Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Orders and Observations Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the DeviceDefinition resource.

DeviceDefinition
Element IdDeviceDefinition
Definition

The characteristics, operational status and capabilities of a medical-related component of a medical device.

Cardinality0..*
TypeDomainResource
Summaryfalse
Comments

For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.

DeviceDefinition.description
Element IdDeviceDefinition.description
Definition

Additional information to describe the device.

Cardinality0..1
Typemarkdown
Summaryfalse
DeviceDefinition.identifier
Element IdDeviceDefinition.identifier
Definition

Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summaryfalse
DeviceDefinition.udiDeviceIdentifier
Element IdDeviceDefinition.udiDeviceIdentifier
Definition

Unique 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..*
Summaryfalse
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Element IdDeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Definition

The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.

Cardinality1..1
Typestring
Summaryfalse
DeviceDefinition.udiDeviceIdentifier.issuer
Element IdDeviceDefinition.udiDeviceIdentifier.issuer
Definition

The organization that assigns the identifier algorithm.

Cardinality1..1
Typeuri
Summaryfalse
DeviceDefinition.udiDeviceIdentifier.jurisdiction
Element IdDeviceDefinition.udiDeviceIdentifier.jurisdiction
Definition

The jurisdiction to which the deviceIdentifier applies.

Cardinality1..1
Typeuri
Summaryfalse
DeviceDefinition.udiDeviceIdentifier.marketDistribution
Element IdDeviceDefinition.udiDeviceIdentifier.marketDistribution
Definition

Indicates where and when the device is available on the market.

Cardinality0..*
Summaryfalse
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
Element IdDeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
Definition

Begin and end dates for the commercial distribution of the device.

Cardinality1..1
TypePeriod
Summaryfalse
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
Element IdDeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
Definition

National state or territory to which the marketDistribution recers, typically where the device is commercialized.

Cardinality1..1
Typeuri
Summaryfalse
DeviceDefinition.partNumber
Element IdDeviceDefinition.partNumber
Definition

The part number or catalog number of the device.

Cardinality0..1
Typestring
Summaryfalse
Comments

Alphanumeric Maximum 20.

DeviceDefinition.manufacturer
Element IdDeviceDefinition.manufacturer
Definition

A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.

Cardinality0..1
TypeReference(Organization)
Summaryfalse
DeviceDefinition.deviceName
Element IdDeviceDefinition.deviceName
Definition

The name or names of the device as given by the manufacturer.

Cardinality0..*
Summaryfalse
DeviceDefinition.deviceName.name
Element IdDeviceDefinition.deviceName.name
Definition

A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.

Cardinality1..1
Typestring
Alternate NamesΣ
Summaryfalse
DeviceDefinition.deviceName.type
Element IdDeviceDefinition.deviceName.type
Definition

The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName.

Cardinality1..1
Terminology BindingDeviceNameType (Required)
Typecode
Summaryfalse
DeviceDefinition.modelNumber
Element IdDeviceDefinition.modelNumber
Definition

The model number for the device for example as defined by the manufacturer or labeler, or other agency.

Cardinality0..1
Typestring
Summaryfalse
DeviceDefinition.classification
Element IdDeviceDefinition.classification
Definition

What kind of device or device system this is.

Cardinality0..*
Summaryfalse
Comments

In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.

DeviceDefinition.classification.type
Element IdDeviceDefinition.classification.type
Definition

A classification or risk class of the device model.

Cardinality1..1
Terminology BindingDevice Type (Example)
TypeCodeableConcept
Summaryfalse
DeviceDefinition.classification.justification
Element IdDeviceDefinition.classification.justification
Definition

Further information qualifying this classification of the device model.

Cardinality0..*
TypeRelatedArtifact
Summaryfalse
DeviceDefinition.specialization
Element IdDeviceDefinition.specialization
Definition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

Cardinality0..*
TypeRelatedArtifact
Summaryfalse
DeviceDefinition.hasPart
Element IdDeviceDefinition.hasPart
Definition

A device that is part (for example a component) of the present device.

