The American Society for Radiation Oncology (ASTRO) applauds the United States Nuclear Regulatory Commission (NRC) for yesterday’s 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 (ACMUI).
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,” said 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.”
ASTRO is the premier radiation oncology society in the world, with nearly 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, the Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes three medical journals, International Journal of Radiation Oncology • Biology • Physics (www.redjournal.org), Practical Radiation Oncology (www.practicalradonc.org) and Advances in Radiation Oncology (www.advancesradonc.org); developed and maintains an extensive patient website, RT Answers (www.rtanswers.org); and created the Radiation Oncology Institute (www.roinstitute.org), a non-profit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org.