R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

8.14 Resource Device - Content

Orders and Observations Work GroupMaturity Level: 0 Trial Use Compartments: Not linked to any defined compartments

This resource identifies 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. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc. This is the catalog description of a device (not the specific instance).

Note to balloters The Orders and Observations work-group has considerably changed this resource and wants to draw the attention of reviewers and implementers.

  • Device is an "instance", DeviceDefinition is a "kind"

    Previously, the Device resource represented both an ‘instance’ of a device (e.g., an IM pin with serial number 123) and a ‘kind’ of device (e.g., 3ml syringes). To differentiate the kind of device from the instance of a device, several proposals have been put forth:

    1. Create separate resources for kind vs instance of Device (current choice)
    2. Create a Device profile to represent a Device Kind
    3. Reorder the elements and group by kind and instance within the Device resource.

    More details on these options can be found here .

  • Representation multipart devices including UDI

    Both Device and DeviceDefinition resources allow nesting of parts, each of them having a UDI representation.

    1. Change Device to support a device that has zero to one DIs (represent type) with multiple UDIs (instance).
    2. In addition to option 2 above, add an element to Device to be able reference other Devices resources. This would allow representation of a number of inter-related devices within a device system. This option is similar to the Device harmonization discussion below.

  • Harmonization between Personal Healthcare Devices (PHD) with Point of Care Device (POCD)

    These resources aim to harmonize the representation of simpler Personal Healthcare Devices (PHD) with Point of Care Device (POCD) by merging DeviceComponent within Device and allow multiple component Devices reference the 'parent' device.

8.14.1 Scope and Usage

This resource is an administrative resource that tracks individual instances of a device and their location. 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.

8.14.2 Boundaries and Relationships

These are the device related resources

  • Device (this resource)
  • DeviceDefinition - Describes a "kind" of device - not a physical instance, cut a "catalog entry" where a device is defined by the manufacturer, reseller, or regulator.
  • DeviceMetric - Describes a measurement, calculation or setting capability of a medical device.

In FHIR, the "Device" is the "administrative" resource for the device (it does not change much and has manufacturer information etc.), whereas the DeviceComponent and DeviceMetric (which is really a kind of DeviceComponent) model the physical part, including operation status and is much more volatile. The physical composition of a Device is represented by the Devices pointing to their "parent".

Devices differ from medications because they are not "used up" - they remain active in a patient in an ongoing fashion. However, the specific boundary between medications and devices is defined at the implementation level and this standard does not enforce a boundary with the exception of devices that are implanted in a patient. The Medication resource should not be used to represent implanted devices.

This resource is referenced by Signature, Account, AdverseEvent, Appointment, AppointmentResponse, AuditEvent, CarePlan, ChargeItem, ChargeItemDefinition, Claim, Communication, CommunicationRequest, Composition, Consent, Contract, DetectedIssue, itself, DeviceMetric, DeviceRequest, DeviceUseStatement, DiagnosticReport, DocumentManifest, DocumentReference, EntryDefinition, ExplanationOfBenefit, Flag, Group, GuidanceResponse, ImagingStudy, Invoice, List, MeasureReport, Media, MedicationAdministration, MedicationDispense, MedicationRequest, MessageHeader, Observation, Procedure, Provenance, QuestionnaireResponse, RequestGroup, RiskAssessment, Schedule, Sequence, ServiceRequest, Specimen, SupplyDelivery, SupplyRequest, Task and UserSession

8.14.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device TUDomainResourceItem used in healthcare
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier 0..*IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
UDIEntryType (Required)
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
FHIRDeviceStatus (Required)
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
FHIRDeviceStatusReason (Extensible)
... distinctIdentificationCode 0..1stringThe distinct identification code for a biological product regulated as a device
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber 0..1stringSerial number assigned by the manufacturer
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 0..1CodeableConceptThe kind or type of device
FHIR Device Types (Example)
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1Reference(Patient)Patient to whom Device is affixed
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format

UML Diagram (Legend)

