Appendix C: Data Exchange Guideline Template Instructions to Reader The following table will be used to organize the various data exchange guidelines and specific implementation considerations. Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes Element/Attribute Name Element XPATH Attribute Element/Attribute Name – indicates the actual element/attribute in the exchange standard. – provides the exchange standards XML location in the message. Datatype – indicates the required datatype (e.g., string, numeric) in the exchange standard for the value provided for the XML element. Element – indicates the XML element that is used to represent the common data element. Attribute – indicates the XML attribute that is used to represent the common data element. Representation in Exchange Standard – provides an XML snippet of the element and attribute and its for the common data element. Implementation Notes – indicates the information that should be contained in the data element values. Note: the may have one or more Data Element/Attributes for each of the common data elements. The entire section will be repeated for the number of elements and attributes needed for each common data element.
XML Snippet Medical Device Brand Name - SPL Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Notes manufacturedProduct.name String Element <name> <name>brand name</name> name = brand name value XPATH: Attribute n/a XML Snippet Medical Device Common Name - SPL The following pattern may be used to exchange additional or alternate medical device names in a message. Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes String Element code
XPATH: value = common name XML Snippet Medical Device Brand Name – N87 Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes brandName String Element brandName Medical Device Common Name – N87 Currently, the model is not included in the message. Medical Device Brand Name - FHIR Note – Currently under development.
manufacturedProduct.code String Element code <code code="12345678901234" codeSystem="1.3.160"/> XPATH: Attribute code Code= DI XPATH: String Attribute CodeSystem = OID for Issuing Agency XML Snippet DI – ICSR Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation identifiedDevice.id String Element id <id extension="10857674002017"/> Attribute extension Extension = DI XML Snippet
DI – FHIR Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes Device.type.coding.system String Element system <system XPATH: Attribute value Value = URI for system which will always be Device.type.coding.code String Element code <code value="10857674002017"/> XPATH: /Device/type/coding/code/@value Attribute value value = DI value XML Snippet DI – N87 Currently, the DI is not included in the message. Implementation Considerations The following conditions should be considered when incorporating the data exchange guidelines into the implementation guides: The DI value should include the issuing agency. The issuing agency is represented differently across the standards, as an OID or URI. Production Identifier - Serial Number The following data representations are applicable to this data element.
Serial Number – RPS Currently, the Serial Number is not included in the message. Serial Number – SPL The serial number may be represented as a numeric value. Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation asIdentifiedEntity.code String Element code <code code="codeSNO" Attribute code code = value for “serial number” XPATH: Attribute codeSystem = OID for value set asIdentifiedEntity.id String Element id <id root="2.16.840.1.113883.13" extension="serial number"/> XPATH: Attribute root root = OID for namespace of serial number XPATH: Attribute extension extension = of serial number
<system XPATH: Attribute Value = value should always be identifier.type.coding.code String Element code <code Attribute value value = value should always be “SNO” identifier.type.text String Element text <text value="Serial Number"/> XPATH: /Device/identifier/type/text/@value Attribute value value = value should always be “Serial Number” identifier.value String Element value <value XPATH: /Device/identifier/value/@value Attribute value = Serial number value XML Snippet Serial Number – N87 Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes serialNum String Element serialNum
Manufacturing Date – RPS Currently, the Manufacture Date is not included in the message. Manufacturing Date – SPL The manufacturing date may be represented as a Boolean Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation characteristic.code String Element code <code code="C101669" XPATH: Attribute code code = value for “manufacturing date” XPATH: String Attribute codeSystem = OID for value set characteristic.value Boolean Element value <value xsi:type="BL" value="false"/> XPATH: Attribute xsi:type xsi:type = value is always “BL” XPATH: Attribute value Value = value to indicate if the serial number is on the label (true or false)
XML Snippet Manufacturing Date – ICSR Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes identifiedDevice.existenceTime Date Element <existenceTime value="20000101"/> XPATH: Attribute value value = manufacturing date XML Snippet Manufacturing Date – FHIR Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes Device.manufactureDate Date Element <manufactureDate XPATH: /Device/manufactureDate/@value Attribute value = manufacture date XML Snippet
Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes contactParty.code String Element <code code="codeCNT" Attribute code code = value for “contact type” String codeSystem = OID for “contact type” XML Snippet Type of Regulated Entity – SPL Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes assignedEntity1.code String Element code XPATH: Attribute code code = for “regulated entity”
manufacturerOrReprocessor.name Element name <name>USA Device Manufacturer</name> XPATH: Attribute name = value of regulated entity name XML Snippet Name of Regulated Entity – FHIR Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes Device.manufacturer String Element <manufacturer value="Acme Devices, Inc"/> XPATH: Attribute XML Snippet Name of Regulated Entity – N87 Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes mfrContactName String Element mfrContactName
XPATH: String Attribute codeSystem = OID for type of address XML Snippet Address of Regulated Entity – ICSR Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes addr.streetAddressLine XPATH: String Element value <streetAddressLine>555 Manufacturer Drive</streetAddressLine> = full street address for regulated entity addr.city XPATH: String Element value <city>Manufacturer City</city> city = city for regulated entity address
Address of Regulated Entity – FHIR Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes address.line String Element line <line value="123 Main Street"/> XPATH: /Location/address/line/@value Attribute value = street address address.city String Element city <city value="Anytown"/> XPATH: /Location/address/city/@value Attribute value String Element state <state value="NY"/> XPATH: Attribute value address.postalCode String Element postalCode <postalCode value="10159"/> XPATH: /Location/address/postalCode/@value Attribute value address.country String Element country <country value="USA"/> /Location/address/country/@value Attribute value physicalType.coding.system String Element <system Attribute physicalType.coding.code String Element
Medical Device System – FHIR Currently, the Medical Device System is not included in the message. Medical Device System – N87 Currently, the Medical Device System is not included in the message. Implementation Considerations The following conditions should be considered when incorporating the data exchange guidelines into the implementation guides: Code values for Medical Device System will need to be created. Contains Biological Material The following data representations are applicable to this data element. Contains Biological Material – RPS Currently, this element not included in the message. Contains Biological Material – SPL Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes characteristic.code String Element code XPATH: Attribute code code = for “contains biological material”
Need for Sterilization Before Use – ICSR Currently, this element not included in the message. Need for Sterilization Before Use – FHIR Currently, this element not included in the message. Need for Sterilization Before Use – N87 Currently, this element not included in the message. Implementation Considerations The following conditions should be considered when incorporating the data exchange guidelines into the implementation guides: Future implementations may need something more specific when determining if the sterilization method was applied by the manufacturer or end-user. Revisit the requirements for additional clarification. Supplied Sterile Guidelines The following data representations are applicable to this data element: Supplied Sterile – RPS Currently, this element not included in the message. Supplied Sterile – SPL Data Element/Attribute Datatype Elements/Attributes Representation in Exchange Standard Implementation Notes characteristic.code String Element code
XPATH: Attribute codeSystem = OID for regulatory status value set XML Snippet Regulatory Authorization or Marketing Status – SPL Currently, this is not available in the message. Regulatory Authorization or Marketing Status – ICSR Currently, this is not available in the message. Regulatory Authorization or Marketing Status – FHIR Currently, this is not available in the message. Regulatory Authorization or Marketing Status – N87 Currently, this is not available in the message. Implementation Considerations The following conditions should be considered when incorporating the data exchange guidelines into the implementation guides: This requirement may need to be further developed in the standards.
Catalog/Reference (REF), 12, 13, 15, 43 Contains Biological Material, 85 Device Identifier, 13, 15, 47 Kit, 12, 14, 15, 82 Lot or Batch Number, 13, 15 Manufacturing Date, 13, 15 Medical Device Risk Classification, 12, 14, 16 Medical Device System, 12, 14, 15 Medical Device Type, 12, 14, 15, 16 Model, 12, 13, 15, 38 Production Identifier, 49 Regulated Entity Identifier, 80 Regulated Entity Information, 63 Regulated Entity Name, 67 Regulatory Authorization or Marketing Number, 13, 14, 16 Regulatory Information, 99 Reusable - Multi-Patient Use Device, 12, 14, 15, 91 Reusable - Single Patient Use Device, 12, 14, 15, 91, 97 Single Use Device, 12, 14, 15, 87 Software or Firmware, 12, 13, 15, 43 Submission Number, 12 Supplied Sterile, 12, 14, 15, 97 Unique Device Identifier, 13, 15, 45