LEGISLATIVE & REGULATORY AFFAIRS REPORT Richard Martin, JD, Alexandria, VA

The Nuclear Regulatory Commission Advisory Committee on the Medical Uses of Isotopes (ACMUI) held their Spring meeting on April 26-27, 2017, at NRC headquarters in Rockville, Maryland. Items discussed included physical presence requirements for the Leksell Gamma Knife^® IconTM, Category 3 source security and accountability evaluation initiatives, and training and experience requirements for authorized individuals.

Elekta requested the ACMUI to consider recommending changing physical presence requirements for the newest Gamma Knife model to allow the authorized user to leave the console after initiation of treatment, but remain immediately available in the department. Under the Elekta proposal, the authorized medical physicist would remain at the console for the entire duration of treatment. Elekta reasoned that this change could be made without adverse safety consequences because of the new model's high level of automation, built-in redundancy for safety, and motion management tracking system. The ACMUI is considering this request.

The Subcommittee on Training and Experience Requirements for all Modalities presented a report outlining a methodology for periodically reviewing training and experience requirements. The subcommittee proposed to assess each modality by looking at medical events, radiation safety events and patient access to treatment. In addition, review would assess competencies required for providers to consistently administer safe, reliable care.

The ACMUI also explored how medical event reporting may impact medical licensee patient safety culture. The subcommittee addressing that issue will present a report at the Fall meeting identifying specific options the NRC may take to encourage a licensee's patient safety culture while maintaining its regulatory authority to protect patients.

Additional information about this meeting is here.

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