-- 0..* CodeableConcept Indicates a high-level grouping of the device --></category> <type><!-- 0..* CodeableConcept The kind or type of device --></type> <version> <!-- 0..* The actual design of the device or software version running on the device --><</type> <</component><type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <installDate value="[dateTime]"/><!-- 0..1 The date the version was installed on the device --> <value value="[string]"/><!-- 1..1 The version text --> </version>< <</type> <</valueQuantity> <</valueCode><conformsTo> <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device --> <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement --></category> <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to --></specification> <version value="[string]"/><!-- 0..1 Specific form or variant of the standard --> </conformsTo> <property> <!-- 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. --> <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type> <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range| Attachment Value of the property --></value[x]> </property><</patient><mode><!-- 0..1 CodeableConcept The designated condition for performing a task --></mode> <cycle><!-- 0..1 Count The series of occurrences that repeats during the operation of the device --></cycle> <duration><!-- 0..1 Duration A measurement of time during the device's operation (e.g., days, hours, mins, etc.) --></duration> <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <location><!-- 0..1 Reference(Location) Where the device is found --></location> <url value="[uri]"/><!-- 0..1 Network address to contact device --> <endpoint><!-- 0..* Reference(Endpoint) Technical endpoints providing access to electronic services provided by the device --></endpoint> <gateway><!-- 0..* CodeableReference(Device) Linked device acting as a communication/data collector, translator or controller --></gateway> <note><!-- 0..* Annotation Device notes and comments --></note><</safety> <</parent><safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety> <parent><!-- 0..1 Reference(Device) The higher level or encompassing device that this device is a logical part of --></parent> </Device>
JSON Template
{
"resourceType" : "Device",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Instance identifier
"
"displayName" : "<string>", // The name used to display by default when the device is referenced
"definition" : { CodeableReference(DeviceDefinition) }, // The reference to the definition for the device
"udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
"
"<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
1) GS1:
http://hl7.org/fhir/NamingSystem/gs1-di,
2) HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI,
3) ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
4) ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">issuer
"
"deviceIdentifier" : "<string>", // R! Mandatory fixed portion of UDI
"issuer" : "<uri>", // R! UDI Issuing Organization
"jurisdiction" : "<uri>", // Regional UDI authority
"carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
"carrierHRF" : "<string>", // UDI Human Readable Barcode String
"
"entryType" : "<code>" // barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
}],
"
"
"
"
"status" : "<code>", // active | inactive | entered-in-error
"availabilityStatus" : { CodeableConcept }, // lost | damaged | destroyed | available
"biologicalSourceEvent" : { Identifier }, // An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
"manufacturer" : "<string>", // Name of device manufacturer
"manufactureDate" : "<dateTime>", // Date when the device was made
"expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
"lotNumber" : "<string>", // Lot number of manufacture
"serialNumber" : "<string>", // Serial number assigned by the manufacturer
"
"
"<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">type
"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" : "<code>", // 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
"version" : [{ // The actual design of the device or software version running on the device
"
"
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"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 }
}],
"mode" : { CodeableConcept }, // The designated condition for performing a task
"cycle" : { Count }, // The series of occurrences that repeats during the operation of the device
"duration" : { Duration }, // A measurement of time during the device's operation (e.g., days, hours, mins, etc.)
