R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #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 Group Maturity Level : 2 0   Trial Use Compartments : Device Not linked to any defined compartments

This resource identifies an instance or 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 to the following active discussions which may result in significant changes to this resource. We would appreciate your feedback on these issues. implementers.

  • How to distinguish between the device “instance” or the “kind” Device is an "instance", DeviceDefinition is a "kind"

    Current list of device 'kind' elements: deviceIdentifier type name jurisdiction issuer manufacturer model version safety Current list of device 'instance' elements: identifier (serial number) carrierAIDC carrierHRF entryType lotNumber manufactureDate expirationDate status Currently, Previously, the Device resource represents 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). The lists above identify the Device elements associated with kind and instance respectively. Note that both kind and instance related elements are typically present when representing instance of a device. To clearly 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 of UDI for multipart devices including UDI

    Currently, the Both Device resource only permits a single UDI, which does not and DeviceDefinition resources allow for devices that are composed nesting of multiple parts parts, each with a separate UDI. The following options are proposed to allow representation of them having a UDI for multipart devices. representation.

    1. Group individual Devices using the Procedure resource focalDevice element. There would be as many devices as necessary represented, but each device will have zero to one DI and UDI. There is no way to define the relationship between devices with DeviceComponent unless add a reference of DeviceComponent in Procedure. 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)

    Similar to the 3rd option above for UDI for multipart devices, there is active discussion within the Devices working group 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 device types or 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 Identifer 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.
    • DeviceComponent that the DeviceMetric is part of. This can be a DeviceComponent of any kind like a VirtualMedicalDevice (VMD), a MedicalDeviceSystem (MDS) , or a Channel

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 DeviceComponents Devices pointing to their "parent" component using DeviceComponent.parent , e.g. channel to VMD and VMD to the MDS. All components point to the "logical" Device they belong to, using DeviceComponent.source . If you want to represent the version ( e.g., a software version) as well as other attributes of the DeviceComponent, the DeviceComponent.productSpecification is used. When representing which logical device your observations came from, use Device. But if you need to be more specific, the Observation resource can point to DeviceMetric or DeviceComponent which in turn reference the "logical" Device they belongs to. "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 , DeviceComponent , 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

