0.3.0 - Second STU ballot

This page is part of a downloaded copy of this specification. This page is part of the Da Vinci Coverage Requirements Discovery (CRD) FHIR IG (v0.3.0: STU 1 Ballot 2) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

## StructureDefinition: DeviceSTU3 - Detailed Descriptions

Definitions for the profile-device-stu3 Profile.

1. Device
Definition | The US Core Implanted Device Profile is based upon the core FHIR Device Resource and created to meet the 2015 Edition Common Clinical Data Set 'Unique device identifier(s) for a patient’s implantable device(s)' requirements.
Control | 0..*
Invariants | Defined on this element dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (: contained.text.empty()) dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (: contained.where(('#'+id in %resource.descendants().reference).not()).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
2. Device.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Control | 0..1
Type | id
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
3. Device.meta
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.
Control | 0..1
Type | Meta
4. Device.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.
Control | 0..1
Type | uri
Is Modifier | true
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.
5. Device.language
Definition | The base language in which the resource is written.
Control | 0..1
Binding | A human language. The codes SHALL be taken from Common Languages; other codes may be used where these codes are not suitable Max Binding: All Languages
Type | code
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
6. Device.text
Definition | A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Control | 0..1 This element is affected by the following invariants: dom-1
Type | Narrative
Alternate Names | narrative, html, xhtml, display
Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later.
7. Device.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Control | 0..*
Type | Resource
Alternate Names | inline resources, anonymous resources, contained resources
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.
8. Device.extension
Definition | May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
9. Device.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Control | 0..*
Type | Extension
Is Modifier | true
Alternate Names | extensions, user content
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
10. Device.identifier
Definition | Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Alternate Names | Serial Number
Comments | ​The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.
11. Device.udi
Definition | ​Unique device identifier (UDI) assigned to device label or package.
Control | 1..1
Type | BackboneElement
Must Support | true
Comments | ​UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
12. Device.udi.id
Definition | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Control | 0..1
Type | string
13. Device.udi.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
14. Device.udi.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Control | 0..*
Type | Extension
Is Modifier | true
Alternate Names | extensions, user content, modifiers
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
15. Device.udi.deviceIdentifier
Definition | The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Control | 0..1
Type | string
Must Support | true
Alternate Names | DI
16. Device.udi.name
Definition | Name of device as used in labeling or catalog.
Control | 0..1
Type | string
Alternate Names | Brand Name
Comments | Use the `Device.type` for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'.
17. Device.udi.jurisdiction
Definition | The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.
Control | 0..1
Type | uri
Requirements | Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
18. Device.udi.carrierHRF
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Control | 0..1
Type | string
Alternate Names | Human Readable Form, UDI, Barcode String
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
19. Device.udi.carrierAIDC
Definition | The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.
Control | 0..1
Type | base64Binary
Alternate Names | Automatic Identification and Data Capture, UDI, Barcode String
Comments | The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
20. Device.udi.issuer
Definition | Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Control | 0..1
Type | uri
Alternate Names | Barcode System
21. Device.udi.entryType
Definition | A coded entry to indicate how the data was entered.
Control | 0..1
Binding | Codes to identify how UDI data was entered The codes SHALL be taken from UDIEntryType
Type | code
Requirements | Supports a way to distinguish hand entered from machine read data.
22. Device.status
Definition | Status of the Device availability.
Control | 0..1
Binding | The availability status of the device. The codes SHALL be taken from FHIRDeviceStatus
Type | code
Is Modifier | true
Comments | This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.
23. Device.type
Definition | Code or identifier to identify a kind of device.
Control | 1..1
Binding | Codes to identify medical devices The codes SHALL be taken from FHIR Device Types; other codes may be used where these codes are not suitable
Type | CodeableConcept
Must Support | true
24. Device.lotNumber
Definition | Lot number assigned by the manufacturer.
Control | 0..1
Type | string
25. Device.manufacturer
Definition | A name of the manufacturer.
Control | 0..1
Type | string
26. Device.manufactureDate
Definition | The date and time when the device was manufactured.
Control | 0..1
Type | dateTime
27. Device.expirationDate
Definition | The date and time beyond which this device is no longer valid or should not be used (if applicable).
Control | 0..1
Type | dateTime
28. Device.model
Definition | 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.
Control | 0..1
Type | string
29. Device.version
Definition | The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.
Note | This is a business versionId, not a resource version id (see discussion)
Control | 0..1
Type | string
30. Device.patient
Definition | Patient information, If the device is affixed to a person.
Control | 1..1
Type | Reference(US Core Patient Profile)
Must Support | true
Requirements | If the device is implanted in a patient, then need to associate the device to the patient.
31. Device.owner
Definition | An organization that is responsible for the provision and ongoing maintenance of the device.
Control | 0..1
Type | Reference(Organization)
32. Device.contact
Definition | Contact details for an organization or a particular human that is responsible for the device.
Control | 0..*
Type | ContactPoint
Comments | used for troubleshooting etc.
33. Device.location
Definition | The place where the device can be found.
Control | 0..1
Type | Reference(Location)
Requirements | Device.location can be used to track device location.
34. Device.url
Definition | A network address on which the device may be contacted directly.
Control | 0..1
Type | uri
Comments | If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
35. Device.note
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element.
Control | 0..*
Type | Annotation
36. Device.safety
Definition | Provides additional safety characteristics about a medical device. For example devices containing latex.
Control | 0..*
Binding | 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. For example codes, see DeviceSafety
Type | CodeableConcept