Profile Comparison between http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq vs http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/DeviceDefinition
copyright
date	2023-12-18T16:00:45+00:00	2024-05-08T13:55:35+00:00	Values Differ
description	This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering.
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	DeviceDefinitionDrugPq
publisher	HL7 International / Biomedical Research and Regulation
purpose
status	active
title	DeviceDefinition - Drug PQ
type	DeviceDefinition
url	http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq
version	1.0.0-ballot	1.0.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!Σ	0..*	Extension	Extensions that cannot be ignored
description		0..1	markdown	Additional information to describe the device		0..1	markdown	Additional information to describe the device
identifier	Σ	0..*	Identifier	Instance identifier	Σ	0..*	Identifier	Instance identifier
udiDeviceIdentifier		0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string		0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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		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		1..1	uri	The organization that assigns the identifier algorithm
jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies		1..1	uri	The jurisdiction to which the deviceIdentifier applies
marketDistribution		0..*	BackboneElement	Indicates whether and when the device is available on the market		0..*	BackboneElement	Indicates whether and when the device is available on the market
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
marketPeriod		1..1	Period	Begin and end dates for the commercial distribution of the device		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		1..1	uri	National state or territory where the device is commercialized
regulatoryIdentifier		0..*	BackboneElement	Regulatory identifier(s) associated with this device		0..*	BackboneElement	Regulatory identifier(s) associated with this device
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	code	basic | master | license Binding: ?? (required): Device regulatory identifier type.		1..1	code	basic | master | license Binding: ?? (required): Device regulatory identifier type.
deviceIdentifier		1..1	string	The identifier itself		1..1	string	The identifier itself
issuer		1..1	uri	The organization that issued this identifier		1..1	uri	The organization that issued this identifier
jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies		1..1	uri	The jurisdiction to which the deviceIdentifier applies
partNumber		0..1	string	The part number or catalog number of the device		0..1	string	The part number or catalog number of the device
manufacturer	Σ	0..1	Reference(Organization)	Name of device manufacturer	Σ	0..1	Reference(Organization)	Name of device manufacturer
deviceName	SΣ	0..*	BackboneElement	The name or names of the device as given by the manufacturer	SΣ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	Σ	1..1	string	A name that is used to refer to the device	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: ?? (required): The type of name the device is referred by.	Σ	1..1	code	registered-name | user-friendly-name | patient-reported-name Binding: ?? (required): The type of name the device is referred by.
modelNumber	Σ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer	Σ	0..1	string	The catalog or model number for the device for example as defined by the manufacturer
classification	SΣ	0..*	BackboneElement	What kind of device or device system this is	SΣ	0..*	BackboneElement	What kind of device or device system this is
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A classification or risk class of the device model Binding: ?? (example)	SΣ	1..1	CodeableConcept	A classification or risk class of the device model Binding: ?? (example)
justification		0..*	RelatedArtifact	Further information qualifying this classification of the device model		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	Σ	0..*	BackboneElement	Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
category	Σ	0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance Binding: ?? (example)	Σ	0..1	CodeableConcept	Describes the common type of the standard, specification, or formal guidance Binding: ?? (example)
specification	Σ	1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: ?? (example)	Σ	1..1	CodeableConcept	Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: ?? (example)
version	Σ	0..*	string	The specific form or variant of the standard, specification or formal guidance	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		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	Σ	0..*	BackboneElement	A device, part of the current one
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
reference	Σ	1..1	Reference(DeviceDefinition)	Reference to the part	Σ	1..1	Reference(DeviceDefinition)	Reference to the part
count		0..1	integer	Number of occurrences of the part		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		0..*	BackboneElement	Information about the packaging of the device, i.e. how the device is packaged
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
identifier		0..1	Identifier	Business identifier of the packaged medication		0..1	Identifier	Business identifier of the packaged medication
type		0..1	CodeableConcept	A code that defines the specific type of packaging		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)		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		0..*	BackboneElement	An organization that distributes the packaged device
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Distributor's human-readable name		0..1	string	Distributor's human-readable name
