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8.14 Ресурс Device - Назначение

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

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.

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

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

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

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

    More details on these options can be found here .

  • Representation multipart devices including UDI

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

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

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

Это административный ресурс для отслеживания отдельных экземпляров устройства и их местонахождения. На него ссылается другой ресурс для записи, какое устройство выполнило действие, например процедуру или наблюдение, на него ссылаются при назначении и выдаче устройств в пользование пациентам или при заказе поставок, и он используется для записи и передачи уникального идентификатора устройства (UDI) и другой информации об устройстве, например об имплантате для пациента. This resource is an administrative resource that tracks individual instances of a device and their location. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, referenced when prescribing and dispensing devices for patient use or for ordering supplies, and used to record and transmit Unique Device Identifier (UDI) information about a device such as a patient's implant.

Ресурсы, связанные с ресурсом Device

  • Device (данный ресурс)
  • 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 - описывает измерение, вычисление или возможную настройку устройства. DeviceMetric - Describes a measurement, calculation or setting capability of a medical device.

В FHIR ресурс Device описывает административную информацию об устройстве (она не изменяется существенным образом и содержит информацию об изготовителе и т. п.), тогда как ресурсы DeviceComponent и DeviceMetric (который, по сути, является разновидностью ресурса DeviceComponent) описывают физическую составляющую устройства, включая рабочее состояние, и являются намного более непостоянными. In FHIR, the "Device" is the "administrative" resource for the device (it does not change much and has manufacturer information etc.), whereas the DeviceComponent and DeviceMetric (which is really a kind of DeviceComponent) model the physical part, including operation status and is much more volatile. The physical composition of a Device is represented by the Devices pointing to their "parent".

Устройства отличаются от медикаментов, поскольку они не "расходуются" - они продолжают работать внутри пациента постоянно. Однако это разграничение между медикаментами и устройствами определяется на уровне реализации, и данный стандарт не принуждает к этому за исключением устройств, которые имплантируются пациенту. Не следует использовать ресурс Medication для представления имплантируемых устройств. 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.

На этот ресурс ссылаются Signature, Account, AdverseEvent, Appointment, AppointmentResponse, AuditEvent, CarePlan, CatalogEntry, ChargeItem, ChargeItemDefinition, Claim, Communication, CommunicationRequest, Composition, Consent, Contract, DetectedIssue, itself, DeviceMetric, DeviceRequest, DeviceUseStatement, DiagnosticReport, DocumentManifest, DocumentReference, ExplanationOfBenefit, Flag, Group, GuidanceResponse, ImagingStudy, Invoice, List, MeasureReport, Media, MedicationAdministration, MedicationDispense, MedicationRequest, MessageHeader, MolecularSequence, Observation, Procedure, Provenance, QuestionnaireResponse, RequestGroup, RiskAssessment, Schedule, ServiceRequest, Specimen, SupplyDelivery, SupplyRequest и Task

Структура

ИмяФлагиКард.ТипОписание и ограниченияdoco
.. Device TUDomainResourceПредмет, применяемый в медицине
Элементы, определённые в прародителе: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier 0..*IdentifierИдентификатор экземпляра
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementСтроковое значение штрих-кода уникального идентификатора устройства (UDI)
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
UDIEntryType (Required)
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
FHIRDeviceStatus (Required)
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
FHIRDeviceStatusReason (Extensible)
... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer 0..1stringНазвание производителя устройства
... manufactureDate 0..1dateTimeДата, когда было произведено устройство
... expirationDate 0..1dateTimeДата и время истечения срока действия этого устройства (если применимо)
... lotNumber 0..1stringНомер партии выпуска
... serialNumber 0..1stringСерийный номер, присвоенный изготовителем
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 0..1CodeableConceptThe kind or type of device
FHIR Device Types (Example)
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1Reference(Patient)Пациент, которому имплантировано устройство
... owner 0..1Reference(Organization)Организация, ответственная за устройство
... contact 0..*ContactPointПодробная информация о человеке/организации из службы поддержки
... location 0..1Reference(Location)Where the device is found
... url 0..1uriСетевой адрес устройства
... note 0..*AnnotationПримечания и комментарии к устройству
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Документация по этому формату

UML-диаграмма (Legend)

