CDC National Healthcare Safety Network (NHSN) Digital Quality Measures (dQM) Content Package IG
1.0.0 - Release 1

CDC National Healthcare Safety Network (NHSN) Digital Quality Measures (dQM) Content Package IG - Downloaded Version 1.0.0 See the Directory of published versions

## Resource Profile: ACH Monthly Event Device

Official URL: http://www.cdc.gov/nhsn/fhirportal/dqm/ig/StructureDefinition/ach-monthly-device | Version: 1.0.0
Standards status: Trial-use | Maturity Level: 1 | Computable Name: AcuteCareHospitalMonthlyDevice

This profile contains Required and Must Support data elements for reporting device information to the NHSN Acute Care Hospital (ACH) Monthly Digital Quality Measure. This profile covers both implantable and other types of devices and is based on the HL7 FHIR® R4 Device Resource v4.0.1.

Usages:

- Examples for this Profile: Device/device-example-ach-monthly-pass1-central-line, Device/device-example-ach-monthly-pass2-compress-hose and Device/device-example-ach-monthly-pass3-ivcs-pump

You can also check for usages in the FHIR IG Statistics

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id | Σ | 1..1 | id | Logical id of this artifact
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiCarrier | S Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 0..1 | string | Mandatory fixed portion of UDI
carrierAIDC | S Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S Σ | 0..1 | string | UDI Human Readable Barcode String
entryType | S | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status | ?!S Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
distinctIdentifier | S | 0..1 | string | The distinct identification string
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 1..1 | string | The name of the device
type |  | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
type |  | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (extensible)
patient |  | 1..1 | Reference(Patient) | Patient to whom Device is affixed
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Device.udiCarrier.entryType | required | UDIEntryType `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` From the FHIR Standard
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` From the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
Device.type | extensible | DeviceType `http://hl7.org/fhir/ValueSet/device-type` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from Device

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id |  | 1..1 | id | Logical id of this artifact
meta |  |  |  |
Slices for extension |  |  |  | Content/Rules for all slices
extension:link-received-date-extension |  | 0..1 | dateTime | Received Date URL: http://www.cdc.gov/nhsn/fhirportal/dqm/ig/StructureDefinition/link-received-date-extension
udiCarrier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier | S | 0..1 | string | Mandatory fixed portion of UDI
carrierAIDC | S | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S | 0..1 | string | UDI Human Readable Barcode String
entryType | S | 0..1 | code | barcode | rfid | manual +
status | S | 0..1 | code | active | inactive | entered-in-error | unknown
distinctIdentifier | S | 0..1 | string | The distinct identification string
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
type |  | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (extensible)
patient |  | 1..1 | Reference(Patient) | Patient to whom Device is affixed
reference | S | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Device.type | extensible | DeviceType `http://hl7.org/fhir/ValueSet/device-type` From the FHIR Standard

