DSTU2 FHIR Release 3 (STU)

This page is part of the FHIR Specification (v1.0.2: DSTU (v3.0.2: STU 2). 3). 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 R3 R2

5.10 8.14 Resource Device - Content

Orders and Observations Work Group Maturity Level : 1 2   Trial Use Compartments : Device

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 includes 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.

5.10.1 8.14.1 Scope and Usage

This resource is primarily used for recording which device performed an action and can also be used to track device location. It is also used for prescribing and dispensing devices for patient use. If the device is implanted in a patient, then the patient element will be present, and there would be no location. 5.10.2 Boundaries and Relationships These are the device related resources Device (this resource) - An administrative resource that tracks individual device types or instances of a device and their location. It Is is referenced by other resource for recording which device performed an action such as a procedure or an observation. It is also referenced when prescribing and dispensing devices for patient use or for ordering supplies. It is used to record and transmit Unique Device Identifer (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)
  • 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.), where as 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 done by the DeviceComponents 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 . Similarly, if for example you want to express which logical device your observation came from, you can just use Device, but if you need to be more specific observation can point to DeviceMetric which in turn points to the "logical" Device it belongs to, using DeviceMetric.source .

Devices that are implanted in a patient 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 resource should not be used to represent implanted devices.

This resource is referenced by Account , AdverseEvent , Appointment , AppointmentResponse , AuditEvent , ChargeItem , Claim , Communication , CommunicationRequest , Composition , Consent , Contract , DetectedIssue , DeviceComponent , DeviceMetric , DeviceUseRequest DeviceRequest , DeviceUseStatement , DiagnosticOrder , DiagnosticReport , DocumentManifest , DocumentReference , ExplanationOfBenefit , Flag , Group , ImagingObjectSelection GuidanceResponse , ImagingManifest , List , Media , MedicationAdministration , MedicationDispense , MedicationRequest , MessageHeader , Observation , Order , OrderResponse , Procedure , ProcedureRequest , Provenance , QuestionnaireResponse , ReferralRequest , RequestGroup , RiskAssessment , Schedule , Sequence , Specimen , SupplyDelivery and , SupplyRequest and Task

5.10.3 8.14.3 Resource Content

Structure

An instance of a manufactured te that is CodeableConcept What kind of device this is DeviceKind Annotation available Name Model id assigned by the manufacturer Version number (i.e. software) Manufacture date FDA mandated Unique Device Identifier Lot If the resource is affixed Details for human/organization for support uri Network address to contact device
Name Flags Card. Type Description & Constraints doco
. . Device DomainResource Item used in the provision of healthcare
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier 0..* Identifier Instance id from manufacturer, owner, and others identifier
. . type . udi Σ 1..1 0..1 BackboneElement Unique Device Identifier (UDI) Barcode string
. . . . deviceIdentifier ( Preferred ) Σ 0..1 string Mandatory fixed portion of UDI
. . note . . name Σ 0..* 0..1 string Device notes and comments Name as appears on UDI label
. . . . jurisdiction 0..1 uri Regional UDI authority
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... issuer 0..1 uri UDI Issuing Organization
.... entryType 0..1 code barcode | rfid | manual +
UDIEntryType ( Required )
... status ?! Σ 0..1 code active | not-available inactive | entered-in-error | unknown
DeviceStatus FHIRDeviceStatus ( Required )
. . manufacturer . type 0..1 string CodeableConcept What kind of device manufacturer this is
FHIR Device Types ( Example )
. . model . lotNumber 0..1 string Lot number of manufacture
. . version . manufacturer 0..1 string Name of device manufacturer
. . . manufactureDate 0..1 dateTime Date when the device was made
. . expiry . expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
. . udi . model 0..1 string Model id assigned by the manufacturer
. . lotNumber . version 0..1 string Version number of manufacture (i.e. software)
. . . 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 is found
. . patient . url 0..1 Reference ( Patient uri ) Network address to a person contact device
. . contact . note 0..* ContactPoint Annotation Device notes and comments
. . url . safety Σ 0..1 0..* CodeableConcept Safety Characteristics of Device
DeviceSafety ( Example )

doco Documentation for this format

UML Diagram ( Legend )

