HdBe-MedicalDevice
Profile | Description | Status | URL |
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HdBe-MedicalDevice | Medical devices are any internally implanted and external devices and/or aids used by the patient (in the past) to reduce the effects of functional limitations in organ systems or to facilitate the treatment of a disease. | draft | https://fhir.healthdata.be/StructureDefinition/HdBe-MedicalDevice |
HdBe-MedicalDevice.Product | This profile defines the actual medical device (internally or externally). | draft | https://fhir.healthdata.be/StructureDefinition/HdBe-MedicalDevice.Product |
UML overview profiles
HdBe-MedicalDevice
DeviceUseStatement | I | DeviceUseStatement | Element IdDeviceUseStatement MedicalDevice Alternate namesMedischHulpmiddel DefinitionA record of a device being used by a patient where the record is the result of a report from the patient or another clinician.
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extension | I | 0..* | Extension | Element IdDeviceUseStatement.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Constraints
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healthProfessional | I | 0..1 | Extension(pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner)) | Element IdDeviceUseStatement.extension:healthProfessional Optional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner)) Extension URLhttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdDeviceUseStatement.extension:healthProfessional.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. System.String Fixed Valuehttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional
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value[x] | I | 0..1 | Element IdDeviceUseStatement.extension:healthProfessional.value[x] HealthProfessional Alternate namesZorgverlener DefinitionThe healthcare provider involved in the indication for use of the medical device implant. Each occurence of the CBB HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of HdBe-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of HdBe-HealthProfessional-Practitioner). The reference to the Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Only in rare circumstances, there is just a Practitioner instance, in which case it is that instance which will be referenced here.
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valueReference | pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner) | There are no (further) constraints on this element Data Type pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner) | ||
location | I | 0..1 | Extension(Reference(HdBe HealthcareOrganization)) | Element IdDeviceUseStatement.extension:location Optional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Reference(HdBe HealthcareOrganization)) Extension URLhttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdDeviceUseStatement.extension:location.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. System.String Fixed Valuehttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location
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value[x] | 0..1 | Element IdDeviceUseStatement.extension:location.value[x] Location Alternate namesLocatie DefinitionThe healthcare provider at which use of the medical device was initiated or where the aid was implanted.
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valueReference | Reference(HdBe HealthcareOrganization) | There are no (further) constraints on this element Data Type | ||
identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdDeviceUseStatement.identifier External identifier for this record DefinitionAn external identifier for this statement such as an IRI.
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basedOn | Σ I | 0..* | Reference(ServiceRequest) | There are no (further) constraints on this element Element IdDeviceUseStatement.basedOn Fulfills plan, proposal or order Alternate namesfulfills DefinitionA plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement. Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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status | Σ ?! | 1..1 | codeBinding | Element IdDeviceUseStatement.status active | completed | entered-in-error + DefinitionA code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed. This element is implictly mapped to the CBB concepts start_date and end_date. Unless the status is explicitly recorded, the following guidance applies:
A coded concept indicating the current status of the Device Usage. DeviceUseStatementStatus (required)Constraints
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subject | Σ I | 1..1 | Reference(Patient | Group) | There are no (further) constraints on this element Element IdDeviceUseStatement.subject Patient using device DefinitionThe patient who used the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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derivedFrom | Σ I | 0..* | Reference(ServiceRequest | Procedure | Claim | Observation | QuestionnaireResponse | DocumentReference) | Element IdDeviceUseStatement.derivedFrom Supporting information DefinitionAllows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement. The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from. Reference(ServiceRequest | Procedure | Claim | Observation | QuestionnaireResponse | DocumentReference) Sliced:Unordered, Open, by resolve()(Profile) Constraints
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procedure | Σ I | 0..* | Reference(HdBe Procedure event | HdBe Procedure request) | Element IdDeviceUseStatement.derivedFrom:procedure Procedure Alternate namesVerrichting DefinitionThe procedure which has the purpose if placing this product in or on the body. Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Reference(HdBe Procedure event | HdBe Procedure request) Constraints
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timing[x] | Σ | 0..1 | Element IdDeviceUseStatement.timing[x] How often the device was used DefinitionHow often the device was used. Unordered, Open, by $this(Type) Constraints
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timingTiming | Timing | There are no (further) constraints on this element Data Type | ||
timingDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
timingPeriod | Σ | 0..1 | Period | Element IdDeviceUseStatement.timing[x]:timingPeriod How often the device was used DefinitionHow often the device was used.
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start | Σ I | 0..1 | dateTime | Element IdDeviceUseStatement.timing[x]:timingPeriod.start StartDate Alternate namesBeginDatum DefinitionThe start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted. If the low element is missing, the meaning is that the low boundary is not known.
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end | Σ I | 0..1 | dateTime | Element IdDeviceUseStatement.timing[x]:timingPeriod.end EndDate Alternate namesEindDatum DefinitionThe end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted. The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
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recordedOn | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDeviceUseStatement.recordedOn When statement was recorded DefinitionThe time at which the statement was made/recorded.
