type: resource-definitionsresource: DeviceDefinition

DeviceDefinition Definitions

DeviceDefinition

The definition of a kind of device or device component

Definition: The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of device.

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.

Cardinality: 0..*

Mappings: w5=administrative.device; workflow=Definition

DeviceDefinition.url

Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)

Definition: An absolute URI that is used to identify this DeviceDefinition when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this DeviceDefinition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the DeviceDefinition is stored on different servers.

Comments: Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version. The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in Technical and Business Versions. In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the meta.source element to indicate where the current master source of the resource can be found.

Requirements: Allows the DeviceDefinition to be referenced by a single globally unique identifier.

Cardinality: 0..1

Type: uri

Must Support: false

Summary: true

Is Modifier: false

Mappings: w5=FiveWs.identifier; workflow=Definition

DeviceDefinition.identifier

Additional identifier for the DeviceDefinition

Definition: A formal identifier that is used to identify this DeviceDefinition when it is represented in other formats, or referenced in a specification, model, design or an instance.

Requirements: Allows externally provided and/or usable business identifiers to be easily associated with the DeviceDefinition.

Cardinality: 0..*

Type: Identifier

Must Support: false

Summary: true

Is Modifier: false

Mappings: w5=FiveWs.identifier

DeviceDefinition.version

Business version of the DeviceDefinition

Definition: The identifier that is used to identify this version of the DeviceDefinition when it is referenced in a specification.

Comments: There may be different DeviceDefinitions that have the same url but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the DeviceDefinition with the format [url]|[version]. The version SHOULD NOT contain a '#' - see Business Version.

Cardinality: 0..1

Type: string

Must Support: false

Summary: true

Is Modifier: false

Mappings: w5=FiveWs.version

DeviceDefinition.versionAlgorithm[x]

How to compare versions

Definition: Indicates the mechanism used to compare versions to determine which is more current.

Comments: If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.

Cardinality: 0..1

Type: string, Coding

Binding: extensible:version-algorithm

Must Support: false

Summary: true

Is Modifier: false

DeviceDefinition.name

Name for this DeviceDefinition (computer friendly)

Definition: A natural language name identifying the DeviceDefinition. This name should be usable as an identifier for the resource by machine processing applications such as code generation.

Comments: The name is not expected to be globally unique. The name should be a simple alphanumeric type no-whitespace name to ensure that it is machine-processing friendly.

Requirements: Supports code generation.

Conditions: cnl-0

Cardinality: 0..1

Type: string

Must Support: false

Summary: true

Is Modifier: false

DeviceDefinition.title

Name for this DeviceDefinition (human friendly)

Definition: A short, descriptive, user-friendly title for the DeviceDefinition.

Comments: This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

Cardinality: 0..1

Type: string

Must Support: false

Summary: true

Is Modifier: false

DeviceDefinition.status

draft | active | retired | unknown

Definition: The current state of this DeviceDefinition.

Comments: A nominal state-transition diagram can be found in the Definition pattern documentation. Unknown does not represent 'other' - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is. See guidance around (not) making local changes to elements here. If a server wishes to reflect whether a given canonical resource is 'supported' or 'enabled' on that server, this is NOT done with status. Instead, expose support for the resource using a 'feature' in the server's CapabilityStatement. (Not all supported canonical resources will necessarily be searchable on a server, and availability of a canonical resource in a search result does not imply support of the resource for any particular usage.)

Requirements: Enables tracking the life-cycle of the content and filtering of DeviceDefinitions that are appropriate for use versus not.

Cardinality: 1..1

Type: code

Binding: required:publication-status|6.0.0-ballot4

Must Support: false

Summary: true

Is Modifier: true (Reason: This is labeled as "Is Modifier" because applications should not use a retired DeviceDefinition without due consideration)

Mappings: w5=FiveWs.status

DeviceDefinition.experimental

For testing only - never for real usage

Definition: A Boolean value to indicate that this DeviceDefinition is authored for testing purposes (or education/evaluation/marketing) and no version of this resource will ever be intended for genuine usage.