Device (DomainResource)Уникальные идентификаторы экземпляра, присваиваемые устройству производителями, другими организациями или владельцамиidentifier : Identifier [0..*]The reference to the definition for the devicedefinition : Reference [0..1] « DeviceDefinition »Состояние готовности устройства (this element modifies the meaning of other elements)status : code [0..1] « Состояние готовности устройства. (Strength=Required)FHIRDeviceStatus! »Reason for the dtatus of the Device availabilitystatusReason : CodeableConcept [0..*] « The availability status reason of the device. (Strength=Extensible)FHIRDeviceStatusReason+ »The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based productdistinctIdentifier : string [0..1]Название производителяmanufacturer : string [0..1]Дата и время, когда было произведено устройствоmanufactureDate : dateTime [0..1]Дата и время, после которого это устройство становится не действительным или не должно больше использоваться (если применимо)expirationDate : dateTime [0..1]Номер партии, присвоенный изготовителемlotNumber : string [0..1]Серийный номер, присвоенный организацией, когда устройство было изготовленоserialNumber : string [0..1]The model number for the devicemodelNumber : string [0..1]The part number of thedevicepartNumber : string [0..1]The kind or type of devicetype : CodeableConcept [0..1] « Коды медицинских изделий. (Strength=Example)FHIRDeviceTypes?? »Информация о пациенте, если ресурс являются принадлежностью человекаpatient : Reference [0..1] « Patient »Организация, которая несет ответственность за предоставление и текущее обслуживание устройстваowner : Reference [0..1] « Organization »Контактная информация организации или конкретного человека, который отвечает за это устройствоcontact : ContactPoint [0..*]Место, где находится это устройствоlocation : Reference [0..1] « Location »Сетевой адрес, по которому с устройством можно непосредственно связатьсяurl : uri [0..1]Описательная информация, информация по применению и имплантации, не попавшая в другие существующие элементыnote : Annotation [0..*]Provides additional safety characteristics about a medical device. For example devices containing latexsafety : CodeableConcept [0..*]The parent deviceparent : Reference [0..1] « Device »UdiCarrierThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a devicedeviceIdentifier : string [0..1]Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-diissuer : uri [0..1]The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udijurisdiction : uri [0..1]The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 encodedcarrierAIDC : base64Binary [0..1]The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the devicecarrierHRF : string [0..1]A coded entry to indicate how the data was enteredentryType : code [0..1] « Codes to identify how UDI data was entered. (Strength=Required)UDIEntryType! »DeviceNameThe name of the devicename : string [1..1]The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « The type of name the device is referred by. (Strength=Required)DeviceNameType! »SpecializationThe standard that is used to operate and communicatesystemType : CodeableConcept [1..1]The version of the standard that is used to operate and communicateversion : string [0..1]VersionThe type of the device versiontype : CodeableConcept [0..1]A single component of the device versioncomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property DeviceDefinitionPropetyCode (Extensible)type : CodeableConcept [1..1]Property value as a quantityvalueQuantity : Quantity [0..*]Property value as a code, e.g., NTP4 (synced to NTP)valueCode : CodeableConcept [0..*]Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been soldudiCarrier[0..*]This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinitiondeviceName[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[0..*]The actual design of the device or software version running on the deviceversion[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[0..*]

XML-шаблон

<Device xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Идентификатор экземпляра --></identifier>
 <definition><!-- 0..1 Reference(DeviceDefinition) The reference to the definition for the device --></definition>
 <udiCarrier>  <!-- 0..* Строковое значение штрих-кода уникального идентификатора устройства (UDI) -->
  <deviceIdentifier value="[string]"/><!-- 0..1 Mandatory fixed portion of UDI -->
  <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual + -->
 </udiCarrier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off --></statusReason>
 <distinctIdentifier value="[string]"/><!-- 0..1 The distinct identification string -->
 <manufacturer value="[string]"/><!-- 0..1 Название производителя устройства -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Дата, когда было произведено устройство -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Дата и время истечения срока действия этого устройства (если применимо) -->
 <lotNumber value="[string]"/><!-- 0..1 Номер партии выпуска -->
 <serialNumber value="[string]"/><!-- 0..1 Серийный номер, присвоенный изготовителем -->
 <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>
  <valueQuantity><!-- 0..* Quantity Property value as a quantity --></valueQuantity>
  <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode>
 </property>
 <patient><!-- 0..1 Reference(Patient) Пациент, которому имплантировано устройство --></patient>
 <owner><!-- 0..1 Reference(Organization) Организация, ответственная за устройство --></owner>
 <contact><!-- 0..* ContactPoint Подробная информация о человеке/организации из службы поддержки --></contact>
 <location><!-- 0..1 Reference(Location) Where the device is found --></location>
 <url value="[uri]"/><!-- 0..1 Сетевой адрес устройства -->
 <note><!-- 0..* Annotation Примечания и комментарии к устройству --></note>
 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The parent device --></parent>
</Device>