Device (DomainResource)Unique instance identifiers assigned to a device by manufacturers other organizations or ownersidentifier : Identifier [0..*]The reference to the definition for the devicedefinition : Reference [0..1] « DeviceDefinition »Status of the Device availability (this element modifies the meaning of other elements)status : code [0..1] « The availability status of the device. (Strength=Required)FHIRDeviceStatus! »Reason for the dtatus of the Device availabilitystatusReason : CodeableConcept [0..*] « The availability status reason of the device. (Strength=Extensible)FHIRDeviceStatusReason+ »The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product regulated as a devicedistinctIdentificationCode : string [0..1]A name of the manufacturermanufacturer : string [0..1]The date and time when the device was manufacturedmanufactureDate : dateTime [0..1]The date and time beyond which this device is no longer valid or should not be used (if applicable)expirationDate : dateTime [0..1]Lot number assigned by the manufacturerlotNumber : string [0..1]The serial number assigned by the organization when the device was manufacturedserialNumber : string [0..1]The model number for the devicemodelNumber : string [0..1]The part number of thedevicepartNumber : string [0..1]The kind or type of devicetype : CodeableConcept [0..1] « Codes to identify medical devices. (Strength=Example)FHIRDeviceTypes?? »Patient information, If the device is affixed to a personpatient : Reference [0..1] « Patient »An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference [0..1] « Organization »Contact details for an organization or a particular human that is responsible for the devicecontact : ContactPoint [0..*]The place where the device can be foundlocation : Reference [0..1] « Location »A network address on which the device may be contacted directlyurl : uri [0..1]Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Provides additional safety characteristics about a medical device. For example devices containing latexsafety : CodeableConcept [0..*]The parent deviceparent : Reference [0..1] « Device »UdiCarrierThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a devicedeviceIdentifier : string [0..1]Organization 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-diissuer : uri [0..1]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/fda-udijurisdiction : uri [0..1]The 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 encodedcarrierAIDC : base64Binary [0..1]The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the devicecarrierHRF : string [0..1]A coded entry to indicate how the data was enteredentryType : code [0..1] « Codes to identify how UDI data was entered. (Strength=Required)UDIEntryType! »DeviceNameThe name of the devicename : string [1..1]The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « The type of name the device is referred by. (Strength=Required)DeviceNameType! »SpecializationThe standard that is used to operate and communicatesystemType : CodeableConcept [1..1]The version of the standard that is used to operate and communicateversion : string [0..1]VersionThe type of the device versiontype : CodeableConcept [0..1]A single component of the device versioncomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property DeviceDefinitionPropetyCode (Extensible)type : CodeableConcept [1..1]Property value as a quantityvalueQuanity : Quantity [0..*]Property value as a code, e.g., NTP4 (synced to NTP)valueCode : CodeableConcept [0..*]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 soldudiCarrier[0..*]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 DeviceDefinitiondeviceName[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[0..*]The actual design of the device or software version running on the deviceversion[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[0..*]

XML Template

<Device xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <definition><!-- 0..1 Reference(DeviceDefinition) The reference to the definition for the device --></definition>
 <udiCarrier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 0..1 Mandatory fixed portion of UDI -->
  <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual + -->
 </udiCarrier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off --></statusReason>
 <distinctIdentificationCode value="[string]"/><!-- 0..1 The distinct identification code for a biological product regulated as a device -->
 <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) -->
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->
 <deviceName>  <!-- 0..* The name of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 The name of the device -->
  <type value="[code]"/><!-- 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other -->
 </deviceName>
 <modelNumber value="[string]"/><!-- 0..1 The model number for the device -->
 <partNumber value="[string]"/><!-- 0..1 The part number of the device -->
 <type><!-- 0..1 CodeableConcept The kind or type of device --></type>
 <specialization>  <!-- 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication -->
  <systemType><!-- 1..1 CodeableConcept The standard that is used to operate and communicate --></systemType>
  <version value="[string]"/><!-- 0..1 The version of the standard that is used to operate and communicate -->
 </specialization>
 <version>  <!-- 0..* The actual design of the device or software version running on the device -->
  <type><!-- 0..1 CodeableConcept The type of the device version --></type>
  <component><!-- 0..1 Identifier A single component of the device version --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </version>
 <property>  <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible) --></type>
  <valueQuanity><!-- 0..* Quantity Property value as a quantity --></valueQuanity>
  <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode>
 </property>
 <patient><!-- 0..1 Reference(Patient) Patient to whom Device is affixed --></patient>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <location><!-- 0..1 Reference(Location) Where the device is found --></location>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The parent device --></parent>
</Device>

