Implant UDI Organizer

back to homepage

Approval Status

  • Approval Status: Pending
  • Example Task Force:
  • SDWG:

C-CDA 2.1 Example:

  • 2.16.840.1.113883.10.20.22.2.23
  • 2.16.840.1.113883.10.20.22.2.23:2014-06-09
  • 2.16.840.1.113883.10.20.22.4.14
  • 2.16.840.1.113883.10.20.22.4.14:2014-06-09
  • 2.16.840.1.113883.10.20.22.4.37

Reference to full CDA sample:

  • Empty CCD

Validation location

Comments

  • This is an example of how to record the full details of a UDI. This examples follows the design in Appendix B of the 2019 C-CDA Companion Guide.

Custodian

  • Emma Jones

Keywords

  • UDI, implant, UDI organizer

 

Example: download example view on GitHub

	<component>
		<structuredBody>
			<component>
				<section>
					<templateId root="2.16.840.1.113883.10.20.22.2.23" extension="2014-06-09"/>
					<templateId root="2.16.840.1.113883.10.20.22.2.23"/>
					<code code="46264-8" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
					<title>Medical Equipment</title>
					<text>
						<table>
							<colgroup>
								<col width="40%"/>
								<col width="20%"/>
								<col width="40%"/>
							</colgroup>
							<tbody styleCode="xRowGroup">
								<tr ID="_9d1b9efd-baff-45b2-8033-cdf2fc02c35f">
									<td>
										<content styleCode="xContentWrapping" ID="_d92f7e16-385c-4079-b9c8-adfb2525ef6c">Breast Implant</content>
									</td>
									<td>
										<content styleCode="xLabel xSecondary">Date: </content>
										<content styleCode="xSecondary ">14-Jul-2020</content>
										<br/>
									</td>
									<td/>
								</tr>
								<tr ID="_2350e0a1-5ffb-4b6d-ba9f-be489d9dfc2f">
									<td>
										<content styleCode="xIndent"> •</content>
										<content styleCode="xContentWrapping">
											<content ID="BrandName_1">Example BrandName</content>
											<br/>
											<content ID="CompanyName_1">Example Company Name</content>
											<br/>
											<content>(GS1)00848486001048</content>
											<br/>
											<content styleCode="xLabel">Serial: </content>
											<content ID="SerialNumber_1">bi12342222</content>
											<br/>
										</content>
									</td>
									<td>
										<content styleCode="xLabel">Expires: </content>
										<content>15-Oct-2022</content>
										<br/>
										<content styleCode="xLabel">Mfd: </content>
										<content>15-Oct-2018</content>
										<br/>
										<content styleCode="xLabel">Model: </content>
										<content ID="ModelNumber_1">Example Model Number</content>
										<br/>
										<br/>
										<content styleCode="xLabel">Catalog Number: </content>
										<content ID="CatalogNumber_1">Example Catalog Number</content>
										<br/>
										<content styleCode="xLabel">Lot: </content>
										<content>ABC999</content>
										<br/>
									</td>
									<td>
										<content styleCode="xLabel">Overall Status: </content>
										<content>Breast Implant (L)</content>
										<br/>
										<content styleCode="xLabel">Implant Status: </content>
										<content ID="ImplantableDeviceStatus_1">Implantable DeviceStatus Text</content>
										<br/>
										<content styleCode="xLabel">MRI: </content>
										<content styleCode="xAlert" ID="MRISafety_1">Labeling does not contain MRI Safety Information</content>
										<br/>
										<content styleCode="xLabel">Latex: </content>
										<content ID="LatexSafety_1">Not Made with Natural Rubber Latex</content>
										<br/>
									</td>
								</tr>
							</tbody>
						</table>
					</text>
					<entry>
						<procedure classCode="PROC" moodCode="EVN">
							<templateId root="2.16.840.1.113883.10.20.22.4.14" extension="2014-06-09"/>
							<templateId root="2.16.840.1.113883.10.20.22.4.14"/>
							<id root="1.2.840.114350.1.13.5552.1.7.2.737780" extension="6239942"/>
							<!-- The procedure that supported the implant is unknown -->
