Current through November 30, 2024
Section 35.491 - Training for ophthalmic use of strontium-90Except as provided in § 35.57 , the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who-
(a) Is an authorized user under § 35.490 or equivalent Agreement State requirements; or(b)(1) Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include-(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 training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve-(i) Examination of each individual to be treated;(ii) Calculation of the dose to be administered;(iii) Administration of the dose; and(iv) Follow up and review of each individual's case history; and(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in § 35.57 , § 35.490 , § 35.491 , or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (b)(1) and (2) of this section and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use. 67 FR 20370 , Apr. 24, 2002, as amended at 68 FR 19326 , Apr. 21, 2003; 71 FR 15011 , Mar. 27, 2006; 74 FR 33906 , July 14, 2009; 83 FR 33109 , July 16, 2018