JSON Template

{doco
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "definition" : { Reference(DeviceDefinition) }, // The reference to the definition for the device
  "udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // Mandatory fixed portion of UDI
    "issuer" : "<uri>", // UDI Issuing Organization
    "jurisdiction" : "<uri>", // Regional UDI authority
    "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
    "carrierHRF" : "<string>", // UDI Human Readable Barcode String
    "entryType" : "<code>" // barcode | rfid | manual +
  }],
  "status" : "<code>", // active | inactive | entered-in-error | unknown
  "statusReason" : [{ CodeableConcept }], // online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
  "distinctIdentificationCode" : "<string>", // The distinct identification code for a biological product regulated as a device
  "manufacturer" : "<string>", // Name of device manufacturer
  "manufactureDate" : "<dateTime>", // Date when the device was made
  "expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
  "lotNumber" : "<string>", // Lot number of manufacture
  "serialNumber" : "<string>", // Serial number assigned by the manufacturer
  "deviceName" : [{ // The name of the device as given by the manufacturer
    "name" : "<string>", // R!  The name of the device
    "type" : "<code>" // R!  udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  }],
  "modelNumber" : "<string>", // The model number for the device
  "partNumber" : "<string>", // The part number of the device
  "type" : { CodeableConcept }, // The kind or type of device
  "specialization" : [{ // The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    "systemType" : { CodeableConcept }, // R!  The standard that is used to operate and communicate
    "version" : "<string>" // The version of the standard that is used to operate and communicate
  }],
  "version" : [{ // The actual design of the device or software version running on the device
    "type" : { CodeableConcept }, // The type of the device version
    "component" : { Identifier }, // A single component of the device version
    "value" : "<string>" // R!  The version text
  }],
  "property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    "type" : { CodeableConcept }, // R!  Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    "valueQuanity" : [{ Quantity }], // Property value as a quantity
    "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP)
  }],
  "patient" : { Reference(Patient) }, // Patient to whom Device is affixed
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "location" : { Reference(Location) }, // Where the device is found
  "url" : "<uri>", // Network address to contact device
  "note" : [{ Annotation }], // Device notes and comments
  "safety" : [{ CodeableConcept }], // Safety Characteristics of Device
  "parent" : { Reference(Device) } // The parent device
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:Device;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:Device.identifier [ Identifier ], ... ; # 0..* Instance identifier
  fhir:Device.definition [ Reference(DeviceDefinition) ]; # 0..1 The reference to the definition for the device
  fhir:Device.udiCarrier [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:Device.udiCarrier.deviceIdentifier [ string ]; # 0..1 Mandatory fixed portion of UDI
    fhir:Device.udiCarrier.issuer [ uri ]; # 0..1 UDI Issuing Organization
    fhir:Device.udiCarrier.jurisdiction [ uri ]; # 0..1 Regional UDI authority
    fhir:Device.udiCarrier.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String
    fhir:Device.udiCarrier.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode String
    fhir:Device.udiCarrier.entryType [ code ]; # 0..1 barcode | rfid | manual +
  ], ...;
  fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown
  fhir:Device.statusReason [ CodeableConcept ], ... ; # 0..* online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
  fhir:Device.distinctIdentificationCode [ string ]; # 0..1 The distinct identification code for a biological product regulated as a device
  fhir:Device.manufacturer [ string ]; # 0..1 Name of device manufacturer
  fhir:Device.manufactureDate [ dateTime ]; # 0..1 Date when the device was made
  fhir:Device.expirationDate [ dateTime ]; # 0..1 Date and time of expiry of this device (if applicable)
  fhir:Device.lotNumber [ string ]; # 0..1 Lot number of manufacture
  fhir:Device.serialNumber [ string ]; # 0..1 Serial number assigned by the manufacturer
  fhir:Device.deviceName [ # 0..* The name of the device as given by the manufacturer
    fhir:Device.deviceName.name [ string ]; # 1..1 The name of the device
    fhir:Device.deviceName.type [ code ]; # 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  ], ...;
  fhir:Device.modelNumber [ string ]; # 0..1 The model number for the device
  fhir:Device.partNumber [ string ]; # 0..1 The part number of the device
  fhir:Device.type [ CodeableConcept ]; # 0..1 The kind or type of device
  fhir:Device.specialization [ # 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    fhir:Device.specialization.systemType [ CodeableConcept ]; # 1..1 The standard that is used to operate and communicate
    fhir:Device.specialization.version [ string ]; # 0..1 The version of the standard that is used to operate and communicate
  ], ...;
  fhir:Device.version [ # 0..* The actual design of the device or software version running on the device
    fhir:Device.version.type [ CodeableConcept ]; # 0..1 The type of the device version
    fhir:Device.version.component [ Identifier ]; # 0..1 A single component of the device version
    fhir:Device.version.value [ string ]; # 1..1 The version text
  ], ...;
  fhir:Device.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    fhir:Device.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    fhir:Device.property.valueQuanity [ Quantity ], ... ; # 0..* Property value as a quantity
    fhir:Device.property.valueCode [ CodeableConcept ], ... ; # 0..* Property value as a code, e.g., NTP4 (synced to NTP)
  ], ...;
  fhir:Device.patient [ Reference(Patient) ]; # 0..1 Patient to whom Device is affixed
  fhir:Device.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device
  fhir:Device.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support
  fhir:Device.location [ Reference(Location) ]; # 0..1 Where the device is found
  fhir:Device.url [ uri ]; # 0..1 Network address to contact device
  fhir:Device.note [ Annotation ], ... ; # 0..* Device notes and comments
  fhir:Device.safety [ CodeableConcept ], ... ; # 0..* Safety Characteristics of Device
  fhir:Device.parent [ Reference(Device) ]; # 0..1 The parent device
]

