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Orders
and
Observations
Work
Group
|
Maturity Level : 1 | Trial Use | Security Category : Anonymous | Compartments : No defined compartments |
The characteristics, operational status and capabilities of a medical-related component of a medical device.
Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health, as well as devices such as a machine, cellphone, computer, software, application, etc. The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn.
Devices can also be subdivded as follows:
Implantable device
Accessed
13
March
2020.
Accessed
13
March
2020.
Patient-use device
Accessed
13
March
2020.
The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the manufacturer or a regulatory entity and allows defining valid hierarchical device configurations (devices as part of other devices).
Device vs deviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location, operational status which the DeviceDefinition resource does not have.
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
DeviceDefinition
|
TU | DomainResource |
An
instance
of
a
medical-related
component
of
a
medical
device
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
description
|
0..1 | markdown |
Additional
information
to
describe
the
device
|
|
identifier
|
Σ | 0..* | Identifier |
Instance
identifier
|
udiDeviceIdentifier
|
0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
|
deviceIdentifier
|
1..1 | string |
The
identifier
that
is
to
be
associated
with
every
Device
that
references
this
DeviceDefintiion
for
the
issuer
and
jurisdiction
provided
in
the
DeviceDefinition.udiDeviceIdentifier
|
|
|
issuer
|
1..1 | uri |
The
organization
that
assigns
the
identifier
algorithm
|
|
|
jurisdiction
|
1..1 | uri |
The
jurisdiction
to
which
the
deviceIdentifier
applies
|
|
marketDistribution
|
0..* | BackboneElement |
Indicates
whether
and
when
the
device
is
available
on
the
market
|
|
marketPeriod
|
1..1 | Period |
Begin
and
end
dates
for
the
commercial
distribution
of
the
device
|
|
subJurisdiction
|
1..1 | uri |
National
state
or
territory
where
the
device
is
commercialized
|
|
|
regulatoryIdentifier
|
0..* | BackboneElement |
Regulatory
identifier(s)
associated
with
this
device
|
|
|
type
|
1..1 | code |
basic
|
master
|
license
Binding: Device Definition Regulatory Identifier Type ( Required ) |
|
|
deviceIdentifier
|
1..1 | string |
The
identifier
itself
|
|
|
issuer
|
1..1 | uri |
The
organization
that
issued
this
identifier
|
|
|
jurisdiction
|
1..1 | uri |
The
jurisdiction
to
which
the
deviceIdentifier
applies
|
|
|
partNumber
|
0..1 | string |
The
part
number
or
catalog
number
of
the
device
|
|
manufacturer
|
Σ | 0..1 | Reference ( Organization ) |
Name
of
device
manufacturer
|
|
deviceName
|
Σ | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
given
by
the
manufacturer
|
|
name
|
Σ | 1..1 | string |
A
name
that
is
used
to
refer
to
the
device
|
|
type
|
Σ | 1..1 | code |
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( Required ) |
|
modelNumber
|
Σ | 0..1 | string |
The
catalog
or
model
number
for
the
device
for
example
as
defined
by
the
manufacturer
|
|
classification
|
Σ | 0..* | BackboneElement |
What
kind
of
device
or
device
system
this
is
|
|
type
|
Σ | 1..1 | CodeableConcept |
A
classification
or
risk
class
of
the
device
model
Binding: Device Type ( Example ) |
|
justification
|
0..* | RelatedArtifact |
Further
information
qualifying
this
classification
of
the
device
model
|
|
|
conformsTo
|
Σ | 0..* | BackboneElement |
Identifies
the
standards,
specifications,
or
formal
guidances
for
the
capabilities
supported
by
the
device
|
|
category
|
Σ | 0..1 | CodeableConcept |
Describes
the
common
type
of
the
standard,
specification,
or
formal
guidance
Binding: Device Specification Category ( Example ) |
|
specification
|
Σ | 1..1 | CodeableConcept |
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
adheres
to
the
Device
Specification
type
Binding: Device Specification Type ( Example ) |
|
version
|
Σ | 0..* | string |
The
specific
form
or
variant
of
the
standard,
specification
or
formal
guidance
|
|
source
|
0..* | RelatedArtifact |
Standard,
regulation,
certification,
or
guidance
website,
document,
or
other
publication,
or
similar,
supporting
the
conformance
|
|
|
hasPart
|
Σ | 0..* | BackboneElement |
A
device,
part
of
the
current
one
|
|
reference
|
Σ | 1..1 | Reference ( DeviceDefinition ) |
Reference
to
the
part
|
|
count
|
0..1 | integer |
Number
of
occurrences
of
the
part
|
|
|
packaging
|
0..* | BackboneElement |
Information
about
the
packaging
of
the
device,
i.e.
