February 10, 2018

ACR Makes Recommendations for NRC Y-90 Proposal

The American College of Radiology (ACR) submitted comments February 7, 2018 to the U.S. Nuclear Regulatory Commission (NRC) regarding the agency’s proposed changes to its licensing guidance for Yttrium-90 (Y-90) microsphere brachytherapy.

The comments were compiled with input from multiple experts within the ACR, including volunteers from the Commission on Nuclear Medicine & Molecular Imaging, Commission on Interventional & Cardiovascular Imaging, Federal Regulatory Committee and Medical Physics-Government Relations Committee.

Y-90 microsphere brachytherapy is currently handled as an emerging modality within NRC’s 10 CFR 35.1000 paradigm, allowing the agency to implement the requirements via referred guidance (instead of regulation), and to revise that guidance over time until the requirements are ready to move into normal regulation. There are various training and experience requirements for authorized users (AUs) in the guidance, including the requirement that the individual receive three AU-supervised patient cases. Alternatively, the individual can receive three manufacturer simulations, obtain AU status on the license and then complete the first three patient cases under direct manufacturer supervision.

The flexibility of this alternate pathway is unique to Y-90 and was put in place over ten years ago to address the interventional radiology community’s concerns about the availability of Y-90 AUs to supervise trainees’ cases. NRC is proposing to remove the manufacturer-provided alternative pathway after a two-year grace period as part of the normalization of the Y-90 requirements.

In response, the ACR argued that NRC should maintain the current paradigm until more information can be gathered about the growth and distribution of the Y-90 AU community and its ability to provide ample replacement training opportunities.

The ACR also recommended that NRC should add professional requirements for manufacturer representatives who proctor patient cases to ensure they are physicians experienced in the procedure.