type: resource-definitionsresource: Device

Device Definitions

Device

Item used in healthcare

Definition: 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.

Cardinality: 0..*

Constraints: dev-1 | error | only one Device.name.display SHALL be true when there is more than one Device.name | name.where(display=true).count() <= 1

Mappings: rim=Device; interface=Participant; w5=administrative.device

Device.identifier

Instance identifier

Definition: Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

Comments: Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. 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. The identifier is typically valued if the serialNumber or lotNumber 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.

Cardinality: 0..*

Type: Identifier

Mappings: w5=FiveWs.identifier; rim=.id; interface=Participant.identifier; 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.; btle=system = urn:oid value = DIS System ID characteristic value (8 octets hexadecimal string); ACOM=system = IEEE EUI-64 or similar value = SystemInfo.system-identifier; DIM=system = IEEE EUI-64 or a local system value = VMS::System-Id, MDS::Soft-ID; BICEPS=system = .../ProductionSpecification/ComponentId/Root value = .../ProductionSpecification/ComponentId/Extension

Device.definition

The reference to the definition for the device

Definition: The reference to the definition for the device.

Cardinality: 0..1

Type: canonical

Device.udiCarrier

Unique Device Identifier (UDI) value

Definition: Unique Device Identifier (UDI) placed on a device label or package. Note that the Device may include multiple UDIs if it is sold in multiple jurisdictions.

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.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: w5=FiveWs.identifier; rim=.id and .code; btle=DIS UDI for Medical Devices characteristic value fields - See Bluetooth GATT Specification Supplement (https://www.bluetooth.com/specifications/gss/) for details)

Device.udiCarrier.deviceIdentifier

Mandatory fixed portion of UDI

Definition: The device identifier (UDI-DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The UDI-DI portion is placed on a device label or package. Note that the DeviceDefinition may include multiple UDI-DIs if it is sold in multiple jurisdictions.

Aliases: DI

Cardinality: 1..1

Type: string

Summary: true

Mappings: 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.; btle=Device Identifier field from DIS UDI for Medical Devices characteristic; ACOM=SystemInfo.udi.deviceIdentifier; DIM=VMS::Production-Specification[spec-type=device-identifier]::prod-spec; BICEPS=MdsDescriptor/MetaData/UDI/DeviceIdentifier

Device.udiCarrier.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

Device.udiCarrier.issuer

UDI Issuing Organization

Definition: Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include:

GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI,
ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.

Aliases: Barcode System

Cardinality: 1..1

Type: uri

Summary: true

Mappings: 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; btle=Issuer field from DIS UDI for Medical Devices characteristic; ACOM=SystemInfo.udi.issuer; DIM=VMS::Udi::udi-issuer; BICEPS=MdsDescriptor/MetaData/UDI/Issuer

Device.udiCarrier.jurisdiction

Regional UDI authority

Definition: The 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/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.

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

Cardinality: 0..1

Type: uri

Mappings: rim=Role.scoper; btle=Authority field from DIS UDI for Medical Devices characteristic; ACOM=SystemInfo.udi.authority; DIM=VMS::Udi::udi-authority; BICEPS=MdsDescriptor/MetaData/UDI/Jurisdictions

Device.udiCarrier.carrierAIDC

UDI Machine Readable value

Definition: The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation as printed on the packaging of the device - e.g., a barcode , 2D Matrix, or RFID. Some AIDC representations contain non-printable characters and cannot be represented in a string format. For this reason, AIDC format SHALL be base64Binary encoded.

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.

Aliases: Automatic Identification and Data Capture

Cardinality: 0..1

Type: base64Binary

Summary: true

Mappings: 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

UDI Human Readable value

Definition: The full UDI carrier as the human readable form (HRF) representation as printed on the packaging of the device.

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.

Aliases: Human Readable Form

Cardinality: 0..1

Type: string

Summary: true

Mappings: rim=Role.id.extension; udi=A unique device identifier (UDI) on a device label in plain text; btle=Label field from DIS UDI for Medical Devices characteristic; ACOM=SystemInfo.udi.label; DIM=VMS::Udi::udi-label; BICEPS=MdsDescriptor/MetaData/UDI/HumanReadableForm

Device.udiCarrier.entryType

Definition: A coded entry to indicate how the data was entered.

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

Cardinality: 0..1

Type: code

Binding: required:udi-entry-type

Mappings: rim=NA; btle=electronic-transmission

Device.status

active | inactive | entered-in-error | unknown

Definition: The Device record status. This is not the status of the device like availability.

Cardinality: 0..1

Type: code

Binding: required:device-status

Summary: true

Is Modifier: true (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)

Mappings: w5=FiveWs.status; rim=.statusCode; interface=Participant.active

Device.availabilityStatus

lost | damaged | destroyed | available

Definition: The availability of the device.

