Path | Short | Definition | Comments |
---|---|---|---|
Item used in healthcare | 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. | ||
identifier | Instance identifier | 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. |
definition | The reference to the definition for the device | The reference to the definition for the device. | |
udiCarrier | 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. | UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device. |
udiCarrier.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. | |
udiCarrier.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. |
udiCarrier.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. |
udiCarrier.deviceIdentifier | Mandatory fixed portion of UDI | 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. | |
udiCarrier.issuer | UDI Issuing Organization | 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. | |
udiCarrier.jurisdiction | Regional UDI authority | 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. | |
udiCarrier.carrierAIDC | UDI Machine Readable Barcode String | 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. |
udiCarrier.carrierHRF | UDI Human Readable Barcode String | 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. |
udiCarrier.entryType | barcode | rfid | manual + | A coded entry to indicate how the data was entered. | |
status | active | inactive | entered-in-error | unknown | Status 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. |
statusReason | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off | Reason for the dtatus of the Device availability. | |
distinctIdentifier | The distinct identification string | 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)*. |
manufacturer | Name of device manufacturer | A name of the manufacturer. | |
manufactureDate | Date when the device was made | The date and time when the device was manufactured. | |
expirationDate | Date and time of expiry of this device (if applicable) | The date and time beyond which this device is no longer valid or should not be used (if applicable). | |
lotNumber | Lot number of manufacture | Lot number assigned by the manufacturer. | |
serialNumber | Serial number assigned by the manufacturer | The serial number assigned by the organization when the device was manufactured. | Alphanumeric Maximum 20. |
deviceName | The name of the device as given by the manufacturer | 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. | |
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. | |
partNumber | The part number of the device | The part number of thedevice. | Alphanumeric Maximum 20. |
type | The kind or type of device | The kind or type of device. | |
specialization | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | 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 | The actual design of the device or software version running on the device | The actual design of the device or software version running on the device. | |
version.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. | |
version.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. |
version.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. |
version.type | The type of the device version | The type of the device version. | |
version.component | A single component of the device version | A single component of the device version. | |
version.value | The version text | The version text. | |
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). | |
patient | Patient to whom Device is affixed | Patient information, If the device is affixed to a person. | |
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. |
location | Where the device is found | The place where the device can be found. | |
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. |
note | Device notes and comments | Descriptive information, usage information or implantation information that is not captured in an existing element. | |
safety | Safety Characteristics of Device | Provides additional safety characteristics about a medical device. For example devices containing latex. | |
parent | The parent device | The parent device. |
This resource is an administrative resource that tracks individual instances of a device and their location. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, referenced when prescribing and dispensing devices for patient use or for ordering supplies, and used to record and transmit Unique Device Identifier (UDI) information about a device such as a patient's implant.
These are the device related resources
In FHIR, the "Device" is the "administrative" resource for the device (it does not change much and has manufacturer information etc.), whereas the DeviceComponent and DeviceMetric (which is really a kind of DeviceComponent) model the physical part, including operation status and is much more volatile. The physical composition of a Device is represented by the Devices pointing to their "parent".
Devices differ from medications because they are not "used up" - they remain active in a patient in an ongoing fashion. However, the specific boundary between medications and devices is defined at the implementation level and this standard does not enforce a boundary with the exception of devices that are implanted in a patient. The Medication resource should not be used to represent implanted devices.
Nearly all devices are assigned a string of characters to represent one or more identifiers or codes, which are usually printed or affixed to the device using either barcodes or RFIDs. The identifier or code can come from the manufacturer (for example, a 'serial number', 'reference number', or 'catalog number'), various institution and registries. Any of these identifiers or codes assigned to the device can and should be recorded in the device resource. However, there can there can be confusion where to represent them in the resource because codes and identifiers are represented in FHIR as semantically distinct elements and because organizations may conflate the term 'code' for an identifier or 'identifier' for a code in their names.
The identifier
element is only intended for use when it's an actual identifier for a specific instance of a device. That would mean that each device would have a separate serial number and would be represented using this element - devices without serial numbers (for example, a box of syringes) would not. Concepts such as a reference number or catalog number or GTIN describe a code which represents a kind of device and are conveyed using the type
element. Some sources of standard codes for devices and translations within type
are listed below:
The International Medical Device Regulators Forum IMDRF UDI Working Group published UDI System for Medical Devices (Version 2.0), the base specification for Unique Device Identifiers (UDI). The United States Food and Drug Administration has produced an implementation guide for Unique Device Identifiers (UDI) which implements the IMDRF specification and other jurisdictions may produce similar IMDRF implementation guides as well. The full UDI string that represents the barcode as printed on the packaging of the device or Automatic Identification and Data Capture (AIDC) representation is called the "UDI carrier". The UDI has 2 components*:
*non-UDI elements may also appear within the UDI carrier. **a "GTIN" (sometimes also called an EAN number) is a code developed by GS1 for the kind of device not an identifier for the device. A GTIN may appear on its own or it may appear in a UDI string as the DI component.
The DI of the UDI may be stored in a jurisdictional repository and used as the primary key to access other device information. For example, in the United States, the DI of the UDI is submitted in a device record to the Global Unique Device Identification Database (GUDID). The UDI may identify an instance of a device uniquely (when the PI includes a serial number), or it may just identify the type of the device. The UDI is parsed into its constituent parts (DI, PI and other elements) by parsing rules developed by each Issuing Agency standard. Where the device has an assigned UDI, the other details carried in the resource (e.g., lot, expiration date, etc.) SHALL be consistent with the information encoded in the UDI string or registered in the local repository.
Best practice guidelines for transmitting UDI data using the Device resource dictate transmitting both the UDI Carrier and all components found within the UDI as described in Device UDI Mapping. Several examples are provided for further guidance.
device-name | A server defined search that may match any of the string fields in Device.deviceName or Device.type. | Device.deviceName.name | Device.type.coding.display | Device.type.text |
identifier | Instance id from manufacturer, owner, and others | Device.identifier |
location | A location, where the resource is found | Device.location |
manufacturer | The manufacturer of the device | Device.manufacturer |
model | The model of the device | Device.modelNumber |
organization | The organization responsible for the device | Device.owner |
patient | Patient information, if the resource is affixed to a person | Device.patient |
status | active | inactive | entered-in-error | unknown | Device.status |
type | The type of the device | Device.type |
udi-carrier | UDI Barcode (RFID or other technology) string in *HRF* format. | Device.udiCarrier.carrierHRF |
udi-di | The udi Device Identifier (DI) | Device.udiCarrier.deviceIdentifier |
url | Network address to contact device | Device.url |