how
the
device
is
packaged
|
|
|
identifier
|
0..1 | Identifier |
Business
identifier
of
the
packaged
medication
|
|
|
type
|
0..1 | CodeableConcept |
A
code
that
defines
the
specific
type
of
packaging
|
|
|
count
|
0..1 | integer |
The
number
of
items
contained
in
the
package
(devices
or
sub-packages)
|
|
|
distributor
|
0..* | BackboneElement |
An
organization
that
distributes
the
packaged
device
|
|
|
name
|
0..1 | string |
Distributor's
human-readable
name
|
|
|
organizationReference
|
0..* | Reference ( Organization ) |
Distributor
as
an
Organization
resource
|
|
udiDeviceIdentifier
|
0..* | see udiDeviceIdentifier |
Unique
Device
Identifier
(UDI)
Barcode
string
on
the
packaging
|
|
|
packaging
|
0..* | see packaging |
Allows
packages
within
packages
|
|
|
version
|
0..* | BackboneElement |
The
version
of
the
device
or
software
|
|
|
type
|
0..1 | CodeableConcept |
The
type
of
the
device
version,
e.g.
manufacturer,
approved,
internal
|
|
|
component
|
0..1 | Identifier |
The
hardware
or
software
module
of
the
device
to
which
the
version
applies
|
|
|
value
|
1..1 | string |
The
version
text
|
|
|
safety
|
Σ | 0..* | CodeableConcept |
Safety
characteristics
of
the
device
Binding: Device Safety ( Example ) |
|
shelfLifeStorage
|
0..* | ProductShelfLife |
Shelf
Life
and
storage
information
|
|
|
languageCode
|
0..* | CodeableConcept |
Language
code
for
the
human-readable
text
strings
produced
by
the
device
(all
supported)
|
|
|
property
|
0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
this
kind
of
device,
e.g.,
time
properties,
size,
etc
|
|
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
being
represented
Binding: Device Property Type ( Example ) |
|
value[x]
|
1..1 |
Value
of
the
property
|
||
|
valueQuantity
|
Quantity | |||
|
valueCodeableConcept
|
CodeableConcept | |||
|
valueString
|
string | |||
|
valueBoolean
|
boolean | |||
|
valueInteger
|
integer | |||
|
valueRange
|
Range | |||
|
valueAttachment
|
Attachment | |||
|
owner
|
0..1 | Reference ( Organization ) |
Organization
responsible
for
device
|
|
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
link
|
0..* | BackboneElement |
An
associated
device,
attached
to,
used
with,
communicating
with
or
linking
a
previous
or
new
device
model
to
the
focal
device
|
|
|
relation
|
1..1 | Coding |
The
type
indicates
the
relationship
of
the
related
device
to
the
device
instance
Binding: Device Definition Relation Type ( Extensible ) |
|
|
relatedDevice
|
1..1 | CodeableReference ( DeviceDefinition ) |
A
reference
to
the
linked
device
|
|
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
|
|
material
|
0..* | BackboneElement |
A
substance
used
to
create
the
material(s)
of
which
the
device
is
made
|
|
|
substance
|
1..1 | CodeableConcept |
A
relevant
substance
that
the
device
contains,
may
contain,
or
is
made
of
|
|
|
alternate
|
0..1 | boolean |
Indicates
an
alternative
material
of
the
device
|
|
|
allergenicIndicator
|
0..1 | boolean |
Whether
the
substance
is
a
known
or
suspected
allergen
|
|
|
productionIdentifierInUDI
|
0..* | code |
lot-number
|
manufactured-date
|
serial-number
|
expiration-date
|
biological-source
|
software-version
Binding: Device Production Identifier In UDI ( Required ) |
|
|
guideline
|
0..1 | BackboneElement |
Information
aimed
at
providing
directions
for
the
usage
of
this
model
of
device
|
|
|
useContext
|
0..* | UsageContext |
The
circumstances
that
form
the
setting
for
using
the
device
|
|
|
usageInstruction
|
0..1 | markdown |
Detailed
written
and
visual
directions
for
the
user
on
how
to
use
the
device
|
|
|
relatedArtifact
|
0..* | RelatedArtifact |
A
source
of
information
or
reference
for
this
guideline
|
|
|
indication
|
0..* | CodeableConcept |
A
clinical
condition
for
which
the
device
was
designed
to
be
used
|
|
|
contraindication
|
0..* | CodeableConcept |
A
specific
situation
when
a
device
should
not
be
used
because
it
may
cause
harm
|
|
|
warning
|
0..* | CodeableConcept |
Specific
hazard
alert
information
that
a
user
needs
to
know
before
using
the
device
|
|
|
intendedUse
|
0..1 | string |
A
description
of
the
general
purpose
or
medical
use
of
the
device
or
its
function
|
|
|
correctiveAction
|
0..1 | BackboneElement |
Tracking
of
latest
field
safety
corrective
action
|
|
|
recall
|
1..1 | boolean |
Whether
the
corrective
action
was
a
recall
|
|
|
scope
|
0..1 | code |
model
|
lot-numbers
|
serial-numbers
Binding: Device Corrective Action Scope ( Required ) |
|
|
period
|
1..1 | Period |
Start
and
end
dates
of
the
corrective
action
|
|
|
chargeItem
|
0..* | BackboneElement |
Billing
code
or
reference
associated
with
the
device
|
|
|
chargeItemCode
|
1..1 | CodeableReference ( ChargeItemDefinition ) |
The
code
or
reference
for
the
charge
item
|
|
|
count
|
1..1 | Quantity |
Coefficient
applicable
to
the
billing
code
|
|
|
effectivePeriod
|
0..1 | Period |
A
specific
time
period
in
which
this
charge
item
applies
|
|
|
useContext
|
0..* | UsageContext |
The
context
to
which
this
charge
item
applies
|
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
UML Diagram ( Legend )
XML Template
