Device

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.

Schema

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.
definition		Reference<DeviceDefinition>	The reference to the definition for the device Details The reference to the definition for the device.
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](device-mappings.html#udi) for a complete mapping of UDI parts to Device.
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.
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.
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.
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.
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.
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.
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.
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.
entryType		code	barcode | rfid | manual + Details A coded entry to indicate how the data was entered.
status		code	active | inactive | entered-in-error | unknown Details 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		CodeableConcept[]	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Details Reason for the dtatus of the Device availability.
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)*.
manufacturer		string	Name of device manufacturer Details A name of the manufacturer.
manufactureDate		dateTime	Date when the device was made Details The date and time when the device was manufactured.
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).
lotNumber		string	Lot number of manufacture Details Lot number assigned by the manufacturer.
serialNumber		string	Serial number assigned by the manufacturer Details The serial number assigned by the organization when the device was manufactured. Alphanumeric Maximum 20.
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.
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.
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.
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.
name	✓	string	The name of the device Details The name of the device.
type	✓	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Details The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
modelNumber		string	The model number for the device Details The model number for the device.
partNumber		string	The part number of the device Details The part number of the device. Alphanumeric Maximum 20.
type		CodeableConcept	The kind or type of device Details The kind or type of device.
specialization		DeviceSpecialization[]	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication Details The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
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.
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.
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.
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.
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.
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.
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.
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.
type		CodeableConcept	The type of the device version Details The type of the device version.
component		Identifier	A single component of the device version Details A single component of the device version.
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.
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.
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.
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.
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.
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).
patient		Reference<Patient>	Patient to whom Device is affixed Details Patient information, If the device is affixed to a person.
owner		Reference<Organization>	Organization responsible for device Details An organization that is responsible for the provision and ongoing maintenance of the device.
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.
location		Reference<Location>	Where the device is found Details The place where the device can be found.
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.
note		Annotation[]	Device notes and comments Details Descriptive information, usage information or implantation information that is not captured in an existing element.
safety		CodeableConcept[]	Safety Characteristics of Device Details Provides additional safety characteristics about a medical device. For example devices containing latex.
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 | Device.type.coding.display | Device.type.text
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 | entered-in-error | unknown	Device.status
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

Inherited Elements

Name	Required	Type	Description
id		string	Logical id of this artifact Details The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
meta		Meta	Metadata about the resource Details The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
implicitRules		uri	A set of rules under which this content was created Details A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
language		code	Language of the resource content Details The base language in which the resource is written. Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
text		Narrative	Text summary of the resource, for human interpretation Details A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
contained		Resource[]	Contained, inline Resources Details These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
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 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.
modifierExtension		Extension[]	Extensions that cannot be ignored Details May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. 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.

Usage

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.

Relationships

These are the device related resources

• Device (this resource)
• DeviceDefinition - Describes a "kind" of device - not a physical instance, cut a "catalog entry" where a device is defined by the manufacturer, reseller, or regulator.
• DeviceMetric - Describes a measurement, calculation or setting capability of a medical device.

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.

Referenced By

• Signature
• Account
• AdverseEvent
• Appointment
• AppointmentResponse
• AuditEvent
• CarePlan
• CatalogEntry
• ChargeItem
• ChargeItemDefinition
• Claim
• Communication
• CommunicationRequest
• Composition
• Consent
• Contract
• DetectedIssue
• DeviceMetric
• DeviceRequest
• DeviceUseStatement
• DiagnosticReport
• DocumentManifest
• DocumentReference
• ExplanationOfBenefit
• Flag
• Group
• GuidanceResponse
• ImagingStudy
• Invoice
• List
• MeasureReport
• Media
• MedicationAdministration
• MedicationDispense
• MedicationRequest
• MessageHeader
• MolecularSequence
• Observation
• Procedure
• Provenance
• QuestionnaireResponse
• RequestGroup
• RiskAssessment
• Schedule
• ServiceRequest
• Specimen
• SupplyDelivery
• SupplyRequest
• Task