DBIR Implementation Guide

ImplantDevice

FHIR Profile

The Implant Device Resource refers to the implant used for breast surgery. The profile is accessible via ImplantDevice and presented below.

This profile is based on the Device base profile for FHIR version R4, see also Device.

DbirImplantDevice (Device)	I		Device	There are no (further) constraints on this element Element id Device Short description Item used in healthcare 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. Data type Device Constraints 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() Mappings rim: Entity. Role, or Act rim: Device
id	Σ	0..1	string	There are no (further) constraints on this element Element id Device.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. 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. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Device.meta Short description Metadata about the resource 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Device.implicitRules Short description A set of rules under which this content was created 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. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
language		0..1	codeBinding	There are no (further) constraints on this element Element id Device.language Short description Language of the resource content Definition The base language in which the resource is written. 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). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
text		0..1	Narrative	There are no (further) constraints on this element Element id Device.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display 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. 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. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Device.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources 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. 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. Data type Resource Mappings rim: N/A
extension	I	0..*	Extension	Element id Device.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Constraints 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()` Mappings rim: N/A
deviceFeatures	I	0..*	Extension(CodeableConcept)	Element id Device.extension:deviceFeatures Short description Features of device Alternate names extensions, user content Definition Optional Extension Element - found in all resources. 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. Data type Extension(CodeableConcept) Extension URL http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures Constraints 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()` Mappings rim: N/A rim: n/a
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
identifier		1..*	Identifier	Element id Device.identifier Short description Instance identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. 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. Data type Identifier Sliced: Unordered, Open, by system(Exists) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.identifier rim: .id udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
GTIN		1..1	Identifier	Element id Device.identifier:GTIN Short description Instance identifier Definition GTIN = Global Trade Item Number of the device. Will be filled in automatically when a barcode scanner is used successfully. In case this variable has to be filled in manually: The GTIN is composed of 14 numbers written in/under the barcode between the (01) and (10) or (17). 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. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.identifier rim: .id udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
id		0..1	string	There are no (further) constraints on this element Element id Device.identifier:GTIN.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.identifier:GTIN.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id Device.identifier:GTIN.use Short description usual \| official \| temp \| secondary \| old (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . IdentifierUse (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Device.identifier:GTIN.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.5 rim: Role.code or implied by context
system	Σ	1..1	uriFixed Value	Element id Device.identifier:GTIN.system Short description GTINProductIDCodelijst Definition Corresponds with GTINProductIDCodelijst: https://zibs.nl/wiki/MedischHulpmiddel-v3.4(2021NL)#ProductTypeCodelijst Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments Identifier.system is always case sensitive. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value urn:oid:2.16.840.1.113883.2.4.3.11.60.40.2.10.1.3 Mappings v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	1..1	string	There are no (further) constraints on this element Element id Device.identifier:GTIN.value Short description The value that is unique Definition The portion of the identifier typically relevant to the user and which is unique within the context of the system. Comments If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General 123456 Mappings v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ	0..1	Period	There are no (further) constraints on this element Element id Device.identifier:GTIN.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ	0..1	Reference(Organization)	There are no (further) constraints on this element Element id Device.identifier:GTIN.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
ReferenceNumber		1..1	Identifier	There are no (further) constraints on this element Element id Device.identifier:ReferenceNumber Short description Instance identifier Definition Unique instance identifiers assigned to a device by manufacturers other organizations or owners. 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. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.identifier rim: .id udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
definition		0..1	Reference(DeviceDefinition)	There are no (further) constraints on this element Element id Device.definition Short description The reference to the definition for the device Definition The reference to the definition for the device. Data type Reference(DeviceDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
udiCarrier	Σ	1..1	BackboneElement	Element id Device.udiCarrier Short description Unique Device Identifier (UDI) Barcode string Definition GS1 barcode. Code starts with (01) 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.identifier rim: .id and .code
id		0..1	string	Element id Device.udiCarrier.id Short description Unique id for inter-element referencing Definition Barcode as defined by the DBIR registry as gs1-barcode Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.udiCarrier.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
deviceIdentifier	Σ	1..1	string	Element id Device.udiCarrier.deviceIdentifier Short description Mandatory fixed portion of UDI Alternate names DI Definition The UDI (Unique Device Identifier) is 1 of the essential variables to trace an implant in the event of a recall. The UDI is a combination of the variables: GTIN + Expiry date + Lot number + Serial number. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: Role.id.extension udi: The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
issuer		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.issuer Short description UDI Issuing Organization Alternate names Barcode System Definition Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Role.id.root udi: All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