<DeviceDefinition xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <description value="[markdown]"/><!-- 0..1 Additional information to describe the device --> <identifier><!-- 0..* Identifier Instance identifier --></identifier> <udiDeviceIdentifier> <!-- 0..* Unique Device Identifier (UDI) Barcode string --> <deviceIdentifier value="[string]"/><!-- 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier --> <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm --> <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies --> <marketDistribution> <!-- 0..* Indicates whether and when the device is available on the market --> <marketPeriod><!-- 1..1 Period Begin and end dates for the commercial distribution of the device --></marketPeriod> <subJurisdiction value="[uri]"/><!-- 1..1 National state or territory where the device is commercialized --> </marketDistribution> </udiDeviceIdentifier> <regulatoryIdentifier> <!-- 0..* Regulatory identifier(s) associated with this device --> <type value="[code]"/><!-- 1..1 basic | master | license --> <deviceIdentifier value="[string]"/><!-- 1..1 The identifier itself --> <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier --> <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies --> </regulatoryIdentifier> <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device --> <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer> <deviceName> <!-- 0..* The name or names of the device as given by the manufacturer --> <name value="[string]"/><!-- 1..1 A name that is used to refer to the device --> <type value="[code]"/><!-- 1..1 registered-name | user-friendly-name | patient-reported-name --> </deviceName> <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer --> <classification> <!-- 0..* What kind of device or device system this is --> <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type> <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification> </classification> <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 --></category> <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification> <version value="[string]"/><!-- 0..* The specific form or variant of the standard, specification or formal guidance --> <source><!-- 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance --></source> </conformsTo> <hasPart> <!-- 0..* A device, part of the current one --> <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference> <count value="[integer]"/><!-- 0..1 Number of occurrences of the part --> </hasPart> <packaging> <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged --> <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier> <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type> <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) --> <distributor> <!-- 0..* An organization that distributes the packaged device --> <name value="[string]"/><!-- 0..1 Distributor's human-readable name --> <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference> </distributor> <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier> <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging> </packaging> <version> <!-- 0..* The version of the device or software --> <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type> <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component> <value value="[string]"/><!-- 1..1 The version text --> </version> <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage> <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode> <property> <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, 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> <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner> <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact> <link> <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device --> <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation> <relatedDevice><!-- 1..1 CodeableReference(DeviceDefinition) A reference to the linked device --></relatedDevice> </link> <note><!-- 0..* Annotation Device notes and comments --></note> <material> <!-- 0..* A substance used to create the material(s) of which the device is made --> <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance> <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device --> <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen --> </material> <productionIdentifierInUDI value="[code]"/><!-- 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --> <guideline> <!-- 0..1 Information aimed at providing directions for the usage of this model of device --> <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext> <usageInstruction value="[markdown]"/><!-- 0..1 Detailed written and visual directions for the user on how to use the device --> <relatedArtifact><!-- 0..* RelatedArtifact A source of information or reference for this guideline --></relatedArtifact> <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication> <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication> <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning> <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function --> </guideline> <correctiveAction> <!-- 0..1 Tracking of latest field safety corrective action --> <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall --> <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers --> <period><!-- 1..1 Period Start and end dates of the corrective action --></period> </correctiveAction> <chargeItem> <!-- 0..* Billing code or reference associated with the device --> <chargeItemCode><!-- 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item --></chargeItemCode> <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count> <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod> <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext> </chargeItem> </DeviceDefinition>
JSON Template
{
"resourceType" : "DeviceDefinition",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"description" : "<markdown>", // Additional information to describe the device
"identifier" : [{ Identifier }], // Instance identifier
"udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
"deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
"issuer" : "<uri>", // R! The organization that assigns the identifier algorithm
"jurisdiction" : "<uri>", // R! The jurisdiction to which the deviceIdentifier applies
"marketDistribution" : [{ // Indicates whether and when the device is available on the market