Device ( DomainResource ) Unique instance identifiers assigned to a device by organizations like manufacturers other organizations or owners. If the identifier identifies the type of device, Device.type should be used owners identifier : Identifier [0..*] 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 of device type : CodeableConcept [1..1] « [0..1] Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it. (Strength=Preferred) Codes to identify medical devices (Strength=Example) DeviceKind FHIR Device Types ? » ?? Descriptive information, usage information or implantation information that is not captured in an existing element Lot number assigned by the manufacturer note lotNumber : Annotation string [0..*] [0..1] Status A name of the Device availability (this element modifies the meaning of other elements) manufacturer status manufacturer : code string [0..1] « The availability status of date and time when the device. (Strength=Required) device was manufactured DeviceStatus ! » manufactureDate : dateTime [0..1] A name of the manufacturer The date and time beyond which this device is no longer valid or should not be used (if applicable) manufacturer expirationDate : string dateTime [0..1] The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type model : string [0..1] The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware version : string [0..1] The date Patient information, If the device is affixed to a person patient : Reference [0..1] Patient An organization that is responsible for the provision and time when ongoing maintenance of the device was manufactured manufactureDate owner : dateTime Reference [0..1] Organization Contact details for an organization or a particular human that is responsible for the device contact : ContactPoint [0..*] The date and time beyond place where the device can be found location : Reference [0..1] Location A network address on which this the device is no longer valid or should not may be used (if applicable) contacted directly expiry url : dateTime uri [0..1] United 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 mandated Unique Device Identifier (UDI). Use the human readable information (the content that the user sees, which recommendations](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example. (Strength=Example) DeviceSafety ?? Udi The device identifier (DI) is sometimes different to a mandatory, fixed portion of a UDI that identifies the exact syntax represented in labeler and the barcode) - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm specific version or model of a device udi deviceIdentifier : string [0..1] Lot number assigned by the manufacturer Name of device as used in labeling or catalog lotNumber name : string [0..1] An organization that is responsible The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the provision and ongoing maintenance appropriate repository uri as the system. For example, UDIs of devices managed in the device U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi owner jurisdiction : Reference uri [0..1] « Organization » The place where full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device can be found location carrierHRF : Reference string [0..1] « Location » Patient information, if The full UDI carrier of the resource is affixed to Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a person 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 patient carrierAIDC : Reference base64Binary [0..1] « Patient » Contact details for an organization or a particular human Organization that is responsible charged with issuing UDIs for devices. For example, the device 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 contact issuer : ContactPoint uri [0..*] [0..1] A network address on which coded entry to indicate how the device may be contacted directly data was entered url entryType : uri code [0..1] Codes to identify how UDI data was entered (Strength=Required) UDIEntryType ! [Unique device identifier (UDI)](device.html#5.11.3.2.2) assigned to device label or package udi [0..1]

XML Template 

<

<Device xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <</type>
 <</note>
 <
 <
 <
 <
 <
 <
 <
 <
 <</owner>
 <</location>
 <</patient>
 <</contact>
 <

 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <udi>  <!-- 0..1 Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 0..1 Mandatory fixed portion of UDI -->
  <name value="[string]"/><!-- 0..1 Device Name as appears on UDI label -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual + -->
 </udi>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown -->
 <type><!-- 0..1 CodeableConcept What kind of device this is --></type>
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <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) -->
 <model value="[string]"/><!-- 0..1 Model id assigned by the manufacturer -->
 <version value="[string]"/><!-- 0..1 Version number (i.e. software) -->
 <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 resource 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>

</Device>

JSON Template 

{
  "resourceType" : "",

{doco
  "resourceType" : "Device",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
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  "identifier" : [{ Identifier }], // Instance identifier
  "udi" : { // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // Mandatory fixed portion of UDI
    "name" : "<string>", // Device Name as appears on UDI label
    "jurisdiction" : "<uri>", // Regional UDI authority
    "carrierHRF" : "<string>", // UDI Human Readable Barcode String
    "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
    "issuer" : "<uri>", // UDI Issuing Organization
    "entryType" : "<code>" // barcode | rfid | manual +
  },
  "status" : "<code>", // active | inactive | entered-in-error | unknown
  "type" : { CodeableConcept }, // What kind of device this is
  "lotNumber" : "<string>", // Lot number of manufacture
  "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)
  "model" : "<string>", // Model id assigned by the manufacturer
  "version" : "<string>", // Version number (i.e. software)
  "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 resource is found
  "url" : "<uri>", // Network address to contact device
  "note" : [{ Annotation }], // Device notes and comments
  "safety" : [{ CodeableConcept }] // Safety Characteristics of 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.udi [ # 0..1 Unique Device Identifier (UDI) Barcode string
    fhir:Device.udi.deviceIdentifier [ string ]; # 0..1 Mandatory fixed portion of UDI
    fhir:Device.udi.name [ string ]; # 0..1 Device Name as appears on UDI label
    fhir:Device.udi.jurisdiction [ uri ]; # 0..1 Regional UDI authority
    fhir:Device.udi.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode String
    fhir:Device.udi.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String
    fhir:Device.udi.issuer [ uri ]; # 0..1 UDI Issuing Organization
    fhir:Device.udi.entryType [ code ]; # 0..1 barcode | rfid | manual +
  ];
  fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown
  fhir:Device.type [ CodeableConcept ]; # 0..1 What kind of device this is
  fhir:Device.lotNumber [ string ]; # 0..1 Lot number of manufacture
  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.model [ string ]; # 0..1 Model id assigned by the manufacturer
  fhir:Device.version [ string ]; # 0..1 Version number (i.e. software)
  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 resource 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
]

