DBIR Implementation Guide

DeviceFeatures

FHIR Profile

The extension DeviceFeatures defines certain features of the breast implant used during surgery. The extension contains 7 slices:

texture
coating
coatingother
shape
fill
fillother
weight

This extension is used for FHIR Profile ImplantDevice, accessible via DeviceFeatures.

This profile is based on the FHIR version R4 specifications for extensions, see also Extensibility.

DeviceFeatures (Extension)	I		Extension	Element id Extension Short description Features of device Definition Optional Extension Element - found in all resources. 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 rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Extension.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 Extension.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
url		1..1	uriFixed Value	Element id Extension.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures Mappings rim: N/A
value[x]		1..1		Element id Extension.value[x] Short description Value of extension Definition Each coding element represent a DICA variable: texture coating coatingother fill fillother shape weight Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
valueCodeableConcept			CodeableConcept	Data type CodeableConcept
id		0..1	string	There are no (further) constraints on this element Element id Extension.value[x].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 Extension.value[x].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	1..*	Coding	There are no (further) constraints on this element Element id Extension.value[x].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 Extension.value[x].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 Extension.value[x].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	uri	There are no (further) constraints on this element Element id Extension.value[x].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())` 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 Extension.value[x].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	0..1	code	There are no (further) constraints on this element Element id Extension.value[x].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 Extension.value[x].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 Extension.value[x].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 Extension.value[x].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

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
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.fill	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

Each slice consists of an valueCodeableConcept. The element has a generic structure, as shown below

      "valueCodeableConcept": {
        "coding": [
          {
            "system": "URL",
            "code": "code",
            "display": "display value"
          }
        ]
      }

Each coding element represent a feature of the Device. The system URL within the coding elements are set with the following base URL: http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures.

This leads to the following system URLs:

The code for texture, coating, fill, and shape variable are set by the following ValueSets:

An example of a fill variable with value 1. The display value is optional, the code value is required.

      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures/fill",
            "code": "2",
            "display": "Saline"
          }
        ]
      }

For variables coatingother and fillother, a code is not applicable as they are represented by string values. For these variables, use the ***display""" value instead.

An example that uses fillother variable. The display value is required, the code value is not applicable.

      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures/fillother",
            "display": "Other fill solution"
          }
        ]
      }

Constraints

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

The following constraints apply:

The extension element must use url "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures".
Each coding element should adhere to the above-mentioned URL listed
Each coding element should abide by the code available in the corresponding ValueSet, except for variables fillother and coatingother

Example Implant Device with extension DeviceFeatures using fill and coating variables

{
   "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"
          }
        ],
      }
    }
  ]
}

Example Implant Device with extension DeviceFeatures using coatingother and fillother variables

{
   "resourceType":"Device",
   "id":"example-2-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":"12345678901236",
         "type":{
            "coding":[
               {
                  "system":"http://terminology.hl7.org/CodeSystem/v2-0404",
                  "code":"GTIN",
                  "display":"Global Trade Item Number"
               }
            ]
         }
      }
   ],
   "udiCarrier":{
      "deviceIdentifier":"12345678901234-20251231-LOT123456-SN1234567897",
      "carrierHRF":"(01)12345678901239",
      "entryType": "barcode"
   },
   "status":"active",
   "manufacturer":"other manufacturer",
   "expirationDate":"2025-12-31",
   "lotNumber":"LOT123456",
   "serialNumber":"SN1234567890",
   "type":{
      "coding":[
         {
            "system":"http://snomed.info/sct",
            "code":"2282003",
            "display":"Breast prosthesis"
         }
      ]
   },
  "extension": [
    {
      "url": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures/coatingother",
            "display": "Another coating"
          },
         {
            "system": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures/fillother",
            "display": "Another fill"
          },
        ],
      }
    }
  ]
}