"marketPeriod" : { Period }, // R! Begin and end dates for the commercial distribution of the device
"subJurisdiction" : "<uri>" // R! National state or territory where the device is commercialized
}]
}],
"regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
"type" : "<code>", // R! basic | master | license
"deviceIdentifier" : "<string>", // R! The identifier itself
"issuer" : "<uri>", // R! The organization that issued this identifier
"jurisdiction" : "<uri>" // R! The jurisdiction to which the deviceIdentifier applies
}],
"partNumber" : "<string>", // The part number or catalog number of the device
"manufacturer" : { Reference(Organization) }, // Name of device manufacturer
"deviceName" : [{ // The name or names of the device as given by the manufacturer
"name" : "<string>", // R! A name that is used to refer to the device
"type" : "<code>" // R! registered-name | user-friendly-name | patient-reported-name
}],
"modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
"classification" : [{ // What kind of device or device system this is
"type" : { CodeableConcept }, // R! A classification or risk class of the device model
"justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
}],
"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
"specification" : { CodeableConcept }, // R! Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
"version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
"source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
}],
"hasPart" : [{ // A device, part of the current one
"reference" : { Reference(DeviceDefinition) }, // R! Reference to the part
"count" : <integer> // Number of occurrences of the part
}],
"packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
"identifier" : { Identifier }, // Business identifier of the packaged medication
"type" : { CodeableConcept }, // A code that defines the specific type of packaging
"count" : <integer>, // The number of items contained in the package (devices or sub-packages)
"distributor" : [{ // An organization that distributes the packaged device
"name" : "<string>", // Distributor's human-readable name
"organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
}],
"udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
"packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
}],
"version" : [{ // The version of the device or software
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"value" : "<string>" // R! The version text
}],
"safety" : [{ CodeableConcept }], // Safety characteristics of the device
"shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
"languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
"property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, 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 }
}],
"owner" : { Reference(Organization) }, // Organization responsible for device
"contact" : [{ ContactPoint }], // Details for human/organization for support
"link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
"relation" : { Coding }, // R! The type indicates the relationship of the related device to the device instance
"relatedDevice" : { CodeableReference(DeviceDefinition) } // R! A reference to the linked device
}],
"note" : [{ Annotation }], // Device notes and comments
"material" : [{ // A substance used to create the material(s) of which the device is made
"substance" : { CodeableConcept }, // R! A relevant substance that the device contains, may contain, or is made of
"alternate" : <boolean>, // Indicates an alternative material of the device
"allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
}],
"productionIdentifierInUDI" : ["<code>"], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
"guideline" : { // Information aimed at providing directions for the usage of this model of device
"useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
"usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
"relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
"indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
"contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
"warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
"intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
},
"correctiveAction" : { // Tracking of latest field safety corrective action
"recall" : <boolean>, // R! Whether the corrective action was a recall
"scope" : "<code>", // model | lot-numbers | serial-numbers
"period" : { Period } // R! Start and end dates of the corrective action
},
"chargeItem" : [{ // Billing code or reference associated with the device
"chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R! The code or reference for the charge item
"count" : { Quantity }, // R! Coefficient applicable to the billing code
"effectivePeriod" : { Period }, // A specific time period in which this charge item applies
"useContext" : [{ UsageContext }] // The context to which this charge item applies
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes from both R4 and R4B
| DeviceDefinition | |
| DeviceDefinition.description |
|
| DeviceDefinition.udiDeviceIdentifier.marketDistribution |
|
| DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod |
|
| DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction |
|
| DeviceDefinition.regulatoryIdentifier |
|
| DeviceDefinition.regulatoryIdentifier.type |
|
| DeviceDefinition.regulatoryIdentifier.deviceIdentifier |
|
| DeviceDefinition.regulatoryIdentifier.issuer |
|
| DeviceDefinition.regulatoryIdentifier.jurisdiction |
|
| DeviceDefinition.partNumber |
|
| DeviceDefinition.manufacturer |
|
| DeviceDefinition.deviceName.type |
|
| DeviceDefinition.classification |
|
| DeviceDefinition.classification.type |
|
| DeviceDefinition.classification.justification |
|
| DeviceDefinition.conformsTo |
|
| DeviceDefinition.conformsTo.category |