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source | Σ I | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | There are no (further) constraints on this element Element IdDeviceUseStatement.source Who made the statement DefinitionWho reported the device was being used by the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Constraints
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device | Σ I | 1..1 | Reference(Device | HdBe MedicalDevice.Product) | Element IdDeviceUseStatement.device Reference to device used DefinitionThe details of the device used. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Device | HdBe MedicalDevice.Product) Constraints
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reasonCode | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDeviceUseStatement.reasonCode Why device was used DefinitionReason or justification for the use of the device. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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reasonReference | Σ I | 0..* | Reference(Condition | Observation | DiagnosticReport | DocumentReference | Media) | Element IdDeviceUseStatement.reasonReference Why was DeviceUseStatement performed? DefinitionIndicates another resource whose existence justifies this DeviceUseStatement. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Condition | Observation | DiagnosticReport | DocumentReference | Media) Sliced:Unordered, Open, by resolve()(Profile) Constraints
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indication | Σ I | 0..* | Reference(HdBe Problem) | Element IdDeviceUseStatement.reasonReference:indication Indication Alternate namesIndicatie DefinitionThe medical reason for use of the medical device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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HdBe-MedicalDeviceReference | Σ I | 0..* | Reference(HdBe FunctionalOrMentalStatus | https://fhir.healthdata.be/StructureDefinition/HdBe-Mobility) | Element IdDeviceUseStatement.reasonReference:HdBe-MedicalDeviceReference CBB MedicalDevice reference Alternate namesFunctioneleOfMentaleStatus, Mobiliteit DefinitionThe association between a CBB MedicalDevice and another zib or other functional model. There are several CBBs that reference CBB MedicalDevice on a functional level, but for which the direction of the reference in FHIR is reversed. Consult the mappings on this element for an overview of which zib concepts are mapped to this element. Note that some CBBs have a reference to MedicalDevice that is further constrained (e.g. with additional constraints on ProductType or AnatomicalLocation), such as HearingFunction and VisualFunction. For these CBBs separate DeviceUseStatement profiles have been created (based on this profile) which also include a specific slice on which their respective MedicalDevice concept mapping is present. Reference(HdBe FunctionalOrMentalStatus | https://fhir.healthdata.be/StructureDefinition/HdBe-Mobility) Constraints
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bodySite | Σ | 0..1 | HdBe AnatomicalLocationBinding | Element IdDeviceUseStatement.bodySite Location / AnatomicalLocation Alternate namesLocatie, AnatomischeLocatie DefinitionPatient’s anatomical location of the medical device used. Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes describing anatomical locations. May include laterality. Location (required)Constraints
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdDeviceUseStatement.note Addition details (comments, instructions) DefinitionDetails about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdDeviceUseStatement.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner | Patient | RelatedPerson | Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner | Patient | RelatedPerson | Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDeviceUseStatement.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdDeviceUseStatement.note.text Comment Alternate namesToelichting DefinitionComment about use or information on the medical device used. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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DeviceUseStatement | I | DeviceUseStatement | Element IdDeviceUseStatement MedicalDevice Alternate namesMedischHulpmiddel DefinitionA record of a device being used by a patient where the record is the result of a report from the patient or another clinician.
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extension | I | 0..* | Extension | Element IdDeviceUseStatement.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Constraints
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healthProfessional | I | 0..1 | Extension(pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner)) | Element IdDeviceUseStatement.extension:healthProfessional Optional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner)) Extension URLhttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdDeviceUseStatement.extension:healthProfessional.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. System.String Fixed Valuehttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional
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value[x] | I | 0..1 | Element IdDeviceUseStatement.extension:healthProfessional.value[x] HealthProfessional Alternate namesZorgverlener DefinitionThe healthcare provider involved in the indication for use of the medical device implant. Each occurence of the CBB HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of HdBe-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of HdBe-HealthProfessional-Practitioner). The reference to the Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Only in rare circumstances, there is just a Practitioner instance, in which case it is that instance which will be referenced here.
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valueReference | pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner) | There are no (further) constraints on this element Data Type pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner) | ||
location | I | 0..1 | Extension(Reference(HdBe HealthcareOrganization)) | Element IdDeviceUseStatement.extension:location Optional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Reference(HdBe HealthcareOrganization)) Extension URLhttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdDeviceUseStatement.extension:location.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. System.String Fixed Valuehttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location
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value[x] | 0..1 | Element IdDeviceUseStatement.extension:location.value[x] Location Alternate namesLocatie DefinitionThe healthcare provider at which use of the medical device was initiated or where the aid was implanted.
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valueReference | Reference(HdBe HealthcareOrganization) | There are no (further) constraints on this element Data Type | ||
identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdDeviceUseStatement.identifier External identifier for this record DefinitionAn external identifier for this statement such as an IRI.
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basedOn | Σ I | 0..* | Reference(ServiceRequest) | There are no (further) constraints on this element Element IdDeviceUseStatement.basedOn Fulfills plan, proposal or order Alternate namesfulfills DefinitionA plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement. Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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status | Σ ?! | 1..1 | codeBinding | Element IdDeviceUseStatement.status active | completed | entered-in-error + DefinitionA code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed. This element is implictly mapped to the CBB concepts start_date and end_date. Unless the status is explicitly recorded, the following guidance applies:
A coded concept indicating the current status of the Device Usage. DeviceUseStatementStatus (required)Constraints
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subject | Σ I | 1..1 | Reference(Patient | Group) | There are no (further) constraints on this element Element IdDeviceUseStatement.subject Patient using device DefinitionThe patient who used the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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derivedFrom | Σ I | 0..* | Reference(ServiceRequest | Procedure | Claim | Observation | QuestionnaireResponse | DocumentReference) | Element IdDeviceUseStatement.derivedFrom Supporting information DefinitionAllows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement. The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from. Reference(ServiceRequest | Procedure | Claim | Observation | QuestionnaireResponse | DocumentReference) Sliced:Unordered, Open, by resolve()(Profile) Constraints
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procedure | Σ I | 0..* | Reference(HdBe Procedure event | HdBe Procedure request) | Element IdDeviceUseStatement.derivedFrom:procedure Procedure Alternate namesVerrichting DefinitionThe procedure which has the purpose if placing this product in or on the body. Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Reference(HdBe Procedure event | HdBe Procedure request) Constraints
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timing[x] | Σ | 0..1 | Element IdDeviceUseStatement.timing[x] How often the device was used DefinitionHow often the device was used. Unordered, Open, by $this(Type) Constraints
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timingTiming | Timing | There are no (further) constraints on this element Data Type | ||
timingDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
timingPeriod | Σ | 0..1 | Period | Element IdDeviceUseStatement.timing[x]:timingPeriod How often the device was used DefinitionHow often the device was used.
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start | Σ I | 0..1 | dateTime | Element IdDeviceUseStatement.timing[x]:timingPeriod.start StartDate Alternate namesBeginDatum DefinitionThe start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted. If the low element is missing, the meaning is that the low boundary is not known.
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end | Σ I | 0..1 | dateTime | Element IdDeviceUseStatement.timing[x]:timingPeriod.end EndDate Alternate namesEindDatum DefinitionThe end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted. The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
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recordedOn | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDeviceUseStatement.recordedOn When statement was recorded DefinitionThe time at which the statement was made/recorded.