Changes since R3

Device
Device.definition
  • Added Element
Device.udiCarrier
  • Added Element
Device.udiCarrier.deviceIdentifier
  • Added Element
Device.udiCarrier.issuer
  • Added Element
Device.udiCarrier.jurisdiction
  • Added Element
Device.udiCarrier.carrierAIDC
  • Added Element
Device.udiCarrier.carrierHRF
  • Added Element
Device.udiCarrier.entryType
  • Added Element
Device.statusReason
  • Added Element
Device.distinctIdentificationCode
  • Added Element
Device.serialNumber
  • Added Element
Device.deviceName
  • Added Element
Device.deviceName.name
  • Added Element
Device.deviceName.type
  • Added Element
Device.modelNumber
  • Added Element
Device.partNumber
  • Added Element
Device.specialization
  • Added Element
Device.specialization.systemType
  • Added Element
Device.specialization.version
  • Added Element
Device.version
  • Max Cardinality changed from 1 to *
  • Type changed from string to BackboneElement
Device.version.type
  • Added Element
Device.version.component
  • Added Element
Device.version.value
  • Added Element
Device.property
  • Added Element
Device.property.type
  • Added Element
Device.property.valueQuanity
  • Added Element
Device.property.valueCode
  • Added Element
Device.parent
  • Added Element
Device.udi
  • deleted
Device.model
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 9 tests of which 1 fail to execute. 8 fail round-trip testing and 8 r3 resources are invalid (0 errors).)

