What’s Happening at the NRC?

By Cindy Tomlinson, ASTRO’s Senior Patient Safety and Regulatory Affairs Manager

The U.S. Nuclear Regulatory Commission (NRC) has been active over the past 12 months – updating medical event reporting criteria, issuing a revised licensing guidance for Gamma Knife and examining training and experience requirements for radiopharmaceuticals. These new and emerging rules and regulations can have a significant impact on the practice of radiation oncology.

The NRC is responsible for formulating policies and regulations governing nuclear reactors and radioactive materials, including those materials used for the diagnosis and treatment of disease. ASTRO closely monitors and actively engages with the NRC to support regulations that balance important safety considerations and patient access to lifesaving radiation therapies.

Here’s the latest update on major radiation therapy-related issues being discussed in the halls of the agency:

Medical Events

After more than a decade, modifications to 10 CFR 35, Medical Use of Byproduct Material, went into effect on January 14, 2019. The biggest change to the regulations was an ASTRO-supported move from a dose-based definition of medical event to an activity-based definition.

Physical Presence

On January 10, 2019, the NRC released revised licensing guidance for Gamma Knife Perfexion and Icon. The guidance requires an authorized user (AU) and an authorized medical physicist (AMP) to be physically present during the initiation of all patient treatments, with the AMP and either an AU or a physician under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, physically present during the continuation of treatment.

This new guidance is consistent with current physical protection requirements for high-dose-rate brachytherapy. ASTRO has long supported the importance of authorized user (AU) presence during Gamma Knife procedures to ensure patient safety. If you use Gamma Knife, how are you implementing this new guidance? Answer in the comments.

Training and Experience

The NRC staff, as well as the NRC’s Advisory Council on the Medical Use of Isotopes (ACMUI), have been reviewing the training and experience requirements found in 10 CFR 35, Medical Use of Byproduct Material, including the use of radiopharmaceuticals. The NRC has been under pressure to lessen the requirements under the so-called “alternate pathway,” which allows those not already board certified to become authorized users (AUs) provided that they meet certain criteria. ASTRO has long argued that reducing the current requirements will put patients at risk and is ill-advised.

The NRC is also interested in receiving comments on whether the agency should have different requirements for different types of radiopharmaceuticals. ASTRO believes that tailored requirements will cause confusion and are not necessary, as the training is the same regardless of the categorization of the radiopharmaceutical. In addition to sending our own comments to the NRC, ASTRO, together with the American Association of Physicists in Medicine (AAPM), American Brachytherapy Society (ABS), American College of Radiology (ACR), Health Physics Society (HPS), and Society of Nuclear Medicine and Molecular Imaging (SNMMI), sent a separate letter outlining why the current requirements should not be changed. It is important to note that the NRC is currently in a fact-finding stage – no changes in regulations have been proposed. What are your thoughts on obtaining AU status – outside of board certification – for radiopharmaceuticals? Are there challenges for patients in accessing an AU in your community or others? Answer in the comments.

ASTRO will continue to monitor and participate in NRC’s deliberation process. If you have questions or concerns, please contact Cindy Tomlinson, ASTRO’s Senior Patient Safety and Regulatory Affairs Manager.

Posted: February 5, 2019 | with 0 comments
Filed under: advocacy, gamma, knife, NRC

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