<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".07" citation="COMAR 10.05.03.07" title_num="10" subtitle_num="05" chapter_num="03" heading="Operating Standards for Safety.">
  <paragraph num="A.">
    <text>A person may not operate major medical equipment unless the operator uses safety measures to protect the patient and the operator in accordance with the requirements of this chapter.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The administrator shall ensure that all equipment:</text>
    <paragraph num="(1)">
      <text>Is manufactured according to the requirements of 21 CFR 800—1299, which is incorporated by reference;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Is appropriately labeled and includes an operating manual;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Is considered safe and effective and approved for marketing by receipt of an FDA classification or a letter of approval according to 21 CFR 800—1050.10, which is incorporated by reference; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Meets all applicable standards for equipment adopted by the Division of Radiation Control of the Department of the Environment.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Safe Operation of Equipment. To ensure safe operation of the equipment, the administrator shall:</text>
    <paragraph num="(1)">
      <text>Develop safety and performance testing procedures;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Maintain records of inspection and test results;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Develop procedures for identifying equipment malfunctions;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Provide instruction and training for equipment operators;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Develop policies and procedures that include the following safety rules:</text>
      <paragraph num="(a)">
        <text>Proper safety precautions against fire, explosion, and electrical or mechanical hazards,</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Guidelines for the management of patients developing emergency situations while undergoing testing, and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Safety precautions for equipment that emits radiation and magnetic fields;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>Develop protocols and procedures to ensure that patients, operators, and individuals are not exposed to unnecessary hazards; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Ensure that operators are familiar with the most current safety procedures.</text>
    </paragraph>
  </paragraph>
</regulation>