Cardinality0..*
Summaryfalse
DeviceDefinition.hasPart.reference
Element IdDeviceDefinition.hasPart.reference
Definition

Reference to the device that is part of the current device.

Cardinality1..1
TypeReference(DeviceDefinition)
Summaryfalse
DeviceDefinition.hasPart.count
Element IdDeviceDefinition.hasPart.count
Definition

Number of instances of the component device in the current device.

Cardinality0..1
Typeinteger
Summaryfalse
DeviceDefinition.packaging
Element IdDeviceDefinition.packaging
Definition

Information about the packaging of the device, i.e. how the device is packaged.

Cardinality0..*
Summaryfalse
DeviceDefinition.packaging.identifier
Element IdDeviceDefinition.packaging.identifier
Definition

The business identifier of the packaged medication.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..1
TypeIdentifier
Summaryfalse
DeviceDefinition.packaging.type
Element IdDeviceDefinition.packaging.type
Definition

A code that defines the specific type of packaging.

Cardinality0..1
TypeCodeableConcept
Summaryfalse
DeviceDefinition.packaging.count
Element IdDeviceDefinition.packaging.count
Definition

The number of items contained in the package (devices or sub-packages).

Cardinality0..1
Typeinteger
Summaryfalse
DeviceDefinition.packaging.distributor
Element IdDeviceDefinition.packaging.distributor
Definition

An organization that distributes the packaged device.

Cardinality0..*
Summaryfalse
DeviceDefinition.packaging.distributor.name
Element IdDeviceDefinition.packaging.distributor.name
Definition

Distributor's human-readable name.

Cardinality0..1
Typestring
Summaryfalse
DeviceDefinition.packaging.distributor.organizationReference
Element IdDeviceDefinition.packaging.distributor.organizationReference
Definition

Distributor as an Organization resource.

Cardinality0..*
TypeReference
Summaryfalse
DeviceDefinition.packaging.udiDeviceIdentifier
Element IdDeviceDefinition.packaging.udiDeviceIdentifier
Definition

Unique Device Identifier (UDI) Barcode string on the packaging.

Cardinality0..*
Summaryfalse
DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier
Element IdDeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier
Definition

Identifier to be associated with every instance for issuer and jurisdiction.

Cardinality1..1
Typestring
Summaryfalse
DeviceDefinition.packaging.udiDeviceIdentifier.issuer
Element IdDeviceDefinition.packaging.udiDeviceIdentifier.issuer
Definition

The organization that assigns the identifier algorithm.

Cardinality1..1
Typeuri
Summaryfalse
DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction
Element IdDeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction
Definition

The jurisdiction to which the deviceIdentifier applies.

Cardinality1..1
Typeuri
Summaryfalse
DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution
Element IdDeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution
Definition

The organization that assigns the identifier algorithm.

Cardinality0..1
Summaryfalse
DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod
Element IdDeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod
Definition

Begin and end dates for the commercial distribution of the device.

Cardinality0..1
TypePeriod
Summaryfalse
DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction
Element IdDeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction
Definition

National state or territory to which the marketDistribution refers, typically where the device is commercialized.

Cardinality0..1
Typeuri
Summaryfalse
DeviceDefinition.packaging.packaging
Element IdDeviceDefinition.packaging.packaging
Definition

Allows packages within packages.

Cardinality0..*
TypeSee DeviceDefinition.packaging
Summaryfalse
DeviceDefinition.version
Element IdDeviceDefinition.version
Definition

The version of the device or software.

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..*
Summaryfalse
DeviceDefinition.version.type
Element IdDeviceDefinition.version.type
Definition

The type of the device version, e.g. manufacturer, approved, internal.

Cardinality0..1
TypeCodeableConcept
Alternate NamesΣ
Summaryfalse
DeviceDefinition.version.component
Element IdDeviceDefinition.version.component
Definition

The hardware or software module of the device to which the version applies.