JSON-шаблон

{doco
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Идентификатор экземпляра
  "definition" : { Reference(DeviceDefinition) }, // The reference to the definition for the device
  "udiCarrier" : [{ // Строковое значение штрих-кода уникального идентификатора устройства (UDI)
    "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
  "distinctIdentifier" : "<string>", // The distinct identification string
  "manufacturer" : "<string>", // Название производителя устройства
  "manufactureDate" : "<dateTime>", // Дата, когда было произведено устройство
  "expirationDate" : "<dateTime>", // Дата и время истечения срока действия этого устройства (если применимо)
  "lotNumber" : "<string>", // Номер партии выпуска
  "serialNumber" : "<string>", // Серийный номер, присвоенный изготовителем
  "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)
    "valueQuantity" : [{ Quantity }], // Property value as a quantity
    "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP)
  }],
  "patient" : { Reference(Patient) }, // Пациент, которому имплантировано устройство
  "owner" : { Reference(Organization) }, // Организация, ответственная за устройство
  "contact" : [{ ContactPoint }], // Подробная информация о человеке/организации из службы поддержки
  "location" : { Reference(Location) }, // Where the device is found
  "url" : "<uri>", // Сетевой адрес устройства
  "note" : [{ Annotation }], // Примечания и комментарии к устройству
  "safety" : [{ CodeableConcept }], // Safety Characteristics of Device
  "parent" : { Reference(Device) } // The parent device
}

Turtle-шаблон

@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..* Идентификатор экземпляра
  fhir:Device.definition [ Reference(DeviceDefinition) ]; # 0..1 The reference to the definition for the device
  fhir:Device.udiCarrier [ # 0..* Строковое значение штрих-кода уникального идентификатора устройства (UDI)
    fhir:Device.udiCarrier.deviceIdentifier [ string ]; # 0..1 Mandatory fixed portion of UDI
    fhir:Device.udiCarrier.issuer [ uri ]; # 0..1 UDI Issuing Organization
    fhir:Device.udiCarrier.jurisdiction [ uri ]; # 0..1 Regional UDI authority
    fhir:Device.udiCarrier.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String
    fhir:Device.udiCarrier.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode String
    fhir:Device.udiCarrier.entryType [ code ]; # 0..1 barcode | rfid | manual +
  ], ...;
  fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown
  fhir:Device.statusReason [ CodeableConcept ], ... ; # 0..* online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
  fhir:Device.distinctIdentifier [ string ]; # 0..1 The distinct identification string
  fhir:Device.manufacturer [ string ]; # 0..1 Название производителя устройства
  fhir:Device.manufactureDate [ dateTime ]; # 0..1 Дата, когда было произведено устройство
  fhir:Device.expirationDate [ dateTime ]; # 0..1 Дата и время истечения срока действия этого устройства (если применимо)
  fhir:Device.lotNumber [ string ]; # 0..1 Номер партии выпуска
  fhir:Device.serialNumber [ string ]; # 0..1 Серийный номер, присвоенный изготовителем
  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.valueQuantity [ 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 Пациент, которому имплантировано устройство
  fhir:Device.owner [ Reference(Organization) ]; # 0..1 Организация, ответственная за устройство
  fhir:Device.contact [ ContactPoint ], ... ; # 0..* Подробная информация о человеке/организации из службы поддержки
  fhir:Device.location [ Reference(Location) ]; # 0..1 Where the device is found
  fhir:Device.url [ uri ]; # 0..1 Сетевой адрес устройства
  fhir:Device.note [ Annotation ], ... ; # 0..* Примечания и комментарии к устройству
  fhir:Device.safety [ CodeableConcept ], ... ; # 0..* Safety Characteristics of Device
  fhir:Device.parent [ Reference(Device) ]; # 0..1 The parent device
]