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source | Σ I | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | There are no (further) constraints on this element Element IdDeviceUseStatement.source Who made the statement DefinitionWho reported the device was being used by the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Constraints
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device | Σ I | 1..1 | Reference(Device | HdBe MedicalDevice.Product) | Element IdDeviceUseStatement.device Reference to device used DefinitionThe details of the device used. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Device | HdBe MedicalDevice.Product) Constraints
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reasonCode | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDeviceUseStatement.reasonCode Why device was used DefinitionReason or justification for the use of the device. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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reasonReference | Σ I | 0..* | Reference(Condition | Observation | DiagnosticReport | DocumentReference | Media) | Element IdDeviceUseStatement.reasonReference Why was DeviceUseStatement performed? DefinitionIndicates another resource whose existence justifies this DeviceUseStatement. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Condition | Observation | DiagnosticReport | DocumentReference | Media) Sliced:Unordered, Open, by resolve()(Profile) Constraints
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indication | Σ I | 0..* | Reference(HdBe Problem) | Element IdDeviceUseStatement.reasonReference:indication Indication Alternate namesIndicatie DefinitionThe medical reason for use of the medical device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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HdBe-MedicalDeviceReference | Σ I | 0..* | Reference(HdBe FunctionalOrMentalStatus | https://fhir.healthdata.be/StructureDefinition/HdBe-Mobility) | Element IdDeviceUseStatement.reasonReference:HdBe-MedicalDeviceReference CBB MedicalDevice reference Alternate namesFunctioneleOfMentaleStatus, Mobiliteit DefinitionThe association between a CBB MedicalDevice and another zib or other functional model. There are several CBBs that reference CBB MedicalDevice on a functional level, but for which the direction of the reference in FHIR is reversed. Consult the mappings on this element for an overview of which zib concepts are mapped to this element. Note that some CBBs have a reference to MedicalDevice that is further constrained (e.g. with additional constraints on ProductType or AnatomicalLocation), such as HearingFunction and VisualFunction. For these CBBs separate DeviceUseStatement profiles have been created (based on this profile) which also include a specific slice on which their respective MedicalDevice concept mapping is present. Reference(HdBe FunctionalOrMentalStatus | https://fhir.healthdata.be/StructureDefinition/HdBe-Mobility) Constraints
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bodySite | Σ | 0..1 | HdBe AnatomicalLocationBinding | Element IdDeviceUseStatement.bodySite Location / AnatomicalLocation Alternate namesLocatie, AnatomischeLocatie DefinitionPatient’s anatomical location of the medical device used. Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes describing anatomical locations. May include laterality. Location (required)Constraints
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdDeviceUseStatement.note Addition details (comments, instructions) DefinitionDetails about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdDeviceUseStatement.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner | Patient | RelatedPerson | Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner | Patient | RelatedPerson | Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDeviceUseStatement.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdDeviceUseStatement.note.text Comment Alternate namesToelichting DefinitionComment about use or information on the medical device used. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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DeviceUseStatement | I | DeviceUseStatement | Element IdDeviceUseStatement MedicalDevice Alternate namesMedischHulpmiddel DefinitionA record of a device being used by a patient where the record is the result of a report from the patient or another clinician.
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extension | I | 0..* | Extension | Element IdDeviceUseStatement.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. 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 can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Constraints
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healthProfessional | I | 0..1 | Extension(pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner)) | Element IdDeviceUseStatement.extension:healthProfessional Optional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner)) Extension URLhttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdDeviceUseStatement.extension:healthProfessional.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. System.String Fixed Valuehttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.HealthProfessional
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value[x] | I | 0..1 | Element IdDeviceUseStatement.extension:healthProfessional.value[x] HealthProfessional Alternate namesZorgverlener DefinitionThe healthcare provider involved in the indication for use of the medical device implant. Each occurence of the CBB HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of HdBe-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of HdBe-HealthProfessional-Practitioner). The reference to the Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Only in rare circumstances, there is just a Practitioner instance, in which case it is that instance which will be referenced here.
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valueReference | pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner) | There are no (further) constraints on this element Data Type pattern HealthProfessional Reference(HdBe HealthProfessional PractitionerRole | HdBe HealthProfessional Practitioner) | ||
location | I | 0..1 | Extension(Reference(HdBe HealthcareOrganization)) | Element IdDeviceUseStatement.extension:location Optional Extensions Element Alternate namesextensions, user content DefinitionOptional Extension Element - found in all resources. 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. Extension(Reference(HdBe HealthcareOrganization)) Extension URLhttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location Constraints
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url | 1..1 | System.StringFixed Value | There are no (further) constraints on this element Element IdDeviceUseStatement.extension:location.url identifies the meaning of the extension DefinitionSource of the definition for the extension code - a logical name or a URL. The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. System.String Fixed Valuehttps://fhir.healthdata.be/StructureDefinition/ext-MedicalDevice.Location
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value[x] | 0..1 | Element IdDeviceUseStatement.extension:location.value[x] Location Alternate namesLocatie DefinitionThe healthcare provider at which use of the medical device was initiated or where the aid was implanted.
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valueReference | Reference(HdBe HealthcareOrganization) | There are no (further) constraints on this element Data Type | ||
identifier | Σ | 0..* | Identifier | There are no (further) constraints on this element Element IdDeviceUseStatement.identifier External identifier for this record DefinitionAn external identifier for this statement such as an IRI.
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basedOn | Σ I | 0..* | Reference(ServiceRequest) | There are no (further) constraints on this element Element IdDeviceUseStatement.basedOn Fulfills plan, proposal or order Alternate namesfulfills DefinitionA plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement. Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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status | Σ ?! | 1..1 | codeBinding | Element IdDeviceUseStatement.status active | completed | entered-in-error + DefinitionA code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed. This element is implictly mapped to the CBB concepts start_date and end_date. Unless the status is explicitly recorded, the following guidance applies:
A coded concept indicating the current status of the Device Usage. DeviceUseStatementStatus (required)Constraints
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subject | Σ I | 1..1 | Reference(Patient | Group) | There are no (further) constraints on this element Element IdDeviceUseStatement.subject Patient using device DefinitionThe patient who used the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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derivedFrom | Σ I | 0..* | Reference(ServiceRequest | Procedure | Claim | Observation | QuestionnaireResponse | DocumentReference) | Element IdDeviceUseStatement.derivedFrom Supporting information DefinitionAllows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement. The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from. Reference(ServiceRequest | Procedure | Claim | Observation | QuestionnaireResponse | DocumentReference) Sliced:Unordered, Open, by resolve()(Profile) Constraints
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procedure | Σ I | 0..* | Reference(HdBe Procedure event | HdBe Procedure request) | Element IdDeviceUseStatement.derivedFrom:procedure Procedure Alternate namesVerrichting DefinitionThe procedure which has the purpose if placing this product in or on the body. Please note that on a functional level, CBB Procedure references CBB MedicalDevice, but in FHIR this direction is reversed. Reference(HdBe Procedure event | HdBe Procedure request) Constraints
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timing[x] | Σ | 0..1 | Element IdDeviceUseStatement.timing[x] How often the device was used DefinitionHow often the device was used. Unordered, Open, by $this(Type) Constraints
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timingTiming | Timing | There are no (further) constraints on this element Data Type | ||
timingDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
timingPeriod | Σ | 0..1 | Period | Element IdDeviceUseStatement.timing[x]:timingPeriod How often the device was used DefinitionHow often the device was used.