							<!-- A patient may be informing provider of a historical implant -->
							<code nullFlavor="UNK"/>
							<text>
								<reference value="#_9d1b9efd-baff-45b2-8033-cdf2fc02c35f"/>
							</text>
							<!-- Procedure is completed, even though the implant is still active -->
							<statusCode code="completed"/>
							<!--time stamp as a point in time-->
							<time value="20200714" /> 
							<!--Product Instance Template-->
							<participant typeCode="DEV">
								<participantRole classCode="MANU">
									<templateId root="2.16.840.1.113883.10.20.22.4.37"/>
									<!-- Full HRF UDI value from GS1, which is a UDI issuing agency: (01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015 -->
									<!-- The order of the GS1 delimiters (01)..(11)... may vary -->
									<!-- Device Identifier (01) – 00848486001048 -->
									<!-- Manufacturing date (11) – 181015 -->
									<!-- Lot or Batch Number (10) - ABC999 -->
									<!-- Serial Number (21) – bi12342222 -->
									<!-- Expiration Date (17) – 221015 -->
									<!-- The entire UDI as a single string is scoped by the FDA OID: 2.16.840.1.113883.3.3719 -->
									<id root="2.16.840.1.113883.3.3719" extension="(01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015" assigningAuthorityName="FDA"/>
									<playingDevice>
										<code code="2282003" codeSystem="2.16.840.1.113883.6.96" displayName="Breast Implant" codeSystemName="SNOMED CT"/>
									</playingDevice>
										<!-- Add original text with device type to playingDevice.code-->
										<originalText>
											<reference value="#_d92f7e16-385c-4079-b9c8-adfb2525ef6c"/>
										</originalText>
									<!-- From Product Instance template: The scopingEntity/id should correspond to FDA or the appropriate issuing agency. -->
									<scopingEntity>
										<id root="2.16.840.1.113883.3.3719"/>
									</scopingEntity>
								</participantRole>
							</participant>
							<entryRelationship typeCode="COMP">
								<!-- UDI Organizer -->
								<organizer classCode="CLUSTER" moodCode="EVN">
									<templateId root="2.16.840.1.113883.10.20.22.4.311" extension="2019-06-21"/>
									<!-- UDI organizer/id matches the participantRole/id -->
									<!-- The organizer splits the full HRF UDI value from GS1 into component observations -->
									<id root="2.16.840.1.113883.3.3719" extension="(01)00848486001048(11)181015(10)ABC999(21)bi12342222(17)221015" assigningAuthorityName="FDA"/>
									<code code="74711-3" displayName="Unique Device Identifier" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
									<sdtc:text>
										<reference value="#_2350e0a1-5ffb-4b6d-ba9f-be489d9dfc2f"/>
									</sdtc:text>
									<statusCode code="completed"/>
									<!-- Device Identifier -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.304" extension="2019-06-21"/>
											<code code="C101722" displayName="Primary DI Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>
											<value xsi:type="II" root="1.3.160" extension="00848486001048" assigningAuthorityName="GS1" displayable="true"/>
										</observation>
									</component>
									<!-- Lot or Batch Number -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.315" extension="2019-06-21"/>
											<code code="C101672" displayName="Lot or Batch Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>
											<!-- Errata logged with Structured Documents to consider ED -->
											<value xsi:type="ST">ABC999</value>
										</observation>
									</component>
									<!-- Serial Number -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.319" extension="2019-06-21"/>
											<code code="C101671" displayName="Serial Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/> 
											<value xsi:type="ED"> 
												<reference value="#SerialNumber_1"/>
											</value> 
											