jurisdiction		0..1	uri	There are no (further) constraints on this element Element id Device.udiCarrier.jurisdiction Short description Regional UDI authority 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. Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Role.scoper
carrierAIDC	Σ	0..1	base64Binary	There are no (further) constraints on this element Element id Device.udiCarrier.carrierAIDC Short description UDI Machine Readable Barcode String Alternate names Automatic Identification and Data Capture 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. 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. Data type base64Binary Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Role.id.extension udi: A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
carrierHRF	Σ	1..1	string	Element id Device.udiCarrier.carrierHRF Short description UDI Human Readable Barcode String Alternate names Human Readable Form Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Defined as variable gs1-barcode in DBIR clinical registry 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. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: Role.id.extension udi: A unique device identifier (UDI) on a device label in plain text
entryType		1..1	codeBinding	There are no (further) constraints on this element Element id Device.udiCarrier.entryType Short description barcode \| rfid \| manual + Definition A coded entry to indicate how the data was entered. Requirements Supports a way to distinguish hand entered from machine read data. Data type code Binding Codes to identify how UDI data was entered. UDIEntryType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: NA
status	Σ ?!	0..1	codeBinding	Element id Device.status Short description active \| inactive \| entered-in-error \| unknown Definition ''Barcode processing status' indicates whether scanning of the GS1 barcode with your barcode scanner was successful or not. If the scan was successful, the fields below are automatically filled (GTIN, expiry date, lot number, serial number). If the scan failed, these fields are empty or only partially filled. 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. Data type code Binding The availability status of the device. FHIRDeviceStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.status rim: .statusCode
statusReason		0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Device.statusReason Short description online \| paused \| standby \| offline \| not-ready \| transduc-discon \| hw-discon \| off Definition Reason for the dtatus of the Device availability. Data type CodeableConcept Binding The availability status reason of the device. FHIRDeviceStatusReason (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.status
distinctIdentifier		0..1	string	There are no (further) constraints on this element Element id Device.distinctIdentifier Short description The distinct identification string Alternate names Distinct Identification Code (DIC) Definition The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. Comments For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
manufacturer		1..1	stringBinding	Element id Device.manufacturer Short description Name of device manufacturer Definition Name of the manufacturer, either provided by DICA variable manufacturer or manother Data type string Binding http://mrdm.nl/profiles/fhir/r4/dbir/ValueSet/Manufacturer (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].scoper.name udi: N/A
manufactureDate		0..1	dateTime	There are no (further) constraints on this element Element id Device.manufactureDate Short description Date when the device was made Definition The date and time when the device was manufactured. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .existenceTime.low udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
expirationDate		1..1	dateTime	Element id Device.expirationDate Short description Expiry date of device Definition Expiry date defined by variable gs1-expiry in DBIR clinical registry Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .expirationTime udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
lotNumber		1..1	string	Element id Device.lotNumber Short description Lot number of manufacture Definition Lot number assigned by the manufacturer, defined by variable gs1-lotno in DBIR clinical registry Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .lotNumberText udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
serialNumber		1..1	string	Element id Device.serialNumber Short description Serial number assigned by the manufacturer Definition Serial number assigned by the manufacturer, defined by variable gs1-serialno in DBIR clinical registry Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
deviceName		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.deviceName Short description The name of the device as given by the manufacturer 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. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
id		0..1	string	There are no (further) constraints on this element Element id Device.deviceName.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.deviceName.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
name		1..1	string	There are no (further) constraints on this element Element id Device.deviceName.name Short description The name of the device Alternate names Σ Definition The name of the device. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
type		1..1	codeBinding	There are no (further) constraints on this element Element id Device.deviceName.type Short description udi-label-name \| user-friendly-name \| patient-reported-name \| manufacturer-name \| model-name \| other Definition The type of deviceName. UDILabelName \| UserFriendlyName \| PatientReportedName \| ManufactureDeviceName \| ModelName. Data type code Binding The type of name the device is referred by. DeviceNameType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].code
modelNumber		0..1	string	There are no (further) constraints on this element Element id Device.modelNumber Short description The model number for the device Definition The model number for the device. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .softwareName (included as part)
partNumber		0..1	string	There are no (further) constraints on this element Element id Device.partNumber Short description The part number of the device Definition The part number of the device. Comments Alphanumeric Maximum 20. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x] rim: .playedRole[typeCode=MANU].id
type		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.type Short description The kind or type of device Definition The kind or type of device. Data type CodeableConcept Binding Codes to identify medical devices. DeviceType (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
id		0..1	string	There are no (further) constraints on this element Element id Device.type.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.type.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id Device.type.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Device.type.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.type.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints 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()` Mappings rim: n/a
