This is the set of resources that conform to either of the profiles DeviceDefinition - Drug PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq) and DeviceDefinition - Drug PQ (http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq). E.g. what you have to deal with if you get resources conforming to one of them
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
DeviceDefinition | 0..* | An instance of a medical-related component of a medical device dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management | ||
meta | Σ | 0..1 | Meta | Metadata about the resource ele-1: All FHIR elements must have a @value or children |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children |
language | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language ele-1: All FHIR elements must have a @value or children | |
text | 0..1 | Narrative | Text summary of the resource, for human interpretation ele-1: All FHIR elements must have a @value or children | |
contained | 0..* | Resource | Contained, inline Resources | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
description | 0..1 | markdown | Additional information to describe the device ele-1: All FHIR elements must have a @value or children | |
identifier | Σ | 0..* | Identifier | Instance identifier ele-1: All FHIR elements must have a @value or children |
udiDeviceIdentifier | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
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 ele-1: All FHIR elements must have a @value or children | |
issuer | 1..1 | uri | The organization that assigns the identifier algorithm ele-1: All FHIR elements must have a @value or children | |
jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies ele-1: All FHIR elements must have a @value or children | |
marketDistribution | 0..* | BackboneElement | Indicates whether and when the device is available on the market ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
marketPeriod | 1..1 | Period | Begin and end dates for the commercial distribution of the device ele-1: All FHIR elements must have a @value or children | |
subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized ele-1: All FHIR elements must have a @value or children | |
regulatoryIdentifier | 0..* | BackboneElement | Regulatory identifier(s) associated with this device ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
type | 1..1 | code | basic | master | license Binding: ?? (required): Device regulatory identifier type. ele-1: All FHIR elements must have a @value or children | |
deviceIdentifier | 1..1 | string | The identifier itself ele-1: All FHIR elements must have a @value or children | |
issuer | 1..1 | uri | The organization that issued this identifier ele-1: All FHIR elements must have a @value or children | |
jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies ele-1: All FHIR elements must have a @value or children | |
partNumber | 0..1 | string | The part number or catalog number of the device ele-1: All FHIR elements must have a @value or children | |
manufacturer | Σ | 0..1 | Reference(Organization) | Name of device manufacturer ele-1: All FHIR elements must have a @value or children |
deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer ele-1: All FHIR elements must have a @value or children |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
name | Σ | 1..1 | string | A name that is used to refer to the device ele-1: All FHIR elements must have a @value or children |
type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: ?? (required): The type of name the device is referred by. ele-1: All FHIR elements must have a @value or children |
modelNumber | Σ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer ele-1: All FHIR elements must have a @value or children |
classification | SΣ | 0..* | BackboneElement | What kind of device or device system this is ele-1: All FHIR elements must have a @value or children |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
type | SΣ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: ?? (example) ele-1: All FHIR elements must have a @value or children |
justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model ele-1: All FHIR elements must have a @value or children | |
conformsTo | Σ | 0..* | BackboneElement | Identifies the standards, specifications, or formal guidances for the capabilities supported by the device ele-1: All FHIR elements must have a @value or children |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
category | Σ | 0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance Binding: ?? (example) ele-1: All FHIR elements must have a @value or children |
specification | Σ | 1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: ?? (example) ele-1: All FHIR elements must have a @value or children |
version | Σ | 0..* | string | The specific form or variant of the standard, specification or formal guidance ele-1: All FHIR elements must have a @value or children |
source | 0..* | RelatedArtifact | Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance ele-1: All FHIR elements must have a @value or children | |
hasPart | Σ | 0..* | BackboneElement | A device, part of the current one ele-1: All FHIR elements must have a @value or children |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
reference | Σ | 1..1 | Reference(DeviceDefinition) | Reference to the part ele-1: All FHIR elements must have a @value or children |
count | 0..1 | integer | Number of occurrences of the part ele-1: All FHIR elements must have a @value or children | |
packaging | 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
identifier | 0..1 | Identifier | Business identifier of the packaged medication ele-1: All FHIR elements must have a @value or children | |
type | 0..1 | CodeableConcept | A code that defines the specific type of packaging ele-1: All FHIR elements must have a @value or children | |
count | 0..1 | integer | The number of items contained in the package (devices or sub-packages) ele-1: All FHIR elements must have a @value or children | |
