10.05.03.07

.07 Operating Standards for Safety.

A. 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.

B. The administrator shall ensure that all equipment:

(1) Is manufactured according to the requirements of 21 CFR 800—1299, which is incorporated by reference;

(2) Is appropriately labeled and includes an operating manual;

(3) 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

(4) Meets all applicable standards for equipment adopted by the Division of Radiation Control of the Department of the Environment.

C. Safe Operation of Equipment. To ensure safe operation of the equipment, the administrator shall:

(1) Develop safety and performance testing procedures;

(2) Maintain records of inspection and test results;

(3) Develop procedures for identifying equipment malfunctions;

(4) Provide instruction and training for equipment operators;

(5) Develop policies and procedures that include the following safety rules:

(a) Proper safety precautions against fire, explosion, and electrical or mechanical hazards,

(b) Guidelines for the management of patients developing emergency situations while undergoing testing, and

(c) Safety precautions for equipment that emits radiation and magnetic fields;

(6) Develop protocols and procedures to ensure that patients, operators, and individuals are not exposed to unnecessary hazards; and

(7) Ensure that operators are familiar with the most current safety procedures.