Changes since R3

Device
Device.definition
  • Added Element
Device.udiCarrier
  • Added Element
Device.udiCarrier.deviceIdentifier
  • Added Element
Device.udiCarrier.issuer
  • Added Element
Device.udiCarrier.jurisdiction
  • Added Element
Device.udiCarrier.carrierAIDC
  • Added Element
Device.udiCarrier.carrierHRF
  • Added Element
Device.udiCarrier.entryType
  • Added Element
Device.statusReason
  • Added Element
Device.distinctIdentifier
  • Added Element
Device.serialNumber
  • Added Element
Device.deviceName
  • Added Element
Device.deviceName.name
  • Added Mandatory Element
Device.deviceName.type
  • Added Mandatory Element
Device.modelNumber
  • Added Element
Device.partNumber
  • Added Element
Device.specialization
  • Added Element
Device.specialization.systemType
  • Added Mandatory 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 Mandatory Element
Device.property
  • Added Element
Device.property.type
  • Added Mandatory Element
Device.property.valueQuantity
  • Added Element
Device.property.valueCode
  • Added Element
Device.parent
  • Added Element
Device.udi
  • deleted
Device.model
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 9 tests of which 9 fail to execute.)

Структура

ИмяФлагиКард.ТипОписание и ограниченияdoco
.. Device TUDomainResourceПредмет, применяемый в медицине
Элементы, определённые в прародителе: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier 0..*IdentifierИдентификатор экземпляра
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementСтроковое значение штрих-кода уникального идентификатора устройства (UDI)
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
UDIEntryType (Required)
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
FHIRDeviceStatus (Required)
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
FHIRDeviceStatusReason (Extensible)
... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer 0..1stringНазвание производителя устройства
... manufactureDate 0..1dateTimeДата, когда было произведено устройство
... expirationDate 0..1dateTimeДата и время истечения срока действия этого устройства (если применимо)
... lotNumber 0..1stringНомер партии выпуска
... serialNumber 0..1stringСерийный номер, присвоенный изготовителем
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... name 1..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 0..1CodeableConceptThe kind or type of device
FHIR Device Types (Example)
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1Reference(Patient)Пациент, которому имплантировано устройство
... owner 0..1Reference(Organization)Организация, ответственная за устройство
... contact 0..*ContactPointПодробная информация о человеке/организации из службы поддержки
... location 0..1Reference(Location)Where the device is found
... url 0..1uriСетевой адрес устройства
... note 0..*AnnotationПримечания и комментарии к устройству
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Документация по этому формату

UML-диаграмма (Legend)

Device (DomainResource)Уникальные идентификаторы экземпляра, присваиваемые устройству производителями, другими организациями или владельцамиidentifier : Identifier [0..*]The reference to the definition for the devicedefinition : Reference [0..1] « DeviceDefinition »Состояние готовности устройства (this element modifies the meaning of other elements)status : code [0..1] « Состояние готовности устройства. (Strength=Required)FHIRDeviceStatus! »Reason for the dtatus of the Device availabilitystatusReason : CodeableConcept [0..*] « The availability status reason of the device. (Strength=Extensible)FHIRDeviceStatusReason+ »The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based productdistinctIdentifier : string [0..1]Название производителяmanufacturer : string [0..1]Дата и время, когда было произведено устройствоmanufactureDate : dateTime [0..1]Дата и время, после которого это устройство становится не действительным или не должно больше использоваться (если применимо)expirationDate : dateTime [0..1]Номер партии, присвоенный изготовителемlotNumber : string [0..1]Серийный номер, присвоенный организацией, когда устройство было изготовленоserialNumber : string [0..1]The model number for the devicemodelNumber : string [0..1]The part number of thedevicepartNumber : string [0..1]The kind or type of devicetype : CodeableConcept [0..1] « Коды медицинских изделий. (Strength=Example)FHIRDeviceTypes?? »Информация о пациенте, если ресурс являются принадлежностью человекаpatient : Reference [0..1] « Patient »Организация, которая несет ответственность за предоставление и текущее обслуживание устройстваowner : Reference [0..1] « Organization »Контактная информация организации или конкретного человека, который отвечает за это устройствоcontact : ContactPoint [0..*]Место, где находится это устройствоlocation : Reference [0..1] « Location »Сетевой адрес, по которому с устройством можно непосредственно связатьсяurl : uri [0..1]Описательная информация, информация по применению и имплантации, не попавшая в другие существующие элементыnote : Annotation [0..*]Provides additional safety characteristics about a medical device. For example devices containing latexsafety : CodeableConcept [0..*]The parent deviceparent : Reference [0..1] « Device »UdiCarrierThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a devicedeviceIdentifier : string [0..1]Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-diissuer : uri [0..1]The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udijurisdiction : uri [0..1]The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 encodedcarrierAIDC : base64Binary [0..1]The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the devicecarrierHRF : string [0..1]A coded entry to indicate how the data was enteredentryType : code [0..1] « Codes to identify how UDI data was entered. (Strength=Required)UDIEntryType! »DeviceNameThe name of the devicename : string [1..1]The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « The type of name the device is referred by. (Strength=Required)DeviceNameType! »SpecializationThe standard that is used to operate and communicatesystemType : CodeableConcept [1..1]The version of the standard that is used to operate and communicateversion : string [0..1]VersionThe type of the device versiontype : CodeableConcept [0..1]A single component of the device versioncomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property DeviceDefinitionPropetyCode (Extensible)type : CodeableConcept [1..1]Property value as a quantityvalueQuantity : Quantity [0..*]Property value as a code, e.g., NTP4 (synced to NTP)valueCode : CodeableConcept [0..*]Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been soldudiCarrier[0..*]This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinitiondeviceName[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[0..*]The actual design of the device or software version running on the deviceversion[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[0..*]