distributor | 0..* | BackboneElement | An organization that distributes the packaged device ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
name | 0..1 | string | Distributor's human-readable name ele-1: All FHIR elements must have a @value or children | |
organizationReference | 0..* | Reference(Organization) | Distributor as an Organization resource ele-1: All FHIR elements must have a @value or children | |
udiDeviceIdentifier | 0..* | Unique Device Identifier (UDI) Barcode string on the packaging ele-1: All FHIR elements must have a @value or children | ||
packaging | 0..* | Allows packages within packages ele-1: All FHIR elements must have a @value or children | ||
version | 0..* | BackboneElement | The version of the device or software ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
type | 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal ele-1: All FHIR elements must have a @value or children | |
component | 0..1 | Identifier | The hardware or software module of the device to which the version applies ele-1: All FHIR elements must have a @value or children | |
value | 1..1 | string | The version text ele-1: All FHIR elements must have a @value or children | |
safety | Σ | 0..* | CodeableConcept | Safety characteristics of the device Binding: ?? (example) ele-1: All FHIR elements must have a @value or children |
shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information ele-1: All FHIR elements must have a @value or children | |
languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) ele-1: All FHIR elements must have a @value or children | |
property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc ele-1: All FHIR elements must have a @value or children |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
type | S | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: ?? (example) ele-1: All FHIR elements must have a @value or children |
value[x] | S | 1..1 | Value of the property ele-1: All FHIR elements must have a @value or children | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueAttachment | Attachment | |||
owner | 0..1 | Reference(Organization) | Organization responsible for device ele-1: All FHIR elements must have a @value or children | |
contact | 0..* | ContactPoint | Details for human/organization for support ele-1: All FHIR elements must have a @value or children | |
link | 0..* | BackboneElement | An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
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. ele-1: All FHIR elements must have a @value or children | |
relatedDevice | 1..1 | CodeableReference(DeviceDefinition) | A reference to the linked device ele-1: All FHIR elements must have a @value or children | |
note | 0..* | Annotation | Device notes and comments ele-1: All FHIR elements must have a @value or children | |
material | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
substance | 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of ele-1: All FHIR elements must have a @value or children | |
alternate | 0..1 | boolean | Indicates an alternative material of the device ele-1: All FHIR elements must have a @value or children | |
allergenicIndicator | 0..1 | boolean | Whether the substance is a known or suspected allergen ele-1: All FHIR elements must have a @value or children | |
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. ele-1: All FHIR elements must have a @value or children | |
guideline | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
useContext | 0..* | UsageContext | The circumstances that form the setting for using the device ele-1: All FHIR elements must have a @value or children | |
usageInstruction | 0..1 | markdown | Detailed written and visual directions for the user on how to use the device ele-1: All FHIR elements must have a @value or children | |
relatedArtifact | 0..* | RelatedArtifact | A source of information or reference for this guideline ele-1: All FHIR elements must have a @value or children | |
indication | 0..* | CodeableConcept | A clinical condition for which the device was designed to be used ele-1: All FHIR elements must have a @value or children | |
contraindication | 0..* | CodeableConcept | A specific situation when a device should not be used because it may cause harm ele-1: All FHIR elements must have a @value or children | |
warning | 0..* | CodeableConcept | Specific hazard alert information that a user needs to know before using the device ele-1: All FHIR elements must have a @value or children | |
intendedUse | 0..1 | string | A description of the general purpose or medical use of the device or its function ele-1: All FHIR elements must have a @value or children | |
correctiveAction | 0..1 | BackboneElement | Tracking of latest field safety corrective action ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
recall | 1..1 | boolean | Whether the corrective action was a recall ele-1: All FHIR elements must have a @value or children | |
scope | 0..1 | code | model | lot-numbers | serial-numbers Binding: ?? (required): The type or scope of the corrective action. ele-1: All FHIR elements must have a @value or children | |
period | 1..1 | Period | Start and end dates of the corrective action ele-1: All FHIR elements must have a @value or children | |
chargeItem | 0..* | BackboneElement | Billing code or reference associated with the device ele-1: All FHIR elements must have a @value or children | |
extension | 0..* | Extension | Additional content defined by implementations ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
chargeItemCode | 1..1 | CodeableReference(ChargeItemDefinition) | The code or reference for the charge item ele-1: All FHIR elements must have a @value or children | |
count | 1..1 | Quantity | Coefficient applicable to the billing code ele-1: All FHIR elements must have a @value or children | |
effectivePeriod | 0..1 | Period | A specific time period in which this charge item applies ele-1: All FHIR elements must have a @value or children | |
useContext | 0..* | UsageContext | The context to which this charge item applies ele-1: All FHIR elements must have a @value or children | |
Documentation for this format |