Cardinality: 0..1

Type: CodeableConcept

Binding: extensible:device-availability-status

Mappings: w5=FiveWs.status

Device.biologicalSourceEvent

A production identifier of the donation, collection, or pooling event from which biological material in this device was derived

Definition: A production identifier of the donation, collection, or pooling event from which biological material in this device was derived.

Comments: Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

Aliases: Distinct Identification Code (DIC)

Cardinality: 0..1

Type: Identifier

Mappings: w5=FiveWs.what[x]; udi=A distinct identification code required by §1271.290(c), the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. This may also be known as the donation identification number (DIN) or a value to trace the product's origin.

Device.manufacturer

Name of device manufacturer

Definition: A name of the manufacturer or entity legally responsible for the device.

Cardinality: 0..1

Type: string

Mappings: w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].scoper.name; udi=N/A; btle=DIS Manufacturer Name String characteristic value; ACOM=SystemInfo.system-manufacturer; DIM=VMS::System-Model::manufacturer, VMD::Vmd-Model::manufacturer; BICEPS=MdsDescriptor/MetaData/Manufacturer

Device.manufactureDate

A production identifier that indicates the date when the device was made

Definition: The date and time when the device was manufactured.

Cardinality: 0..1

Type: dateTime

Mappings: 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”.; DIM=VMS::Production-Specification[spec-type=manufacture-date]::prod-spec; BICEPS=MdsDescriptor/MetaData/ManufactureDate

Device.expirationDate

A production identifier that indicates the date and time of expiry of this device (if applicable)

Definition: The date and time beyond which this device is no longer valid or should not be used (if applicable).

Cardinality: 0..1

Type: dateTime

Mappings: 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”.; DIM=VMS::Production-Specification[spec-type=expiry-date]::prod-spec; BICEPS=MdsDescriptor/MetaData/ExpirationDate

Device.lotNumber

A production identifier that indicates the Lot number of manufacture

Definition: Lot number assigned by the manufacturer.

Cardinality: 0..1

Type: string

Mappings: 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.; DIM=VMS::Production-Specification[spec-type=lot-number]::prod-spec; BICEPS=MdsDescriptor/MetaData/LotNumber

Device.serialNumber

A production identifier that indicates the Serial number assigned by the manufacturer

Definition: The serial number assigned by the organization when the device was manufactured.

Comments: Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.

Cardinality: 0..1

Type: string

Mappings: w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].id; btle=DIS Serial Number String characteristic value; ACOM=SystemInfo.serial-number; DIM=VMS::Production-Specification[spec-type=serial-number]::prod-spec; BICEPS=MdsDescriptor/MetaData/SerialNumber

Device.name

The name or names of the device as known to the manufacturer and/or patient

Definition: This 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.

Conditions: dev-1

Cardinality: 0..*

Type: BackboneElement

Mappings: interface=Participant.name

Device.name.value

The term that names the device

Definition: The actual name that identifies the device.

Aliases: Σ

Cardinality: 1..1

Type: string

Summary: true

Device.name.type

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

Definition: Indicates the kind of name. 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

Device.name.display

The preferred device name

Definition: Indicates the default or preferred name to be displayed.

Conditions: dev-1

Cardinality: 0..1

Type: boolean

Summary: true

Is Modifier: true (Reason: This element is labelled as a modifier because it is a status element that can indicate that that a name is preferred.)

Mappings: w5=FiveWs.status; rim=statusCode

Device.modelNumber

The manufacturer's model number for the device

Definition: The manufacturer's model number for the device.

Cardinality: 0..1

Type: string

Mappings: w5=FiveWs.what[x]; rim=.softwareName (included as part); btle=DIS Model Number String characteristic value; ACOM=SystemInfo.system-model-number; DIM=VMS::System-Model::model-number, VMD::Vmd-Model::model-number; BICEPS=modelNumber = MdsDescriptor/MetaData/ModelNumber name = MdsDescriptor/MetaData/ModelName

Device.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; DIM=VMS::Production-Specification[spec-type=part-number]::prod-spec; BICEPS=MdsDescriptor/MetaData/PartNumber

Device.category

Indicates a high-level grouping of the device

Definition: Devices may be associated with one or more categories.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:device-category

Device.type

The kind or type of device

Definition: The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.

Comments: Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor. Device.type relates DeviceDefinition.classification.type using the same binding enabling referencing.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:device-type

Mappings: btle=text = Appearance Value name or Primary Service name coding = Appearance Value or Primary Service UUID; ACOM=MDC_MOC_VMS_MDS_SIMP (fixed value for PHD); DIM=type = VMO::Type, VMS::System-Type type.text = VMO::Label-String; BICEPS=MdsDescriptor/Type, MdsDescriptor/Vmd/Type, MdsDescriptor/Vmd/Channel/Type

Device.deviceVersion

The actual design of the device or software version running on the device

Definition: The actual design of the device or software version running on the device.