Comments: Allows filtering of DeviceDefinitions that are appropriate for use versus not. Experimental resources might include example instances in implementation guides, instances created solely for testing purposes, etc. If experimental is 'true' for any version of a resource, it should be true for all versions of the resource. (If experimental changes, then it is being misused or a resource that was never intended for real-world use has unexpectedly changed its purpose.). Experimental resources are not expected to be stable and may well have breaking changes without a corresponding change to the 'version' element.

Requirements: Enables experimental content to be developed following the same lifecycle that would be used for a production-level DeviceDefinition.

Meaning if Missing: If absent, this resource is treated as though it is not experimental.

Cardinality: 0..1

Type: boolean

Must Support: false

Summary: true

Is Modifier: false

Mappings: w5=FiveWs.class

DeviceDefinition.date

Date last changed

Definition: The date (and optionally time) when the DeviceDefinition was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the DeviceDefinition changes.

Comments: The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the DeviceDefinition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource. See guidance around (not) making local changes to elements here.

Aliases: Revision Date

Cardinality: 0..1

Type: dateTime

Must Support: false

Summary: true

Is Modifier: false

Mappings: w5=FiveWs.recorded

DeviceDefinition.publisher

Name of the publisher/steward (organization or individual)

Definition: The name of the organization or individual responsible for the release and ongoing maintenance of the DeviceDefinition.

Comments: Usually an organization but may be an individual. The publisher (or steward) of the DeviceDefinition is the organization or individual primarily responsible for the maintenance and upkeep of the DeviceDefinition. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the DeviceDefinition. This item SHOULD be populated unless the information is available from context.

Requirements: Helps establish the "authority/credibility" of the DeviceDefinition. May also allow for contact.

Cardinality: 0..1

Type: string

Must Support: false

Summary: true

Is Modifier: false

Mappings: w5=FiveWs.witness

DeviceDefinition.contact

Contact details for the publisher

Definition: Contact details to assist a user in finding and communicating with the publisher.

Comments: May be a web site, an email address, a telephone number, etc. See guidance around (not) making local changes to elements here.

Cardinality: 0..*

Type: ContactDetail

Must Support: false

Summary: true

Is Modifier: false

DeviceDefinition.description

Natural language description of the DeviceDefinition

Definition: A free text natural language description of the DeviceDefinition from a consumer's perspective.

Comments: This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the DeviceDefinition as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context.

Cardinality: 0..1

Type: markdown

Must Support: false

Summary: false

Is Modifier: false

DeviceDefinition.useContext

The context that the content is intended to support

Definition: The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate DeviceDefinitions.

Comments: When multiple useContexts are specified, there is no expectation that all or even any of the contexts apply.

Requirements: Assist in searching for appropriate content.

Cardinality: 0..*

Type: UsageContext

Must Support: false

Summary: true

Is Modifier: false

DeviceDefinition.jurisdiction

Jurisdiction of the authority that maintains the DeviceDefinition (if applicable)

Definition: A legal or geographic region in which the authority that maintains the resource is operating. In general, the jurisdiction is also found in the useContext. The useContext may reference additional jurisdictions because the defining jurisdiction does not necessarily limit the jurisdictions of use.

Comments: It may be possible for the DeviceDefinition to be used in jurisdictions other than those for which it was originally designed or intended. DEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'jurisdiction' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#jurisdiction and useContext.valueCodeableConcept indicating the jurisdiction.)

Cardinality: 0..*

Type: CodeableConcept

Binding: extensible:jurisdiction

Must Support: false

Summary: true

Is Modifier: false

DeviceDefinition.purpose

Why this DeviceDefinition is defined

Definition: Explanation of why this DeviceDefinition is needed and why it has been designed as it has.

Comments: This element does not describe the usage of the DeviceDefinition. Instead, it provides traceability of "why" the resource is either needed or "why" it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this DeviceDefinition.

Cardinality: 0..1

Type: markdown

Must Support: false

Summary: false

Is Modifier: false

Mappings: w5=FiveWs.why[x]

DeviceDefinition.copyright

Notice about intellectual property ownership, can include restrictions on use

Definition: A copyright statement relating to the DeviceDefinition and/or its contents. Copyright statements are notices of intellectual property ownership and can include restrictions on the use and publishing of the DeviceDefinition.

Comments: The short copyright declaration (e.g. (c) '2015+ xyz organization') should be sent in the copyrightLabel element without the copyright prefix (i.e., do not include '(c)' or the symbol).

