CDA Examples, published by Health Level Seven. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CDA-Examples/ and changes regularly. See the Directory of published versions
This is an example of a medical equipment section containing an implantable device where the full unique device identifier (UDI) is unknown.
This file includes examples of the following templates:
<!-- This is meant to represent multiple implants during the same procedure and where one of the procedures has an unknown UDI. -->
<!-- This is not necessarily an ideal modeling and other changes to transition away from procedure act may be in future -->
<!-- That said, this is designed for compliance with current C-CDA 1.1 & 2.1 (and MU rules) -->
<!-- Note: This is current state and only representative of the UDI unknown. An example of multiple implants which includes UDI unknown will be release. -->
<section xmlns="urn:hl7-org:v3">
<templateId root="2.16.840.1.113883.10.20.22.2.23"/>
<templateId root="2.16.840.1.113883.10.20.22.2.23" extension="2014-06-09"/>
<code displayName="Medical Equipment" codeSystemName="LOINC"
codeSystem="2.16.840.1.113883.6.1" code="46264-8"/>
<title>Implants</title>
<text>
<table>
<thead>
<tr>
<th>Device Type</th>
<!-- This is the generic name of the device. -->
<th>Procedure</th>
<th>Procedure Site</th>
<th>Laterality</th>
<th>Implant Date</th>
<!-- separated out implant date -->
<th>Provider Name and Organization</th>
<th>Informant</th>
</tr>
</thead>
<tbody>
<tr>
<td ID="implantDevice1">Cardiac pacemaker</td>
<td ID="procedureCodeTextReference1">Insertion of intracardiac pacemaker</td>
<td ID="procedureSiteCodeReference1">Structure of upper chest wall</td>
<td>2012</td>
<td/>
<!-- Laterality not appropriate for this device. -->
<td>Winston, Harry</td>
<td>Patient</td>
</tr>
</tbody>
</table>
</text>
<!-- An example where the UDI is unknown or unavailable. In this scenario,
the patient asserts that a pacemaker was inserted 5 years ago. -->
<entry>
<procedure moodCode="EVN" classCode="PROC">
<templateId root="2.16.840.1.113883.10.20.22.4.14"/>
<templateId root="2.16.840.1.113883.10.20.22.4.14"
extension="2014-06-09"/>
<!-- Note - not sending the 2024-05-01 C-CDA 3.0 templateId because
that changed the requirement of date to being precise to at least the day
See https://jira.hl7.org/browse/CDA-21387 for updates -->
<!-- This a different procedure at the same facility, so the extension is different while the root is the same -->
<id root="1.2.840.114350.1.13.5552.1.7.2.737780"
extension="1122334455"/>
<code displayName="Insertion of intracardiac pacemaker"
codeSystemName="SNOMED" codeSystem="2.16.840.1.113883.6.96" code="25267002">
<originalText>
<reference value="#procedureCodeTextReference1"/>
</originalText>
</code>
<!-- Procedure is completed, even though the implant is still active -->
<statusCode code="completed"/>
<effectiveTime>
<!-- Placed Date -->
<low value="2012"/>
</effectiveTime>
<targetSiteCode displayName="Structure of upper chest wall"
codeSystemName="SNOMED CT" codeSystem="2.16.840.1.113883.6.96" code="699646004">
<originalText>
<reference value="#procedureSiteCodeReference1"/>
</originalText>
</targetSiteCode>
<performer typeCode="PRF">
<assignedEntity>
<id root="2.16.840.1.113883.4.6" extension="2222222222"/>
<addr>
<streetAddressLine>123 Any Street</streetAddressLine>
<streetAddressLine>Suite 101</streetAddressLine>
<city>Anytown</city>
<state>AR</state>
<postalCode>10010</postalCode>
<country>US</country>
</addr>
<telecom value="tel:+1-(555)555-1234"/>
<assignedPerson>
<name>
<family>Harry</family>
<given>Winston</given>
</name>
</assignedPerson>
</assignedEntity>
</performer>
<!-- The informant is identified as the patient. -->
<informant>
<assignedEntity>
<id root="1.2.840.114350.1.13.5552.1.7.2.12345" extension="12345"/>
<!-- the informant is the patient -->
<code displayName="self" codeSystemName="HL7 Role code"
codeSystem="2.16.840.1.113883.5.111" code="ONESELF"/>
<addr use="HP">
<streetAddressLine>222 Home Street</streetAddressLine>
<city>Anytown</city>
<state>NY</state>
<postalCode>10010</postalCode>
<country>US</country>
</addr>
<telecom value="tel:(555)555-2004" use="HP"/>
<assignedPerson>
<name>
<given>PatientFirstName</given>
<family>PatientLastName</family>
</name>
</assignedPerson>
</assignedEntity>
</informant>
<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" nullFlavor="NI"/>
<!-- There is no UDI information available -->
<playingDevice>
<code nullFlavor="OTH">
<!-- Vendor doesn't code specific device. -->
<originalText>
<reference value="#implantDevice1"/>
</originalText>
</code>
</playingDevice>
<!-- The FDA is the issuing agency as a default. -->
<scopingEntity>
<id root="2.16.840.1.113883.3.3719"/>
</scopingEntity>
</participantRole>
</participant>
</procedure>
</entry>
</section>