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device TUDomainResourceItem used in healthcare
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier 0..*IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
UDIEntryType (Required)
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
FHIRDeviceStatus (Required)
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
FHIRDeviceStatusReason (Extensible)
... distinctIdentificationCode 0..1stringThe distinct identification code for a biological product regulated as a device
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber 0..1stringSerial number assigned by the manufacturer
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 0..1CodeableConceptThe kind or type of device
FHIR Device Types (Example)
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1Reference(Patient)Patient to whom Device is affixed
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format

UML Diagram (Legend)

Device (DomainResource)Unique instance identifiers assigned to a device by manufacturers other organizations or ownersidentifier : Identifier [0..*]The reference to the definition for the devicedefinition : Reference [0..1] « DeviceDefinition »Status of the Device availability (this element modifies the meaning of other elements)status : code [0..1] « The availability status of the device. (Strength=Required)FHIRDeviceStatus! »Reason for the dtatus of the Device availabilitystatusReason : CodeableConcept [0..*] « The availability status reason of the device. (Strength=Extensible)FHIRDeviceStatusReason+ »The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product regulated as a devicedistinctIdentificationCode : string [0..1]A name of the manufacturermanufacturer : string [0..1]The date and time when the device was manufacturedmanufactureDate : dateTime [0..1]The date and time beyond which this device is no longer valid or should not be used (if applicable)expirationDate : dateTime [0..1]Lot number assigned by the manufacturerlotNumber : string [0..1]The serial number assigned by the organization when the device was manufacturedserialNumber : string [0..1]The model number for the devicemodelNumber : string [0..1]The part number of thedevicepartNumber : string [0..1]The kind or type of devicetype : CodeableConcept [0..1] « Codes to identify medical devices. (Strength=Example)FHIRDeviceTypes?? »Patient information, If the device is affixed to a personpatient : Reference [0..1] « Patient »An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference [0..1] « Organization »Contact details for an organization or a particular human that is responsible for the devicecontact : ContactPoint [0..*]The place where the device can be foundlocation : Reference [0..1] « Location »A network address on which the device may be contacted directlyurl : uri [0..1]Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Provides additional safety characteristics about a medical device. For example devices containing latexsafety : CodeableConcept [0..*]The parent deviceparent : Reference [0..1] « Device »UdiCarrierThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a devicedeviceIdentifier : string [0..1]Organization 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-diissuer : uri [0..1]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/fda-udijurisdiction : uri [0..1]The 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 encodedcarrierAIDC : base64Binary [0..1]The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the devicecarrierHRF : string [0..1]A coded entry to indicate how the data was enteredentryType : code [0..1] « Codes to identify how UDI data was entered. (Strength=Required)UDIEntryType! »DeviceNameThe name of the devicename : string [1..1]The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « The type of name the device is referred by. (Strength=Required)DeviceNameType! »SpecializationThe standard that is used to operate and communicatesystemType : CodeableConcept [1..1]The version of the standard that is used to operate and communicateversion : string [0..1]VersionThe type of the device versiontype : CodeableConcept [0..1]A single component of the device versioncomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property DeviceDefinitionPropetyCode (Extensible)type : CodeableConcept [1..1]Property value as a quantityvalueQuanity : Quantity [0..*]Property value as a code, e.g., NTP4 (synced to NTP)valueCode : CodeableConcept [0..*]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 soldudiCarrier[0..*]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 DeviceDefinitiondeviceName[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[0..*]The actual design of the device or software version running on the deviceversion[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[0..*]

XML Template

<Device xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <definition><!-- 0..1 Reference(DeviceDefinition) The reference to the definition for the device --></definition>
 <udiCarrier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 0..1 Mandatory fixed portion of UDI -->
  <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual + -->
 </udiCarrier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off --></statusReason>
 <distinctIdentificationCode value="[string]"/><!-- 0..1 The distinct identification code for a biological product regulated as a device -->
 <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) -->
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <serialNumber value="[string]"/><!-- 0..1 Serial number assigned by the manufacturer -->
 <deviceName>  <!-- 0..* The name of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 The name of the device -->
  <type value="[code]"/><!-- 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other -->
 </deviceName>
 <modelNumber value="[string]"/><!-- 0..1 The model number for the device -->
 <partNumber value="[string]"/><!-- 0..1 The part number of the device -->
 <type><!-- 0..1 CodeableConcept The kind or type of device --></type>
 <specialization>  <!-- 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication -->
  <systemType><!-- 1..1 CodeableConcept The standard that is used to operate and communicate --></systemType>
  <version value="[string]"/><!-- 0..1 The version of the standard that is used to operate and communicate -->
 </specialization>
 <version>  <!-- 0..* The actual design of the device or software version running on the device -->
  <type><!-- 0..1 CodeableConcept The type of the device version --></type>
  <component><!-- 0..1 Identifier A single component of the device version --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </version>
 <property>  <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible) --></type>
  <valueQuanity><!-- 0..* Quantity Property value as a quantity --></valueQuanity>
  <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode>
 </property>
 <patient><!-- 0..1 Reference(Patient) Patient to whom Device is affixed --></patient>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <location><!-- 0..1 Reference(Location) Where the device is found --></location>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The parent device --></parent>
</Device>