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start | Σ I | 0..1 | dateTime | Element IdDeviceUseStatement.timing[x]:timingPeriod.start StartDate Alternate namesBeginDatum DefinitionThe start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted. If the low element is missing, the meaning is that the low boundary is not known.
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end | Σ I | 0..1 | dateTime | Element IdDeviceUseStatement.timing[x]:timingPeriod.end EndDate Alternate namesEindDatum DefinitionThe end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted. The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
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recordedOn | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDeviceUseStatement.recordedOn When statement was recorded DefinitionThe time at which the statement was made/recorded.
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source | Σ I | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | There are no (further) constraints on this element Element IdDeviceUseStatement.source Who made the statement DefinitionWho reported the device was being used by the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Constraints
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device | Σ I | 1..1 | Reference(Device | HdBe MedicalDevice.Product) | Element IdDeviceUseStatement.device Reference to device used DefinitionThe details of the device used. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Device | HdBe MedicalDevice.Product) Constraints
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reasonCode | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDeviceUseStatement.reasonCode Why device was used DefinitionReason or justification for the use of the device. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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reasonReference | Σ I | 0..* | Reference(Condition | Observation | DiagnosticReport | DocumentReference | Media) | Element IdDeviceUseStatement.reasonReference Why was DeviceUseStatement performed? DefinitionIndicates another resource whose existence justifies this DeviceUseStatement. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(Condition | Observation | DiagnosticReport | DocumentReference | Media) Sliced:Unordered, Open, by resolve()(Profile) Constraints
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indication | Σ I | 0..* | Reference(HdBe Problem) | Element IdDeviceUseStatement.reasonReference:indication Indication Alternate namesIndicatie DefinitionThe medical reason for use of the medical device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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HdBe-MedicalDeviceReference | Σ I | 0..* | Reference(HdBe FunctionalOrMentalStatus | https://fhir.healthdata.be/StructureDefinition/HdBe-Mobility) | Element IdDeviceUseStatement.reasonReference:HdBe-MedicalDeviceReference CBB MedicalDevice reference Alternate namesFunctioneleOfMentaleStatus, Mobiliteit DefinitionThe association between a CBB MedicalDevice and another zib or other functional model. There are several CBBs that reference CBB MedicalDevice on a functional level, but for which the direction of the reference in FHIR is reversed. Consult the mappings on this element for an overview of which zib concepts are mapped to this element. Note that some CBBs have a reference to MedicalDevice that is further constrained (e.g. with additional constraints on ProductType or AnatomicalLocation), such as HearingFunction and VisualFunction. For these CBBs separate DeviceUseStatement profiles have been created (based on this profile) which also include a specific slice on which their respective MedicalDevice concept mapping is present. Reference(HdBe FunctionalOrMentalStatus | https://fhir.healthdata.be/StructureDefinition/HdBe-Mobility) Constraints
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bodySite | Σ | 0..1 | HdBe AnatomicalLocationBinding | Element IdDeviceUseStatement.bodySite Location / AnatomicalLocation Alternate namesLocatie, AnatomischeLocatie DefinitionPatient’s anatomical location of the medical device used. Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes describing anatomical locations. May include laterality. Location (required)Constraints
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdDeviceUseStatement.note Addition details (comments, instructions) DefinitionDetails about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdDeviceUseStatement.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner | Patient | RelatedPerson | Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner | Patient | RelatedPerson | Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDeviceUseStatement.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdDeviceUseStatement.note.text Comment Alternate namesToelichting DefinitionComment about use or information on the medical device used. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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Mapping FHIR profile to CBB
Path | map | CBB | comment |
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DeviceUseStatement | MedicalDevice | HdBe-MedicalDevice | |
DeviceUseStatement.extension:healthProfessional.value[x] | MedicalDevice.HealthProfessional | HdBe-MedicalDevice | |
DeviceUseStatement.extension:location.value[x] | MedicalDevice.Location | HdBe-MedicalDevice | |
DeviceUseStatement.status | MedicalDevice.StartDate | HdBe-MedicalDevice | implicit, main mapping is on DeviceUseStatement.timingPeriod.start |
DeviceUseStatement.status | MedicalDevice.EndDate | HdBe-MedicalDevice | implicit, main mapping is on DeviceUseStatement.timingPeriod.end |
DeviceUseStatement.derivedFrom:procedure | MedicalDevice | HdBe-Procedure | Reversed reference for CBB Procedure.medical_device |
DeviceUseStatement.timing[x]:timingPeriod.start | MedicalDevice.StartDate | HdBe-MedicalDevice | |
DeviceUseStatement.timing[x]:timingPeriod.end | MedicalDevice.EndDate | HdBe-MedicalDevice | |
DeviceUseStatement.reasonReference:indication | MedicalDevice.Indication | HdBe-MedicalDevice | |
DeviceUseStatement.reasonReference:HdBe-MedicalDeviceReference | MedicalDevice | HdBe-FunctionalOrMentalStatus | Reversed reference for CBB FunctionalOrMentalStatus.medical_device |
DeviceUseStatement.reasonReference:HdBe-MedicalDeviceReference | MedicalDevice | HdBe-Mobility | Reversed reference for CBB Mobility.medical_device |
DeviceUseStatement.bodySite | MedicalDevice.AnatomicalLocation | HdBe-MedicalDevice | |
DeviceUseStatement.note.text | MedicalDevice.Comment | HdBe-MedicalDevice |
zib MedicalDevice difference
Concept | Category | Description |
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HdBe-MedicalDevice.Product
Device | I | Device | Element IdDevice Product Alternate namesProduct DefinitionThe medical device (internally or externally).