|
| DeviceDefinition.conformsTo.specification |
|
| DeviceDefinition.conformsTo.version |
|
| DeviceDefinition.conformsTo.source |
|
| DeviceDefinition.hasPart |
|
| DeviceDefinition.hasPart.reference |
|
| DeviceDefinition.hasPart.count |
|
| DeviceDefinition.packaging |
|
| DeviceDefinition.packaging.identifier |
|
| DeviceDefinition.packaging.type |
|
| DeviceDefinition.packaging.count |
|
| DeviceDefinition.packaging.distributor |
|
| DeviceDefinition.packaging.distributor.name |
|
| DeviceDefinition.packaging.distributor.organizationReference |
|
| DeviceDefinition.packaging.udiDeviceIdentifier |
|
| DeviceDefinition.packaging.packaging |
|
| DeviceDefinition.version |
|
| DeviceDefinition.version.type |
|
| DeviceDefinition.version.component |
|
| DeviceDefinition.version.value |
|
| DeviceDefinition.property.value[x] |
|
| DeviceDefinition.link |
|
| DeviceDefinition.link.relation |
|
| DeviceDefinition.link.relatedDevice |
|
| DeviceDefinition.productionIdentifierInUDI |
|
| DeviceDefinition.guideline |
|
| DeviceDefinition.guideline.useContext |
|
| DeviceDefinition.guideline.usageInstruction |
|
| DeviceDefinition.guideline.relatedArtifact |
|
| DeviceDefinition.guideline.indication |
|
| DeviceDefinition.guideline.contraindication |
|
| DeviceDefinition.guideline.warning |
|
| DeviceDefinition.guideline.intendedUse |
|
| DeviceDefinition.correctiveAction |
|
| DeviceDefinition.correctiveAction.recall |
|
| DeviceDefinition.correctiveAction.scope |
|
| DeviceDefinition.correctiveAction.period |
|
| DeviceDefinition.chargeItem |
|
| DeviceDefinition.chargeItem.chargeItemCode |
|
| DeviceDefinition.chargeItem.count |
|
| DeviceDefinition.chargeItem.effectivePeriod |
|
| DeviceDefinition.chargeItem.useContext |
|
| DeviceDefinition.specialization.systemType |
|
| DeviceDefinition.physicalCharacteristics |
|
| DeviceDefinition.capability |
|
| DeviceDefinition.property.valueQuantity |
|
| DeviceDefinition.property.valueCode |
|
| DeviceDefinition.url |
|
| DeviceDefinition.quantity |
|
| DeviceDefinition.parentDevice |
|
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
|
|---|---|---|---|---|
|
DeviceDefinition
|
TU | DomainResource |
An
instance
of
a
medical-related
component
of
a
medical
device
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
|
description
|
0..1 | markdown |
Additional
information
to
describe
the
device
|
|
|
identifier
|
Σ | 0..* | Identifier |
Instance
identifier
|
|
udiDeviceIdentifier
|
0..* | BackboneElement |
Unique
Device
Identifier
(UDI)
Barcode
string
|
|
|
deviceIdentifier
|
1..1 | string |
The
identifier
that
is
to
be
associated
with
every
Device
that
references
this
DeviceDefintiion
for
the
issuer
and
jurisdiction
provided
in
the
DeviceDefinition.udiDeviceIdentifier
|
|
|
issuer
|
1..1 | uri |
The
organization
that
assigns
the
identifier
algorithm
|
|
|
jurisdiction
|
1..1 | uri |
The
jurisdiction
to
which
the
deviceIdentifier
applies
|
|
|
marketDistribution
|
0..* | BackboneElement |
Indicates
whether
and
when
the
device
is
available
on
the
market
|
|
|
marketPeriod
|
1..1 | Period |
Begin
and
end
dates
for
the
commercial
distribution
of
the
device
|
|
|
subJurisdiction
|
1..1 | uri |
National
state
or
territory
where
the
device
is
commercialized
|
|
|
regulatoryIdentifier
|
0..* | BackboneElement |
Regulatory
identifier(s)
associated
with
this
device
|
|
|
type
|
1..1 | code |
basic
|
master
|
license
Binding: Device Definition Regulatory Identifier Type ( Required ) |
|
|
deviceIdentifier
|
1..1 | string |
The
identifier
itself
|
|
|
issuer
|
1..1 | uri |
The
organization
that
issued
this
identifier
|
|
|
jurisdiction
|
1..1 | uri |
The
jurisdiction
to
which
the
deviceIdentifier
applies
|
|
|
partNumber
|
0..1 | string |
The
part
number
or
catalog
number
of
the
device
|
|
|
manufacturer
|
Σ | 0..1 | Reference ( Organization ) |
Name
of
device
manufacturer
|
|
deviceName
|
Σ | 0..* | BackboneElement |
The
name
or
names
of
the
device
as
given
by
the
manufacturer
|
|
name
|
Σ | 1..1 | string |
A
name
that
is
used
to
refer
to
the
device
|
|
type
|
Σ | 1..1 | code |
registered-name
|
user-friendly-name
|
patient-reported-name
Binding: Device Name Type ( Required ) |
|
modelNumber
|
Σ | 0..1 | string |
The
catalog
or
model
number
for
the
device
for
example
as
defined
by
the
manufacturer
|
|
classification
|
Σ | 0..* | BackboneElement |
What
kind
of
device
or
device
system
this
is
|
|
type
|
Σ | 1..1 | CodeableConcept |
A
classification
or
risk
class
of
the
device
model
Binding: Device Type ( Example ) |
|
justification
|
0..* | RelatedArtifact |
Further
information
qualifying
this
classification
of
the
device
model
|
|
|
conformsTo
|
Σ | 0..* | BackboneElement |
Identifies
the
standards,
specifications,
or
formal
guidances
for
the
capabilities
supported
by
the
device
|
|
category
|
Σ | 0..1 | CodeableConcept |
Describes
the
common
type
of
the
standard,
specification,
or
formal
guidance
Binding: Device Specification Category ( Example ) |
|
specification
|
Σ | 1..1 | CodeableConcept |
Identifies
the
standard,
specification,
or
formal
guidance
that
the
device
adheres
to
the
Device
Specification
type
Binding: Device Specification Type ( Example ) |
|
version
|
Σ | 0..* | string |
The
specific
form
or
variant
of
the
standard,
specification
or
formal
guidance
|
|
source
|
0..* | RelatedArtifact |
Standard,
regulation,
certification,
or
guidance
website,
document,
or
other
publication,
or
similar,
supporting
the
conformance
|
|
|
hasPart
|
Σ | 0..* | BackboneElement |
A
device,
part
of
the
current
one
|
|
reference
|
Σ | 1..1 | Reference ( DeviceDefinition ) |
Reference
to
the
part
|
|
count
|
0..1 | integer |
Number
of
occurrences
of
the
part
|
|
|
packaging
|
0..* | BackboneElement |
Information
about
the
packaging
of
the
device,
i.e.