system	Σ	1..1	uriFixed Value	Element id Device.type.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Fixed value http://snomed.info/sct Mappings v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Device.type.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	1..1	code	There are no (further) constraints on this element Element id Device.type.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Device.type.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Device.type.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Device.type.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
specialization		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.specialization Short description The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication Definition The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
id		0..1	string	There are no (further) constraints on this element Element id Device.specialization.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.specialization.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
systemType		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.specialization.systemType Short description The standard that is used to operate and communicate Alternate names Σ Definition The standard that is used to operate and communicate. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
version		0..1	string	There are no (further) constraints on this element Element id Device.specialization.version Short description The version of the standard that is used to operate and communicate Definition The version of the standard that is used to operate and communicate. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x]
version		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.version Short description The actual design of the device or software version running on the device Definition The actual design of the device or software version running on the device. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
id		0..1	string	There are no (further) constraints on this element Element id Device.version.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.version.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
type		0..1	CodeableConcept	There are no (further) constraints on this element Element id Device.version.type Short description The type of the device version Alternate names Σ Definition The type of the device version. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
component		0..1	Identifier	There are no (further) constraints on this element Element id Device.version.component Short description A single component of the device version Definition A single component of the device version. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.what[x]
value		1..1	string	There are no (further) constraints on this element Element id Device.version.value Short description The version text Definition The version text. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
property		0..*	BackboneElement	There are no (further) constraints on this element Element id Device.property Short description The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties Definition The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
id		0..1	string	There are no (further) constraints on this element Element id Device.property.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. 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. Data type Extension Constraints 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()` Mappings rim: n/a
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Device.property.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). 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. 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. Data type Extension Constraints 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()` Mappings rim: N/A
type		1..1	CodeableConcept	There are no (further) constraints on this element Element id Device.property.type Short description Code that specifies the property DeviceDefinitionPropetyCode (Extensible) Definition Code that specifies the property DeviceDefinitionPropetyCode (Extensible). Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
valueQuantity		0..*	Quantity	There are no (further) constraints on this element Element id Device.property.valueQuantity Short description Property value as a quantity Definition Property value as a quantity. Data type Quantity Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
valueCode		0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.property.valueCode Short description Property value as a code, e.g., NTP4 (synced to NTP) Definition Property value as a code, e.g., NTP4 (synced to NTP). Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
patient		0..1	Reference(Patient)	There are no (further) constraints on this element Element id Device.patient Short description Patient to whom Device is affixed Definition Patient information, If the device is affixed to a person. Requirements If the device is implanted in a patient, then need to associate the device to the patient. Data type Reference(Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.subject[x] rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT] w5: FiveWs.subject
owner		0..1	Reference(Organization)	There are no (further) constraints on this element Element id Device.owner Short description Organization responsible for device Definition An organization that is responsible for the provision and ongoing maintenance of the device. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.source rim: .playedRole[typeCode=OWN].scoper
contact		0..*	ContactPoint	There are no (further) constraints on this element Element id Device.contact Short description Details for human/organization for support Definition Contact details for an organization or a particular human that is responsible for the device. Comments used for troubleshooting etc. Data type ContactPoint Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.source rim: .scopedRole[typeCode=CON].player
location		0..1	Reference(Location)	There are no (further) constraints on this element Element id Device.location Short description Where the device is found Definition The place where the device can be found. Requirements Device.location can be used to track device location. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.where[x] rim: .playedRole[typeCode=LOCE].scoper
url		0..1	uri	There are no (further) constraints on this element Element id Device.url Short description Network address to contact device Definition A network address on which the device may be contacted directly. 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings w5: FiveWs.where[x] rim: .telecom
note		0..*	Annotation	There are no (further) constraints on this element Element id Device.note Short description Device notes and comments Definition Descriptive information, usage information or implantation information that is not captured in an existing element. Data type Annotation Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: .text
safety	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id Device.safety Short description Safety Characteristics of Device Definition Provides additional safety characteristics about a medical device. For example devices containing latex. Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: NA
parent		0..1	Reference(Device)	There are no (further) constraints on this element Element id Device.parent Short description The parent device Definition The parent device. Data type Reference(Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`