Cardinality0..1
TypeIdentifier
Summaryfalse
Comments

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

DeviceDefinition.version.value
Element IdDeviceDefinition.version.value
Definition

The version text.

Cardinality1..1
Typestring
Summaryfalse
DeviceDefinition.safety
Element IdDeviceDefinition.safety
Definition

Safety characteristics of the device.

Cardinality0..*
Terminology BindingSafety :
TypeCodeableConcept
Summarytrue
DeviceDefinition.shelfLifeStorage
Element IdDeviceDefinition.shelfLifeStorage
Definition

Shelf Life and storage information.

Cardinality0..*
TypeProductShelfLife
Summaryfalse
DeviceDefinition.languageCode
Element IdDeviceDefinition.languageCode
Definition

Language code for the human-readable text strings produced by the device (all supported).

Cardinality0..*
TypeCodeableConcept
Summaryfalse
DeviceDefinition.property
Element IdDeviceDefinition.property
Definition

The potential, valid configuration settings of a device, e.g., regulation status, time properties.

Cardinality0..*
Summaryfalse
DeviceDefinition.property.type
Element IdDeviceDefinition.property.type
Definition

Code that specifies the property.

Cardinality1..1
TypeCodeableConcept
Summaryfalse
DeviceDefinition.property.value[x]
Element IdDeviceDefinition.property.value[x]
Definition

Property value - the data type depends on the property type.

Cardinality1..1
TypeQuantity|CodeableConcept|string|boolean|integer|Range|Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
Comments

The usage of CodeableConcept is for concepts that are normally coded but for which a code is not available - for example a device implant size that is not standardized. The property string is for text characteristics, e.g. long descriptions, warnings, etc.

DeviceDefinition.owner
Element IdDeviceDefinition.owner
Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Cardinality0..1
TypeReference(Organization)
Summaryfalse
DeviceDefinition.contact
Element IdDeviceDefinition.contact
Definition

Contact details for an organization or a particular human that is responsible for the device.

Cardinality0..*
TypeContactPoint
Summaryfalse
Comments

used for troubleshooting etc.

DeviceDefinition.link
Element IdDeviceDefinition.link
Definition

An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.

Cardinality0..*
Summaryfalse
DeviceDefinition.link.relation
Element IdDeviceDefinition.link.relation
Definition

The type indicates the relationship of the related device to the device instance.

Cardinality1..1
Terminology BindingDeviceDefinitionRelationType (Extensible)
TypeCoding
Summaryfalse
DeviceDefinition.link.relatedDevice
Element IdDeviceDefinition.link.relatedDevice
Definition

A reference to the linked device.

Cardinality1..1
TypeCodeableReference(DeviceDefinition)
Summaryfalse
DeviceDefinition.note
Element IdDeviceDefinition.note
Definition

Descriptive information, usage information or implantation information that is not captured in an existing element.

Cardinality0..*
TypeAnnotation
Summaryfalse
DeviceDefinition.parentDevice
Element IdDeviceDefinition.parentDevice
Definition

The parent device it can be part of.

Cardinality0..1
TypeReference(DeviceDefinition)
Summarytrue
DeviceDefinition.material
Element IdDeviceDefinition.material
Definition

A substance used to create the material(s) of which the device is made.

Cardinality0..*
Summaryfalse
DeviceDefinition.material.substance
Element IdDeviceDefinition.material.substance
Definition

A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.

Cardinality1..1
TypeCodeableConcept
Summaryfalse
DeviceDefinition.material.alternate
Element IdDeviceDefinition.material.alternate
Definition

Indicates an alternative material of the device.

Cardinality0..1
Typeboolean
Summaryfalse
DeviceDefinition.material.allergenicIndicator
Element IdDeviceDefinition.material.allergenicIndicator
Definition

Whether the substance is a known or suspected allergen.

Cardinality0..1
Typeboolean
Summaryfalse
DeviceDefinition.productionIdentifierInUDI
Element IdDeviceDefinition.productionIdentifierInUDI
Definition

Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.