Changes since DSTU2

Device
Device.udi
  • Type changed from string to BackboneElement
Device.udi.deviceIdentifier
  • Added Element
Device.udi.name
  • Added Element
Device.udi.jurisdiction
  • Added Element
Device.udi.carrierHRF
  • Added Element
Device.udi.carrierAIDC
  • Added Element
Device.udi.issuer
  • Added Element
Device.udi.entryType
  • Added Element
Device.status
  • Change value set from http://hl7.org/fhir/ValueSet/devicestatus to http://hl7.org/fhir/ValueSet/device-status
Device.type
  • Min Cardinality changed from 1 to 0
Device.expirationDate
  • Renamed from expiry to expirationDate
Device.safety
  • Added Element

See the Full Difference for further information

This analysis is available as XML or JSON .

See R2 <--> R3 Conversion Maps (status = 5 tests that all execute ok. 2 fail round-trip testing and all r3 resources are valid.).

Structure

An instance of a manufactured te that is CodeableConcept What kind of device this is DeviceKind Annotation available Name Model id assigned by the manufacturer Version number (i.e. software) Manufacture date FDA mandated Unique Device Identifier Lot If the resource is affixed Details for human/organization for support uri Network address to contact device
Name Flags Card. Type Description & Constraints doco
. . Device DomainResource Item used in the provision of healthcare
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier 0..* Identifier Instance id from manufacturer, owner, and others identifier
. . type . udi Σ 1..1 0..1 BackboneElement Unique Device Identifier (UDI) Barcode string
. . . . deviceIdentifier ( Preferred ) Σ 0..1 string Mandatory fixed portion of UDI
. . note . . name Σ 0..* 0..1 string Device notes and comments Name as appears on UDI label
. . . . jurisdiction 0..1 uri Regional UDI authority
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... issuer 0..1 uri UDI Issuing Organization
.... entryType 0..1 code barcode | rfid | manual +
UDIEntryType ( Required )
... status ?! Σ 0..1 code active | not-available inactive | entered-in-error | unknown
DeviceStatus FHIRDeviceStatus ( Required )
. . manufacturer . type 0..1 string CodeableConcept What kind of device manufacturer this is
FHIR Device Types ( Example )
. . model . lotNumber 0..1 string Lot number of manufacture
. . version . manufacturer 0..1 string Name of device manufacturer
. . . manufactureDate 0..1 dateTime Date when the device was made
. . expiry . expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
. . udi . model 0..1 string Model id assigned by the manufacturer
. . lotNumber . version 0..1 string Version number of manufacture (i.e. software)
. . . 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 is found
. . patient . url 0..1 Reference ( Patient uri ) Network address to a person contact device
. . contact . note 0..* ContactPoint Annotation Device notes and comments
. . url . safety Σ 0..1 0..* CodeableConcept Safety Characteristics of Device
DeviceSafety ( Example )

doco Documentation for this format

UML Diagram ( Legend )

