StructureDefinition-UKCore-Device

Canonical_URLStatusCurrent_VersionLast_UpdatedDescription
https://fhir.hl7.org.uk/StructureDefinition/UKCore-Devicedraft1.2.02023-12-12

This profile defines the UK constraints and extensions on the International FHIR resource Device.


Profile_Purpose

The purpose of this profile is to hold information about a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, referenced when prescribing and dispensing devices for patient use or for ordering supplies, and used to record and transmit Unique Device Identifier (UDI) information about a device such as a patient's implant.

identifier0..*Identifier
definitionI0..1Reference(DeviceDefinition)
deviceIdentifierΣ0..1string
issuer0..1uri
jurisdiction0..1uri
carrierAIDCΣ0..1base64Binary
carrierHRFΣ0..1string
entryType0..1codeBinding
statusS Σ ?!0..1codeBinding
statusReason0..*CodeableConceptBinding
distinctIdentifier0..1string
manufacturer0..1string
manufactureDate0..1dateTime
expirationDate0..1dateTime
lotNumber0..1string
serialNumber0..1string
name1..1string
type1..1codeBinding
modelNumber0..1string
partNumber0..1string
typeS0..1CodeableConceptBinding
systemType1..1CodeableConcept
version0..1string
type0..1CodeableConcept
component0..1Identifier
value1..1string
type1..1CodeableConcept
valueQuantityI0..*Quantity
valueCode0..*CodeableConcept
patientI0..1Reference(Patient)
ownerI0..1Reference(Organization)
contactI0..*ContactPoint
locationI0..1Reference(Location)
url0..1uri
note0..*Annotation
safetyΣ0..*CodeableConcept
parentI0..1Reference(Device)

Detailed Descriptions

Device
DefinitionA type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.
Cardinality0...*
Invariants
  • dom-2:If the resource is contained in another resource, it SHALL NOT contain nested Resources
    contained.contained.empty()
  • dom-4:If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
  • 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
    contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
  • dom-6:A resource should have narrative for robust management
    text.`div`.exists()
  • dom-5:If a resource is contained in another resource, it SHALL NOT have a security label
    contained.meta.security.empty()
Mappings
  • rim:Entity. Role, or Act
  • rim:Device
Device.id
DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Cardinality0...1
TypeSystem.String
SummaryTrue
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Device.meta
DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Cardinality0...1
TypeMeta
SummaryTrue
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • rim:N/A
Device.implicitRules
DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Cardinality0...1
Typeuri
ModifierTrue
SummaryTrue
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.language
DefinitionThe base language in which the resource is written.
Cardinality0...1
Typecode
Binding

A human language.

CommonLanguages (preferred)
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.text
DefinitionA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Cardinality0...1
TypeNarrative
Aliasnarrative, html, xhtml, display
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • rim:N/A
  • rim:Act.text?
Device.contained
DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Cardinality0...*
TypeResource
Aliasinline resources, anonymous resources, contained resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Mappings
  • rim:Entity. Role, or Act
  • rim:N/A
Device.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.modifierExtension
DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality0...*
TypeExtension
ModifierTrue
Aliasextensions, user content
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.identifier
DefinitionUnique instance identifiers assigned to a device by manufacturers other organizations or owners.
Cardinality0...*
TypeIdentifier
Comments

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CX / EI (occasionally, more often EI maps to a resource id or a URL)
  • rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
  • servd:Identifier
  • w5:FiveWs.identifier
  • rim:.id
  • udi:The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
Device.definition
DefinitionThe reference to the definition for the device.
Cardinality0...1
TypeReference(DeviceDefinition)
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1:SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim:n/a
  • rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
Device.udiCarrier
DefinitionUnique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
Cardinality0...*
TypeBackboneElement
SummaryTrue
Comments

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.identifier
  • rim:.id and .code
Device.udiCarrier.id
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
Device.udiCarrier.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.udiCarrier.modifierExtension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.udiCarrier.deviceIdentifier
DefinitionThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Cardinality0...1
Typestring
SummaryTrue
AliasDI
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:Role.id.extension
  • udi:The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Device.udiCarrier.issuer
DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Cardinality0...1
Typeuri
AliasBarcode System
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • rim:Role.id.root
  • udi:All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
Device.udiCarrier.jurisdiction
DefinitionThe identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.
Cardinality0...1
Typeuri
Requirements

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • rim:Role.scoper
Device.udiCarrier.carrierAIDC
DefinitionThe full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 encoded.
Cardinality0...1
Typebase64Binary
SummaryTrue
AliasAutomatic Identification and Data Capture
Comments

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • rim:Role.id.extension
  • udi:A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
Device.udiCarrier.carrierHRF
DefinitionThe full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Cardinality0...1
Typestring
SummaryTrue
AliasHuman Readable Form
Comments

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • rim:Role.id.extension
  • udi:A unique device identifier (UDI) on a device label in plain text
Device.udiCarrier.entryType
DefinitionA coded entry to indicate how the data was entered.
Cardinality0...1
Typecode
Binding

Codes to identify how UDI data was entered.