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identifier | 0..* | Identifier | Element IdDevice.identifier Instance identifier DefinitionAdditional unique identification code(s) of the product. The UDI (Unique Device Identifier) is the preferred identification code, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). This code should not be mapped here, but in the specified udiCarrier. Additionally, other codes can be registered here if needed. Such as:
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.
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definition | I | 0..1 | Reference(DeviceDefinition) | There are no (further) constraints on this element Element IdDevice.definition The reference to the definition for the device DefinitionThe reference to the definition for the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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udiCarrier | Σ | 0..1 | BackboneElement | Element IdDevice.udiCarrier Unique Device Identifier (UDI) Barcode string DefinitionUnique device identifier (UDI) assigned to device label or package. The UDI is the preferred identifier code. When having an UDI, it is preferred to sent at least the deviceIdentifier, issuer and carrierHRF. 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.
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deviceIdentifier | Σ | 0..1 | string | There are no (further) constraints on this element Element IdDevice.udiCarrier.deviceIdentifier Mandatory fixed portion of UDI Alternate namesDI DefinitionThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Note that FHIR strings SHALL NOT exceed 1MB in size
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issuer | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.udiCarrier.issuer UDI Issuing Organization Alternate namesBarcode System DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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jurisdiction | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.udiCarrier.jurisdiction Regional UDI authority DefinitionThe 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. Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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carrierAIDC | Σ | 0..1 | base64Binary | There are no (further) constraints on this element Element IdDevice.udiCarrier.carrierAIDC UDI Machine Readable Barcode String Alternate namesAutomatic Identification and Data Capture DefinitionThe 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. 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.
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carrierHRF | Σ | 0..1 | string | There are no (further) constraints on this element Element IdDevice.udiCarrier.carrierHRF UDI Human Readable Barcode String Alternate namesHuman Readable Form DefinitionThe full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
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entryType | 0..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.udiCarrier.entryType barcode | rfid | manual + DefinitionA coded entry to indicate how the data was entered. Supports a way to distinguish hand entered from machine read data. Note that FHIR strings SHALL NOT exceed 1MB in size Codes to identify how UDI data was entered. UDIEntryType (required)Constraints
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status | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.status active | inactive | entered-in-error | unknown DefinitionStatus of the Device availability. 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. The availability status of the device. FHIRDeviceStatus (required)Constraints
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statusReason | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdDevice.statusReason online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off DefinitionReason for the dtatus of the Device availability. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The availability status reason of the device. FHIRDeviceStatusReason (extensible)Constraints
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distinctIdentifier | 0..1 | string | There are no (further) constraints on this element Element IdDevice.distinctIdentifier The distinct identification string Alternate namesDistinct Identification Code (DIC) DefinitionThe distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).
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manufacturer | 0..1 | string | There are no (further) constraints on this element Element IdDevice.manufacturer Name of device manufacturer DefinitionA name of the manufacturer. Note that FHIR strings SHALL NOT exceed 1MB in size
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manufactureDate | 0..1 | dateTime | Element IdDevice.manufactureDate Date when the device was made DefinitionThe date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11).
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expirationDate | 0..1 | dateTime | Element IdDevice.expirationDate Date and time of expiry of this device (if applicable) DefinitionThe expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17).
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lotNumber | 0..1 | string | Element IdDevice.lotNumber Lot number of manufacture DefinitionThe lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10). Note that FHIR strings SHALL NOT exceed 1MB in size
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serialNumber | 0..1 | string | Element IdDevice.serialNumber Serial number assigned by the manufacturer DefinitionThe serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21). Alphanumeric Maximum 20.
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deviceName | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.deviceName The name of the device as given by the manufacturer DefinitionThis represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.
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name | 1..1 | string | There are no (further) constraints on this element Element IdDevice.deviceName.name The name of the device Alternate namesΣ DefinitionThe name of the device. Note that FHIR strings SHALL NOT exceed 1MB in size
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type | 1..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.deviceName.type udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other DefinitionThe type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. Note that FHIR strings SHALL NOT exceed 1MB in size The type of name the device is referred by. DeviceNameType (required)Constraints
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modelNumber | 0..1 | string | There are no (further) constraints on this element Element IdDevice.modelNumber The model number for the device DefinitionThe model number for the device. Note that FHIR strings SHALL NOT exceed 1MB in size
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partNumber | 0..1 | string | There are no (further) constraints on this element Element IdDevice.partNumber The part number of the device DefinitionThe part number of the device. Alphanumeric Maximum 20.
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type | 0..1 | CodeableConceptBinding | Element IdDevice.type ProductType Alternate namesProductType DefinitionThe code of the type of product. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes to identify medical devices. ProductType (extensible)Constraints
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specialization | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.specialization The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication DefinitionThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
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systemType | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.specialization.systemType The standard that is used to operate and communicate Alternate namesΣ DefinitionThe standard that is used to operate and communicate. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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version | 0..1 | string | There are no (further) constraints on this element Element IdDevice.specialization.version The version of the standard that is used to operate and communicate DefinitionThe version of the standard that is used to operate and communicate. Note that FHIR strings SHALL NOT exceed 1MB in size
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version | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.version The actual design of the device or software version running on the device DefinitionThe actual design of the device or software version running on the device.
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type | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.version.type The type of the device version Alternate namesΣ DefinitionThe type of the device version. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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component | 0..1 | Identifier | There are no (further) constraints on this element Element IdDevice.version.component A single component of the device version DefinitionA single component of the device version.
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value | 1..1 | string | There are no (further) constraints on this element Element IdDevice.version.value The version text DefinitionThe version text. Note that FHIR strings SHALL NOT exceed 1MB in size
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property | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.property The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties DefinitionThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
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type | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.property.type Code that specifies the property DeviceDefinitionPropetyCode (Extensible) DefinitionCode that specifies the property DeviceDefinitionPropetyCode (Extensible). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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valueQuantity | I | 0..* | Quantity | There are no (further) constraints on this element Element IdDevice.property.valueQuantity Property value as a quantity DefinitionProperty value as a quantity. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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valueCode | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDevice.property.valueCode Property value as a code, e.g., NTP4 (synced to NTP) DefinitionProperty value as a code, e.g., NTP4 (synced to NTP). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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patient | I | 0..1 | Reference(Patient) | There are no (further) constraints on this element Element IdDevice.patient Patient to whom Device is affixed DefinitionPatient information, If the device is affixed to a person. If the device is implanted in a patient, then need to associate the device to the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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owner | I | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element IdDevice.owner Organization responsible for device DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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contact | I | 0..* | ContactPoint | There are no (further) constraints on this element Element IdDevice.contact Details for human/organization for support DefinitionContact details for an organization or a particular human that is responsible for the device. used for troubleshooting etc.
