Strontium-90 Sources for Ophthalmic Treatments

Section 335.7100 Strontium-90 Sources for Ophthalmic Treatments Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in subsection (c) are performed by either: a)         An authorized medical physicist; or b)         An individual who: 1)         is identified as an ophthalmic physicist on a specific medical use license issued by the Agency, U.S. Nuclear Regulatory Commission, or Agreement State ;  a permit issued by the Agency, U.S. Nuclear Regulatory Commission, or Agreement State broad scope medical use licensee; a medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee; or permit issued by a U.S. Nuclear Regulatory Commission master material licensee broad scope medical use permittee; and 2)         holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and 3)         has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and 4)         Has documented training in: A)        The creation, modification, and completion of written directives; B)        Procedures for administrations requiring a written directive; and C)        Performing the calibration measurements of brachytherapy sources as detailed in Section 335.7070. c)         The individuals who are identified in subsections (a) and (b) shall: 1)         Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments.  The decay shall be based on the activity determined under Section 335.7070; and 2)         Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive.  These procedures shall include the frequencies that the individual meeting the requirements in subsection (a) or (b) will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives. d)         Licensees must retain a record of the activity of each strontium-90 source. The record shall include: 1)         The date and initial activity of the source as determined under Section 335.7070; and 2)         For each decay calculation, the date and the source activity as determined under this section.