§ 35.491 - Training for ophthalmic use of strontium-90.

§ 35.491 Training for ophthalmic use of strontium-90.

Cross Reference

Link to an amendment published at 83 FR 33109, July 16, 2018.

Except 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 paragraph paragraphs (b)(1) and (2) of this section and has achieved a level of competency sufficient to function independently 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]