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location | I | 0..1 | Reference(Location) | There are no (further) constraints on this element Element IdDevice.location Where the device is found DefinitionThe place where the device can be found. Device.location can be used to track device location. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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url | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.url Network address to contact device DefinitionA network address on which the device may be contacted directly. If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdDevice.note Device notes and comments DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdDevice.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner | Patient | RelatedPerson | Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner | Patient | RelatedPerson | Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDevice.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdDevice.note.text ProductDescription Alternate namesProductOmschrijving DefinitionTextual description of the product. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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safety | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDevice.safety Safety Characteristics of Device DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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parent | I | 0..1 | Reference(Device) | There are no (further) constraints on this element Element IdDevice.parent The parent device DefinitionThe parent device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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Device | I | Device | Element IdDevice Product Alternate namesProduct DefinitionThe medical device (internally or externally).
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identifier | 0..* | Identifier | Element IdDevice.identifier Instance identifier DefinitionAdditional unique identification code(s) of the product. The UDI (Unique Device Identifier) is the preferred identification code, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). This code should not be mapped here, but in the specified udiCarrier. Additionally, other codes can be registered here if needed. Such as:
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.
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definition | I | 0..1 | Reference(DeviceDefinition) | There are no (further) constraints on this element Element IdDevice.definition The reference to the definition for the device DefinitionThe reference to the definition for the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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udiCarrier | Σ | 0..1 | BackboneElement | Element IdDevice.udiCarrier Unique Device Identifier (UDI) Barcode string DefinitionUnique device identifier (UDI) assigned to device label or package. The UDI is the preferred identifier code. When having an UDI, it is preferred to sent at least the deviceIdentifier, issuer and carrierHRF. 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.
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deviceIdentifier | Σ | 0..1 | string | There are no (further) constraints on this element Element IdDevice.udiCarrier.deviceIdentifier Mandatory fixed portion of UDI Alternate namesDI DefinitionThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Note that FHIR strings SHALL NOT exceed 1MB in size
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issuer | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.udiCarrier.issuer UDI Issuing Organization Alternate namesBarcode System DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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jurisdiction | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.udiCarrier.jurisdiction Regional UDI authority DefinitionThe 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. Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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carrierAIDC | Σ | 0..1 | base64Binary | There are no (further) constraints on this element Element IdDevice.udiCarrier.carrierAIDC UDI Machine Readable Barcode String Alternate namesAutomatic Identification and Data Capture DefinitionThe 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. 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.
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carrierHRF | Σ | 0..1 | string | There are no (further) constraints on this element Element IdDevice.udiCarrier.carrierHRF UDI Human Readable Barcode String Alternate namesHuman Readable Form DefinitionThe full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
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entryType | 0..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.udiCarrier.entryType barcode | rfid | manual + DefinitionA coded entry to indicate how the data was entered. Supports a way to distinguish hand entered from machine read data. Note that FHIR strings SHALL NOT exceed 1MB in size Codes to identify how UDI data was entered. UDIEntryType (required)Constraints
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status | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.status active | inactive | entered-in-error | unknown DefinitionStatus of the Device availability. 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. The availability status of the device. FHIRDeviceStatus (required)Constraints
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statusReason | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdDevice.statusReason online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off DefinitionReason for the dtatus of the Device availability. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The availability status reason of the device. FHIRDeviceStatusReason (extensible)Constraints
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distinctIdentifier | 0..1 | string | There are no (further) constraints on this element Element IdDevice.distinctIdentifier The distinct identification string Alternate namesDistinct Identification Code (DIC) DefinitionThe distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).
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manufacturer | 0..1 | string | There are no (further) constraints on this element Element IdDevice.manufacturer Name of device manufacturer DefinitionA name of the manufacturer. Note that FHIR strings SHALL NOT exceed 1MB in size
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manufactureDate | 0..1 | dateTime | Element IdDevice.manufactureDate Date when the device was made DefinitionThe date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11).
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expirationDate | 0..1 | dateTime | Element IdDevice.expirationDate Date and time of expiry of this device (if applicable) DefinitionThe expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17).
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lotNumber | 0..1 | string | Element IdDevice.lotNumber Lot number of manufacture DefinitionThe lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10). Note that FHIR strings SHALL NOT exceed 1MB in size
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serialNumber | 0..1 | string | Element IdDevice.serialNumber Serial number assigned by the manufacturer DefinitionThe serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21). Alphanumeric Maximum 20.
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deviceName | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.deviceName The name of the device as given by the manufacturer DefinitionThis represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.
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name | 1..1 | string | There are no (further) constraints on this element Element IdDevice.deviceName.name The name of the device Alternate namesΣ DefinitionThe name of the device. Note that FHIR strings SHALL NOT exceed 1MB in size
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type | 1..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.deviceName.type udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other DefinitionThe type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. Note that FHIR strings SHALL NOT exceed 1MB in size The type of name the device is referred by. DeviceNameType (required)Constraints
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modelNumber | 0..1 | string | There are no (further) constraints on this element Element IdDevice.modelNumber The model number for the device DefinitionThe model number for the device. Note that FHIR strings SHALL NOT exceed 1MB in size
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partNumber | 0..1 | string | There are no (further) constraints on this element Element IdDevice.partNumber The part number of the device DefinitionThe part number of the device. Alphanumeric Maximum 20.
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type | 0..1 | CodeableConceptBinding | Element IdDevice.type ProductType Alternate namesProductType DefinitionThe code of the type of product. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes to identify medical devices. ProductType (extensible)Constraints
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specialization | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.specialization The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication DefinitionThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
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systemType | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.specialization.systemType The standard that is used to operate and communicate Alternate namesΣ DefinitionThe standard that is used to operate and communicate. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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version | 0..1 | string | There are no (further) constraints on this element Element IdDevice.specialization.version The version of the standard that is used to operate and communicate DefinitionThe version of the standard that is used to operate and communicate. Note that FHIR strings SHALL NOT exceed 1MB in size
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version | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.version The actual design of the device or software version running on the device DefinitionThe actual design of the device or software version running on the device.
