Valueset-device-safety.xml

Definition for Value SetDevice safety

<?xml version="1.0" encoding="UTF-8"?>

<ValueSet xmlns="http://hl7.org/fhir">
  <id value="device-safety"/> 
  <meta> 
    <lastUpdated value="2020-05-02T22:43:35.811+00:00"/> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablevalueset"/> 
  </meta> 
  <text> 
    <status value="extensions"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <h2> Device safety</h2> 
      <div> 
        <p> Codes used to identify medical devices safety characteristics. These codes are taken from
           the 
          <a href="https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf">NCI Thesaurus</a>  and are provided here as a suggestive example.
        </p> 

      </div> 
      <p> 
        <b> Copyright Statement:</b>  MRI safety definitions reprinted, with permission, from F2503-08 Standard Practice for
         Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment,
         copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.  See
         [ASTM F2503](https://www.astm.org/Standards/F2503.htm).
      </p> 
      <ul> 
        <li> Include these codes as defined in 
          <code> urn:oid:2.16.840.1.113883.3.26.1.1</code> 
          <table class="none">
            <tr> 
              <td style="white-space:nowrap">
                <b> Code</b> 
              </td> 
              <td> 
                <b> Display</b> 
              </td> 
              <td> 
                <b> Definition</b> 
              </td> 
            </tr> 
            <tr> 
              <td> C106046</td> 
              <td> Magnetic Resonance Conditional</td> 
              <td> A device with demonstrated safety in the MR environment within defined conditions. At
                 a minimum, address the conditions of the static magnetic field, the switched gradient
                 magnetic field and the radiofrequency fields. Additional conditions, including specific
                 configurations of the item, may be required. See ASTM F2503</td> 
            </tr> 
            <tr> 
              <td> C106045</td> 
              <td> Magnetic Resonance Safe</td> 
              <td> The device poses no known hazards resulting from exposure to any MR environment. MR Safe
                 items are composed of materials that are electrically nonconductive, nonmetallic, and
                 nonmagnetic. See ASTM F2503</td> 
            </tr> 
            <tr> 
              <td> C106047</td> 
              <td> Magnetic Resonance Unsafe</td> 
              <td> The device which poses unacceptable risks to the patient, medical staff or other persons
                 within the MR environment. See ASTM F2503</td> 
            </tr> 
            <tr> 
              <td> C113844</td> 
              <td> Labeling does not Contain MRI Safety Information</td> 
              <td> Information on the safety of using a device in a magnetic resonance (MR) environment has
                 not been provided in the labeling by the labeler.</td> 
            </tr> 
            <tr> 
              <td> C101673</td> 
              <td> Labeled as Containing Natural Rubber Latex</td> 
              <td> The device label indicates natural rubber latex as a component.</td> 
            </tr> 
            <tr> 
              <td> C106038</td> 
              <td> Not Made with Natural Rubber Latex</td> 
              <td> The composition of the materials of an item do not contain natural rubber latex.</td> 
            </tr> 
          </table> 
        </li> 
      </ul> 
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="oo"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="draft"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://hl7.org/fhir/ValueSet/device-safety"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.3.213"/> 
  </identifier> 
  <version value="4.4.0"/> 
  <name value="DeviceSafety"/> 
  <title value="Device safety"/> 
  <status value="draft"/> 
  <experimental value="false"/> 
  <date value="2017-02-17T23:28:06+00:00"/> 
  <publisher value="HL7 (FHIR Project)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
    <telecom> 
      <system value="email"/> 
      <value value="fhir@lists.hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="Codes used to identify medical devices safety characteristics. These codes are taken from
   the [NCI Thesaurus](https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf) and are provided
   here as a suggestive example."/> 
  <immutable value="true"/> 
  <copyright value="MRI safety definitions reprinted, with permission, from F2503-08 Standard Practice for
   Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment,
   copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.  See
   [ASTM F2503](https://www.astm.org/Standards/F2503.htm)."/> 
  <compose> 
    <include> 
      <extension url="http://hl7.org/fhir/StructureDefinition/valueset-systemName">
        <valueString value="NCI Thesaurus"/> 
      </extension> 
      <system value="urn:oid:2.16.840.1.113883.3.26.1.1"/> 
      <concept> 
        <extension url="http://hl7.org/fhir/StructureDefinition/valueset-concept-definition">
          <valueString value="A device with demonstrated safety in the MR environment within defined conditions. At
           a minimum, address the conditions of the static magnetic field, the switched gradient
           magnetic field and the radiofrequency fields. Additional conditions, including specific
           configurations of the item, may be required. See ASTM F2503"/> 
        </extension> 
        <code value="C106046"/> 
        <display value="Magnetic Resonance Conditional"/> 
        <designation> 
          <value value="MR Conditional"/> 
        </designation> 
      </concept> 
      <concept> 
        <extension url="http://hl7.org/fhir/StructureDefinition/valueset-concept-definition">
          <valueString value="The device poses no known hazards resulting from exposure to any MR environment. MR Safe
           items are composed of materials that are electrically nonconductive, nonmetallic, and
           nonmagnetic. See ASTM F2503"/> 
        </extension> 
        <code value="C106045"/> 
        <display value="Magnetic Resonance Safe"/> 
        <designation> 
          <value value="MR Safe"/> 
        </designation> 
      </concept> 
      <concept> 
        <extension url="http://hl7.org/fhir/StructureDefinition/valueset-concept-definition">
          <valueString value="The device which poses unacceptable risks to the patient, medical staff or other persons
           within the MR environment. See ASTM F2503"/> 
        </extension> 
        <code value="C106047"/> 
        <display value="Magnetic Resonance Unsafe"/> 
        <designation> 
          <value value="MR Unsafe"/> 
        </designation> 
      </concept> 
      <concept> 
        <extension url="http://hl7.org/fhir/StructureDefinition/valueset-concept-definition">
          <valueString value="Information on the safety of using a device in a magnetic resonance (MR) environment has
           not been provided in the labeling by the labeler."/> 
        </extension> 
        <code value="C113844"/> 
        <display value="Labeling does not Contain MRI Safety Information"/> 
      </concept> 
      <concept> 
        <extension url="http://hl7.org/fhir/StructureDefinition/valueset-concept-definition">
          <valueString value="The device label indicates natural rubber latex as a component."/> 
        </extension> 
        <code value="C101673"/> 
        <display value="Labeled as Containing Natural Rubber Latex"/> 
      </concept> 
      <concept> 
        <extension url="http://hl7.org/fhir/StructureDefinition/valueset-concept-definition">
          <valueString value="The composition of the materials of an item do not contain natural rubber latex."/> 
        </extension> 
        <code value="C106038"/> 
        <display value="Not Made with Natural Rubber Latex"/> 
      </concept> 
    </include> 
  </compose> 
</ValueSet>