XML-шаблон

<Device xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Идентификатор экземпляра --></identifier>
 <definition><!-- 0..1 Reference(DeviceDefinition) The reference to the definition for the device --></definition>
 <udiCarrier>  <!-- 0..* Строковое значение штрих-кода уникального идентификатора устройства (UDI) -->
  <deviceIdentifier value="[string]"/><!-- 0..1 Mandatory fixed portion of UDI -->
  <issuer value="[uri]"/><!-- 0..1 UDI Issuing Organization -->
  <jurisdiction value="[uri]"/><!-- 0..1 Regional UDI authority -->
  <carrierAIDC value="[base64Binary]"/><!-- 0..1 UDI Machine Readable Barcode String -->
  <carrierHRF value="[string]"/><!-- 0..1 UDI Human Readable Barcode String -->
  <entryType value="[code]"/><!-- 0..1 barcode | rfid | manual + -->
 </udiCarrier>
 <status value="[code]"/><!-- 0..1 active | inactive | entered-in-error | unknown -->
 <statusReason><!-- 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off --></statusReason>
 <distinctIdentifier value="[string]"/><!-- 0..1 The distinct identification string -->
 <manufacturer value="[string]"/><!-- 0..1 Название производителя устройства -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Дата, когда было произведено устройство -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Дата и время истечения срока действия этого устройства (если применимо) -->
 <lotNumber value="[string]"/><!-- 0..1 Номер партии выпуска -->
 <serialNumber value="[string]"/><!-- 0..1 Серийный номер, присвоенный изготовителем -->
 <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>
  <valueQuantity><!-- 0..* Quantity Property value as a quantity --></valueQuantity>
  <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode>
 </property>
 <patient><!-- 0..1 Reference(Patient) Пациент, которому имплантировано устройство --></patient>
 <owner><!-- 0..1 Reference(Organization) Организация, ответственная за устройство --></owner>
 <contact><!-- 0..* ContactPoint Подробная информация о человеке/организации из службы поддержки --></contact>
 <location><!-- 0..1 Reference(Location) Where the device is found --></location>
 <url value="[uri]"/><!-- 0..1 Сетевой адрес устройства -->
 <note><!-- 0..* Annotation Примечания и комментарии к устройству --></note>
 <safety><!-- 0..* CodeableConcept Safety Characteristics of Device --></safety>
 <parent><!-- 0..1 Reference(Device) The parent device --></parent>
</Device>