how
the
device
is
packaged
|
|
|
identifier
|
0..1 | Identifier |
Business
identifier
of
the
packaged
medication
|
|
|
type
|
0..1 | CodeableConcept |
A
code
that
defines
the
specific
type
of
packaging
|
|
|
count
|
0..1 | integer |
The
number
of
items
contained
in
the
package
(devices
or
sub-packages)
|
|
|
distributor
|
0..* | BackboneElement |
An
organization
that
distributes
the
packaged
device
|
|
|
name
|
0..1 | string |
Distributor's
human-readable
name
|
|
|
organizationReference
|
0..* | Reference ( Organization ) |
Distributor
as
an
Organization
resource
|
|
|
udiDeviceIdentifier
|
0..* | see udiDeviceIdentifier |
Unique
Device
Identifier
(UDI)
Barcode
string
on
the
packaging
|
|
|
packaging
|
0..* | see packaging |
Allows
packages
within
packages
|
|
|
version
|
0..* | BackboneElement |
The
version
of
the
device
or
software
|
|
|
type
|
0..1 | CodeableConcept |
The
type
of
the
device
version,
e.g.
manufacturer,
approved,
internal
|
|
|
component
|
0..1 | Identifier |
The
hardware
or
software
module
of
the
device
to
which
the
version
applies
|
|
|
value
|
1..1 | string |
The
version
text
|
|
|
safety
|
Σ | 0..* | CodeableConcept |
Safety
characteristics
of
the
device
Binding: Device Safety ( Example ) |
|
shelfLifeStorage
|
0..* | ProductShelfLife |
Shelf
Life
and
storage
information
|
|
|
languageCode
|
0..* | CodeableConcept |
Language
code
for
the
human-readable
text
strings
produced
by
the
device
(all
supported)
|
|
|
property
|
0..* | BackboneElement |
Inherent,
essentially
fixed,
characteristics
of
this
kind
of
device,
e.g.,
time
properties,
size,
etc
|
|
|
type
|
1..1 | CodeableConcept |
Code
that
specifies
the
property
being
represented
Binding: Device Property Type ( Example ) |
|
|
value[x]
|
1..1 |
Value
of
the
property
|
||
|
valueQuantity
|
Quantity | |||
|
valueCodeableConcept
|
CodeableConcept | |||
|
valueString
|
string | |||
|
valueBoolean
|
boolean | |||
|
valueInteger
|
integer | |||
|
valueRange
|
Range | |||
|
valueAttachment
|
Attachment | |||
|
owner
|
0..1 | Reference ( Organization ) |
Organization
responsible
for
device
|
|
|
contact
|
0..* | ContactPoint |
Details
for
human/organization
for
support
|
|
|
link
|
0..* | BackboneElement |
An
associated
device,
attached
to,
used
with,
communicating
with
or
linking
a
previous
or
new
device
model
to
the
focal
device
|
|
|
relation
|
1..1 | Coding |
The
type
indicates
the
relationship
of
the
related
device
to
the
device
instance
Binding: Device Definition Relation Type ( Extensible ) |
|
|
relatedDevice
|
1..1 | CodeableReference ( DeviceDefinition ) |
A
reference
to
the
linked
device
|
|
|
note
|
0..* | Annotation |
Device
notes
and
comments
|
|
|
material
|
0..* | BackboneElement |
A
substance
used
to
create
the
material(s)
of
which
the
device
is
made
|
|
|
substance
|
1..1 | CodeableConcept |
A
relevant
substance
that
the
device
contains,
may
contain,
or
is
made
of
|
|
|
alternate
|
0..1 | boolean |
Indicates
an
alternative
material
of
the
device
|
|
|
allergenicIndicator
|
0..1 | boolean |
Whether
the
substance
is
a
known
or
suspected
allergen
|
|
|
productionIdentifierInUDI
|
0..* | code |
lot-number
|
manufactured-date
|
serial-number
|
expiration-date
|
biological-source
|
software-version
Binding: Device Production Identifier In UDI ( Required ) |
|
|
guideline
|
0..1 | BackboneElement |
Information
aimed
at
providing
directions
for
the
usage
of
this
model
of
device
|
|
|
useContext
|
0..* | UsageContext |
The
circumstances
that
form
the
setting
for
using
the
device
|
|
|
usageInstruction
|
0..1 | markdown |
Detailed
written
and
visual
directions
for
the
user
on
how
to
use
the
device
|
|
|
relatedArtifact
|
0..* | RelatedArtifact |
A
source
of
information
or
reference
for
this
guideline
|
|
|
indication
|
0..* | CodeableConcept |
A
clinical
condition
for
which
the
device
was
designed
to
be
used
|
|
|
contraindication
|
0..* | CodeableConcept |
A
specific
situation
when
a
device
should
not
be
used
because
it
may
cause
harm
|
|
|
warning
|
0..* | CodeableConcept |
Specific
hazard
alert
information
that
a
user
needs
to
know
before
using
the
device
|
|
|
intendedUse
|
0..1 | string |
A
description
of
the
general
purpose
or
medical
use
of
the
device
or
its
function
|
|
|
correctiveAction
|
0..1 | BackboneElement |
Tracking
of
latest
field
safety
corrective
action
|
|
|
recall
|
1..1 | boolean |
Whether
the
corrective
action
was
a
recall
|
|
|
scope
|
0..1 | code |
model
|
lot-numbers
|
serial-numbers
Binding: Device Corrective Action Scope ( Required ) |
|
|
period
|
1..1 | Period |
Start
and
end
dates
of
the
corrective
action
|
|
|
chargeItem
|
0..* | BackboneElement |
Billing
code
or
reference
associated
with
the
device
|
|
|
chargeItemCode
|
1..1 | CodeableReference ( ChargeItemDefinition ) |
The
code
or
reference
for
the
charge
item
|
|
|
count
|
1..1 | Quantity |
Coefficient
applicable
to
the
billing
code
|
|
|
effectivePeriod
|
0..1 | Period |
A
specific
time
period
in
which
this
charge
item
applies
|
|
|
useContext
|
0..* | UsageContext |
The
context
to
which
this
charge
item
applies
|
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
XML Template
<DeviceDefinition xmlns="http://hl7.org/fhir">
JSON Template
{
"resourceType" : "DeviceDefinition",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"description" : "<markdown>", // Additional information to describe the device
"identifier" : [{ Identifier }], // Instance identifier
"udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
"deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
"issuer" : "<uri>", // R! The organization that assigns the identifier algorithm
"jurisdiction" : "<uri>", // R! The jurisdiction to which the deviceIdentifier applies
"marketDistribution" : [{ // Indicates whether and when the device is available on the market
"marketPeriod" : { Period }, // R! Begin and end dates for the commercial distribution of the device
"subJurisdiction" : "<uri>" // R! National state or territory where the device is commercialized
}]
}],
"regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
"type" : "<code>", // R! basic | master | license
"deviceIdentifier" : "<string>", // R! The identifier itself
"issuer" : "<uri>", // R! The organization that issued this identifier
"jurisdiction" : "<uri>" // R! The jurisdiction to which the deviceIdentifier applies
}],
"partNumber" : "<string>", // The part number or catalog number of the device
"manufacturer" : { Reference(Organization) }, // Name of device manufacturer
"deviceName" : [{ // The name or names of the device as given by the manufacturer
"name" : "<string>", // R! A name that is used to refer to the device
"type" : "<code>" // R! registered-name | user-friendly-name | patient-reported-name
}],
"modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
"classification" : [{ // What kind of device or device system this is
"type" : { CodeableConcept }, // R! A classification or risk class of the device model
"justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
}],
"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
"specification" : { CodeableConcept }, // R! Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
"version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
"source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
}],
"hasPart" : [{ // A device, part of the current one
"reference" : { Reference(DeviceDefinition) }, // R! Reference to the part
"count" : <integer> // Number of occurrences of the part
}],
"packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
"identifier" : { Identifier }, // Business identifier of the packaged medication
"type" : { CodeableConcept }, // A code that defines the specific type of packaging
"count" : <integer>, // The number of items contained in the package (devices or sub-packages)
"distributor" : [{ // An organization that distributes the packaged device
"name" : "<string>", // Distributor's human-readable name
"organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
}],
"udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
"packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
}],
"version" : [{ // The version of the device or software
"type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
"component" : { Identifier }, // The hardware or software module of the device to which the version applies
"value" : "<string>" // R! The version text
}],
"safety" : [{ CodeableConcept }], // Safety characteristics of the device
"shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
"languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
"property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, 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 }
}],
"owner" : { Reference(Organization) }, // Organization responsible for device
"contact" : [{ ContactPoint }], // Details for human/organization for support
"link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
"relation" : { Coding }, // R! The type indicates the relationship of the related device to the device instance
"relatedDevice" : { CodeableReference(DeviceDefinition) } // R! A reference to the linked device
}],
"note" : [{ Annotation }], // Device notes and comments
"material" : [{ // A substance used to create the material(s) of which the device is made
"substance" : { CodeableConcept }, // R! A relevant substance that the device contains, may contain, or is made of
"alternate" : <boolean>, // Indicates an alternative material of the device
"allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
}],
"productionIdentifierInUDI" : ["<code>"], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
"guideline" : { // Information aimed at providing directions for the usage of this model of device
"useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
"usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
"relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
"indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
"contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
"warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
"intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
},
"correctiveAction" : { // Tracking of latest field safety corrective action
"recall" : <boolean>, // R! Whether the corrective action was a recall
"scope" : "<code>", // model | lot-numbers | serial-numbers
"period" : { Period } // R! Start and end dates of the corrective action
},
"chargeItem" : [{ // Billing code or reference associated with the device
"chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R! The code or reference for the charge item
"count" : { Quantity }, // R! Coefficient applicable to the billing code
"effectivePeriod" : { Period }, // A specific time period in which this charge item applies
"useContext" : [{ UsageContext }] // The context to which this charge item applies
}]
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes from both R4 and R4B
| DeviceDefinition | |
| DeviceDefinition.description |
|