JSON Template

{doco
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "definition" : { Reference(DeviceDefinition) }, // The reference to the definition for the device
  "udiCarrier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // Mandatory fixed portion of UDI
    "issuer" : "<uri>", // UDI Issuing Organization
    "jurisdiction" : "<uri>", // Regional UDI authority
    "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
    "carrierHRF" : "<string>", // UDI Human Readable Barcode String
    "entryType" : "<code>" // barcode | rfid | manual +
  }],
  "status" : "<code>", // active | inactive | entered-in-error | unknown
  "statusReason" : [{ CodeableConcept }], // online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
  "distinctIdentificationCode" : "<string>", // The distinct identification code for a biological product regulated as a device
  "manufacturer" : "<string>", // Name of device manufacturer
  "manufactureDate" : "<dateTime>", // Date when the device was made
  "expirationDate" : "<dateTime>", // Date and time of expiry of this device (if applicable)
  "lotNumber" : "<string>", // Lot number of manufacture
  "serialNumber" : "<string>", // Serial number assigned by the manufacturer
  "deviceName" : [{ // The name of the device as given by the manufacturer
    "name" : "<string>", // R!  The name of the device
    "type" : "<code>" // R!  udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  }],
  "modelNumber" : "<string>", // The model number for the device
  "partNumber" : "<string>", // The part number of the device
  "type" : { CodeableConcept }, // The kind or type of device
  "specialization" : [{ // The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    "systemType" : { CodeableConcept }, // R!  The standard that is used to operate and communicate
    "version" : "<string>" // The version of the standard that is used to operate and communicate
  }],
  "version" : [{ // The actual design of the device or software version running on the device
    "type" : { CodeableConcept }, // The type of the device version
    "component" : { Identifier }, // A single component of the device version
    "value" : "<string>" // R!  The version text
  }],
  "property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    "type" : { CodeableConcept }, // R!  Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    "valueQuanity" : [{ Quantity }], // Property value as a quantity
    "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP)
  }],
  "patient" : { Reference(Patient) }, // Patient to whom Device is affixed
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "location" : { Reference(Location) }, // Where the device is found
  "url" : "<uri>", // Network address to contact device
  "note" : [{ Annotation }], // Device notes and comments
  "safety" : [{ CodeableConcept }], // Safety Characteristics of Device
  "parent" : { Reference(Device) } // The parent device
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:Device;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:Device.identifier [ Identifier ], ... ; # 0..* Instance identifier
  fhir:Device.definition [ Reference(DeviceDefinition) ]; # 0..1 The reference to the definition for the device
  fhir:Device.udiCarrier [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:Device.udiCarrier.deviceIdentifier [ string ]; # 0..1 Mandatory fixed portion of UDI
    fhir:Device.udiCarrier.issuer [ uri ]; # 0..1 UDI Issuing Organization
    fhir:Device.udiCarrier.jurisdiction [ uri ]; # 0..1 Regional UDI authority
    fhir:Device.udiCarrier.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String
    fhir:Device.udiCarrier.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode String
    fhir:Device.udiCarrier.entryType [ code ]; # 0..1 barcode | rfid | manual +
  ], ...;
  fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown
  fhir:Device.statusReason [ CodeableConcept ], ... ; # 0..* online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
  fhir:Device.distinctIdentificationCode [ string ]; # 0..1 The distinct identification code for a biological product regulated as a device
  fhir:Device.manufacturer [ string ]; # 0..1 Name of device manufacturer
  fhir:Device.manufactureDate [ dateTime ]; # 0..1 Date when the device was made
  fhir:Device.expirationDate [ dateTime ]; # 0..1 Date and time of expiry of this device (if applicable)
  fhir:Device.lotNumber [ string ]; # 0..1 Lot number of manufacture
  fhir:Device.serialNumber [ string ]; # 0..1 Serial number assigned by the manufacturer
  fhir:Device.deviceName [ # 0..* The name of the device as given by the manufacturer
    fhir:Device.deviceName.name [ string ]; # 1..1 The name of the device
    fhir:Device.deviceName.type [ code ]; # 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  ], ...;
  fhir:Device.modelNumber [ string ]; # 0..1 The model number for the device
  fhir:Device.partNumber [ string ]; # 0..1 The part number of the device
  fhir:Device.type [ CodeableConcept ]; # 0..1 The kind or type of device
  fhir:Device.specialization [ # 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    fhir:Device.specialization.systemType [ CodeableConcept ]; # 1..1 The standard that is used to operate and communicate
    fhir:Device.specialization.version [ string ]; # 0..1 The version of the standard that is used to operate and communicate
  ], ...;
  fhir:Device.version [ # 0..* The actual design of the device or software version running on the device
    fhir:Device.version.type [ CodeableConcept ]; # 0..1 The type of the device version
    fhir:Device.version.component [ Identifier ]; # 0..1 A single component of the device version
    fhir:Device.version.value [ string ]; # 1..1 The version text
  ], ...;
  fhir:Device.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    fhir:Device.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    fhir:Device.property.valueQuanity [ Quantity ], ... ; # 0..* Property value as a quantity
    fhir:Device.property.valueCode [ CodeableConcept ], ... ; # 0..* Property value as a code, e.g., NTP4 (synced to NTP)
  ], ...;
  fhir:Device.patient [ Reference(Patient) ]; # 0..1 Patient to whom Device is affixed
  fhir:Device.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device
  fhir:Device.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support
  fhir:Device.location [ Reference(Location) ]; # 0..1 Where the device is found
  fhir:Device.url [ uri ]; # 0..1 Network address to contact device
  fhir:Device.note [ Annotation ], ... ; # 0..* Device notes and comments
  fhir:Device.safety [ CodeableConcept ], ... ; # 0..* Safety Characteristics of Device
  fhir:Device.parent [ Reference(Device) ]; # 0..1 The parent device
]

