DBIR Implementation Guide

SurgeryComponents

FHIR Profile

The SurgeryComponents extension covers several componenents that are possibly included in breast implant surgery.

The extension includes the following components:

IncisionSite
Plane
TimingReconstruction
PlannedReplacement

This extension is used for FHIR Profile Breast Implant Surgery, accessible via BreastImplantSurgery.

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

SurgeryComponents (Extension)	I		Extension	There are no (further) constraints on this element Element id Extension Short description Optional Extensions Element 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/SurgeryComponents Mappings rim: N/A
value[x]		0..1		Element id Extension.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Sliced: Unordered, Open, by $this(Value), $this(Type) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
IncisionSite		0..1	CodeableConcept	Element id Extension.value[x]:IncisionSite Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Data type CodeableConcept Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
Plane		0..1	code	Element id Extension.value[x]:Plane Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
TimingReconstruction		0..1	date	Element id Extension.value[x]:TimingReconstruction Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Data type date Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A
PlannedReplacement		0..1	integer	Element id Extension.value[x]:PlannedReplacement Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Data type integer Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: N/A

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
incissite	extension.deviceFeatures.texture	105	identical to ValueSet	Implant Texture
plane	extension.deviceFeatures.coating	139	identical to ValueSet	Implant Coating
timingrec	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"
          },
        ],
      }
    }
  ]
}