Requirements: Consumers must be able to determine any legal restrictions on the use of the DeviceDefinition and/or its content.

Aliases: License, Restrictions

Cardinality: 0..1

Type: markdown

Must Support: false

Summary: false

Is Modifier: false

DeviceDefinition.copyrightLabel

Definition: A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are restricted. (e.g. 'All rights reserved', 'Some rights reserved').

Comments: The copyright symbol and the '(c)' textual representation SHOULD NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.

Requirements: Defines the content expected to be rendered in all representations of the artifact.

Cardinality: 0..1

Type: string

Must Support: false

Summary: false

Is Modifier: false

DeviceDefinition.approvalDate

When DeviceDefinition was approved by publisher

Definition: The date on which the asset content was approved by the publisher. Approval happens once when the content is officially approved for usage.

Comments: The date may be more recent than the approval date because of minor changes / editorial corrections.

See guidance around (not) making local changes to elements here.

Cardinality: 0..1

Type: date

Mappings: w5=FiveWs.recorded

DeviceDefinition.lastReviewDate

Date on which the asset content was last reviewed by the publisher

Definition: The date on which the asset content was last reviewed. Review happens periodically after that, but doesn't change the original approval date.

Comments: If specified, this is usually after the approval date.

See guidance around (not) making local changes to elements here.

Cardinality: 0..1

Type: date

Mappings: w5=FiveWs.recorded

DeviceDefinition.effectivePeriod

The effective date range for the DeviceDefinition

Definition: The period during which the DeviceDefinition content was or is planned to be effective.

Comments: The effective period for a DeviceDefinition determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2021 might be published in 2020.

See guidance around (not) making local changes to elements here.

Cardinality: 0..1

Type: Period

Summary: true

Mappings: w5=FiveWs.done[x]

DeviceDefinition.partNumber

The part number or catalog number of the device

Definition: The part number or catalog number of the device.

Comments: Alphanumeric Maximum 20.

Cardinality: 0..1

Type: string

Mappings: w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].id

DeviceDefinition.manufacturer

Name of device 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.

Cardinality: 0..1

Type: Reference(Organization)

Summary: true

Mappings: w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].scoper.name

DeviceDefinition.modelNumber

The catalog or model number for the device for example as defined by the manufacturer

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

Cardinality: 0..1

Type: string

Summary: true

Mappings: w5=FiveWs.what[x]; rim=.softwareName (included as part)

DeviceDefinition.udiDeviceIdentifier

Unique Device Identifier (UDI) Barcode string

Definition: The Device Identifier (DI) portion of the Unique Device Identifier (UDI) placed on a device label or package. Also known as UDI-DI. Note that the DeviceDefinition may include multiple UDI-DIs if it is sold in multiple jurisdictions.

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.udiDeviceIdentifier.deviceIdentifier

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

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.

Cardinality: 1..1

Type: string

DeviceDefinition.udiDeviceIdentifier.issuer

The organization that assigns the identifier algorithm

Definition: The organization that assigns the identifier algorithm.

Cardinality: 1..1

Type: uri

DeviceDefinition.udiDeviceIdentifier.jurisdiction

The jurisdiction to which the deviceIdentifier applies

Definition: The jurisdiction to which the deviceIdentifier applies.

Cardinality: 1..1

Type: uri

DeviceDefinition.udiDeviceIdentifier.marketDistribution

Indicates whether and when the device is available on the market

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

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod

Begin and end dates for the commercial distribution of the device

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

Cardinality: 1..1

Type: Period

DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction

National state or territory where the device is commercialized

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

Cardinality: 1..1

Type: uri

DeviceDefinition.udiDeviceIdentifier.deviceIdentifierSystem

The namespace for the device identifier value

Definition: Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to create the device identifier.

Cardinality: 0..1

Type: uri

DeviceDefinition.regulatoryIdentifier

Regulatory identifier(s) associated with this device

Definition: Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.

Comments: This should not be used for regulatory authorization numbers which are to be captured elsewhere.

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.regulatoryIdentifier.type

basic | master | license

Definition: The type of identifier itself.