Changes since Release 3

Device
Device.definition
  • Added Element
Device.udiCarrier
  • Added Element
Device.udiCarrier.deviceIdentifier
  • Added Element
Device.udiCarrier.issuer
  • Added Element
Device.udiCarrier.jurisdiction
  • Added Element
Device.udiCarrier.carrierAIDC
  • Added Element
Device.udiCarrier.carrierHRF
  • Added Element
Device.udiCarrier.entryType
  • Added Element
Device.statusReason
  • Added Element
Device.distinctIdentificationCode
  • Added Element
Device.serialNumber
  • Added Element
Device.deviceName
  • Added Element
Device.deviceName.name
  • Added Element
Device.deviceName.type
  • Added Element
Device.modelNumber
  • Added Element
Device.partNumber
  • Added Element
Device.specialization
  • Added Element
Device.specialization.systemType
  • Added Element
Device.specialization.version
  • Added Element
Device.version
  • Max Cardinality changed from 1 to *
  • Type changed from string to BackboneElement
Device.version.type
  • Added Element
Device.version.component
  • Added Element
Device.version.value
  • Added Element
Device.property
  • Added Element
Device.property.type
  • Added Element
Device.property.valueQuanity
  • Added Element
Device.property.valueCode
  • Added Element
Device.parent
  • Added Element
Device.udi
  • deleted
Device.model
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 9 tests of which 1 fail to execute. 8 fail round-trip testing and 8 r3 resources are invalid (0 errors).)

