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" ID="_9d1b9efd-baff-45b2-8033-cdf2fc02c35f">
              <tr ID="_8d8065c7-e42f-4b85-961d-c87947fc1b7d">
                <!-- Example Task Force members stated they DO NOT include a procedure unknown row -->
                <!-- Example Task Force added to be faithful to CDA rules to have Narrative match Entries -->
                <!-- Example Task Force will submit a comment to Structured Documents to NOT require a Procedure Activity Procedure for Implanted Medical Equipment -->
                <td>
                  <content styleCode="xContentWrapping">Procedure Unknown</content>
                </td>
              </tr>
              <tr>
                <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>#BrandName_1</content>
                    <br/>
                    <content>#CompanyName_1</content>
                    <br/>
                    <content>(GSI) 1.3.160 00999998998989</content>
                    <br/>
                    <content styleCode="xLabel">Serial: </content>
                    <content>#SerialNumber_1</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>#ModelNumber_1</content>
                  <br/>
                  <content styleCode="xLabel">Lot: </content>
                  <content>#LotOrBatchNumber_1</content>
                  <br/>
                </td>
                <td>
                  <content styleCode="xLabel">Overall Status: </content>
                  <content>Breast Implant (L)</content>
                  <br/>
                  <content styleCode="xLabel">Implant Status: </content>
                  <content>#ImplantableDeviceStatus_1</content>
                  <br/>
                  <content styleCode="xLabel">MRI: </content>
                  <content styleCode="xAlert">Labeling does not contain MRI Safety Information</content>
                  <br/>
                  <content styleCode="xLabel">Latex: </content>
                  <content>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"/>
            <!-- Historical Procedure and Patient/Provider is unsure of the Procedure done -->
            <code nullFlavor="UNK">
              <originalText>
                <reference value="#_8d8065c7-e42f-4b85-961d-c87947fc1b7d"/>
              </originalText>
            </code>
            <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-->
            <effectiveTime value="20200714"/> 
            <!--Product Instance Template-->
            <participant typeCode="DEV">
              <participantRole classCode="MANU">
                <templateId root="2.16.840.1.113883.10.20.22.4.37"/>
                <id root="2.16.840.1.113883.3.3719" extension="(01)00848486001048(11)160542(10)ABC999" assigningAuthorityName="FDA"/>
                <playingDevice>
                  <code code="2282003" codeSystem="2.16.840.1.113883.6.96" displayName="Breast Implant" codeSystemName="SNOMED CT">
                    <!-- Add original text with device type to playingDevice.code-->
                    <originalText>
                      <reference value="#_d92f7e16-385c-4079-b9c8-adfb2525ef6c"/>
                    </originalText>
                  </code>
                </playingDevice>									
                <!-- 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"/>
                <id root="2.16.840.1.113883.3.3719" extension="(01)00848486001048(11)160542(10)ABC999" assigningAuthorityName="FDA"/>
                <code code="74711-3" codeSystem="2.16.840.1.113883.6.1"/>
                <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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="II" root="1.3.160" extension="00999998998989" assigningAuthorityName="GSI" 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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="ST">#LotOrBatchNumber_1</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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="ST">#SerialNumber_1</value>
                  </observation>
                </component>
                <!-- Manufacturing Date -->
                <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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="TS" value="20181015"/>
                  </observation>
                </component>
                <!-- Expiration Date -->
                <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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="TS" value="20221015"/>
                  </observation>
                </component>
                <!-- Distinct Identification -->
                <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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="ST">#DistinctIdentificationCode_1</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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="ST">#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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="ST">#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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="ST">#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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <value xsi:type="ST">#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" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <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"/>
                  </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"/>
                  </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="C160942" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Reduced Function" codeSystemName="NCI Thesaurus">
                      <originalText>#ImplantableDeviceStatus_1</originalText>
                    </value>
                  </observation>
                </component>
              </organizer>
            </entryRelationship>
          </procedure>
        </entry>
      </section>
    </component>
  </structuredBody>
</component>
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