CDC National Healthcare Safety Network (NHSN) Digital Quality Measures (dQM) Content Package IG - Local Development build (v3.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: AcuteCareHospitalMonthlyDevice - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the ach-monthly-device resource profile.

See the documentation on how to interpret the contents of this table

0. Device
Definition

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.

Short Item used in healthcare
Control 0..*
Is Modifier false
Summary false
Invariants dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: 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())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Device.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Short (NHSN-MS) Logical id of this artifactLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control 10..1
Type id
Is Modifier false
Must Support true
Summary true
4. Device.implicitRules
Definition

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.

Short A set of rules under which this content was created
Comments

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.

Control 0..1
Type uri
Is Modifier true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Device.modifierExtension
Definition

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).

Short Extensions that cannot be ignored
Comments

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.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary false
Requirements

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.

Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Device.status
Definition

Status of the Device availability.

Short (NHSN-MS) active | inactive | entered-in-error | unknownactive | inactive | entered-in-error | unknown
Comments

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.

Control 0..1
Binding The codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

The availability status of the device.

Type code
Is Modifier true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Must Support true
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.type
Definition

The kind or type of device.

Short (NHSN-MS) The kind or type of deviceThe kind or type of device
Control 10..1
Binding Unless not suitable, these codes SHALL be taken from For example codes, see DeviceTypehttp://hl7.org/fhir/ValueSet/device-type|4.0.1
(extensible to http://hl7.org/fhir/ValueSet/device-type)
Type CodeableConcept
Is Modifier false
Must Support true
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.patient
Definition

Patient information, If the device is affixed to a person.

Short (NHSN-MS)(QI-Core) Patient to whom Device is affixedPatient to whom Device is affixed
Control 10..1
Type Reference(Cross-Measure Patient Profile, Patient)bundled
Is Modifier false
Must Support true
Summary false
Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Device.patient.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Short (NHSN-MS) Literal reference, Relative, internal or absolute URLLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control 10..1
This element is affected by the following invariants: ref-1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Must Support true
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

See the documentation on how to interpret the contents of this table

0. Device
2. Device.id
Short (NHSN-MS) Logical id of this artifact
Control 1..?
Must Support true
4. Device.meta
6. Device.meta.extension:link-received-date-extension
Slice Name link-received-date-extension
Control 0..1
Type Extension(Received Date) (Extension Type: dateTime)
8. Device.status
Short (NHSN-MS) active | inactive | entered-in-error | unknown
Must Support true
10. Device.type
Short (NHSN-MS) The kind or type of device
Control 1..?
Binding Unless not suitable, these codes SHALL be taken from DeviceType
(extensible to http://hl7.org/fhir/ValueSet/device-type)
Must Support true
12. Device.patient
Short (NHSN-MS)(QI-Core) Patient to whom Device is affixed
Type Reference(Cross-Measure Patient Profile)bundled
Must Support true
14. Device.patient.reference
Short (NHSN-MS) Literal reference, Relative, internal or absolute URL
Control 1..?
Must Support true

See the documentation on how to interpret the contents of this table

0. Device
Definition

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.

Short Item used in healthcare
Control 0..*
Is Modifier false
Summary false
Invariants dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: 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())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Device.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Short (NHSN-MS) Logical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control 1..1
Type id
Is Modifier false
Must Support true
Summary true
4. Device.meta
Definition

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.

Short Metadata about the resource
Control 0..1
Type Meta
Is Modifier false
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Device.meta.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Short Unique id for inter-element referencing
Control 0..1
Type string
Is Modifier false
XML Format In the XML format, this property is represented as an attribute.
Summary false
8. Device.meta.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
Slicing This element introduces a set of slices on Device.meta.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
10. Device.meta.extension:link-received-date-extension
Slice Name link-received-date-extension
Definition

This extension stores the date and time a Resource was received by the processing system (e.g., NHSNLink).