JSON-шаблон

{doco
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Идентификатор экземпляра
  "definition" : { Reference(DeviceDefinition) }, // The reference to the definition for the device
  "udiCarrier" : [{ // Строковое значение штрих-кода уникального идентификатора устройства (UDI)
    "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
  "distinctIdentifier" : "<string>", // The distinct identification string
  "manufacturer" : "<string>", // Название производителя устройства
  "manufactureDate" : "<dateTime>", // Дата, когда было произведено устройство
  "expirationDate" : "<dateTime>", // Дата и время истечения срока действия этого устройства (если применимо)
  "lotNumber" : "<string>", // Номер партии выпуска
  "serialNumber" : "<string>", // Серийный номер, присвоенный изготовителем
  "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)
    "valueQuantity" : [{ Quantity }], // Property value as a quantity
    "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP)
  }],
  "patient" : { Reference(Patient) }, // Пациент, которому имплантировано устройство
  "owner" : { Reference(Organization) }, // Организация, ответственная за устройство
  "contact" : [{ ContactPoint }], // Подробная информация о человеке/организации из службы поддержки
  "location" : { Reference(Location) }, // Where the device is found
  "url" : "<uri>", // Сетевой адрес устройства
  "note" : [{ Annotation }], // Примечания и комментарии к устройству
  "safety" : [{ CodeableConcept }], // Safety Characteristics of Device
  "parent" : { Reference(Device) } // The parent device
}

Turtle-шаблон

@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..* Идентификатор экземпляра
  fhir:Device.definition [ Reference(DeviceDefinition) ]; # 0..1 The reference to the definition for the device
  fhir:Device.udiCarrier [ # 0..* Строковое значение штрих-кода уникального идентификатора устройства (UDI)
    fhir:Device.udiCarrier.deviceIdentifier [ string ]; # 0..1 Mandatory fixed portion of UDI
    fhir:Device.udiCarrier.issuer [ uri ]; # 0..1 UDI Issuing Organization
    fhir:Device.udiCarrier.jurisdiction [ uri ]; # 0..1 Regional UDI authority
    fhir:Device.udiCarrier.carrierAIDC [ base64Binary ]; # 0..1 UDI Machine Readable Barcode String
    fhir:Device.udiCarrier.carrierHRF [ string ]; # 0..1 UDI Human Readable Barcode String
    fhir:Device.udiCarrier.entryType [ code ]; # 0..1 barcode | rfid | manual +
  ], ...;
  fhir:Device.status [ code ]; # 0..1 active | inactive | entered-in-error | unknown
  fhir:Device.statusReason [ CodeableConcept ], ... ; # 0..* online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
  fhir:Device.distinctIdentifier [ string ]; # 0..1 The distinct identification string
  fhir:Device.manufacturer [ string ]; # 0..1 Название производителя устройства
  fhir:Device.manufactureDate [ dateTime ]; # 0..1 Дата, когда было произведено устройство
  fhir:Device.expirationDate [ dateTime ]; # 0..1 Дата и время истечения срока действия этого устройства (если применимо)
  fhir:Device.lotNumber [ string ]; # 0..1 Номер партии выпуска
  fhir:Device.serialNumber [ string ]; # 0..1 Серийный номер, присвоенный изготовителем
  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.valueQuantity [ 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 Пациент, которому имплантировано устройство
  fhir:Device.owner [ Reference(Organization) ]; # 0..1 Организация, ответственная за устройство
  fhir:Device.contact [ ContactPoint ], ... ; # 0..* Подробная информация о человеке/организации из службы поддержки
  fhir:Device.location [ Reference(Location) ]; # 0..1 Where the device is found
  fhir:Device.url [ uri ]; # 0..1 Сетевой адрес устройства
  fhir:Device.note [ Annotation ], ... ; # 0..* Примечания и комментарии к устройству
  fhir:Device.safety [ CodeableConcept ], ... ; # 0..* Safety Characteristics of Device
  fhir:Device.parent [ Reference(Device) ]; # 0..1 The parent device
]

Changes since Release 3

Device
Device.definition
  • Added Element
Device.udiCarrier
  • Added Element
Device.udiCarrier.deviceIdentifier
  • Added Element
Device.udiCarrier.issuer
  • Added Element
Device.udiCarrier.jurisdiction
  • Added Element
Device.udiCarrier.carrierAIDC
  • Added Element
Device.udiCarrier.carrierHRF
  • Added Element
Device.udiCarrier.entryType
  • Added Element
Device.statusReason
  • Added Element
Device.distinctIdentifier
  • Added Element
Device.serialNumber
  • Added Element
Device.deviceName
  • Added Element
Device.deviceName.name
  • Added Mandatory Element
Device.deviceName.type
  • Added Mandatory Element
Device.modelNumber
  • Added Element
Device.partNumber
  • Added Element
Device.specialization
  • Added Element
Device.specialization.systemType
  • Added Mandatory 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 Mandatory Element
Device.property
  • Added Element
Device.property.type
  • Added Mandatory Element
Device.property.valueQuantity
  • Added Element
Device.property.valueCode
  • Added Element
Device.parent
  • Added Element
Device.udi
  • deleted
Device.model
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 9 tests of which 9 fail to execute.)