Mapping

Here is a list of the exact mapping for this FHIR Profile. The mapping includes the DICA variable and corresponding FHIR data element. In case of a DICA option set, the relation between the DICA options and available values within the FHIR data element are defined.

DICA variable	FHIR Data Element	DICA OptionSet	Value DICA OptionSet	FHIR ValueSet/Code/System
manufacturer	manufacturer	131	n/a	ImplantManufacturer
manother	manufacturer	n/a	n/a	n/a
gs1-serialno	serialNumber	n/a	n/a	n/a
gs1-lotno	lotNumber	n/a	n/a	n/a
refno	identifier	n/a	n/a	n/a
admcatalogus	type.coding.system	n/a	n/a	http://snomed.info/sct
implanttype	type.coding.code	136	1-Permanent Implant	2282003
implanttype	type.coding.code	136	2-Tissue expander	310630001
texture	extension.deviceFeatures.texture	105	identical to ValueSet	Implant Texture
coating	extension.deviceFeatures.coating	139	identical to ValueSet	Implant Coating
coatingother	extension.deviceFeatures.coating	n/a	n/a	n/a
fill	extension.deviceFeatures.fill	106	identical to ValueSet	Implant Fill
fillother	extension.deviceFeatures.fillother	n/a	n/a	n/a
shape	extension.deviceFeatures.shape	107	identical to ValueSet	Implant Shape
maxweightvol	extension.deviceFeatures.weight	n/a	n/a	n/a
gs1-expiry	expirationDate	n/a	n/a	n/a
gs1-gtin	identifier.system	n/a	n/a	2.16.840.1.113883.2.4.3.11.60.40.2.10.1.3
gs1-gtin	identifier.value	n/a	n/a	n/a
gs1-ai-processing-status	status	140	1-Success	FHIRDeviceStatus - active
gs1-ai-processing-status	status	140	2-Failure	FHIRDeviceStatus - inactive
UDI	udiCarrier.deviceIdentifier	n/a	n/a	n/a
gs1-barcode	udiCarrier.carrierHRF	n/a	n/a	n/a
scan-manual-indicator	udiCarrier.entryType	143	0-no	UDIEntryType-manual
scan-manual-indicator	udiCarrier.entryType	143	1-yes	UDIEntryType-barcode
isdeviceregistered	owner	101	1-yes	n/a

Constraints

Constraints can refer to the cardinality of an element, required value or type of value.

The following constraints apply:

The Device Resource should contain at least one identifier. The identifier defines the GTIN represented by DICA variable gs1-gtin using predefined system and coding. See the example Resource below for its system and coding values.
The Device Resource should include the udiCarrier element. In this element, subelements carrierHRF, deviceIdentifier and entryType are required.
The Device should include the extension DeviceFeatures, which is explained in detail in DeviceFeatures.
If the device is registered by the hospital for the DBIR (isdeviceregistered), the owner element should refer to the Organization id of this hospital.
Element manufacturer is mandatory. The value should contain a code listed in ValueSet ImplantManufacturer. The codes in this ValueSet are identical to the codes used in DICA option set 131. In case of manother, set the value for this variable in the element, see example 2.

Example Device using coating and weightmaxvol variables and which has been registered by the hospital

{
   "resourceType":"Device",
   "id":"example-1-dbir-device",
   "meta":{
      "profile":[
         "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/ImplantDevice"
      ]
   },
   "identifier":[
      {
         "system":"urn:oid:2.16.840.1.113883.2.4.3.11.60.40.2.10.1.3",
         "value":"12345678901234",
         "type":{
            "coding":[
               {
                  "system":"http://terminology.hl7.org/CodeSystem/v2-0203",
                  "code":"GTIN",
                  "display":"Global Trade Item Number"
               }
            ]
         }
      }
   ],
   "udiCarrier":{
      "deviceIdentifier":"12345678901234-20251231-LOT123456-SN1234567890",
      "carrierHRF":"(01)12345678901234",
      "entryType":"barcode"
   },
   "status":"active",
   "manufacturer":"32",
   "expirationDate":"2025-12-31",
   "lotNumber":"LOT123456",
   "serialNumber":"SN1234567890",
   "type":{
      "coding":[
         {
            "system":"http://snomed.info/sct",
            "code":"2282003",
            "display":"Breast prosthesis"
         }
      ]
   },
   "owner":{
      "reference":"Organization/1"
   },
  "extension": [
    {
      "url": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures/fill",
            "code": "4",
            "display": "Air"
          },
         {
            "system": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures/maxweightvol",
            "code": "445"
          }
        ]
      }
    }
  ]
}