"owner" : { Reference(Organization) }, // Organization responsible for device
"contact" : [{ ContactPoint }], // Details for human/organization for support
"location" : { Reference(Location) }, // Where the device is found
"url" : "<uri>", // Network address to contact device
"endpoint" : [{ Reference(Endpoint) }], // Technical endpoints providing access to electronic services provided by the device
"gateway" : [{ CodeableReference(Device) }], // Linked device acting as a communication/data collector, translator or controller
"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/> .fhir: fhir: fhir: fhir: fhir:<a href="device-definitions.html#Device.udiCarrier.issuer" title="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">Device.udiCarrier.issuer fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:<a href="device-definitions.html#Device.deviceName.type" title="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName." class="dict">Device.deviceName.type ], ...; fhir: fhir: fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: ], ...; fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:fhir:identifier ( [ Identifier ] ... ) ; # 0..* Instance identifier fhir:displayName [ string ] ; # 0..1 The name used to display by default when the device is referenced fhir:definition [ CodeableReference(DeviceDefinition) ] ; # 0..1 The reference to the definition for the device fhir:udiCarrier ( [ # 0..* Unique Device Identifier (UDI) Barcode string fhir:deviceIdentifier [ string ] ; # 1..1 Mandatory fixed portion of UDI fhir:issuer [ uri ] ; # 1..1 UDI Issuing Organization fhir:jurisdiction [ uri ] ; # 0..1 Regional UDI authority fhir:carrierAIDC [ base64Binary ] ; # 0..1 UDI Machine Readable Barcode String fhir:carrierHRF [ string ] ; # 0..1 UDI Human Readable Barcode String fhir:entryType [ code ] ; # 0..1 barcode | rfid | manual | card | self-reported | electronic-transmission | unknown ] ... ) ; fhir:status [ code ] ; # 0..1 active | inactive | entered-in-error fhir:availabilityStatus [ CodeableConcept ] ; # 0..1 lost | damaged | destroyed | available fhir:biologicalSourceEvent [ Identifier ] ; # 0..1 An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled fhir:manufacturer [ string ] ; # 0..1 Name of device manufacturer fhir:manufactureDate [ dateTime ] ; # 0..1 Date when the device was made fhir:expirationDate [ dateTime ] ; # 0..1 Date and time of expiry of this device (if applicable) fhir:lotNumber [ string ] ; # 0..1 Lot number of manufacture fhir:serialNumber [ string ] ; # 0..1 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 [ code ] ; # 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:version ( [ # 0..* The actual design of the device or software version running on the device fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies fhir:installDate [ dateTime ] ; # 0..1 The date the version was installed on the device fhir:value [ string ] ; # 1..1 The version text ] ... ) ; fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to fhir:version [ string ] ; # 0..1 Specific form or variant of the standard ] ... ) ; fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented # value[x] : 1..1 Value of the property. One of these 7 fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:string ; string ] fhir:value [ a fhir:boolean ; boolean ] fhir:value [ a fhir:integer ; integer ] fhir:value [ a fhir:Range ; Range ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:mode [ CodeableConcept ] ; # 0..1 The designated condition for performing a task fhir:cycle [ Count ] ; # 0..1 The series of occurrences that repeats during the operation of the device fhir:duration [ Duration ] ; # 0..1 A measurement of time during the device's operation (e.g., days, hours, mins, etc.) fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device fhir:contact ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support fhir:location [ Reference(Location) ] ; # 0..1 Where the device is found fhir:url [ uri ] ; # 0..1 Network address to contact device fhir:endpoint ( [ Reference(Endpoint) ] ... ) ; # 0..* Technical endpoints providing access to electronic services provided by the device fhir:gateway ( [ CodeableReference(Device) ] ... ) ; # 0..* Linked device acting as a communication/data collector, translator or controller fhir:note ( [ Annotation ] ... ) ; # 0..* Device notes and comments fhir:safety ( [ CodeableConcept ] ... ) ; # 0..* Safety Characteristics of Device fhir:parent [ Reference(Device) ] ; # 0..1 The higher level or encompassing device that this device is a logical part of ]
Changes
since
Release
4
from
both
R4
and
R4B
| Device | |
| Device.displayName |
|
| Device.definition |
|
| Device.udiCarrier.deviceIdentifier |
|
| Device.udiCarrier.issuer |
|
| Device.udiCarrier.entryType |
|
| Device.status |
|
| Device.availabilityStatus |
|
| Device.biologicalSourceEvent |
|
| Device.name |
|
| Device.name.value |
|
| Device.name.type |
|
| Device.name.display |
|
| Device.category |
|
| Device.type |
|
| Device.version.installDate |
|
| Device.conformsTo |
|
| Device.conformsTo.category |
|
| Device.conformsTo.specification |
|
| Device.conformsTo.version |
|
| Device.property.value[x] |
|
| Device.mode |
|
| Device.cycle |
|
| Device.duration |
|
| Device.endpoint |
|
| Device.gateway |
|
| Device.statusReason |
|
| Device.distinctIdentifier |
|
| Device.deviceName.name |
|
| Device.specialization.systemType |
|
| Device.property.valueQuantity |
|
| Device.property.valueCode |
|
| Device.patient |
|
See the Full Difference for further information
This
analysis
is
available
for
R4
as
XML
or
JSON
.
Conversions
between
R3
and
R4
for
R4B
as
XML
or
JSON
.
See
R3
<-->
R4
<-->
R5
Conversion
Maps
(status
=
9
tests
that
all
execute
ok.
All
tests
pass
round-trip
testing
and
1
r3
resources
are
invalid
(0
errors).
)
See
Conversions
Summary
.)