Device ( DomainResource ) Unique instance identifiers assigned to a device by organizations like manufacturers other organizations or owners. If the identifier identifies the type of device, Device.type should be used owners identifier : Identifier [0..*] 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 of device type : CodeableConcept [1..1] « [0..1] Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it. (Strength=Preferred) Codes to identify medical devices (Strength=Example) DeviceKind FHIR Device Types ? » ?? Descriptive information, usage information or implantation information that is not captured in an existing element Lot number assigned by the manufacturer note lotNumber : Annotation string [0..*] [0..1] Status A name of the Device availability (this element modifies the meaning of other elements) manufacturer status manufacturer : code string [0..1] « The availability status of date and time when the device. (Strength=Required) device was manufactured DeviceStatus ! » manufactureDate : dateTime [0..1] A name of the manufacturer The date and time beyond which this device is no longer valid or should not be used (if applicable) manufacturer expirationDate : string dateTime [0..1] The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type model : string [0..1] The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware version : string [0..1] The date Patient information, If the device is affixed to a person patient : Reference [0..1] Patient An organization that is responsible for the provision and time when ongoing maintenance of the device was manufactured manufactureDate owner : dateTime Reference [0..1] Organization Contact details for an organization or a particular human that is responsible for the device contact : ContactPoint [0..*] The date and time beyond place where the device can be found location : Reference [0..1] Location A network address on which this the device is no longer valid or should not may be used (if applicable) contacted directly expiry url : dateTime uri [0..1] United 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 mandated Unique Device Identifier (UDI). Use the human readable information (the content that the user sees, which recommendations](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example. (Strength=Example) DeviceSafety ?? Udi The device identifier (DI) is sometimes different to a mandatory, fixed portion of a UDI that identifies the exact syntax represented in labeler and the barcode) - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm specific version or model of a device udi deviceIdentifier : string [0..1] Lot number assigned by the manufacturer Name of device as used in labeling or catalog lotNumber name : string [0..1] An organization that is responsible The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the provision and ongoing maintenance appropriate repository uri as the system. For example, UDIs of devices managed in the device U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi owner jurisdiction : Reference uri [0..1] « Organization » The place where full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device can be found location carrierHRF : Reference string [0..1] « Location » Patient information, if The full UDI carrier of the resource is affixed to Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a person 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 patient carrierAIDC : Reference base64Binary [0..1] « Patient » Contact details for an organization or a particular human Organization that is responsible charged with issuing UDIs for devices. For example, the device 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 contact issuer : ContactPoint uri [0..*] [0..1] A network address on which coded entry to indicate how the device may be contacted directly data was entered url entryType : uri code [0..1] Codes to identify how UDI data was entered (Strength=Required) UDIEntryType ! [Unique device identifier (UDI)](device.html#5.11.3.2.2) assigned to device label or package udi [0..1]

XML Template 

<

<Device xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <</type>
 <</note>
 <
 <
 <
 <
 <
 <
 <
 <
 <</owner>
 <</location>
 <</patient>
 <</contact>
 <

 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <udi>  <!-- 0..1 Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 0..1 Mandatory fixed portion of UDI -->
  <name value="[string]"/><!-- 0..1 Device Name as appears on UDI label -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual + -->
 </udi>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown -->
 <type><!-- 0..1 CodeableConcept What kind of device this is --></type>
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <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) -->
 <model value="[string]"/><!-- 0..1 Model id assigned by the manufacturer -->
 <version value="[string]"/><!-- 0..1 Version number (i.e. software) -->
 <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 resource 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>

</Device>

JSON Template 

{
  "resourceType" : "",

{doco
  "resourceType" : "Device",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
  "
  "
  "
  "
  "
  "
  "
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  "identifier" : [{ Identifier }], // Instance identifier
  "udi" : { // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // Mandatory fixed portion of UDI
    "name" : "<string>", // Device Name as appears on UDI label
    "jurisdiction" : "<uri>", // Regional UDI authority
    "carrierHRF" : "<string>", // UDI Human Readable Barcode String
    "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
    "issuer" : "<uri>", // UDI Issuing Organization
    "entryType" : "<code>" // barcode | rfid | manual +
  },
  "status" : "<code>", // active | inactive | entered-in-error | unknown
  "type" : { CodeableConcept }, // What kind of device this is
  "lotNumber" : "<string>", // Lot number of manufacture
  "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)
  "model" : "<string>", // Model id assigned by the manufacturer
  "version" : "<string>", // Version number (i.e. software)
  "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 resource is found
  "url" : "<uri>", // Network address to contact device
  "note" : [{ Annotation }], // Device notes and comments
  "safety" : [{ CodeableConcept }] // Safety Characteristics of 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.udi [ # 0..1 Unique Device Identifier (UDI) Barcode string
    fhir:Device.udi.deviceIdentifier [ string ]; # 0..1 Mandatory fixed portion of UDI
    fhir:Device.udi.name [ string ]; # 0..1 Device Name as appears on UDI label
    fhir:Device.udi.jurisdiction [ uri ]; # 0..1 Regional UDI authority
    fhir:Device.udi.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode String
    fhir:Device.udi.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String
    fhir:Device.udi.issuer [ uri ]; # 0..1 UDI Issuing Organization
    fhir:Device.udi.entryType [ code ]; # 0..1 barcode | rfid | manual +
  ];
  fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown
  fhir:Device.type [ CodeableConcept ]; # 0..1 What kind of device this is
  fhir:Device.lotNumber [ string ]; # 0..1 Lot number of manufacture
  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.model [ string ]; # 0..1 Model id assigned by the manufacturer
  fhir:Device.version [ string ]; # 0..1 Version number (i.e. software)
  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 resource 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
]

