(1)Only individuals approved by a Radiation Therapy Physician, Radiation Safety Officer, or Qualified Medical Physicist shall be present in the treatment room during treatment.
(2)Electronic brachytherapy devices shall not be made available for medical use unless the requirements of OAR 333-123-0010 (General Requirements, Operating Procedures, Surveys, Dosimetry, and Instrument Calibration for Facilities Using Therapeutic Radiation Machines)(4), 333-123-0090 (Safety Precautions for Electronic Brachytherapy Devices) and 333-123-0095 (Electronic Brachytherapy Source Calibration Measurements) have been met.
(3)The electronic brachytherapy device shall be inoperable, either by hardware or password, when unattended by qualified staff or service personnel.
(4)During operation, the electronic brachytherapy device operator shall monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent entering persons from unshielded exposure from the treatment beam.
(5)If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used.
(6)Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include:
(a)Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and
(b)The names and telephone numbers of the Radiation Therapy Physician, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally.
(7)A copy of the current operating and emergency procedures shall be physically located at the electronic brachytherapy device control console. For control consoles that are integral to the electronic brachytherapy device, the required procedures shall be kept where the operator is located during electronic brachytherapy device operation.
(8)Instructions shall be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the authorized users, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally.
(9)A Radiation Therapy Physician shall be notified as soon as possible if the patient receiving brachytherapy treatment has a medical emergency, suffers injury or dies. A Radiation Safety Officer or designee shall be notified as soon as possible if there is any radiation related injury to the patient. A Radiation Safety Officer or a Qualified Medical Physicist shall inform the manufacturer and the Authority of the event.
Rule 333-123-0085 — Operating Procedures,