UDIEntryType (required)
Requirements

Supports a way to distinguish hand entered from machine read data.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • rim:NA
Device.status
DefinitionStatus of the Device availability.
Cardinality0...1
Typecode
Binding

The availability status of the device.

FHIRDeviceStatus (required)
Must SupportTrue
ModifierTrue
SummaryTrue
Comments

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.status
  • rim:.statusCode
Device.statusReason
DefinitionReason for the dtatus of the Device availability.
Cardinality0...*
TypeCodeableConcept
Binding

The availability status reason of the device.

FHIRDeviceStatusReason (extensible)
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CE/CNE/CWE
  • rim:CD
  • orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
  • w5:FiveWs.status
Device.distinctIdentifier
DefinitionThe distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.
Cardinality0...1
Typestring
AliasDistinct Identification Code (DIC)
Comments

For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.lotNumberText
  • udi:The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
Device.manufacturer
DefinitionA name of the manufacturer.
Cardinality0...1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.playedRole[typeCode=MANU].scoper.name
  • udi:N/A
Device.manufactureDate
DefinitionThe date and time when the device was manufactured.
Cardinality0...1
TypedateTime
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.existenceTime.low
  • udi:The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
Device.expirationDate
DefinitionThe date and time beyond which this device is no longer valid or should not be used (if applicable).
Cardinality0...1
TypedateTime
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.expirationTime
  • udi:the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
Device.lotNumber
DefinitionLot number assigned by the manufacturer.
Cardinality0...1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.lotNumberText
  • udi:The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
Device.serialNumber
DefinitionThe serial number assigned by the organization when the device was manufactured.
Cardinality0...1
Typestring
Comments

Alphanumeric Maximum 20.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.playedRole[typeCode=MANU].id
Device.deviceName
DefinitionThis represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.
Cardinality0...*
TypeBackboneElement
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.deviceName.id
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
Device.deviceName.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.deviceName.modifierExtension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.deviceName.name
DefinitionThe name of the device.
Cardinality1...1
Typestring
AliasΣ
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.deviceName.type
DefinitionThe type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
Cardinality1...1
Typecode
Binding

The type of name the device is referred by.

DeviceNameType (required)
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.playedRole[typeCode=MANU].code
Device.modelNumber
DefinitionThe model number for the device.
Cardinality0...1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.softwareName (included as part)
Device.partNumber
DefinitionThe part number of the device.
Cardinality0...1
Typestring
Comments

Alphanumeric Maximum 20.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
  • rim:.playedRole[typeCode=MANU].id
Device.type
DefinitionThe kind or type of device.
Cardinality0...1
TypeCodeableConcept
Binding

A code from the SNOMED Clinical Terminology UK coding system that describes a type of device.

UKCoreDeviceType (preferred)
Must SupportTrue
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CE/CNE/CWE
  • rim:CD
  • orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
Device.specialization
DefinitionThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
Cardinality0...*
TypeBackboneElement
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.specialization.id
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
Device.specialization.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.specialization.modifierExtension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.specialization.systemType
DefinitionThe standard that is used to operate and communicate.
Cardinality1...1
TypeCodeableConcept
AliasΣ
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CE/CNE/CWE
  • rim:CD
  • orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
Device.specialization.version
DefinitionThe version of the standard that is used to operate and communicate.
Cardinality0...1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.what[x]
Device.version
DefinitionThe actual design of the device or software version running on the device.
Cardinality0...*
TypeBackboneElement
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.version.id
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
Device.version.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.version.modifierExtension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.version.type
DefinitionThe type of the device version.
Cardinality0...1
TypeCodeableConcept
AliasΣ
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CE/CNE/CWE
  • rim:CD
  • orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
Device.version.component
DefinitionA single component of the device version.
Cardinality0...1
TypeIdentifier
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CX / EI (occasionally, more often EI maps to a resource id or a URL)
  • rim:II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
  • servd:Identifier
  • w5:FiveWs.what[x]
Device.version.value
DefinitionThe version text.
Cardinality1...1
Typestring
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.property
DefinitionThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
Cardinality0...*
TypeBackboneElement
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
Device.property.id
DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
TypeSystem.String
Mappings
  • rim:n/a
Device.property.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.property.modifierExtension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ext-1:Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim:n/a
  • rim:N/A
Device.property.type
DefinitionCode that specifies the property DeviceDefinitionPropetyCode (Extensible).
Cardinality1...1
TypeCodeableConcept
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CE/CNE/CWE
  • rim:CD
  • orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
Device.property.valueQuantity
DefinitionProperty value as a quantity.
Cardinality0...*
TypeQuantity
Comments