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type | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.version.type The type of the device version Alternate namesΣ DefinitionThe type of the device version. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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component | 0..1 | Identifier | There are no (further) constraints on this element Element IdDevice.version.component A single component of the device version DefinitionA single component of the device version.
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value | 1..1 | string | There are no (further) constraints on this element Element IdDevice.version.value The version text DefinitionThe version text. Note that FHIR strings SHALL NOT exceed 1MB in size
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property | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.property The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties DefinitionThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
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type | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.property.type Code that specifies the property DeviceDefinitionPropetyCode (Extensible) DefinitionCode that specifies the property DeviceDefinitionPropetyCode (Extensible). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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valueQuantity | I | 0..* | Quantity | There are no (further) constraints on this element Element IdDevice.property.valueQuantity Property value as a quantity DefinitionProperty value as a quantity. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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valueCode | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDevice.property.valueCode Property value as a code, e.g., NTP4 (synced to NTP) DefinitionProperty value as a code, e.g., NTP4 (synced to NTP). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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patient | I | 0..1 | Reference(Patient) | There are no (further) constraints on this element Element IdDevice.patient Patient to whom Device is affixed DefinitionPatient information, If the device is affixed to a person. If the device is implanted in a patient, then need to associate the device to the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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owner | I | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element IdDevice.owner Organization responsible for device DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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contact | I | 0..* | ContactPoint | There are no (further) constraints on this element Element IdDevice.contact Details for human/organization for support DefinitionContact details for an organization or a particular human that is responsible for the device. used for troubleshooting etc.
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location | I | 0..1 | Reference(Location) | There are no (further) constraints on this element Element IdDevice.location Where the device is found DefinitionThe place where the device can be found. Device.location can be used to track device location. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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url | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.url Network address to contact device DefinitionA network address on which the device may be contacted directly. If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdDevice.note Device notes and comments DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdDevice.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner | Patient | RelatedPerson | Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner | Patient | RelatedPerson | Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDevice.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdDevice.note.text ProductDescription Alternate namesProductOmschrijving DefinitionTextual description of the product. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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safety | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDevice.safety Safety Characteristics of Device DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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parent | I | 0..1 | Reference(Device) | There are no (further) constraints on this element Element IdDevice.parent The parent device DefinitionThe parent device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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Device | I | Device | Element IdDevice Product Alternate namesProduct DefinitionThe medical device (internally or externally).
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identifier | 0..* | Identifier | Element IdDevice.identifier Instance identifier DefinitionAdditional unique identification code(s) of the product. The UDI (Unique Device Identifier) is the preferred identification code, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). This code should not be mapped here, but in the specified udiCarrier. Additionally, other codes can be registered here if needed. Such as:
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.
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definition | I | 0..1 | Reference(DeviceDefinition) | There are no (further) constraints on this element Element IdDevice.definition The reference to the definition for the device DefinitionThe reference to the definition for the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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udiCarrier | Σ | 0..1 | BackboneElement | Element IdDevice.udiCarrier Unique Device Identifier (UDI) Barcode string DefinitionUnique device identifier (UDI) assigned to device label or package. The UDI is the preferred identifier code. When having an UDI, it is preferred to sent at least the deviceIdentifier, issuer and carrierHRF. 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.
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deviceIdentifier | Σ | 0..1 | string | There are no (further) constraints on this element Element IdDevice.udiCarrier.deviceIdentifier Mandatory fixed portion of UDI Alternate namesDI DefinitionThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Note that FHIR strings SHALL NOT exceed 1MB in size
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issuer | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.udiCarrier.issuer UDI Issuing Organization Alternate namesBarcode System DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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jurisdiction | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.udiCarrier.jurisdiction Regional UDI authority DefinitionThe 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. Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. see http://en.wikipedia.org/wiki/Uniform_resource_identifier
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carrierAIDC | Σ | 0..1 | base64Binary | There are no (further) constraints on this element Element IdDevice.udiCarrier.carrierAIDC UDI Machine Readable Barcode String Alternate namesAutomatic Identification and Data Capture DefinitionThe 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. 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.
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carrierHRF | Σ | 0..1 | string | There are no (further) constraints on this element Element IdDevice.udiCarrier.carrierHRF UDI Human Readable Barcode String Alternate namesHuman Readable Form DefinitionThe full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
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entryType | 0..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.udiCarrier.entryType barcode | rfid | manual + DefinitionA coded entry to indicate how the data was entered. Supports a way to distinguish hand entered from machine read data. Note that FHIR strings SHALL NOT exceed 1MB in size Codes to identify how UDI data was entered. UDIEntryType (required)Constraints
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status | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.status active | inactive | entered-in-error | unknown DefinitionStatus of the Device availability. 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. The availability status of the device. FHIRDeviceStatus (required)Constraints
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statusReason | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element IdDevice.statusReason online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off DefinitionReason for the dtatus of the Device availability. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The availability status reason of the device. FHIRDeviceStatusReason (extensible)Constraints
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distinctIdentifier | 0..1 | string | There are no (further) constraints on this element Element IdDevice.distinctIdentifier The distinct identification string Alternate namesDistinct Identification Code (DIC) DefinitionThe distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).
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manufacturer | 0..1 | string | There are no (further) constraints on this element Element IdDevice.manufacturer Name of device manufacturer DefinitionA name of the manufacturer. Note that FHIR strings SHALL NOT exceed 1MB in size
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manufactureDate | 0..1 | dateTime | Element IdDevice.manufactureDate Date when the device was made DefinitionThe date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11).
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expirationDate | 0..1 | dateTime | Element IdDevice.expirationDate Date and time of expiry of this device (if applicable) DefinitionThe expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17).
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lotNumber | 0..1 | string | Element IdDevice.lotNumber Lot number of manufacture DefinitionThe lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10). Note that FHIR strings SHALL NOT exceed 1MB in size
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serialNumber | 0..1 | string | Element IdDevice.serialNumber Serial number assigned by the manufacturer DefinitionThe serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21). Alphanumeric Maximum 20.
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deviceName | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.deviceName The name of the device as given by the manufacturer DefinitionThis represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.