Short Received Date
Control 0..1
Type Extension(Received Date) (Extension Type: dateTime)
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
12. Device.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

Short Version specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Control 0..1
Type id
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Device.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

Short When the resource version last changed
Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control 0..1
Type instant
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Device.meta.source
Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

Short Identifies where the resource comes from
Comments

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Control 0..1
Type uri
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Device.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Short Profiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control 0..*
Type canonical(StructureDefinition)
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Device.meta.security
Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Short Security Labels applied to this resource
Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Control 0..*
Binding Unless not suitable, these codes SHALL be taken from All Security Labels
(extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)

Security Labels from the Healthcare Privacy and Security Classification System.

Type Coding
Is Modifier false
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Device.meta.tag
Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Short Tags applied to this resource
Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Control 0..*
Binding For example codes, see CommonTags
(example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)

Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

Type Coding
Is Modifier false
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Device.implicitRules
Definition

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.

Short A set of rules under which this content was created
Comments

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.

Control 0..1
Type uri
Is Modifier true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Device.language
Definition

The base language in which the resource is written.

Short Language of the resource content
Comments

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).

Control 0..1
Binding The codes SHOULD be taken from CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages)

A human language.

Additional Bindings Purpose
AllLanguages Max Binding
Type code
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Device.text
Definition

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.

Short Text summary of the resource, for human interpretation
Comments

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.

Control 0..1
Type Narrative
Is Modifier false
Summary false
Alternate Names narrative, html, xhtml, display
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Device.contained
Definition

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.

Short Contained, inline Resources
Comments

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.

Control 0..*
Type Resource
Is Modifier false
Summary false
Alternate Names inline resources, anonymous resources, contained resources
32. Device.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
34. Device.modifierExtension
Definition

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).

Short Extensions that cannot be ignored
Comments

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.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary false
Requirements

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.

Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
36. Device.identifier
Definition

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

Short Instance identifier
Comments

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.

Note This is a business identifier, not a resource identifier (see discussion)
Control 0..*
Type Identifier
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Device.definition
Definition

The reference to the definition for the device.

Short The reference to the definition for the device
Control 0..1
Type Reference(DeviceDefinition)
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Device.udiCarrier
Definition

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.

Short Unique Device Identifier (UDI) Barcode string
Comments

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

Control 0..*
Type BackboneElement
Is Modifier false
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Device.udiCarrier.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Short Unique id for inter-element referencing
Control 0..1
Type string
Is Modifier false
XML Format In the XML format, this property is represented as an attribute.
Summary false
44. Device.udiCarrier.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
46. Device.udiCarrier.modifierExtension
Definition

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).

Short Extensions that cannot be ignored even if unrecognized
Comments

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.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary true
Requirements

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.

Alternate Names extensions, user content, modifiers
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
48. Device.udiCarrier.deviceIdentifier
Definition

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.

Short Mandatory fixed portion of UDI
Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Alternate Names DI
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Device.udiCarrier.issuer
Definition

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.
Short UDI Issuing Organization
Control 0..1
Type uri
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Alternate Names Barcode System
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Device.udiCarrier.jurisdiction
Definition

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.

Short Regional UDI authority
Control 0..1
Type uri
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Requirements

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

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Device.udiCarrier.carrierAIDC
Definition

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.

Short UDI Machine Readable Barcode String
Comments

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.

Control 0..1
Type base64Binary
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Alternate Names Automatic Identification and Data Capture
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Device.udiCarrier.carrierHRF
Definition

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

Short UDI Human Readable Barcode String
Comments

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Alternate Names Human Readable Form
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. Device.udiCarrier.entryType
Definition

A coded entry to indicate how the data was entered.

Short barcode | rfid | manual +
Control 0..1
Binding The codes SHALL be taken from UDIEntryType
(required to http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1)

Codes to identify how UDI data was entered.

Type code
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Requirements

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

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Device.status
Definition

Status of the Device availability.

Short (NHSN-MS) active | inactive | entered-in-error | unknown
Comments

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.