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

8.14.3.1 Terminology Bindings

PathDefinitionTypeReference
Device.udiCarrier.entryType Codes to identify how UDI data was entered.RequiredUDIEntryType
Device.status The availability status of the device.RequiredFHIRDeviceStatus
Device.statusReason The availability status reason of the device.ExtensibleFHIRDeviceStatusReason
Device.deviceName.type The type of name the device is referred by.RequiredDeviceNameType
Device.type Codes to identify medical devices.ExampleFHIRDeviceTypes

8.14.3.2 Notes

8.14.3.2.1 Device Identifier and Device Type

Nearly all devices are assigned a string of characters to represent one or more identifiers or codes, which are usually printed or affixed to the device using either barcodes or RFIDs. The identifier or code can come from the manufacturer (for example, a 'serial number', 'reference number', or 'catalog number'), various institution and registries. Any of these identifiers or codes assigned to the device can and should be recorded in the device resource. However, there can there can be confusion where to represent them in the resource because codes and identifiers are represented in FHIR as semantically distinct elements and because organizations may conflate the term 'code' for an identifier or 'identifier' for a code in their names.

The identifier element is only intended for use when it's an actual identifier for a specific instance of a device. That would mean that each device would have a separate serial number and would be represented using this element - devices without serial numbers (for example, a box of syringes) would not. Concepts such as a reference number or catalog number or GTIN describe a code which represents a kind of device and are conveyed using the type element. Some sources of standard codes for devices and translations within type are listed below:

8.14.3.2.2 Unique Device Identifier (UDI)

The International Medical Device Regulators Forum IMDRF UDI Working Group published UDI System for Medical Devices (Version 2.0) , the base specification for Unique Device Identifiers (UDI). The United States Food and Drug Administration has produced an implementation guide for Unique Device Identifiers (UDI) which implements the IMDRF specification and other jurisdictions may produce similar IMDRF implementation guides as well. The full UDI string that represents the barcode as printed on the packaging of the device or Automatic Identification and Data Capture (AIDC) representation is called the "UDI carrier". The UDI has 2 components*:

  • Device identifier (DI)**, which is the actual identification component
  • Production identifier(s)(PI) which provide the means to track a device through its manufacture, distribution and use.

*non-UDI elements may also appear within the UDI carrier. **a "GTIN" (sometimes also called an EAN number) is a code developed by GS1 for the kind of device not an identifier for the device. A GTIN may appear on its own or it may appear in a UDI string as the DI component.

The DI of the UDI may be stored in a jurisdictional repository and used as the primary key to access other device information. For example, in the United States, the DI of the UDI is submitted in a device record to the Global Unique Device Identification Database (GUDID) . The UDI may identify an instance of a device uniquely (when the PI includes a serial number), or it may just identify the type of the device. The UDI is parsed into its constituent parts (DI, PI and other elements) by parsing rules developed by each Issuing Agency standard. Where the device has an assigned UDI, the other details carried in the resource (e.g., lot, expiration date, etc.) SHALL be consistent with the information encoded in the UDI string or registered in the local repository.

Best practice guidelines for transmitting UDI data using the Device resource dictate transmitting both the UDI Carrier and all components found within the UDI as described in Device UDI Mapping. Several examples are provided for further guidance.

8.14.4 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
device-namestringA server defined search that may match any of the string fields in the Device.udi.name or Device.type.coding.display or Device.type.textDevice.type.text | Device.type.coding.display
identifiertokenInstance id from manufacturer, owner, and othersDevice.identifier
locationreferenceA location, where the resource is foundDevice.location
(Location)
manufacturerstringThe manufacturer of the deviceDevice.manufacturer
modelstringThe model of the device
organizationreferenceThe organization responsible for the deviceDevice.owner
(Organization)
patientreferencePatient information, if the resource is affixed to a personDevice.patient
(Patient)
statustokenactive | inactive | entered-in-error | unknownDevice.status
typetokenThe type of the deviceDevice.type
udi-carrierstringUDI Barcode (RFID or other technology) string either in HRF format or AIDC format converted to base64 string.
udi-distringThe udi Device Identifier (DI)
urluriNetwork address to contact deviceDevice.url