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • qty-3:If a code for the unit is present, the system SHALL also be present
    code.empty() or system.exists()
Mappings
  • rim:n/a
  • v2:SN (see also Range) or CQ
  • rim:PQ, IVL<PQ>, MO, CO, depending on the values
Device.property.valueCode
DefinitionProperty value as a code, e.g., NTP4 (synced to NTP).
Cardinality0...*
TypeCodeableConcept
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CE/CNE/CWE
  • rim:CD
  • orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
Device.patient
DefinitionPatient information, If the device is affixed to a person.
Cardinality0...1
TypeReference(Patient)
Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1:SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim:n/a
  • rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • w5:FiveWs.subject[x]
  • rim:.playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
  • w5:FiveWs.subject
Device.owner
DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device.
Cardinality0...1
TypeReference(Organization)
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1:SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim:n/a
  • rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • w5:FiveWs.source
  • rim:.playedRole[typeCode=OWN].scoper
Device.contact
DefinitionContact details for an organization or a particular human that is responsible for the device.
Cardinality0...*
TypeContactPoint
Comments

used for troubleshooting etc.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • cpt-2:A system is required if a value is provided.
    value.empty() or system.exists()
Mappings
  • rim:n/a
  • v2:XTN
  • rim:TEL
  • servd:ContactPoint
  • w5:FiveWs.source
  • rim:.scopedRole[typeCode=CON].player
Device.location
DefinitionThe place where the device can be found.
Cardinality0...1
TypeReference(Location)
Requirements

Device.location can be used to track device location.

Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1:SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim:n/a
  • rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • w5:FiveWs.where[x]
  • rim:.playedRole[typeCode=LOCE].scoper
Device.url
DefinitionA network address on which the device may be contacted directly.
Cardinality0...1
Typeuri
Comments

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • w5:FiveWs.where[x]
  • rim:.telecom
Device.note
DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element.
Cardinality0...*
TypeAnnotation
Comments

For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:N/A
  • rim:Act
  • rim:.text
Device.safety
DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex.
Cardinality0...*
TypeCodeableConcept
SummaryTrue
Comments

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
Mappings
  • rim:n/a
  • v2:CE/CNE/CWE
  • rim:CD
  • orim:fhir:CodeableConcept rdfs:subClassOf dt:CD
  • rim:NA
Device.parent
DefinitionThe parent device.
Cardinality0...1
TypeReference(Device)
Comments

References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Invariants
  • ele-1:All FHIR elements must have a @value or children
    hasValue() or (children().count() > id.count())
  • ref-1:SHALL have a contained resource if a local reference is provided
    reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))
Mappings
  • rim:n/a
  • rim:The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Table View

Device..
Device.status..
Device.type..


XML View

<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="UKCore-Device" />
    <url value="https://fhir.hl7.org.uk/StructureDefinition/UKCore-Device" />
    <version value="1.2.0" />
    <name value="UKCoreDevice" />
    <title value="UK Core Device" />
    <status value="draft" />
    <date value="2023-12-12" />
    <publisher value="HL7 UK" />
    <contact>
        <name value="HL7 UK" />
        <telecom>
            <system value="email" />
            <value value="ukcore@hl7.org.uk" />
            <use value="work" />
            <rank value="1" />
        </telecom>
    </contact>
    <description value="This profile defines the UK constraints and extensions on the International FHIR resource [Device](https://hl7.org/fhir/R4/Device.html)." />
    <purpose value="The purpose of this profile is to hold information about a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, referenced when prescribing and dispensing devices for patient use or for ordering supplies, and used to record and transmit Unique Device Identifier (UDI) information about a device such as a patient&#39;s implant." />
    <copyright value="Copyright &#169; 2021+ HL7 UK Licensed under the Apache License, Version 2.0 (the &quot;License&quot;); you may not use this file except in compliance with the License. You may obtain a copy of the License at  http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an &quot;AS IS&quot; BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License. HL7&#174; FHIR&#174; standard Copyright &#169; 2011+ HL7 The HL7&#174; FHIR&#174; standard is used under the FHIR license. You may obtain a copy of the FHIR license at  https://www.hl7.org/fhir/license.html." />
    <fhirVersion value="4.0.1" />
    <kind value="resource" />
    <abstract value="false" />
    <type value="Device" />
    <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Device" />
    <derivation value="constraint" />
    <differential>
        <element id="Device.status">
            <path value="Device.status" />
            <short value="The status of the Device." />
            <mustSupport value="true" />
        </element>
        <element id="Device.type">
            <path value="Device.type" />
            <short value="The type of the Device." />
            <mustSupport value="true" />
            <binding>
                <strength value="preferred" />
                <description value="A code from the SNOMED Clinical Terminology UK coding system that describes a type of device." />
                <valueSet value="https://fhir.hl7.org.uk/ValueSet/UKCore-DeviceType" />
            </binding>
        </element>
    </differential>
</StructureDefinition>