Name Flags Card. Type Description & Constraints doco
. . Device TU DomainResource Item used in healthcare
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier 0..* Identifier Instance identifier
. . udi . definition Σ 0..1 BackboneElement Reference ( DeviceDefinition ) Unique Device Identifier (UDI) Barcode string The reference to the definition for the device
. . deviceIdentifier . udiCarrier Σ 0..1 0..* string BackboneElement Mandatory fixed portion of UDI Unique Device Identifier (UDI) Barcode string
. . . . name deviceIdentifier Σ 0..1 string Device Name as appears on Mandatory fixed portion of UDI label
. . . . jurisdiction issuer 0..1 uri Regional UDI authority Issuing Organization
. . . . carrierHRF jurisdiction Σ 0..1 string uri Regional UDI Human Readable Barcode String authority
. . . . carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
. . . . issuer carrierHRF Σ 0..1 uri string UDI Issuing Organization Human Readable Barcode String
. . . . entryType 0..1 code barcode | rfid | manual +
UDIEntryType ( Required )
. . . status ?! Σ 0..1 code active | inactive | entered-in-error | unknown
FHIRDeviceStatus ( Required )
. . . type statusReason 0..1 0..* CodeableConcept What kind of device this is online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
FHIR Device Types FHIRDeviceStatusReason ( Example Extensible )
. . . lotNumber distinctIdentificationCode 0..1 string Lot number of manufacture The distinct identification code for a biological product regulated as a device
. . . manufacturer 0..1 string Name of device manufacturer
. . . manufactureDate 0..1 dateTime Date when the device was made
. . . expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
. . . model lotNumber 0..1 string Model id Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
. . . deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType ( Required )
. . . modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type 0..1 CodeableConcept The kind or type of device
FHIR Device Types ( Example )
... specialization 0..* BackboneElement 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
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string Version number (i.e. software) The version text
... property 0..* BackboneElement 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)
.... valueQuanity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
. . . patient 0..1 Reference ( Patient ) Patient to whom Device is affixed
. . . owner 0..1 Reference ( Organization ) Organization responsible for device
. . . contact 0..* ContactPoint Details for human/organization for support
. . . location 0..1 Reference ( Location ) Where the resource device is found
. . . url 0..1 uri Network address to contact device
. . . note 0..* Annotation Device notes and comments
. . . safety Σ 0..* CodeableConcept Safety Characteristics of Device
DeviceSafety
. . . parent 0..1 Reference ( Example 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 owners identifier : Identifier [0..*] The reference to the definition for the device definition : 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 ! » Code or identifier to identify a kind Reason for the dtatus of device the Device availability type statusReason : CodeableConcept [0..1] [0..*] « Codes to identify medical devices (Strength=Example) The availability status reason of the device. (Strength=Extensible) FHIR Device Types FHIRDeviceStatusReason ?? + » Lot number assigned The distinct identification code required by the manufacturer §1271.290(c) for a human cell, tissue, or cellular and tissue-based product regulated as a device lotNumber distinctIdentificationCode : string [0..1] A name of the manufacturer manufacturer : string [0..1] The date and time when the device was manufactured manufactureDate : 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] The "model" is an identifier Lot number assigned by the manufacturer to identify the product by its type. This lotNumber : string [0..1] The serial number is shared assigned by the all devices sold as organization when the same type device was manufactured model serialNumber : string [0..1] The version of the device, if model number for the device has multiple releases under the same model, modelNumber : string [0..1] The part number of thedevice partNumber : string [0..1] The kind or if the type of device is software or carries firmware version type : string CodeableConcept [0..1] « Codes to identify medical devices. (Strength=Example) FHIRDeviceTypes ?? » Patient information, If the device is affixed to a person patient : Reference [0..1] « Patient » An organization that is responsible for the provision and ongoing maintenance of the device owner : Reference [0..1] « Organization » Contact details for an organization or a particular human that is responsible for the device contact : ContactPoint [0..*] The place where the device can be found location : Reference [0..1] « Location » A network address on which the device may be contacted directly url : uri [0..1] Descriptive information, usage information or implantation information that is not captured in an existing element note : Annotation [0..*] Provides additional safety characteristics about a medical device. For example devices containing latex safety : CodeableConcept [0..*] « Codes used to identify medical devices safety characterics. These codes are derived in part from the United States Food and Drug Administration recommendations (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example. (Strength=Example) The parent device DeviceSafety parent : Reference [0..1] « Device ?? » Udi UdiCarrier The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device deviceIdentifier : string [0..1] Name of device as used in labeling or catalog 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-di name issuer : string 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-udi jurisdiction : uri [0..1] The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device carrierHRF : string [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 encoded carrierAIDC : base64Binary [0..1] Organization that is charged with issuing UDIs for devices. For example, The full UDI carrier as the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di human readable form (HRF) representation of the barcode string as printed on the packaging of the device issuer carrierHRF : uri string [0..1] A coded entry to indicate how the data was entered entryType : code [0..1] « Codes to identify how UDI data was entered entered. (Strength=Required) UDIEntryType ! » DeviceName The name of the device name : string [1..1] The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName type : code [1..1] « The type of name the device is referred by. (Strength=Required) DeviceNameType ! » Specialization The standard that is used to operate and communicate systemType : CodeableConcept [1..1] The version of the standard that is used to operate and communicate version : string [0..1] Version The type of the device version type : CodeableConcept [0..1] A single component of the device version component : Identifier [0..1] The version text value : string [1..1] Property Code that specifies the property DeviceDefinitionPropetyCode (Extensible) type : CodeableConcept [1..1] Property value as a quantity valueQuanity : Quantity [0..*] Property value as a code, e.g., NTP4 (synced to NTP) valueCode : CodeableConcept [0..*] [Unique Unique device identifier (UDI)](device.html#udi) (UDI) assigned to device label or package package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold udi udiCarrier [0..1] [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 DeviceDefinition deviceName [0..*] The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication specialization [0..*] The actual design of the device or software version running on the device version [0..*] The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties property [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>
 <
  <
  <
  <
  <
  <
  <<a href="device-definitions.html#Device.udi.issuer" title="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :

 <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 -->
  <
 </udi>

  <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 -->
 <</type>
 <

 <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>

 <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>

 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The parent device --></parent>

</Device>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "Device",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "
    "
    "
    "
    "
    "
    "<a href="device-definitions.html#Device.udi.issuer" title="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :

  "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:;

[ 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:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:<a href="device-definitions.html#Device.udi.issuer" title="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :

  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:http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">Device.udi.issuer
    fhir:
  ];

http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">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:
  fhir:

  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:
  fhir:

  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:

  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
  • No Changes 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 R2 <--> R3 <--> R4 Conversion Maps (status = 5 9 tests that all of which 1 fail to execute ok. . 2 8 fail round-trip testing and all 8 r3 resources are valid.). Note: these have note yet been updated to be R3 to R4 invalid (0 errors). )

Structure

Name Flags Card. Type Description & Constraints doco
. . Device TU DomainResource Item used in healthcare
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier 0..* Identifier Instance identifier
. . udi . definition Σ 0..1 BackboneElement Reference ( DeviceDefinition ) Unique Device Identifier (UDI) Barcode string The reference to the definition for the device
. . deviceIdentifier . udiCarrier Σ 0..1 0..* string BackboneElement Mandatory fixed portion of UDI Unique Device Identifier (UDI) Barcode string
. . . . name deviceIdentifier Σ 0..1 string Device Name as appears on Mandatory fixed portion of UDI label
. . . . jurisdiction issuer 0..1 uri Regional UDI authority Issuing Organization
. . . . carrierHRF jurisdiction Σ 0..1 string uri Regional UDI Human Readable Barcode String authority
. . . . carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
. . . . issuer carrierHRF Σ 0..1 uri string UDI Issuing Organization Human Readable Barcode String
. . . . entryType 0..1 code barcode | rfid | manual +
UDIEntryType ( Required )
. . . status ?! Σ 0..1 code active | inactive | entered-in-error | unknown
FHIRDeviceStatus ( Required )
. . . type statusReason 0..1 0..* CodeableConcept What kind of device this is online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
FHIR Device Types FHIRDeviceStatusReason ( Example Extensible )
. . . lotNumber distinctIdentificationCode 0..1 string Lot number of manufacture The distinct identification code for a biological product regulated as a device
. . . manufacturer 0..1 string Name of device manufacturer
. . . manufactureDate 0..1 dateTime Date when the device was made
. . . expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
. . . model lotNumber 0..1 string Model id Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
. . . deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType ( Required )
. . . modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type 0..1 CodeableConcept The kind or type of device
FHIR Device Types ( Example )
... specialization 0..* BackboneElement 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
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string Version number (i.e. software) The version text
... property 0..* BackboneElement 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)
.... valueQuanity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
. . . patient 0..1 Reference ( Patient ) Patient to whom Device is affixed
. . . owner 0..1 Reference ( Organization ) Organization responsible for device
. . . contact 0..* ContactPoint Details for human/organization for support
. . . location 0..1 Reference ( Location ) Where the resource device is found
. . . url 0..1 uri Network address to contact device
. . . note 0..* Annotation Device notes and comments
. . . safety Σ 0..* CodeableConcept Safety Characteristics of Device
DeviceSafety
. . . parent 0..1 Reference ( Example 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 owners identifier : Identifier [0..*] The reference to the definition for the device definition : 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 ! » Code or identifier to identify a kind Reason for the dtatus of device the Device availability type statusReason : CodeableConcept [0..1] [0..*] « Codes to identify medical devices (Strength=Example) The availability status reason of the device. (Strength=Extensible) FHIR Device Types FHIRDeviceStatusReason ?? + » Lot number assigned The distinct identification code required by the manufacturer §1271.290(c) for a human cell, tissue, or cellular and tissue-based product regulated as a device lotNumber distinctIdentificationCode : string [0..1] A name of the manufacturer manufacturer : string [0..1] The date and time when the device was manufactured manufactureDate : 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] The "model" is an identifier Lot number assigned by the manufacturer to identify the product by its type. This lotNumber : string [0..1] The serial number is shared assigned by the all devices sold as organization when the same type device was manufactured model serialNumber : string [0..1] The version of the device, if model number for the device has multiple releases under the same model, modelNumber : string [0..1] The part number of thedevice partNumber : string [0..1] The kind or if the type of device is software or carries firmware version type : string CodeableConcept [0..1] « Codes to identify medical devices. (Strength=Example) FHIRDeviceTypes ?? » Patient information, If the device is affixed to a person patient : Reference [0..1] « Patient » An organization that is responsible for the provision and ongoing maintenance of the device owner : Reference [0..1] « Organization » Contact details for an organization or a particular human that is responsible for the device contact : ContactPoint [0..*] The place where the device can be found location : Reference [0..1] « Location » A network address on which the device may be contacted directly url : uri [0..1] Descriptive information, usage information or implantation information that is not captured in an existing element note : Annotation [0..*] Provides additional safety characteristics about a medical device. For example devices containing latex safety : CodeableConcept [0..*] « Codes used to identify medical devices safety characterics. These codes are derived in part from the United States Food and Drug Administration recommendations (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example. (Strength=Example) The parent device DeviceSafety parent : Reference [0..1] « Device ?? » Udi UdiCarrier The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device deviceIdentifier : string [0..1] Name of device as used in labeling or catalog 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-di name issuer : string 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-udi jurisdiction : uri [0..1] The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device carrierHRF : string [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 encoded carrierAIDC : base64Binary [0..1] Organization that is charged with issuing UDIs for devices. For example, The full UDI carrier as the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di human readable form (HRF) representation of the barcode string as printed on the packaging of the device issuer carrierHRF : uri string [0..1] A coded entry to indicate how the data was entered entryType : code [0..1] « Codes to identify how UDI data was entered entered. (Strength=Required) UDIEntryType ! » DeviceName The name of the device name : string [1..1] The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName type : code [1..1] « The type of name the device is referred by. (Strength=Required) DeviceNameType ! » Specialization The standard that is used to operate and communicate systemType : CodeableConcept [1..1] The version of the standard that is used to operate and communicate version : string [0..1] Version The type of the device version type : CodeableConcept [0..1] A single component of the device version component : Identifier [0..1] The version text value : string [1..1] Property Code that specifies the property DeviceDefinitionPropetyCode (Extensible) type : CodeableConcept [1..1] Property value as a quantity valueQuanity : Quantity [0..*] Property value as a code, e.g., NTP4 (synced to NTP) valueCode : CodeableConcept [0..*] [Unique Unique device identifier (UDI)](device.html#udi) (UDI) assigned to device label or package package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold udi udiCarrier [0..1] [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 DeviceDefinition deviceName [0..*] The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication specialization [0..*] The actual design of the device or software version running on the device version [0..*] The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties property [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>
 <
  <
  <
  <
  <
  <
  <<a href="device-definitions.html#Device.udi.issuer" title="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :

 <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 -->
  <
 </udi>

  <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 -->
 <</type>
 <

 <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>

 <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>

 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The parent device --></parent>

</Device>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "Device",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance identifier
  "
    "
    "
    "
    "
    "
    "<a href="device-definitions.html#Device.udi.issuer" title="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :

  "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:;

[ 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:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:<a href="device-definitions.html#Device.udi.issuer" title="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :

  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:http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">Device.udi.issuer
    fhir:
  ];

http://hl7.org/fhir/NamingSystem/iccbba-other-di." class="dict">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:
  fhir:

  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:
  fhir:

  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:

  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 DSTU2 Release 3

Device
Device.definition
  • No Changes 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 R2 <--> R3 <--> R4 Conversion Maps (status = 5 9 tests that all of which 1 fail to execute ok. . 2 8 fail round-trip testing and all 8 r3 resources are valid.). Note: these have note yet been updated to be R3 to R4 invalid (0 errors). )

 

Alternate 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

Device.type Device.safety
Path Definition Type Reference
Device.udi.entryType Device.udiCarrier.entryType Codes to identify how UDI data was entered entered. Required UDIEntryType
Device.status The availability status of the device. Required FHIRDeviceStatus
Device.statusReason Codes to identify medical devices The availability status reason of the device. Example Extensible FHIR Device Types FHIRDeviceStatusReason
Device.deviceName.type The type of name the device is referred by. Required DeviceNameType
Device.type Codes used to identify medical devices safety characterics. These codes are derived in part from the United States Food and Drug Administration recommendations (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example. devices. Example DeviceSafety FHIRDeviceTypes

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.

Name Type Description Expression In Common
device-name string A server defined search that may match any of the string fields in the Device.udi.name or Device.type.coding.display or Device.type.text Device.udi.name | Device.type.text | Device.type.coding.display
identifier token Instance id from manufacturer, owner, and others Device.identifier
location reference A location, where the resource is found Device.location
( Location )
manufacturer string The manufacturer of the device Device.manufacturer
model string The model of the device Device.model
organization reference The organization responsible for the device Device.owner
( Organization )
patient reference Patient information, if the resource is affixed to a person Device.patient
( Patient )
status token active | inactive | entered-in-error | unknown Device.status
type token The type of the device Device.type
udi-carrier string UDI Barcode (RFID or other technology) string either in HRF format or AIDC format converted to base64 string. Device.udi.carrierHRF | Device.udi.carrierAIDC
udi-di string The udi Device Identifier (DI) Device.udi.deviceIdentifier
url uri Network address to contact device Device.url