Cardinality: 1..1

Type: code

Binding: required:devicedefinition-regulatory-identifier-type

DeviceDefinition.regulatoryIdentifier.identifier

The identifier itself

Definition: The identifier used in the associated regulatory context.

Cardinality: 1..1

Type: string

DeviceDefinition.regulatoryIdentifier.issuer

The organization that issued this identifier

Definition: The organization that issued this identifier.

Cardinality: 1..1

Type: uri

DeviceDefinition.regulatoryIdentifier.jurisdiction

Relevant jurisdiction governing the identifier

Definition: The applicable jurisdiction overseeing the enforcement of the Identifier.

Cardinality: 1..1

Type: uri

DeviceDefinition.regulatoryIdentifier.identifierSystem

The namespace for the device identifier value

Definition: Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to create the identifier.

Cardinality: 0..1

Type: uri

DeviceDefinition.deviceName

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

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

DeviceDefinition.deviceName.name

A name that is used to refer to the device

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.

Aliases: Σ

Cardinality: 1..1

Type: string

Summary: true

DeviceDefinition.deviceName.type

registered-name | user-friendly-name | patient-reported-name

Definition: The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName.

Comments: The implementation or jurisdiction must clarify which name is to be used as the registered-name. As a result a device definition may have multiple names that are the same, but then used for different purposes per the name type and jurisdictional guidance.

Cardinality: 1..1

Type: CodeableConcept

Binding: extensible:device-nametype

Summary: true

Mappings: w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].code

DeviceDefinition.classification

What kind of device or device system this is

Definition: What kind of device or device system this is.

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

DeviceDefinition.classification.type

A classification or risk class of the device model

Definition: A classification or risk class of the device model.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:device-type

Summary: true

DeviceDefinition.classification.justification

Further information qualifying this classification of the device model

Definition: Further information qualifying this classification of the device model.

Cardinality: 0..*

Type: RelatedArtifact

DeviceDefinition.conformsTo

Identifies the standards, specifications, or formal guidances for the capabilities supported by the device

Definition: Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.

Cardinality: 0..*

Type: BackboneElement

Summary: true

DeviceDefinition.conformsTo.category

Describes the common type of the standard, specification, or formal guidance

Definition: Describes the type of the standard, specification, or formal guidance.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:device-specification-category

Summary: true

DeviceDefinition.conformsTo.specification

Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type

Definition: Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:device-specification-type

Summary: true

DeviceDefinition.conformsTo.version

The specific form or variant of the standard, specification or formal guidance

Definition: Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.

Cardinality: 0..*

Type: string

Summary: true

DeviceDefinition.conformsTo.source

Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance

Definition: Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.

Cardinality: 0..*

Type: RelatedArtifact

DeviceDefinition.hasPart

A device, part of the current one

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

DeviceDefinition.hasPart.definition[x]

Reference to the part

Definition: The device that is part of the current device.

Cardinality: 1..1

Type: canonical, CodeableConcept

Binding: example:device-type

Summary: true

DeviceDefinition.hasPart.count

Number of occurrences of the part

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

Cardinality: 0..1

Type: integer

DeviceDefinition.packaging

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

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

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.packaging.identifier

Business identifier of the packaged medication

Definition: The business identifier of the packaged medication.

Cardinality: 0..1

Type: Identifier

DeviceDefinition.packaging.type

A code that defines the specific type of packaging

Definition: A code that defines the specific type of packaging.

Cardinality: 0..1

Type: CodeableConcept

DeviceDefinition.packaging.count

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

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

Cardinality: 0..1

Type: integer

DeviceDefinition.packaging.distributor

An organization that distributes the packaged device

Definition: An organization that distributes the packaged device.

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.packaging.distributor.name

Distributor's human-readable name

Definition: Distributor's human-readable name.

Cardinality: 0..1

Type: string

DeviceDefinition.packaging.distributor.organizationReference

Distributor as an Organization resource

Definition: Distributor as an Organization resource.

Cardinality: 0..*

Type: Reference(Organization)

DeviceDefinition.packaging.udiDeviceIdentifier

Unique Device Identifier (UDI) Barcode string on the packaging

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

Cardinality: 0..*

DeviceDefinition.packaging.packaging

Allows packages within packages

Definition: Allows packages within packages.