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name | 1..1 | string | There are no (further) constraints on this element Element IdDevice.deviceName.name The name of the device Alternate namesΣ DefinitionThe name of the device. Note that FHIR strings SHALL NOT exceed 1MB in size
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type | 1..1 | codeBinding | There are no (further) constraints on this element Element IdDevice.deviceName.type udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other DefinitionThe type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. Note that FHIR strings SHALL NOT exceed 1MB in size The type of name the device is referred by. DeviceNameType (required)Constraints
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modelNumber | 0..1 | string | There are no (further) constraints on this element Element IdDevice.modelNumber The model number for the device DefinitionThe model number for the device. Note that FHIR strings SHALL NOT exceed 1MB in size
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partNumber | 0..1 | string | There are no (further) constraints on this element Element IdDevice.partNumber The part number of the device DefinitionThe part number of the device. Alphanumeric Maximum 20.
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type | 0..1 | CodeableConceptBinding | Element IdDevice.type ProductType Alternate namesProductType DefinitionThe code of the type of product. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes to identify medical devices. ProductType (extensible)Constraints
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specialization | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.specialization The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication DefinitionThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
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systemType | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.specialization.systemType The standard that is used to operate and communicate Alternate namesΣ DefinitionThe standard that is used to operate and communicate. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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version | 0..1 | string | There are no (further) constraints on this element Element IdDevice.specialization.version The version of the standard that is used to operate and communicate DefinitionThe version of the standard that is used to operate and communicate. Note that FHIR strings SHALL NOT exceed 1MB in size
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version | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.version The actual design of the device or software version running on the device DefinitionThe actual design of the device or software version running on the device.
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type | 0..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.version.type The type of the device version Alternate namesΣ DefinitionThe type of the device version. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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component | 0..1 | Identifier | There are no (further) constraints on this element Element IdDevice.version.component A single component of the device version DefinitionA single component of the device version.
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value | 1..1 | string | There are no (further) constraints on this element Element IdDevice.version.value The version text DefinitionThe version text. Note that FHIR strings SHALL NOT exceed 1MB in size
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property | 0..* | BackboneElement | There are no (further) constraints on this element Element IdDevice.property The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties DefinitionThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
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type | 1..1 | CodeableConcept | There are no (further) constraints on this element Element IdDevice.property.type Code that specifies the property DeviceDefinitionPropetyCode (Extensible) DefinitionCode that specifies the property DeviceDefinitionPropetyCode (Extensible). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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valueQuantity | I | 0..* | Quantity | There are no (further) constraints on this element Element IdDevice.property.valueQuantity Property value as a quantity DefinitionProperty value as a quantity. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
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valueCode | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDevice.property.valueCode Property value as a code, e.g., NTP4 (synced to NTP) DefinitionProperty value as a code, e.g., NTP4 (synced to NTP). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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patient | I | 0..1 | Reference(Patient) | There are no (further) constraints on this element Element IdDevice.patient Patient to whom Device is affixed DefinitionPatient information, If the device is affixed to a person. If the device is implanted in a patient, then need to associate the device to the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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owner | I | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element IdDevice.owner Organization responsible for device DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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contact | I | 0..* | ContactPoint | There are no (further) constraints on this element Element IdDevice.contact Details for human/organization for support DefinitionContact details for an organization or a particular human that is responsible for the device. used for troubleshooting etc.
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location | I | 0..1 | Reference(Location) | There are no (further) constraints on this element Element IdDevice.location Where the device is found DefinitionThe place where the device can be found. Device.location can be used to track device location. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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url | 0..1 | uri | There are no (further) constraints on this element Element IdDevice.url Network address to contact device DefinitionA network address on which the device may be contacted directly. If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
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note | 0..1 | Annotation | There are no (further) constraints on this element Element IdDevice.note Device notes and comments DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
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author[x] | Σ | 0..1 | There are no (further) constraints on this element Element IdDevice.note.author[x] Individual responsible for the annotation DefinitionThe individual responsible for making the annotation. Organization is used when there's no need for specific attribution as to who made the comment.
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authorString | string | There are no (further) constraints on this element Data Type | ||
authorReference | Reference(Practitioner | Patient | RelatedPerson | Organization) | There are no (further) constraints on this element Data Type Reference(Practitioner | Patient | RelatedPerson | Organization) | ||
time | Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdDevice.note.time When the annotation was made DefinitionIndicates when this particular annotation was made.
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text | Σ | 1..1 | markdown | Element IdDevice.note.text ProductDescription Alternate namesProductOmschrijving DefinitionTextual description of the product. Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
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safety | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element IdDevice.safety Safety Characteristics of Device DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
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parent | I | 0..1 | Reference(Device) | There are no (further) constraints on this element Element IdDevice.parent The parent device DefinitionThe parent device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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Mapping FHIR profile to CBB
Path | map | CBB |
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Device | MedicalDevice.Product | HdBe-MedicalDevice |
Device.identifier | MedicalDevice.Product.ProductId | HdBe-MedicalDevice |
Device.udiCarrier | MedicalDevice.Product.ProductId | HdBe-MedicalDevice |
Device.type | MedicalDevice.Product.ProductType | HdBe-MedicalDevice |
Device.note.text | MedicalDevice.ProductDescription | HdBe-MedicalDevice |
zib MedicalDevice.Product difference
Concept | Category | Description |
---|---|---|
Description | textual | Replaced duplicat CBB concept description with somehting specific for the Device profile. |
device |
textual | Removed Instructions as they are not applicable and described in the added to the specific elements. |
identifier |
slicing | Removed slicing on identifier because the CBB did not define multiple CodeSystems in the definition of the productId. |
identifier |
cardinality | Relaxed the cardinality from 0..1 to 0..* as multiple product identifications codes could be possible. |
Identifier |
textual | Added guidance on the placement of productId codes. |
udiCarrier |
slicing | Removed slicing on identifier because the CBB did not define multiple CodeSystems in the definition of the productId. |
udiCarrier |
textual | Added guidance on the placement of productId codes. |
type |
terminology | Loosened the binding strength from required to extensible (zib issue #1536). |
Terminology Bindings
Path | Name | Strength | URL | ConceptMap |
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DeviceUseStatement.bodySite | Location | required | https://fhir.healthdata.be/ValueSet/Location | No bound ConceptMap |
Device.type | ProductType | extensible | https://fhir.healthdata.be/ValueSet/ProductType | No bound ConceptMap |