Comments: The combination of type and component SHOULD be unique across all repetitions of version.

Cardinality: 0..*

Type: BackboneElement

Device.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

Binding: example:device-versiontype

Mappings: btle=Bluetooth-UUID; ACOM=MDC code for a version (MDC_ID_PROD_SPEC_FW, MDC_ID_PROD_SPEC_HW, MDC_ID_PROD_SPEC_SW); DIM=VMS::Production-Specification[spec-type=xx-revision]::spec-type (with xx replaced by hw, sw or fw); BICEPS=.../ProductionSpecification/SpecType

Device.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]; DIM=VMS::Production-Specification[spec-type=xx-revision]::component-id (with xx replaced by hw, sw or fw); BICEPS=/ProductionSpecification/ComponentId

Device.deviceVersion.installDate

The date the version was installed on the device

Definition: The date the version was installed on the device.

Cardinality: 0..1

Type: dateTime

Mappings: w5=FiveWs.what[x]

Device.deviceVersion.value

The version text

Definition: The version text.

Cardinality: 1..1

Type: string

Mappings: btle=DIS Firmware Revision characteristic value or DIS Hardware Revision characteristic value or DIS Software Revision characteristic value; ACOM=SystemInfo.firmware-, hardware-, software-revision; DIM=VMS::Production-Specification[spec-type=xx-revision]::prod-spec (with xx replaced by hw, sw or fw); BICEPS=.../ProductionSpecification/ProductionSpec

Device.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

Device.conformsTo.category

Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:device-specification-category

Mappings: ACOM=communication (fixed value)

Device.conformsTo.specification

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

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

Mappings: ACOM=SystemInfo.System-Type-Spec-List[i].type

Device.conformsTo.version

Specific form or variant of the standard

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..1

Type: string

Mappings: ACOM=SystemInfo.System-Type-Spec-List[i].version

Device.property

Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.

Definition: Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific 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 a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition.

Cardinality: 0..*

Type: BackboneElement

Mappings: ACOM=clock attributes (as ASN1ToHL7 code); DIM=MDS::Clock::time-support attributes; BICEPS=MdsDescriptor/Clock/TimeProtocol, MdsDescriptor/Clock/Type

Device.property.type

Code that specifies the property being represented

Definition: Code that specifies the property, such as resolution, color, size, being represented.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:device-property-type

Device.property.value[x]

Value of the property

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

Comments: The text element in CodeableConcept.text 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 string choice type is used for descriptive properties, or instructions.

Cardinality: 1..1

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

Device.additive

Material added to a container device

Definition: Material added to a container device (typically used in specimen collection or initial processing). The material may be added by the device manufacturer or by a different party subsequent to manufacturing.

Comments: A Procedure can be used to document details of the addition of a substance to the device.

Cardinality: 0..*

Type: BackboneElement

Mappings: w5=FiveWs.what[x]; rim=Material

Device.additive.type

The additive substance

Definition: The type of the substance added to the container. This is represented as a concept from a code system or described in a Substance resource.

Cardinality: 1..1

Type: CodeableReference

Binding: example:substance-code

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

Device.additive.quantity

Quantity of additive substance within container

Definition: The quantity of the additive substance in the container; may be volume, dimensions, or other appropriate measurements, depending on the container and additive substance type.

Cardinality: 0..1

Type: Quantity(SimpleQuantity)

Mappings: w5=FiveWs.what[x]; rim=.playedRole[classCode=CONT].quantity

Device.contact

Details for human/organization for support

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

Comments: used for troubleshooting etc.

Cardinality: 0..*

Type: ContactPoint

The distributor of the model of device

Definition: The distributor of the model of device, other than the manufacturer.

Cardinality: 0..1

Type: BackboneElement

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

Device.distributor.name

The name of the distributor

Definition: The human-readble name of the device distributor.

Cardinality: 0..1

Type: string

Device.distributor.organizationReference

The organization of the device distributor

Definition: The organization that the distributor of the device belongs to.

Cardinality: 0..1

Type: Reference(Organization)

Device.location

Where the device is found

Definition: The place where the device can be found.

Requirements: Device.location can be used to track device location.

Cardinality: 0..1

Type: Reference(Location)

Mappings: w5=FiveWs.where[x]; rim=.playedRole[typeCode=LOCE].scoper

Device.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

Device.safety

Safety Characteristics of Device

Definition: Provides additional safety characteristics about a medical device. For example devices containing latex.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:device-safety

Summary: true

Mappings: rim=NA; BICEPS=MdsDescriptor/Vmd/Channel/SafetyClassification

Device.parent

The higher level or encompassing device that this device is a logical part of

Definition: The higher level or encompassing device that this device is a logical part of.

Comments: For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.

Cardinality: 0..1

Type: Reference(Device)