JSON View

{
    "resourceType": "StructureDefinition",
    "id": "UKCore-Device",
    "url": "https://fhir.hl7.org.uk/StructureDefinition/UKCore-Device",
    "version": "1.2.0",
    "name": "UKCoreDevice",
    "title": "UK Core Device",
    "status": "draft",
    "date": "2023-12-12",
    "publisher": "HL7 UK",
    "contact":  [
        {
            "name": "HL7 UK",
            "telecom":  [
                {
                    "system": "email",
                    "value": "ukcore@hl7.org.uk",
                    "use": "work",
                    "rank": 1
                }
            ]
        }
    ],
    "description": "This profile defines the UK constraints and extensions on the International FHIR resource [Device](https://hl7.org/fhir/R4/Device.html).",
    "purpose": "The purpose of this profile is to hold information about a type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, referenced when prescribing and dispensing devices for patient use or for ordering supplies, and used to record and transmit Unique Device Identifier (UDI) information about a device such as a patient's implant.",
    "copyright": "Copyright © 2021+ HL7 UK Licensed under the Apache License, Version 2.0 (the \"License\"); you may not use this file except in compliance with the License. You may obtain a copy of the License at  http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an \"AS IS\" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License. HL7® FHIR® standard Copyright © 2011+ HL7 The HL7® FHIR® standard is used under the FHIR license. You may obtain a copy of the FHIR license at  https://www.hl7.org/fhir/license.html.",
    "fhirVersion": "4.0.1",
    "kind": "resource",
    "abstract": false,
    "type": "Device",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Device",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Device.status",
                "path": "Device.status",
                "short": "The status of the Device.",
                "mustSupport": true
            },
            {
                "id": "Device.type",
                "path": "Device.type",
                "short": "The type of the Device.",
                "mustSupport": true,
                "binding": {
                    "strength": "preferred",
                    "description": "A code from the SNOMED Clinical Terminology UK coding system that describes a type of device.",
                    "valueSet": "https://fhir.hl7.org.uk/ValueSet/UKCore-DeviceType"
                }
            }
        ]
    }
}

Usage

This Profile has the following derived profiles:
idbaseDefinitionstatus
UKCore-Device-BloodPressurehttps://fhir.hl7.org.uk/StructureDefinition/UKCore-Deviceactive


This Profile is referenced in the following Extensions:
idtargetProfile
Extension-UKCore-DeviceReferencehttp://hl7.org/fhir/StructureDefinition/Device
Extension-UKCore-FamilyMemberHistoryParticipanthttp://hl7.org/fhir/StructureDefinition/Patient; http://hl7.org/fhir/StructureDefinition/Practitioner; http://hl7.org/fhir/StructureDefinition/PractitionerRole; http://hl7.org/fhir/StructureDefinition/RelatedPerson; http://hl7.org/fhir/StructureDefinition/Device; http://hl7.org/fhir/StructureDefinition/Organization; http://hl7.org/fhir/StructureDefinition/CareTeam


This Profile is referenced in the following Profiles:

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Examples

Colostomy Bag - An example to illustrate a colostomy bag
Example UKCore-Device-ColostomyBag Software as a Medical Device - An example to illustrate recording AI softweare as a medical device.
Example UKCore-Device-SoftwareAsAMedicalDevice

Sphygmomanometer - An example to illustrate recording a specific blood pressure device.
Example UKCore-Device-Sphygmomanometer

Example Usage Scenarios

The following are example usage scenarios for the UK Core Device profile:

  • Query and retrieve information regarding a medical device
  • Record or update a device used during a patient's care

Profile Specific Implementation Guidance:

Minimum Viable Content

A minimum viable content that all provider and consumer systems SHALL support are the following elements.

Element Reason
Device.status The status of the Device.
Device.type The type of the Device.

Bindings (differential)

More information about the bindings to UK Core ValueSets can be found below.

Context Strength Link
Device.type Preferred ValueSet UKCore-DeviceType

patient

Where possible, it is expected that the resource being referenced SHOULD conform to Profile UKCore-Patient.


owner

Where possible, it is expected that the resource being referenced SHOULD conform to Profile UKCore-Organization.


location

Where possible, it is expected that the resource being referenced SHOULD conform to Profile UKCore-Location.


parent

Where possible, it is expected that the resource being referenced SHOULD conform to Profile UKCore-Device.