See
the
Profiles
&
Extensions
and
the
alternate
Additional
definitions:
Master
Definition
XML
+
JSON
,
XML
Schema
/
Schematron
+
JSON
Schema
,
ShEx
(for
Turtle
)
+
see
the
extensions
,
the
spreadsheet
version
&
the
dependency
analysis
| Path |
|
Type |
|
|---|---|---|---|
| Device.udiCarrier.entryType | UDIEntryType | Required |
Codes to identify how UDI data was entered. |
| Device.status | FHIRDeviceStatus | Required |
The status of the Device record. |
| Device.availabilityStatus | FHIRDeviceAvailabilityStatus | Extensible |
The availability status of the device. |
| Device.name.type | DeviceNameType | Required |
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.version.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 | 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.mode | FHIRDeviceOperationMode | Example | The operation mode of the device. |
| 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:
For
systems
that
do
have
a
system
URI
for
device
types
(indicating
the
model
number
or
part
number),
they
can
and
should
appear
as
codings
in
Device.type
.
The
International
Medical
Device
Regulators
Forum
IMDRF
UDI
Working
Group
published
UDI
System
for
Medical
Devices
(Version
2.0)
,
the
base
specification
for
Unique
Device
Identifiers
(UDI).
The
United
States
Food
and
Drug
Administration
has
produced
an
implementation
guide
for
Unique
Device
Identifiers
(UDI)
which
implements
the
IMDRF
specification
and
other
jurisdictions
may
produce
similar
IMDRF
implementation
guides
as
well.
The
full
UDI
string
that
represents
the
barcode
as
printed
on
the
packaging
of
the
device
or
Automatic
Identification
and
Data
Capture
(AIDC)
representation
is
called
the
"UDI
carrier".
The
UDI
has
2
components*:
*non-UDI
elements
may
also
appear
within
the
UDI
carrier.
**a
"GTIN"
(sometimes
also
called
an
EAN
number)
is
a
code
developed
by
GS1
for
the
kind
of
device
not
an
identifier
for
the
device.
A
GTIN
may
appear
on
its
own
or
it
may
appear
in
a
UDI
string
as
the
DI
component.
The
DI
of
the
UDI
may
be
stored
in
a
jurisdictional
repository
and
used
as
the
primary
key
to
access
other
device
information.
For
example,
in
the
United
States,
the
DI
of
the
UDI
is
submitted
in
a
device
record
to
the
Global
Unique
Device
Identification
Database
(GUDID)
.
The
UDI
may
identify
an
instance
of
a
device
uniquely
(when
the
PI
includes
a
serial
number),
or
it
may
just
identify
the
type
of
the
device.
The
UDI
is
parsed
into
its
constituent
parts
(DI,
PI
and
other
elements)
by
parsing
rules
developed
by
each
Issuing
Agency
standard.
Where
the
device
has
an
assigned
UDI,
the
other
details
carried
in
the
resource
(e.g.,
lot,
expiration
date,
etc.)
SHALL
be
consistent
with
the
information
encoded
in
the
UDI
string
or
registered
in
the
local
repository.
Best practice guidelines for transmitting UDI data using the Device resource dictate transmitting both the UDI Carrier and all components found within the UDI as described in Device UDI Mapping . Several examples are provided for further guidance.
Devices.status is about the record, while operationalStatus and associationStatus are about other aspects of the device.
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.definition.concept | |
| 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.reference | |
| device-name | string |
A
server
defined
search
that
may
match
any
of
the
string
fields
in
|
|
|
| expiration-date | date | The expiration date of the device | Device.expirationDate | |
| identifier | token | Instance id from manufacturer, owner, and others | Device.identifier | |
| location | reference | A location, where the resource is found |
Device.location
( Location ) |
|
| lot-number | string | The lot number of the device | Device.lotNumber | |
| manufacture-date | date | The manufacture date of the device | Device.manufactureDate | |
| manufacturer | string | The manufacturer of the device | Device.manufacturer | |
| model | string | The model of the device | Device.modelNumber | |
| organization | reference | The organization responsible for the device |
Device.owner
( Organization ) |
|
|
|
reference |
|
( |
|
| 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 | string |
UDI Barcode (RFID or other technology) string in HRF format. |
Device.udiCarrier.carrierHRF | |
| udi-di | string | The udi Device Identifier (DI) | Device.udiCarrier.deviceIdentifier | |
| url | uri | Network address to contact device | Device.url | |
| version | string | The specific version of the device | Device.version.value |
FHIR
®©
HL7.org
2011+.
FHIR
Release
4B
(v4.3.0)
hl7.fhir.r4b.core#4.3.0
R5
hl7.fhir.core#5.0.0
generated
on
Sat,
May
28,
2022
12:54+1000.
Sun,
Mar
26,
2023
15:24+1100.
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