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ASTRO Supports US Nuclear Regulatory Commission Brachytherapy Rule

ASTRO applauds the US Nuclear Regulatory Commission (NRC) for its recent announcement of a final rule that updates the definition of medical events for permanent implant brachytherapy and protects patients' access to this treatment. The modifications to Part 35, Medical Use of Byproduct Material, of Title 10, the Code of Federal Regulations, are consistent with ASTRO recommendations and follow more than a decade of ASTRO members and staff working with the NRC and the Advisory Committee on the Medical Use of Isotopes.

Under the final rule, states authorized by the NRC to regulate radioactive materials, such as those used in brachytherapy, must maintain a consistent program for reporting medical events for permanent implant brachytherapy and strive to avoid conflicts, duplications, and gaps in reporting. The final rule makes several key changes to how the NRC defines medical events for permanent implant brachytherapy, most notably adopting activity-based rather than dose-based criteria for event reporting. The NRC states that the use of a dose-based definition "captures insignificant events as medical events," echoing concerns raised by ASTRO about the incorrect characterization of medically acceptable implants—such as brachytherapy seeds—as medical events. The current rule will become official 180 days after its publication in the Federal Register.

"ASTRO commends the NRC for moving forward with changes that maintain its rigorous standards of quality and safety while demonstrating a flexibility to meet modern medical needs," says ASTRO Chair David C. Beyer, MD, FASTRO. "As the number of patients seeking permanent implant brachytherapy continues to grow, so does the need for physicians and practices to provide this treatment. By adopting more accurate and more appropriate criteria for reporting brachytherapy-related medical events, the NRC has removed a barrier for clinicians looking to treat patients with this established therapeutic option. This step is likely to both protect and increase access to cancer care for a large number of patients."