organizationReference		0..*	Reference(Organization)	Distributor as an Organization resource		0..*	Reference(Organization)	Distributor as an Organization resource
udiDeviceIdentifier		0..*	See udiDeviceIdentifier (DeviceDefinition)	Unique Device Identifier (UDI) Barcode string on the packaging		0..*	See udiDeviceIdentifier (DeviceDefinition)	Unique Device Identifier (UDI) Barcode string on the packaging
packaging		0..*	See packaging (DeviceDefinition)	Allows packages within packages		0..*	See packaging (DeviceDefinition)	Allows packages within packages
version		0..*	BackboneElement	The version of the device or software		0..*	BackboneElement	The version of the device or software
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	The type of the device version, e.g. manufacturer, approved, internal		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		0..1	Identifier	The hardware or software module of the device to which the version applies
value		1..1	string	The version text		1..1	string	The version text
safety	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: ?? (example)	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: ?? (example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information		0..*	ProductShelfLife	Shelf Life and storage information
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
property	S	0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc	S	0..*	BackboneElement	Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	S	1..1	CodeableConcept	Code that specifies the property being represented Binding: ?? (example)	S	1..1	CodeableConcept	Code that specifies the property being represented Binding: ?? (example)
value[x]	S	1..1	Quantity, CodeableConcept, string, boolean, integer, Range, Attachment	Value of the property	S	1..1	Quantity, CodeableConcept, string, boolean, integer, Range, Attachment	Value of the property
owner		0..1	Reference(Organization)	Organization responsible for device		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support		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		0..*	BackboneElement	An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relation		1..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ?? (extensible): The type of relation between this and the linked device.		1..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ?? (extensible): The type of relation between this and the linked device.
relatedDevice		1..1	CodeableReference(DeviceDefinition)	A reference to the linked device		1..1	CodeableReference(DeviceDefinition)	A reference to the linked device
note		0..*	Annotation	Device notes and comments		0..*	Annotation	Device notes and comments
material		0..*	BackboneElement	A substance used to create the material(s) of which the device is made		0..*	BackboneElement	A substance used to create the material(s) of which the device is made
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
substance		1..1	CodeableConcept	A relevant substance that the device contains, may contain, or is made of		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		0..1	boolean	Indicates an alternative material of the device
allergenicIndicator		0..1	boolean	Whether the substance is a known or suspected allergen		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: ?? (required): The production identifier(s) that are expected to appear in the UDI carrier.		0..*	code	lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: ?? (required): The production identifier(s) that are expected to appear in the UDI carrier.
guideline		0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device		0..1	BackboneElement	Information aimed at providing directions for the usage of this model of device
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
useContext		0..*	UsageContext	The circumstances that form the setting for using the device		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		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		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		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		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		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		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		0..1	BackboneElement	Tracking of latest field safety corrective action
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
recall		1..1	boolean	Whether the corrective action was a recall		1..1	boolean	Whether the corrective action was a recall
scope		0..1	code	model | lot-numbers | serial-numbers Binding: ?? (required): The type or scope of the corrective action.		0..1	code	model | lot-numbers | serial-numbers Binding: ?? (required): The type or scope of the corrective action.
period		1..1	Period	Start and end dates of the corrective action		1..1	Period	Start and end dates of the corrective action
chargeItem		0..*	BackboneElement	Billing code or reference associated with the device		0..*	BackboneElement	Billing code or reference associated with the device
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
chargeItemCode		1..1	CodeableReference(ChargeItemDefinition)	The code or reference for the charge item		1..1	CodeableReference(ChargeItemDefinition)	The code or reference for the charge item
count		1..1	Quantity	Coefficient applicable to the billing code		1..1	Quantity	Coefficient applicable to the billing code
effectivePeriod		0..1	Period	A specific time period in which this charge item applies		0..1	Period	A specific time period in which this charge item applies
useContext		0..*	UsageContext	The context to which this charge item applies		0..*	UsageContext	The context to which this charge item applies
Documentation for this format