Path | Short | Definition | Comments |
---|---|---|---|
An instance of a medical-related component of a medical device | The characteristics, operational status and capabilities of a medical-related component of a medical device. | For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel. | |
identifier | Instance identifier | Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. | |
udiDeviceIdentifier | Unique Device Identifier (UDI) Barcode string | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold. | |
udiDeviceIdentifier.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
udiDeviceIdentifier.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. 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. |
udiDeviceIdentifier.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | 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. |
udiDeviceIdentifier.deviceIdentifier | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier. | |
udiDeviceIdentifier.issuer | The organization that assigns the identifier algorithm | The organization that assigns the identifier algorithm. | |
udiDeviceIdentifier.jurisdiction | The jurisdiction to which the deviceIdentifier applies | The jurisdiction to which the deviceIdentifier applies. | |
manufacturer[x] | Name of device manufacturer | A name of the manufacturer. | |
deviceName | A name given to the device to identify it | A name given to the device to identify it. | |
deviceName.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
deviceName.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. 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. |
deviceName.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | 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. |
deviceName.name | The name of the device | The name of the device. | |
deviceName.type | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other | The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. | |
modelNumber | The model number for the device | The model number for the device. | |
type | What kind of device or device system this is | What kind of device or device system this is. | |
specialization | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. | |
specialization.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
specialization.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. 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. |
specialization.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | 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. |
specialization.systemType | The standard that is used to operate and communicate | The standard that is used to operate and communicate. | |
specialization.version | The version of the standard that is used to operate and communicate | The version of the standard that is used to operate and communicate. | |
version | Available versions | The available versions of the device, e.g., software versions. | |
safety | Safety characteristics of the device | Safety characteristics of the device. | |
shelfLifeStorage | Shelf Life and storage information | Shelf Life and storage information. | |
physicalCharacteristics | Dimensions, color etc. | Dimensions, color etc. | |
languageCode | Language code for the human-readable text strings produced by the device (all supported) | Language code for the human-readable text strings produced by the device (all supported). | |
capability | Device capabilities | Device capabilities. | |
capability.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
capability.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. 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. |
capability.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | 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. |
capability.type | Type of capability | Type of capability. | |
capability.description | Description of capability | Description of capability. | |
property | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. | |
property.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
property.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. 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. |
property.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | 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. |
property.type | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | Code that specifies the property DeviceDefinitionPropetyCode (Extensible). | |
property.valueQuantity | Property value as a quantity | Property value as a quantity. | |
property.valueCode | Property value as a code, e.g., NTP4 (synced to NTP) | Property value as a code, e.g., NTP4 (synced to NTP). | |
owner | Organization responsible for device | An organization that is responsible for the provision and ongoing maintenance of the device. | |
contact | Details for human/organization for support | Contact details for an organization or a particular human that is responsible for the device. | used for troubleshooting etc. |
url | Network address to contact device | A 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. |
onlineInformation | Access to on-line information | Access to on-line information about the device. | |
note | Device notes and comments | Descriptive information, usage information or implantation information that is not captured in an existing element. | |
quantity | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product) | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product). | |
parentDevice | The parent device it can be part of | The parent device it can be part of. | |
material | A substance used to create the material(s) of which the device is made | A substance used to create the material(s) of which the device is made. | |
material.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
material.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. 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. |
material.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | 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. |
material.substance | The substance | The substance. | |
material.alternate | Indicates an alternative material of the device | Indicates an alternative material of the device. | |
material.allergenicIndicator | Whether the substance is a known or suspected allergen | Whether the substance is a known or suspected allergen. |
The DeviceDefinition resource is used to describe the characteristics and capabilities of a medical device.
The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the regulatory entities, or it is a local definition that includes assembled device configurations. The DeviceDefinition allows defining hierarchical device configurations (devices as part of other devices).
Device vs deviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location, which the DeviceDefinition resource does not have.
identifier | The identifier of the component | DeviceDefinition.identifier |
parent | The parent DeviceDefinition resource | DeviceDefinition.parentDevice |
type | The device component type | DeviceDefinition.type |