{
  "resourceType": "StructureDefinition",
  "id": "DbirImplantDevice",
  "url": "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/ImplantDevice",
  "name": "DbirImplantDevice",
  "status": "draft",
  "description": "The implant used in breast surgery as defined in the DBIR clinical registry.",
  "fhirVersion": "4.0.1",
  "kind": "resource",
  "abstract": false,
  "type": "Device",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Device",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "Device.extension:deviceFeatures",
        "path": "Device.extension",
        "sliceName": "deviceFeatures",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://mrdm.nl/profiles/fhir/r4/dbir/StructureDefinition/DeviceFeatures"
            ]
          }
        ],
        "isModifier": false
      },
      {
        "id": "Device.identifier",
        "path": "Device.identifier",
        "slicing": {
          "discriminator": [
            {
              "type": "exists",
              "path": "system"
            }
          ],
          "rules": "open"
        },
        "min": 1
      },
      {
        "id": "Device.identifier:GTIN",
        "path": "Device.identifier",
        "sliceName": "GTIN",
        "definition": "GTIN = Global Trade Item Number of the device.\r\nWill be filled in automatically when a barcode scanner is used successfully.\r\nIn 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).",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Device.identifier:GTIN.system",
        "path": "Device.identifier.system",
        "short": "GTINProductIDCodelijst",
        "definition": "Corresponds with GTINProductIDCodelijst: https://zibs.nl/wiki/MedischHulpmiddel-v3.4(2021NL)#ProductTypeCodelijst",
        "min": 1,
        "fixedUri": "urn:oid:2.16.840.1.113883.2.4.3.11.60.40.2.10.1.3"
      },
      {
        "id": "Device.identifier:GTIN.value",
        "path": "Device.identifier.value",
        "min": 1
      },
      {
        "id": "Device.identifier:ReferenceNumber",
        "path": "Device.identifier",
        "sliceName": "ReferenceNumber",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Device.udiCarrier",
        "path": "Device.udiCarrier",
        "definition": "GS1 barcode. Code starts with (01)",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Device.udiCarrier.id",
        "path": "Device.udiCarrier.id",
        "definition": "Barcode as defined by the DBIR registry as gs1-barcode"
      },
      {
        "id": "Device.udiCarrier.deviceIdentifier",
        "path": "Device.udiCarrier.deviceIdentifier",
        "definition": "The UDI (Unique Device Identifier) is 1 of the essential variables to trace an implant in the event of a recall.\n\nThe UDI is a combination of the variables:\n- GTIN +\n- Expiry date +\n- Lot number +\n- Serial number.",
        "min": 1
      },
      {
        "id": "Device.udiCarrier.carrierHRF",
        "path": "Device.udiCarrier.carrierHRF",
        "definition": "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Defined as variable gs1-barcode in DBIR clinical registry",
        "min": 1
      },
      {
        "id": "Device.udiCarrier.entryType",
        "path": "Device.udiCarrier.entryType",
        "min": 1
      },
      {
        "id": "Device.status",
        "path": "Device.status",
        "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."
      },
      {
        "id": "Device.manufacturer",
        "path": "Device.manufacturer",
        "definition": "Name of the manufacturer, either provided by DICA variable manufacturer or manother",
        "min": 1,
        "binding": {
          "strength": "preferred",
          "valueSet": "http://mrdm.nl/profiles/fhir/r4/dbir/ValueSet/Manufacturer"
        }
      },
      {
        "id": "Device.expirationDate",
        "path": "Device.expirationDate",
        "short": "Expiry date of device",
        "definition": "Expiry date defined by variable gs1-expiry in DBIR clinical registry",
        "min": 1
      },
      {
        "id": "Device.lotNumber",
        "path": "Device.lotNumber",
        "definition": "Lot number assigned by the manufacturer, defined by variable gs1-lotno in DBIR clinical registry",
        "min": 1
      },
      {
        "id": "Device.serialNumber",
        "path": "Device.serialNumber",
        "definition": "Serial number assigned by the manufacturer, defined by variable gs1-serialno in DBIR clinical registry",
        "min": 1
      },
      {
        "id": "Device.type",
        "path": "Device.type",
        "min": 1
      },
      {
        "id": "Device.type.coding.system",
        "path": "Device.type.coding.system",
        "min": 1,
        "fixedUri": "http://snomed.info/sct"
      },
      {
        "id": "Device.type.coding.code",
        "path": "Device.type.coding.code",
        "code": [
          {
            "system": "http://snomed.info/sct",
            "code": "2282003",
            "display": "Breast prosthesis"
          },
          {
            "system": "http://snomed.info/sct",
            "code": "310630001",
            "display": "Breast tissue expander"
          }
        ],
        "min": 1
      }
    ]
  }
}