Control 0..1
Binding The codes SHALL be taken from FHIRDeviceStatus
(required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

The availability status of the device.

Type code
Is Modifier true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Must Support true
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Device.statusReason
Definition

Reason for the dtatus of the Device availability.

Short online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Control 0..*
Binding Unless not suitable, these codes SHALL be taken from FHIRDeviceStatusReason
(extensible to http://hl7.org/fhir/ValueSet/device-status-reason)

The availability status reason of the device.

Type CodeableConcept
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. Device.distinctIdentifier
Definition

The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

Short The distinct identification string
Comments

For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Alternate Names Distinct Identification Code (DIC)
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. Device.manufacturer
Definition

A name of the manufacturer.

Short Name of device manufacturer
Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Device.manufactureDate
Definition

The date and time when the device was manufactured.

Short Date when the device was made
Control 0..1
Type dateTime
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Device.expirationDate
Definition

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

Short Date and time of expiry of this device (if applicable)
Control 0..1
Type dateTime
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Short Lot number of manufacture
Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Device.serialNumber
Definition

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

Short Serial number assigned by the manufacturer
Comments

Alphanumeric Maximum 20.

Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. Device.deviceName
Definition

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.

Short The name of the device as given by the manufacturer
Control 0..*
Type BackboneElement
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. Device.deviceName.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Short Unique id for inter-element referencing
Control 0..1
Type string
Is Modifier false
XML Format In the XML format, this property is represented as an attribute.
Summary false
80. Device.deviceName.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
82. Device.deviceName.modifierExtension
Definition

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).

Short Extensions that cannot be ignored even if unrecognized
Comments

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.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary true
Requirements

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.

Alternate Names extensions, user content, modifiers
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
84. Device.deviceName.name
Definition

The name of the device.

Short The name of the device
Control 1..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Alternate Names Σ
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. Device.deviceName.type
Definition

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Short udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Control 1..1
Binding The codes SHALL be taken from DeviceNameType
(required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

The type of name the device is referred by.

Type code
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Device.modelNumber
Definition

The model number for the device.

Short The model number for the device
Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. Device.partNumber
Definition

The part number of the device.

Short The part number of the device
Comments

Alphanumeric Maximum 20.

Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Device.type
Definition

The kind or type of device.

Short (NHSN-MS) The kind or type of device
Control 1..1
Binding Unless not suitable, these codes SHALL be taken from DeviceType
(extensible to http://hl7.org/fhir/ValueSet/device-type)
Type CodeableConcept
Is Modifier false
Must Support true
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. Device.specialization
Definition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

Short The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
Control 0..*
Type BackboneElement
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. Device.specialization.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Short Unique id for inter-element referencing
Control 0..1
Type string
Is Modifier false
XML Format In the XML format, this property is represented as an attribute.
Summary false
98. Device.specialization.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
100. Device.specialization.modifierExtension
Definition

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).

Short Extensions that cannot be ignored even if unrecognized
Comments

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.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary true
Requirements

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.

Alternate Names extensions, user content, modifiers
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
102. Device.specialization.systemType
Definition

The standard that is used to operate and communicate.

Short The standard that is used to operate and communicate
Control 1..1
Type CodeableConcept
Is Modifier false
Summary false
Alternate Names Σ
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. Device.specialization.version
Definition

The version of the standard that is used to operate and communicate.

Short The version of the standard that is used to operate and communicate
Note This is a business version Id, not a resource version Id (see discussion)
Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. Device.version
Definition

The actual design of the device or software version running on the device.

Short The actual design of the device or software version running on the device
Note This is a business version Id, not a resource version Id (see discussion)
Control 0..*
Type BackboneElement
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. Device.version.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Short Unique id for inter-element referencing
Control 0..1
Type string
Is Modifier false
XML Format In the XML format, this property is represented as an attribute.
Summary false
110. Device.version.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
112. Device.version.modifierExtension
Definition

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).

Short Extensions that cannot be ignored even if unrecognized
Comments

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.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary true
Requirements

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.