 

See the Profiles & Extensions and the Альтернативные определения: Основное определение XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the Анализ зависимостей

PathОписаниеТипСсылка
Device.udiCarrier.entryType Codes to identify how UDI data was entered.RequiredUDIEntryType
Device.status Состояние готовности устройства.RequiredFHIRDeviceStatus
Device.statusReason The availability status reason of the device.ExtensibleFHIRDeviceStatusReason
Device.deviceName.type The type of name the device is referred by.RequiredDeviceNameType
Device.type Коды медицинских изделий.ExampleFHIRDeviceTypes

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:

На форуме международных регулирующих органов медицинских изделий (IMDRF) Рабочая группа по UDI опубликовала Систему UDI для медицинских изделий (версия 2.0) - базовую спецификацию Уникальных идентификаторов устройств (UDI). Комитет по использованию пищевых продуктов и лекарственных средств США выпустил руководство по реализации для Уникальных идентификаторов устройств (UDI), реализующее спецификацию IMDRF, другие юрисдикции также могут выпустить подобные руководства по реализации IMDRF. Полная строка UDI, представляющая собой штрих-код, печатаемый на упаковке устройства, или Автоматическую идентификации и сбор данных (AIDC), называется "носитель UDI". UDI содержит 2 компонента*:

  • Идентификатор устройства (DI)**, который является фактическим компонентом идентификации
  • Производственный идентификатор(ы)(PI), который предоставляет средства отслеживания устройства через его производство, распределение и использование.

*не-UDI элементы могут также появляться в носителе UDI. **"GTIN" (который иногда ещё называют EAN-номером) - это код, разработанный GS1 для этого вида устройства, не являющийся идентификатором этого устройства. GTIN может использоваться как сам по себе, так и в строке UDI в качестве DI-компонента.

DI-часть UDI может храниться в юрисдикционном хранилище и использоваться в качестве основного ключа для доступа к остальной информации об устройстве. Например в США DI-часть UDI подаётся в записи устройства в Глобальную базу данных уникальных идентификаторов устройств (GUDID) . UDI может идентифицировать экземпляр устройства уникальным образом (если PI включает в себя серийный номер), либо может указывать всего лишь тип устройства. UDI анализируется и разбирается на составляющие его части (DI, PI и другие элементы) с помощью правил разбора, разрабатываемых каждым агентством, выпускающим стандарты. Если устройству назначен UDI, остальная информация, передаваемая в этом ресурсе (например номер партии, срок годности и т. п.) не должна противоречить информации, закодированной в строке UDI или зарегистрированной в локальном хранилище.

Руководства по наилучшей практике передачи UDI-данных с помощью ресурса Device предписывают передавать и UDI Carrier, и все компоненты этого UDI, как описано в Device UDI Mapping. Кроме того, можно руководствоваться предоставленными примерами.

Параметры поиска для этого ресурса. Также к нему применяются общие параметры. Более подробную информацию о поиске в REST, обмене сообщениями и сервисах см. в разделе Поиск.

ИмяТипОпределениеВыражениеIn Common
device-namestringA server defined search that may match any of the string fields in Device.deviceName or Device.type.Device.deviceName.name | Device.type.coding.display | Device.type.text
identifiertokenИдентификатор экземпляра от изготовителя, владельца, или другойDevice.identifier
locationreferenceA location, Где находится этот ресурсDevice.location
(Location)
manufacturerstringИзготовитель устройстваDevice.manufacturer
modelstringМодель устройстваDevice.modelNumber
organizationreferenceОрганизация, ответственная за это устройствоDevice.owner
(Organization)
patientreferenceИнформация о пациенте, если устройство имплантировано человекуDevice.patient
(Patient)
statustokenactive | inactive | entered-in-error | unknownDevice.status
typetokenТип устройстваDevice.type
udi-carrierstringUDI Barcode (RFID or other technology) string in *HRF* format.Device.udiCarrier.carrierHRF
udi-distringThe udi Device Identifier (DI)Device.udiCarrier.deviceIdentifier
urluriСетевой адрес устройстваDevice.url