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id | Σ | 1..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
extension:link-received-date-extension |  | 0..1 | dateTime | Received Date URL: http://www.cdc.gov/nhsn/fhirportal/dqm/ig/StructureDefinition/link-received-date-extension
versionId | Σ | 0..1 | id | Version specific identifier
lastUpdated | Σ | 0..1 | instant | When the resource version last changed
source | Σ | 0..1 | uri | Identifies where the resource comes from
profile | Σ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to
security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier |  | 0..* | Identifier | Instance identifier
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | S Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 0..1 | string | Mandatory fixed portion of UDI
issuer |  | 0..1 | uri | UDI Issuing Organization
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierAIDC | S Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S Σ | 0..1 | string | UDI Human Readable Barcode String
entryType | S | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status | ?!S Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason |  | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate |  | 0..1 | dateTime | Date when the device was made
expirationDate |  | 0..1 | dateTime | Date and time of expiry of this device (if applicable)
lotNumber |  | 0..1 | string | Lot number of manufacture
serialNumber |  | 0..1 | string | Serial number assigned by the manufacturer
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 1..1 | string | The name of the device
type |  | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
modelNumber |  | 0..1 | string | The model number for the device
partNumber |  | 0..1 | string | The part number of the device
type |  | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (extensible)
specialization |  | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
systemType |  | 1..1 | CodeableConcept | The standard that is used to operate and communicate
version |  | 0..1 | string | The version of the standard that is used to operate and communicate
version |  | 0..* | BackboneElement | The actual design of the device or software version running on the device
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 0..1 | CodeableConcept | The type of the device version
component |  | 0..1 | Identifier | A single component of the device version
value |  | 1..1 | string | The version text
property |  | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity |  | 0..* | Quantity | Property value as a quantity
valueCode |  | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP)
patient |  | 1..1 | Reference(Patient) | Patient to whom Device is affixed
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known
display | Σ | 0..1 | string | Text alternative for the resource
owner |  | 0..1 | Reference(Organization) | Organization responsible for device
contact |  | 0..* | ContactPoint | Details for human/organization for support
location |  | 0..1 | Reference(Location) | Where the device is found
url |  | 0..1 | uri | Network address to contact device
note |  | 0..* | Annotation | Device notes and comments
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device
parent |  | 0..1 | Reference(Device) | The parent device
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Device.meta.security | extensible | All Security Labels `http://hl7.org/fhir/ValueSet/security-labels|4.0.1` From the FHIR Standard
Device.meta.tag | example | CommonTags `http://hl7.org/fhir/ValueSet/common-tags|4.0.1` From the FHIR Standard
Device.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages|4.0.1` From the FHIR Standard
Additional Bindings | Purpose
AllLanguages | Max Binding
Device.udiCarrier.entryType | required | UDIEntryType `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` From the FHIR Standard
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` From the FHIR Standard
Device.statusReason | extensible | FHIRDeviceStatusReason `http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1` From the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
Device.type | extensible | DeviceType `http://hl7.org/fhir/ValueSet/device-type` From the FHIR Standard
Device.patient.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types|4.0.1` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from Device

Summary

Mandatory: 4 elements
Must-Support: 9 elements

Extensions

This structure refers to these extensions:

- http://www.cdc.gov/nhsn/fhirportal/dqm/ig/StructureDefinition/link-received-date-extension

Maturity: 1

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id | Σ | 1..1 | id | Logical id of this artifact
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiCarrier | S Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 0..1 | string | Mandatory fixed portion of UDI
carrierAIDC | S Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S Σ | 0..1 | string | UDI Human Readable Barcode String
entryType | S | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status | ?!S Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
distinctIdentifier | S | 0..1 | string | The distinct identification string
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 1..1 | string | The name of the device
type |  | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
type |  | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (extensible)
patient |  | 1..1 | Reference(Patient) | Patient to whom Device is affixed
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Device.udiCarrier.entryType | required | UDIEntryType `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` From the FHIR Standard
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` From the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
Device.type | extensible | DeviceType `http://hl7.org/fhir/ValueSet/device-type` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Differential View

This structure is derived from Device

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id |  | 1..1 | id | Logical id of this artifact
meta |  |  |  |
Slices for extension |  |  |  | Content/Rules for all slices
extension:link-received-date-extension |  | 0..1 | dateTime | Received Date URL: http://www.cdc.gov/nhsn/fhirportal/dqm/ig/StructureDefinition/link-received-date-extension
udiCarrier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier | S | 0..1 | string | Mandatory fixed portion of UDI
carrierAIDC | S | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S | 0..1 | string | UDI Human Readable Barcode String
entryType | S | 0..1 | code | barcode | rfid | manual +
status | S | 0..1 | code | active | inactive | entered-in-error | unknown
distinctIdentifier | S | 0..1 | string | The distinct identification string
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
type |  | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (extensible)
patient |  | 1..1 | Reference(Patient) | Patient to whom Device is affixed
reference | S | 1..1 | string | Literal reference, Relative, internal or absolute URL
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
Device.type | extensible | DeviceType `http://hl7.org/fhir/ValueSet/device-type` From the FHIR Standard

