Device | Medplum
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A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device. For more on implantable devices, refer to US Core Implantable Device Profile.
Elements
| Name | Required | Type | Description |
|---|---|---|---|
| identifier | Identifier[] | Instance identifier Details Unique instance identifiers assigned to a device by manufacturers other organizations or owners. 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 | Reference< DeviceDefinition > | The reference to the definition for the device Details The reference to the definition for the device. |
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| udiCarrier | DeviceUdiCarrier[] | Unique Device Identifier (UDI) Barcode string Details 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. 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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| id | string | Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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| extension | Extension[] | Additional content defined by implementations Details 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. |
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| modifierExtension | Extension[] | Extensions that cannot be ignored even if unrecognized Details 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. |
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| deviceIdentifier | string | Mandatory fixed portion of UDI Details The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. |
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| issuer | uri | UDI Issuing Organization Details Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. |
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| jurisdiction | uri | Regional UDI authority Details The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. |
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| carrierAIDC | base64Binary | UDI Machine Readable Barcode String Details The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. 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 | string | UDI Human Readable Barcode String Details The 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 | code | barcode | |
| status | code | active | |
| statusReason | CodeableConcept[] | online | |
| distinctIdentifier | string | The distinct identification string Details The 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 | string | Name of device manufacturer Details A name of the manufacturer. |
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| manufactureDate | dateTime | Date when the device was made Details The date and time when the device was manufactured. |
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| expirationDate | dateTime | Date and time of expiry of this device (if applicable) Details The date and time beyond which this device is no longer valid or should not be used (if applicable). |
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| lotNumber | string | Lot number of manufacture Details Lot number assigned by the manufacturer. |
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| serialNumber | string | Serial number assigned by the manufacturer Details The serial number assigned by the organization when the device was manufactured. Alphanumeric Maximum 20. |
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| deviceName | DeviceDeviceName[] | The name of the device as given by the manufacturer Details This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. |
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| id | string | Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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| extension | Extension[] | Additional content defined by implementations Details 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. |
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| modifierExtension | Extension[] | Extensions that cannot be ignored even if unrecognized Details 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. |
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| systemType | ✓ | CodeableConcept | The standard that is used to operate and communicate Details The standard that is used to operate and communicate. |
| version | string | The version of the standard that is used to operate and communicate Details The version of the standard that is used to operate and communicate. |
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| version | DeviceVersion[] | The actual design of the device or software version running on the device Details The actual design of the device or software version running on the device. |
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| id | string | Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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| extension | Extension[] | Additional content defined by implementations Details 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. |
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| modifierExtension | Extension[] | Extensions that cannot be ignored even if unrecognized Details 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. |
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| type | CodeableConcept | The type of the device version Details The type of the device version. |
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| component | Identifier | A single component of the device version Details A single component of the device version. |
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| value | ✓ | string | The version text Details The version text. |
| property | DeviceProperty[] | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties Details The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. |
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| id | string | Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
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| extension | Extension[] | Additional content defined by implementations Details 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. |
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| modifierExtension | Extension[] | Extensions that cannot be ignored even if unrecognized Details 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. |
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| type | ✓ | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) Details Code that specifies the property DeviceDefinitionPropetyCode (Extensible). |
| valueQuantity | Quantity[] | Property value as a quantity Details Property value as a quantity. |
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| valueCode | CodeableConcept[] | Property value as a code, e.g., NTP4 (synced to NTP) Details Property value as a code, e.g., NTP4 (synced to NTP). |
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| patient | Reference< Patient > | Patient to whom Device is affixed Details Patient information, If the device is affixed to a person. |
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| owner | Reference< Organization > | Organization responsible for device Details An organization that is responsible for the provision and ongoing maintenance of the device. |
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| contact | ContactPoint[] | Details for human/organization for support Details Contact details for an organization or a particular human that is responsible for the device. used for troubleshooting etc. |
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| location | Reference< Location > | Where the device is found Details The place where the device can be found. |
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| url | uri | Network address to contact device Details 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. |
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| note | Annotation[] | Device notes and comments Details Descriptive information, usage information or implantation information that is not captured in an existing element. |
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| safety | CodeableConcept[] | Safety Characteristics of Device Details Provides additional safety characteristics about a medical device. For example devices containing latex. |
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| parent | Reference< Device > | The parent device Details The parent device. |
Search Parameters
| Name | Type | Description | Expression |
|---|---|---|---|
| device-name | string | A server defined search that may match any of the string fields in Device.deviceName or Device.type. | Device.deviceName.name |
| identifier | token | Instance id from manufacturer, owner, and others | Device.identifier |
| location | reference | A location, where the resource is found | Device.location |
| manufacturer | string | The manufacturer of the device | Device.manufacturer |
| model | string | The model of the device | Device.modelNumber |
| organization | reference | The organization responsible for the device | Device.owner |
| patient | reference | Patient information, if the resource is affixed to a person | Device.patient |
| status | token | active | inactive |
| type | token | The type of the device | Device.type |
| udi-carrier | string | UDI Barcode (RFID or other technology) string in HRF format. | Device.udiCarrier.carrierHRF |
| udi-di | string | The udi Device Identifier (DI) | Device.udiCarrier.deviceIdentifier |
| url | uri | Network address to contact device | Device.url |