| DeviceDefinition.udiDeviceIdentifier.marketDistribution |
|
| DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod |
|
| DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction |
|
| DeviceDefinition.regulatoryIdentifier |
|
| DeviceDefinition.regulatoryIdentifier.type |
|
| DeviceDefinition.regulatoryIdentifier.deviceIdentifier |
|
| DeviceDefinition.regulatoryIdentifier.issuer |
|
| DeviceDefinition.regulatoryIdentifier.jurisdiction |
|
| DeviceDefinition.partNumber |
|
| DeviceDefinition.manufacturer |
|
| DeviceDefinition.deviceName.type |
|
| DeviceDefinition.classification |
|
| DeviceDefinition.classification.type |
|
| DeviceDefinition.classification.justification |
|
| DeviceDefinition.conformsTo |
|
| DeviceDefinition.conformsTo.category |
|
| DeviceDefinition.conformsTo.specification |
|
| DeviceDefinition.conformsTo.version |
|
| DeviceDefinition.conformsTo.source |
|
| DeviceDefinition.hasPart |
|
| DeviceDefinition.hasPart.reference |
|
| DeviceDefinition.hasPart.count |
|
| DeviceDefinition.packaging |
|
| DeviceDefinition.packaging.identifier |
|
| DeviceDefinition.packaging.type |
|
| DeviceDefinition.packaging.count |
|
| DeviceDefinition.packaging.distributor |
|
| DeviceDefinition.packaging.distributor.name |
|
| DeviceDefinition.packaging.distributor.organizationReference |
|
| DeviceDefinition.packaging.udiDeviceIdentifier |
|
| DeviceDefinition.packaging.packaging |
|
| DeviceDefinition.version |
|
| DeviceDefinition.version.type |
|
| DeviceDefinition.version.component |
|
| DeviceDefinition.version.value |
|
| DeviceDefinition.property.value[x] |
|
| DeviceDefinition.link |
|
| DeviceDefinition.link.relation |
|
| DeviceDefinition.link.relatedDevice |
|
| DeviceDefinition.productionIdentifierInUDI |
|
| DeviceDefinition.guideline |
|
| DeviceDefinition.guideline.useContext |
|
| DeviceDefinition.guideline.usageInstruction |
|
| DeviceDefinition.guideline.relatedArtifact |
|
| DeviceDefinition.guideline.indication |
|
| DeviceDefinition.guideline.contraindication |
|
| DeviceDefinition.guideline.warning |
|
| DeviceDefinition.guideline.intendedUse |
|
| DeviceDefinition.correctiveAction |
|
| DeviceDefinition.correctiveAction.recall |
|
| DeviceDefinition.correctiveAction.scope |
|
| DeviceDefinition.correctiveAction.period |
|
| DeviceDefinition.chargeItem |
|
| DeviceDefinition.chargeItem.chargeItemCode |
|
| DeviceDefinition.chargeItem.count |
|
| DeviceDefinition.chargeItem.effectivePeriod |
|
| DeviceDefinition.chargeItem.useContext |
|
| DeviceDefinition.specialization.systemType |
|
| DeviceDefinition.physicalCharacteristics |
|
| DeviceDefinition.capability |
|
| DeviceDefinition.property.valueQuantity |
|
| DeviceDefinition.property.valueCode |
|
| DeviceDefinition.url |
|
| DeviceDefinition.quantity |
|
| DeviceDefinition.parentDevice |
|
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 |
|---|---|---|---|
| DeviceDefinition.regulatoryIdentifier.type | DeviceDefinitionRegulatoryIdentifierType (a valid code from Device Regulatory Identifier Type ) | Required |
Regulatory Identifier type |
| DeviceDefinition.deviceName.type | DeviceNameType | Required |
The type of name the device is referred by. |
| DeviceDefinition.classification.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. |
| DeviceDefinition.conformsTo.category | DeviceSpecificationCategory (a valid code from FHIR Device Specialization Category ) | Example |
The kind of standards used by the device. |
| DeviceDefinition.conformsTo.specification | DeviceSpecificationType | Example |
The type or specification of a standard that devices can adhere to |
| DeviceDefinition.safety | DeviceSafety | Example |
Codes
used
to
identify
medical
devices
safety
characteristics.
These
codes
are
taken
from
the
NCI
Thesaurus
|
| DeviceDefinition.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. |
| DeviceDefinition.link.relation | DeviceDefinitionRelationType | Extensible |
Description Needed Here |
| DeviceDefinition.productionIdentifierInUDI | DeviceProductionIdentifierInUDI | Required |
Device Production Identifier in UDI |
| DeviceDefinition.correctiveAction.scope | DeviceCorrectiveActionScope | Required |
Device - Corrective action scope |
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 |
| device-name | string | A server defined search that may match any of the string fields in DeviceDefinition.name or DeviceDefinition.classification.type - the latter to search for 'generic' devices. | DeviceDefinition.deviceName.name | DeviceDefinition.classification.type.coding.display | DeviceDefinition.classification.type.text | |
| identifier | token | The identifier of the component | DeviceDefinition.identifier | |
| manufacturer | reference | The manufacturer of the device |
DeviceDefinition.manufacturer
( Organization ) |
|
| organization | reference | The organization responsible for the device |
DeviceDefinition.owner
( Organization ) |
|
| specification | token | The specification that the device conforms to | DeviceDefinition.conformsTo.specification | |
| specification-version | composite | A composite of both specification and version |
On
DeviceDefinition.conformsTo:
specification: specification version: version |
|
| type | token | The device type | DeviceDefinition.conformsTo.category |
FHIR
®©
HL7.org
2011+.
FHIR
R5
hl7.fhir.core#5.0.0
R6
hl7.fhir.core#6.0.0-ballot1
generated
on
Sun,
Mar
26,
Mon,
Dec
18,
2023
15:24+1100.
15:17+1100.
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