  Changes since DSTU2

Device
Device.udi
  • Type changed from string to BackboneElement
Device.udi.deviceIdentifier
  • Added Element
Device.udi.name
  • Added Element
Device.udi.jurisdiction
  • Added Element
Device.udi.carrierHRF
  • Added Element
Device.udi.carrierAIDC
  • Added Element
Device.udi.issuer
  • Added Element
Device.udi.entryType
  • Added Element
Device.status
  • Change value set from http://hl7.org/fhir/ValueSet/devicestatus to http://hl7.org/fhir/ValueSet/device-status
Device.type
  • Min Cardinality changed from 1 to 0
Device.expirationDate
  • Renamed from expiry to expirationDate
Device.safety
  • Added Element

See the Full Difference for further information

This analysis is available as XML or JSON .

See R2 <--> R3 Conversion Maps (status = 5 tests that all execute ok. 2 fail round-trip testing and all r3 resources are valid.).

 

Alternate definitions: Schema / Schematron , Resource Profile Master Definition ( XML , JSON ), Questionnaire XML Schema / Schematron (for ) + JSON Schema , ShEx (for Turtle )

5.10.3.1 8.14.3.1 Terminology Bindings

Device.type
Path Definition Type Reference
Device.udi.entryType Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it. Codes to identify how UDI data was entered Preferred Required Global Medical Device Nomenclature (GMDN®). UDIEntryType
Device.status The availability status of the device. Required DeviceStatus FHIRDeviceStatus
Device.type Codes to identify medical devices Example FHIR Device Types
Device.safety 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. Example DeviceSafety

5.10.3.2 8.14.3.2 Notes

5.10.3.2.1 8.14.3.2.1 Device Types

There The example binding used for the device element is from SNOMED CT. However, there are many other sources of possible codes for device type. The example uses device codes from type including:

Note that there may be appropriate is RTM (Rosetta Terminology Mapping). The local UDI repository (in the US this is the GUDID database) is another source as well, however, the full UDI string is placed in the Device.udi element. Alternatively, many jurisdictions have their own supply chain arrangements which define many useful codes. translations of type code using one or more of these and other vocabularies

5.10.3.2.2 8.14.3.2.2 Device Identifiers

Nearly all devices are assigned one or more identifiers, which are usually printed or affixed to the device using either barcodes or RFIDs. The identifiers can come from the manufacturer (often called the "serial number," "reference number," or "catalog number"), various institution and registries. Any of these identifiers assigned to the device can and should be recorded in the device resource. The different identifiers are differentiated by their use, label, and system values.

8.14.3.2.3 Unique Device Identifier (UDI)

The most important of the identifiers is International Medical Device Regulators Forum IMDRF UDI Working Group published UDI System for Medical Devices (Version 2.0) , the US Realm FDA Mandated base specification for Unique Device Identifier Identifiers (UDI). The United States Food and Drug Administration has produced an implementation guide for Unique Device Identifiers (UDI) required by which implements the FDA for every medical device to bear on its label (unless excepted). IMDRF specification and other jurisdictions may produce similar IMDRF implementation guides as well. The full UDI has 2 components - string that represents the device identifier (DI), which is assigned at barcode as printed on the version/model level packaging of the device or Automatic Identification and Data Capture (AIDC) representation is called the production "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. The UDI string

*non-UDI elements may also contain additional elements which are not formally part of appear within the local defined UDI elements but which are non-the-less contained within carrier. **a "GTIN" (sometimes also called an EAN number) is a code developed by GS1 for the same string and are kind of value locally. 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(s) include PI includes a serial number), or it may just identify the type of the device. The UDI can be broken 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, expiry expiration date, etc.) SHALL be consistent with the information encoded in the UDI string or registered in the local repository. In the US, a UDI will be required by the FDA

Best practice guidelines for every medical device to bear on its label (unless excepted). The DI of the transmitting UDI is submitted in a device record to data using the Global Unique Device Identification Database (GUDID) and is used as the primary key to access other device information. Note that a GTIN (sometimes also called an EAN number) is a code developed by GS1 for resource dictate transmitting both the kind of device not an identifier for UDI Carrier and all components found within the device. A GTIN may appear on its own or it may appear in a UDI string as the DI component. GTIN example described in Device UDI Mapping . Several examples are provided for futher guidance.

<type> <coding> <system value="urn:oid:1.3.160‎"/> <value value="00614141999996"/> </coding> <!-- other codes for type --> </type>

5.10.4 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 Paths 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 udi-carrier string FDA mandated Unique 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 Device.udi.deviceIdentifier
url uri Network address to contact device Device.url