										</observation>
									</component>
									<!-- Manufacturing Date -->
									<!-- If the value is parsed from UDI the format is YYMMDD and is transformed to YYYYMMDD. -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.316" extension="2019-06-21"/>
											<code code="C101669" displayName="Manufacturing Date" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>
											<value xsi:type="TS" value="20181015"/>
										</observation>
									</component>
									<!-- Expiration Date -->
									<!-- If the value is parsed from UDI the format is YYMMDD and is transformed to YYYYMMDD. -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.309" extension="2019-06-21"/>
											<code code="C101670" displayName="Expiration Date" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>
											<value xsi:type="TS" value="20221015"/>
										</observation>
									</component>
									<!-- Distinct Identification assigned wherever donation pulled from-->
									<!-- The distinct identification code may be equivalent to the serial number, lot or batch number, or the donation identification number.  -->
									<!-- The appropriate value should be provided as the distinct identification code. -->
									<!-- <component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.308" extension="2019-06-21"/>
											<code code="C113843" displayName="Distinct Identification" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>
											<value xsi:type="ST">1111</value>
										</observation>
									</component> 
									-->
									<!-- Brand Name -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.301" extension="2019-06-21"/>
											<code code="C71898" displayName="Brand Name" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>											
											<value xsi:type="ED"> 
												<reference value="#BrandName_1"/> 
											</value> 											
										</observation>
									</component>
									<!-- Model Number -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.317" extension="2019-06-21"/>
											<code code="C99285" displayName="Model Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/> 
											<value xsi:type="ED"> 
												<reference value="#ModelNumber_1"/>
											</value> 											
										</observation>
									</component>
									<!-- Company Name -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.303" extension="2019-06-21"/>
											<code code="C54131" displayName="Company Name" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/> 
											<value xsi:type="ED"> 
												<reference value="#CompanyName_1"/>
											</value> 											
										</observation>
									</component>
									<!-- Catalog Number -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.302" extension="2019-06-21"/>
											<code code="C99286" displayName="Catalog Number" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/> 
											<value xsi:type="ED"> 
												<reference value="#CatalogNumber_1"/> 
											</value> 
										</observation>
									</component>
									<!-- Latex Safety -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.314" extension="2019-06-21"/>
											<code code="C160938" displayName="Latex Safety Status" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI Thesaurus"/>								
											<value xsi:type="CD" code="C106038" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Not Made with Natural Rubber Latex" codeSystemName="NCI Thesaurus">
												<reference value="#LatexSafety_1"/> 
											</value>
										</observation>
									</component>
									<!-- MRI Safety Status -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.318" extension="2019-06-21"/>
											<code code="C106044" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CD" code="C113844" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Labeling does not Contain MRI Safety Information" codeSystemName="NCI Thesaurus">
												<reference value="#MRISafety_1"/> 
											</value>
										</observation>
									</component>
									<!-- Device Status Implanted -->
									<component>
										<observation classCode="OBS" moodCode="EVN">
											<templateId root="2.16.840.1.113883.10.20.22.4.305" extension="2019-06-04"/>
											<code code="C160939" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CD" code="C45329" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Active" codeSystemName="NCI Thesaurus">
												<reference value="#ImplantableDeviceStatus_1"/>
											</value>
										</observation>
									</component>
								</organizer>
							</entryRelationship>
						</procedure>
					</entry>
				</section>
			</component>
		</structuredBody>
	</component>
  1. C-CDA Example Search Help

    C-CDA Example Search Results
    This screen displays the results of executing the example search criteria against the existing examples recorded in the example database.

  2. Search Criteria Panel

    This panel allow you to further refine your queries and narrow the results

  3. Text Search Words

    Use this field to enter words related to your search. These words can appear in the title, the comments or as part of a special list of keywords associated with the example. The search words should be entered with spaces separating the items.

  4. Filter by example status

    By selecting the various statuses, the search results can be limited to only the example that are set to the selected status(es). By removing all status selections, the filtering is removed and examples from all statuses will be returned (based on any other filtering).

  5. Select only ONC Certified examples

    These are samples referenced in a government rule or certification companion guide.

  6. Execute the search based on the criteria entered (or retrieve all examples if no criteria specified).

  7. The number of results that match the query parameters can be found here.

  8. Use this link to jump back to the initial page of the application (that lists the sections).

  9. This columns list the names of the examples that match the criteria (and the comment for each example).

  10. This columns lists the area in the C-CDA specification (the specification is broken into distinct topics for the various exchangeable documents, the common header, and the sections that occur within the exchangeable documents) that the example demonstrates.

  11. This columns lists the state of the example in the example verification and approval process.

  12. You can select to download the examples directly or navigate to page with the full detailed description of the example.

  13. Tour Complete

    Return to the C-CDA Example Search Results page.