Implant UDI Organizer

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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>
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