Resource Profile: Device

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. 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. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

The reference to the definition for the device.

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.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

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-diI,
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 # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

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/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

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.

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.

A coded entry to indicate how the data was entered.

Supports a way to distinguish hand entered from machine read data.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Codes to identify how UDI data was entered.

The availability of the device.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

The availability status reason of the device.

An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled.

Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

A name of the manufacturer or entity legally responsible for the device.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

The date and time when the device was manufactured.

UTC offset is allowed for dates and partial dates

The date and time beyond which this device is no longer valid or should not be used (if applicable).

UTC offset is allowed for dates and partial dates

Lot number assigned by the manufacturer.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

The serial number assigned by the organization when the device was manufactured.

Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.

The actual name that identifies the device.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

The type of name the device is referred by.

Indicates the default or preferred name to be displayed.

The manufacturer's model number for the device.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

The part number or catalog number of the device.

Alphanumeric Maximum 20.

Devices may be associated with one or more categories.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Categories of medical devices.

The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.

Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor.

Codes to identify medical devices.

The type of the device version, e.g. manufacturer, approved, internal.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

The type of version indicated for the device.

The hardware or software module of the device to which the version applies.

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

The date the version was installed on the device.

UTC offset is allowed for dates and partial dates

The version text.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Describes the type of the standard, specification, or formal guidance.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

The kind of standards used by the device.

Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Code that specifies the property, such as resolution, color, size, being represented.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Device property type.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Note that FHIR strings SHALL NOT exceed 1,048,576 (1024*1024) characters in size

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Very often the text is the same as a displayName of one of the codings.

The designated condition for performing a task with the device.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Operational mode of a device.

The series of occurrences that repeats during the operation of the device.

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

A measurement of time during the device's operation (e.g., days, hours, mins, etc.).

The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

An organization that is responsible for the provision and ongoing maintenance of the device.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

Contact details for an organization or a particular human that is responsible for the device.

used for troubleshooting etc.

The place where the device can be found.

Device.location can be used to track device location.

References SHALL be a reference to an actual FHIR resource, and SHALL be resolvable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

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.

The linked device acting as a communication controller, data collector, translator, or concentrator for the current device (e.g., mobile phone application that relays a blood pressure device's data).

The Device.gateway may be used when the Device being referenced has a gateway and/or to capture one or more gateways associated with the device. If the Gateway is included in the Observation resource, the Observation.gatewayDevice should be used instead.

Descriptive information, usage information or implantation information that is not captured in an existing element.

For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

Provides additional safety characteristics about a medical device. For example devices containing latex.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.