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Device |  | 0..* | Device | Item used in healthcare
id | Σ | 1..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
extension:link-received-date-extension |  | 0..1 | dateTime | Received Date URL: http://www.cdc.gov/nhsn/fhirportal/dqm/ig/StructureDefinition/link-received-date-extension
versionId | Σ | 0..1 | id | Version specific identifier
lastUpdated | Σ | 0..1 | instant | When the resource version last changed
source | Σ | 0..1 | uri | Identifies where the resource comes from
profile | Σ | 0..* | canonical(StructureDefinition) | Profiles this resource claims to conform to
security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
identifier |  | 0..* | Identifier | Instance identifier
definition |  | 0..1 | Reference(DeviceDefinition) | The reference to the definition for the device
udiCarrier | S Σ | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 0..1 | string | Mandatory fixed portion of UDI
issuer |  | 0..1 | uri | UDI Issuing Organization
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierAIDC | S Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S Σ | 0..1 | string | UDI Human Readable Barcode String
entryType | S | 0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
status | ?!S Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
statusReason |  | 0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate |  | 0..1 | dateTime | Date when the device was made
expirationDate |  | 0..1 | dateTime | Date and time of expiry of this device (if applicable)
lotNumber |  | 0..1 | string | Lot number of manufacture
serialNumber |  | 0..1 | string | Serial number assigned by the manufacturer
deviceName | S | 0..* | BackboneElement | The name of the device as given by the manufacturer
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
name |  | 1..1 | string | The name of the device
type |  | 1..1 | code | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
modelNumber |  | 0..1 | string | The model number for the device
partNumber |  | 0..1 | string | The part number of the device
type |  | 1..1 | CodeableConcept | The kind or type of device Binding: DeviceType (extensible)
specialization |  | 0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
systemType |  | 1..1 | CodeableConcept | The standard that is used to operate and communicate
version |  | 0..1 | string | The version of the standard that is used to operate and communicate
version |  | 0..* | BackboneElement | The actual design of the device or software version running on the device
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 0..1 | CodeableConcept | The type of the device version
component |  | 0..1 | Identifier | A single component of the device version
value |  | 1..1 | string | The version text
property |  | 0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
type |  | 1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity |  | 0..* | Quantity | Property value as a quantity
valueCode |  | 0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP)
patient |  | 1..1 | Reference(Patient) | Patient to whom Device is affixed
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
reference | S Σ C | 1..1 | string | Literal reference, Relative, internal or absolute URL
type | Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier | Σ | 0..1 | Identifier | Logical reference, when literal reference is not known
display | Σ | 0..1 | string | Text alternative for the resource
owner |  | 0..1 | Reference(Organization) | Organization responsible for device
contact |  | 0..* | ContactPoint | Details for human/organization for support
location |  | 0..1 | Reference(Location) | Where the device is found
url |  | 0..1 | uri | Network address to contact device
note |  | 0..* | Annotation | Device notes and comments
safety | Σ | 0..* | CodeableConcept | Safety Characteristics of Device
parent |  | 0..1 | Reference(Device) | The parent device
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Device.meta.security | extensible | All Security Labels `http://hl7.org/fhir/ValueSet/security-labels|4.0.1` From the FHIR Standard
Device.meta.tag | example | CommonTags `http://hl7.org/fhir/ValueSet/common-tags|4.0.1` From the FHIR Standard
Device.language | preferred | CommonLanguages `http://hl7.org/fhir/ValueSet/languages|4.0.1` From the FHIR Standard
Additional Bindings | Purpose
AllLanguages | Max Binding
Device.udiCarrier.entryType | required | UDIEntryType `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` From the FHIR Standard
Device.status | required | FHIRDeviceStatus `http://hl7.org/fhir/ValueSet/device-status|4.0.1` From the FHIR Standard
Device.statusReason | extensible | FHIRDeviceStatusReason `http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1` From the FHIR Standard
Device.deviceName.type | required | DeviceNameType `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` From the FHIR Standard
Device.type | extensible | DeviceType `http://hl7.org/fhir/ValueSet/device-type` From the FHIR Standard
Device.patient.type | extensible | ResourceType `http://hl7.org/fhir/ValueSet/resource-types|4.0.1` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Device | 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 | error | Device | 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 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from Device

Summary

Mandatory: 4 elements
Must-Support: 9 elements

Extensions

This structure refers to these extensions:

- http://www.cdc.gov/nhsn/fhirportal/dqm/ig/StructureDefinition/link-received-date-extension

Maturity: 1

Other representations of profile: CSV, Excel, Schematron