THERAPEUTIC USE OF RADIOACTIVE MATERIALS | This type of use is primarily for the Departments of Nuclear Medicine and Radiation Oncology (i.e., use of radioactive materials for treating patients). To be an Authorized User, a person must meet the following requirements for the types of diagnostic procedures listed below. In addition, documentation must be sent to EH&S Radiation Safety. 1. Therapeutic use of unsealed byproduct material 2. Treatment of hyperthyroidism 3. Treatment of thyroid carcinoma 4. Use of brachytherapy sources 5. Ophthalmic use of strontium-90 6. Use of therapeutic medical devices | 10 CFR 35.930 Training for therapeutic use of unsealed byproduct material
Return to top | | Except as provided in § 35.57, the licensee shall require the authorized user of radiopharmaceuticals in § 35.300 to be a physician who-- (a) Is certified in-- (1) | The American Board of Nuclear Medicine; | (2) | The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; | (3) | The Royal College of Physicians and Surgeons of Canada in nuclear medicine; or | (4) | The American Osteopathic Board of Radiology after 1984; or |
(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows-- (1) | 80 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; and |
| (2) | Supervised clinical experience under the supervision of an authorized user at a medical institution that includes-- (i) | Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and | (ii) | Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals. |
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| | | Except as provided in § 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experience as follows-- (a) 80 hours of classroom and laboratory training that includes-- (1) | Radiation physics and instrumentation; | (2) | Radiation protection, | (3) | Mathematics pertaining to the use and measurement of radioactivity; and | (4) | Radiation biology; and |
(b) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for diagnosis of thyroid function, and the treatment of hyperthyroidism in 10 individuals. |
| | | Except as provided in § 35.57, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows-- (a) 80 hours of classroom and laboratory training that includes-- (1) | Radiation physics and instrumentation; | (2) | Radiation protection; | (3) | Mathematics pertaining to the use and measurement of radioactivity; and | (4) | Radiation biology; and |
(b) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for the treatment of thyroid carcinoma in 3 individuals. |
| | | Except as provided in § 35.57, the licensee shall require the authorized user of radiopharmaceuticals in § 35.300 to be a physician who-- (a) Is certified in-- (1) | The American Board of Nuclear Medicine; | (2) | The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; | (3) | The Royal College of Physicians and Surgeons of Canada in nuclear medicine; or | (4) | The American Osteopathic Board of Radiology after 1984; or |
(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows-- (1) | 80 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; and |
| (2) | Supervised clinical experience under the supervision of an authorized user at a medical institution that includes-- (i) | Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and | (ii) | Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals. |
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| | | Except as provided in § 35.57, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows-- (a) 24 hours of classroom and laboratory training that includes-- (1) | Radiation physics and instrumentation; | (2) | Radiation protection; | (3) | Mathematics pertaining to the use and measurement of radioactivity; and | (4) | Radiation biology; |
(b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes-- (1) | Examination of each individual to be treated; | (2) | Calculation of the dose to be administered; | (3) | Administration of the dose; and | (4) | Follow up and review of each individual's case history. |
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| | | 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. |
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