Alternate Names extensions, user content, modifiers
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
114. Device.version.type
Definition

The type of the device version.

Short The type of the device version
Control 0..1
Type CodeableConcept
Is Modifier false
Summary false
Alternate Names Σ
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. Device.version.component
Definition

A single component of the device version.

Short A single component of the device version
Control 0..1
Type Identifier
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
118. Device.version.value
Definition

The version text.

Short The version text
Control 1..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. Device.property
Definition

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Short The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Control 0..*
Type BackboneElement
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. Device.property.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Short Unique id for inter-element referencing
Control 0..1
Type string
Is Modifier false
XML Format In the XML format, this property is represented as an attribute.
Summary false
124. Device.property.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
126. Device.property.modifierExtension
Definition

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).

Short Extensions that cannot be ignored even if unrecognized
Comments

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.

Control 0..*
Type Extension
Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary true
Requirements

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.

Alternate Names extensions, user content, modifiers
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
128. Device.property.type
Definition

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Short Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Control 1..1
Type CodeableConcept
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. Device.property.valueQuantity
Definition

Property value as a quantity.

Short Property value as a quantity
Control 0..*
Type Quantity
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. Device.property.valueCode
Definition

Property value as a code, e.g., NTP4 (synced to NTP).

Short Property value as a code, e.g., NTP4 (synced to NTP)
Control 0..*
Type CodeableConcept
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. Device.patient
Definition

Patient information, If the device is affixed to a person.

Short (NHSN-MS)(QI-Core) Patient to whom Device is affixed
Control 1..1
Type Reference(Cross-Measure Patient Profile)bundled
Is Modifier false
Must Support true
Summary false
Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
136. Device.patient.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Short Unique id for inter-element referencing
Control 0..1
Type string
Is Modifier false
XML Format In the XML format, this property is represented as an attribute.
Summary false
138. Device.patient.extension
Definition

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.

Short Additional content defined by implementations
Comments

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.

Control 0..*
Type Extension
Is Modifier false
Summary false
Alternate Names extensions, user content
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
Slicing This element introduces a set of slices on Device.patient.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
140. Device.patient.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Short (NHSN-MS) Literal reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control 1..1
This element is affected by the following invariants: ref-1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Must Support true
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
142. Device.patient.type
Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

Short Type the reference refers to (e.g. "Patient")
Comments

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

Control 0..1
Binding Unless not suitable, these codes SHALL be taken from ResourceType
(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

Aa resource (or, for logical models, the URI of the logical model).

Type uri
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. Device.patient.identifier
Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

Short Logical reference, when literal reference is not known
Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

Note This is a business identifier, not a resource identifier (see discussion)
Control 0..1
Type Identifier
Is Modifier false
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
146. Device.patient.display
Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Short Text alternative for the resource
Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control 0..1
Type string
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
148. Device.owner
Definition

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

Short Organization responsible for device
Control 0..1
Type Reference(Organization)
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
150. Device.contact
Definition

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

Short Details for human/organization for support
Comments

used for troubleshooting etc.

Control 0..*
Type ContactPoint
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
152. Device.location
Definition

The place where the device can be found.

Short Where the device is found
Control 0..1
Type Reference(Location)
Is Modifier false
Summary false
Requirements

Device.location can be used to track device location.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
154. Device.url
Definition

A network address on which the device may be contacted directly.

Short Network address to contact device
Comments

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Control 0..1
Type uri
Is Modifier false
Primitive Value This primitive element may be present, or absent, or replaced by an extension
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
156. Device.note
Definition

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

Short Device notes and comments
Control 0..*
Type Annotation
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
158. Device.safety
Definition

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

Short Safety Characteristics of Device
Control 0..*
Type CodeableConcept
Is Modifier false
Summary true
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
160. Device.parent
Definition

The parent device.

Short The parent device
Control 0..1
Type Reference(Device)
Is Modifier false
Summary false
Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

National Center for Emerging and Zoonotic Infectious Diseases