Cardinality: 0..*

DeviceDefinition.deviceVersion

The version of the device or software

Definition: The version of the device or software.

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.deviceVersion.type

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

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

Aliases: Σ

Cardinality: 0..1

Type: CodeableConcept

DeviceDefinition.deviceVersion.component

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

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

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.

Cardinality: 0..1

Type: Identifier

Mappings: w5=FiveWs.what[x]

DeviceDefinition.deviceVersion.value

The version text

Definition: The version text.

Cardinality: 1..1

Type: string

DeviceDefinition.safety

Safety characteristics of the device

Definition: Safety characteristics of the device.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:device-safety

Summary: true

DeviceDefinition.shelfLifeStorage

Shelf Life and storage information

Definition: Shelf Life and storage information.

Cardinality: 0..*

Type: ProductShelfLife

DeviceDefinition.outputLanguage

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

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

Cardinality: 0..*

Type: code

Binding: required:all-languages

DeviceDefinition.property

Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

Definition: Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.

Comments: Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.property.type

Code that specifies the property being represented

Definition: Code that specifies the property such as a resolution or color being represented.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:device-property-type

DeviceDefinition.property.value[x]

Value of the property

Definition: The value of the property specified by the associated property.type code.

Comments: This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.

Cardinality: 1..1

Type: Quantity, CodeableConcept, string, boolean, integer, Range, Attachment

DeviceDefinition.link

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

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

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.link.relation

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

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

Cardinality: 1..1

Type: Coding

Binding: extensible:devicedefinition-relationtype

DeviceDefinition.link.relatedDevice[x]

A reference to the linked device

Definition: A reference to the linked device.

Cardinality: 1..1

Type: canonical, CodeableConcept

Binding: example:device-type

DeviceDefinition.note

Device notes and comments

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

Cardinality: 0..*

Type: Annotation

Mappings: rim=.text

DeviceDefinition.material

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

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

Cardinality: 0..*

Type: BackboneElement

DeviceDefinition.material.substance

A relevant substance that the device contains, may contain, or is made of

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.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:substance-code

DeviceDefinition.material.alternate

Indicates an alternative material of the device

Definition: Indicates an alternative material of the device.

Cardinality: 0..1

Type: boolean

DeviceDefinition.material.allergenicIndicator

Whether the substance is a known or suspected allergen

Definition: Whether the substance is a known or suspected allergen.

Cardinality: 0..1

Type: boolean

DeviceDefinition.productionIdentifierInUDI

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

Comments: Jurisdictions may define other production identifier types and by way of regulation and/or implementation guidance indicate which identifier(s) are to be used for that jurisdiction.

Cardinality: 0..*

Type: CodeableConcept

Binding: extensible:device-productidentifierinudi

DeviceDefinition.guideline

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

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

Comments: For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.

Cardinality: 0..1

Type: BackboneElement

DeviceDefinition.guideline.useContext

The circumstances that form the setting for using the device

Definition: The circumstances that form the setting for using the device.

Cardinality: 0..*

Type: UsageContext

DeviceDefinition.guideline.usageInstruction

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

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

Cardinality: 0..1

Type: markdown

DeviceDefinition.guideline.relatedArtifact

A source of information or reference for this guideline

Definition: A source of information or reference for this guideline.

Cardinality: 0..*

Type: RelatedArtifact

DeviceDefinition.guideline.indication

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

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

Comments: A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

Cardinality: 0..*

Type: CodeableConcept

DeviceDefinition.guideline.contraindication

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

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

Comments: A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

Cardinality: 0..*

Type: CodeableConcept

DeviceDefinition.guideline.warning

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

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

Comments: A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

Cardinality: 0..*

Type: CodeableConcept

DeviceDefinition.guideline.intendedUse

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

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

Cardinality: 0..1

Type: string

DeviceDefinition.correctiveAction

Tracking of latest field safety corrective action

Definition: Tracking of latest field safety corrective action.

Cardinality: 0..1

Type: BackboneElement

DeviceDefinition.correctiveAction.recall

Whether the corrective action was a recall

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

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

Cardinality: 1..1

Type: boolean

DeviceDefinition.correctiveAction.scope

model | lot-numbers | serial-numbers

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.

Cardinality: 0..1

Type: code

Binding: required:device-correctiveactionscope