Name Flags Card. Type Description & Constraints DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device deviceName S 0..* BackboneElement The name or names of the device as given by the manufacturer classification S 0..* BackboneElement What kind of device or device system this is type S 1..1 CodeableConcept A classification or risk class of the device model Binding: Device Type (example) property S 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc type S 1..1 CodeableConcept Code that specifies the property being represented Binding: Device Properties (example) value[x] S 1..1 Value of the property valueQuantity Quantity valueCodeableConcept CodeableConcept valueString string valueBoolean boolean valueInteger integer valueRange Range valueAttachment Attachment Documentation for this format
HL7 International / Biomedical Research and Regulation
HL7 International - Biomedical Research and Regulation
This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering.
An instance of a medical-related component of a medical device
The characteristics, operational status and capabilities of a medical-related component of a medical device.
For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
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 its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
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 summary of the resource, for human interpretation
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 a 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.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
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.
Additional content defined by implementations
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 managable, 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.
Must have either extensions or value[x], not both
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 managable, 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).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Additional information to describe the device
Additional information to describe the device.
Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber 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.
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.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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 managable, 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.
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 managable, 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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.
The organization that assigns the identifier algorithm
The organization that assigns the identifier algorithm.
The jurisdiction to which the deviceIdentifier applies
The jurisdiction to which the deviceIdentifier applies.
Indicates whether and when the device is available on the market
Indicates where and when the device is available on the market.
Begin and end dates for the commercial distribution of the device
Begin and end dates for the commercial distribution of the device.
National state or territory where the device is commercialized
National state or territory to which the marketDistribution recers, typically where the device is commercialized.
Regulatory identifier(s) associated with this device
Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.
This should not be used for regulatory authorization numbers which are to be captured elsewhere.
The organization that issued this identifier
The organization that issued this identifier.
The part number or catalog number of the device
The part number or catalog number of the device.
A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.
The name or names of the device as given by the manufacturer
The name or names of the device as given by the manufacturer.
A name that is used to refer to the device
A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.
registered-name | user-friendly-name | patient-reported-name
The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedName.
The type of name the device is referred by.
The catalog or model number for the device for example as defined by the manufacturer
The model number for the device for example as defined by the manufacturer or labeler, or other agency.
What kind of device or device system this is
What kind of device or device system this is.
In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.
A classification or risk class of the device model
A classification or risk class of the device model.
Further information qualifying this classification of the device model
Further information qualifying this classification of the device model.
Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.
Describes the common type of the standard, specification, or formal guidance
Describes the type of the standard, specification, or formal guidance.
Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.
The specific form or variant of the standard, specification or formal guidance
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.
Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.
A device that is part (for example a component) of the present device.
Reference to the device that is part of the current device.
Number of instances of the component device in the current device.
Information about the packaging of the device, i.e. how the device is packaged
Information about the packaging of the device, i.e. how the device is packaged.
Business identifier of the packaged medication
The business identifier of the packaged medication.
A code that defines the specific type of packaging
A code that defines the specific type of packaging.
The number of items contained in the package (devices or sub-packages)
The number of items contained in the package (devices or sub-packages).
An organization that distributes the packaged device
An organization that distributes the packaged device.
Distributor as an Organization resource.
Unique Device Identifier (UDI) Barcode string on the packaging
Unique Device Identifier (UDI) Barcode string on the packaging.
The type of the device version, e.g. manufacturer, approved, internal
The type of the device version, e.g. manufacturer, approved, internal.
The hardware or software module of the device to which the version applies
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.
Language code for the human-readable text strings produced by the device (all supported)
Language code for the human-readable text strings produced by the device (all supported).
Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.
Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.
Code that specifies the property being represented
Code that specifies the property such as a resolution or color being represented.
The value of the property specified by the associated property.type code.
This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.
An organization that is responsible for the provision and ongoing maintenance of the device.
Details for human/organization for support
Contact details for an organization or a particular human that is responsible for the device.
An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.
The type indicates the relationship of the related device to the device instance
The type indicates the relationship of the related device to the device instance.
The type of relation between this and the linked device.
Descriptive information, usage information or implantation information that is not captured in an existing element.
A substance used to create the material(s) of which the device is made
A substance used to create the material(s) of which the device is made.
A relevant substance that the device contains, may contain, or is made of
A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.
Indicates an alternative material of the device
Indicates an alternative material of the device.
Whether the substance is a known or suspected allergen
Whether the substance is a known or suspected allergen.
lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.
The production identifier(s) that are expected to appear in the UDI carrier.
Information aimed at providing directions for the usage of this model of device
Information aimed at providing directions for the usage of this model of device.
For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.
The circumstances that form the setting for using the device
The circumstances that form the setting for using the device.
Detailed written and visual directions for the user on how to use the device
Detailed written and visual directions for the user on how to use the device.
A source of information or reference for this guideline
A source of information or reference for this guideline.
A clinical condition for which the device was designed to be used
A clinical condition for which the device was designed to be used.
A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.
A specific situation when a device should not be used because it may cause harm
A specific situation when a device should not be used because it may cause harm.
Specific hazard alert information that a user needs to know before using the device
Specific hazard alert information that a user needs to know before using the device.
A description of the general purpose or medical use of the device or its function
A description of the general purpose or medical use of the device or its function.
Tracking of latest field safety corrective action
Tracking of latest field safety corrective action.
Whether the corrective action was a recall
Whether the last corrective action known for this device was a recall.
When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.
The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.
The type or scope of the corrective action.
Start and end dates of the corrective action
Start and end dates of the corrective action.
Billing code or reference associated with the device
Billing code or reference associated with the device.
The code or reference for the charge item
The code or reference for the charge item.
Coefficient applicable to the billing code
Coefficient applicable to the billing code.
A specific time period in which this charge item applies
A specific time period in which this charge item applies.
The context to which this charge item applies
The context to which this charge item applies.