January 09, 2020

NRC Publishes 10th Guidance Revision for Y-90 Microspheres

The U.S. Nuclear Regulatory Commission (NRC) released the final Revision 10 of their yttrium-90 (Y-90) microsphere brachytherapy sources guidance on Dec. 26, 2019.

Y-90 microsphere brachytherapy is currently handled as an emerging modality within NRC’s 10 CFR 35.1000 paradigm, allowing the agency to implement medical use requirements via referred guidance (instead of regulation) and to revise that guidance over time until the requirements are ready to be moved into normal regulation.

The NRC’s draft version of Revision 10 was released for public comment in Nov. 2017. That draft proposed eliminating the “alternate pathway” to authorized user (AU) eligibility primarily used by practicing interventional radiologists. This pathway allowed a physician with appropriate training to complete patient casework requirements through three manufacturer-provided simulations, followed by obtaining AU status on the license/permit and then finally completing their first three patient cases under direct manufacturer supervision.

In response, the American College of Radiology® (ACR®) filed comments in Feb. 2018 to recommend that NRC maintain the alternate pathway paradigm until more information could be gathered about the AU community and its readiness for such changes. ACR also recommended professional requirements for manufacturer representatives who proctor patient cases to ensure they are appropriately experienced physicians—a key issue that was a top priority for NRC and state regulators as well as the NRC’s Advisory Committee on the Medical Uses of Isotopes.

In the final version of Revision 10, NRC decided to maintain the flexibility of the alternate pathway used by interventional radiologists, as the ACR had recommended.

To address NRC’s concern about previously unspecified expertise for proctors, NRC finalized new requirements for manufacturer representatives that may supervise certain work experience requirements in the alternate pathway. NRC also finalized a one-year time limit (with the ability to extend) for completing the three patient cases and a written attestation requirement to align with the agency’s oversight of other modalities.

For questions or concerns, please contact Michael Peters, ACR director of legislative and regulatory affairs, at (202) 223-1670 ext. 4546 or mpeters@acr.org.