Cardinality0..*
Terminology BindingDeviceProductionIdentifierInUDI (Required)
Typecode
Summaryfalse
DeviceDefinition.guideline
Element IdDeviceDefinition.guideline
Definition

Information aimed at providing directions for the usage of this model of device.

Cardinality0..1
Summaryfalse
DeviceDefinition.guideline.useContext
Element IdDeviceDefinition.guideline.useContext
Definition

The circumstances that form the setting for using the device.

Cardinality0..*
TypeUsageContext
Summaryfalse
DeviceDefinition.guideline.usageInstruction
Element IdDeviceDefinition.guideline.usageInstruction
Definition

Detailed written and visual directions for the user on how to use the device.

Cardinality0..1
Typemarkdown
Summaryfalse
DeviceDefinition.guideline.relatedArtifact
Element IdDeviceDefinition.guideline.relatedArtifact
Definition

A source of information or reference for this guideline.

Cardinality0..*
TypeRelatedArtifact
Summaryfalse
DeviceDefinition.guideline.indication
Element IdDeviceDefinition.guideline.indication
Definition

A clinical condition for which the device was designed to be used.

Cardinality0..*
TypeCodeableReference(ClinicalUseDefinition)
Summaryfalse
DeviceDefinition.guideline.contraindication
Element IdDeviceDefinition.guideline.contraindication
Definition

A specific situation when a device should not be used because it may cause harm.

Cardinality0..*
TypeCodeableReference(ClinicalUseDefinition)
Summaryfalse
DeviceDefinition.guideline.warning
Element IdDeviceDefinition.guideline.warning
Definition

Specific hazard alert information that a user needs to know before using the device.

Cardinality0..*
TypeCodeableReference(ClinicalUseDefinition)
Summaryfalse
DeviceDefinition.guideline.intendedUse
Element IdDeviceDefinition.guideline.intendedUse
Definition

A description of the general purpose or medical use of the device or its function.

Cardinality0..1
Typestring
Summaryfalse
DeviceDefinition.correctiveAction
Element IdDeviceDefinition.correctiveAction
Definition

Tracking of latest field safety corrective action.

Cardinality0..1
Summaryfalse
DeviceDefinition.correctiveAction.recall
Element IdDeviceDefinition.correctiveAction.recall
Definition

Whether the last corrective action known for this device was a recall.

Cardinality1..1
Typeboolean
Summaryfalse
Comments

When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.

DeviceDefinition.correctiveAction.scope
Element IdDeviceDefinition.correctiveAction.scope
Definition

The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.

Cardinality0..1
Terminology BindingDeviceCorrectiveActionScope (Required)
Typecode
Summaryfalse
DeviceDefinition.correctiveAction.period
Element IdDeviceDefinition.correctiveAction.period
Definition

Start and end dates of the corrective action.

Cardinality1..1
TypePeriod
Summaryfalse
DeviceDefinition.chargeItem
Element IdDeviceDefinition.chargeItem
Definition

Billing code or reference associated with the device.

Cardinality0..*
Summaryfalse
DeviceDefinition.chargeItem.chargeItemCode
Element IdDeviceDefinition.chargeItem.chargeItemCode
Definition

The code or reference for the charge item.

Cardinality1..1
TypeCodeableReference(ChargeItemDefinition)
Summaryfalse
DeviceDefinition.chargeItem.count
Element IdDeviceDefinition.chargeItem.count
Definition

Coefficient applicable to the billing code.

Cardinality1..1
TypeQuantity
Summaryfalse
DeviceDefinition.chargeItem.effectivePeriod
Element IdDeviceDefinition.chargeItem.effectivePeriod
Definition

A specific time period in which this charge item applies.

Cardinality0..1
TypePeriod
Summaryfalse
DeviceDefinition.chargeItem.useContext
Element IdDeviceDefinition.chargeItem.useContext
Definition

The context to which this charge item applies.

Cardinality0..*
TypeUsageContext
Summaryfalse