§ 35.960 - Training for use of therapeutic medical devices.

Except as provided in § 35.57, the licensee shall require the authorized user of a sealed source listed in § 35.600 to be a physician who—

(a) Is certified in—

(1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;

(2) Radiation oncology by the American Osteopathic Board of Radiology;

(3) Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or

(4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

(b) Is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a therapeutic medical device, supervised work experience, and supervised clinical experience as follows—

(1) 200 hours of classroom and laboratory training that includes—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity; and

(iv) Radiation biology;

(2) 500 hours of supervised work experience under the supervision of an authorized user at a medical institution that includes—

(i) Review of the full calibration measurements and periodic spot-checks;

(ii) Preparing treatment plans and calculating treatment times;

(iii) Using administrative controls to prevent medical events;

(iv) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical device or console; and

(v) Checking and using survey meters; and

(3) Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes—

(i) Examining individuals and reviewing their case histories to determine their suitability for teletherapy, remote afterloader, or gamma stereotactic radiosurgery treatment, and any limitations or contraindications;

(ii) Selecting the proper dose and how it is to be administered;

(iii) Calculating the doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses as warranted by patients' or human research subjects' reaction to radiation; and

(iv) Post-administration follow up and review of case histories.