The Nuclear Regulatory Commission's (NRC's) Advisory Committee on the Medical Uses of Isotopes (ACMUI) once again will address training and experience issues at its meeting on September 20-21, 2018. NRC staff will present a stakeholder outreach plan for the ongoing evaluation of training and experience requirements for authorized users (AUs).
Previously, on July 16, 2018, the ACMUI Training and Experience for All Modalities Subcommittee presented an update on its review of training and experience requirements for different categories of radiopharmaceuticals in Title 10 of the Code of Federal Regulations (10 CFR), Part 35, “Medical Use of Byproduct Material," Subpart E, "Unsealed Byproduct Material--Written Directive Required." The subcommittee noted the U.S. Food and Drug Administration's (FDA's) recent approval of Lutathera (lutetium Lu 177 dotatate) treatment for gastrointestinal tumors and expressed concern that patients have access to these treatments, while ensuring safety by requiring adequate training of AUs providing these treatments. The subcommittee recommended reconsideration of the existing pathways to AU status under 10 CFR 35.300. It cited the need to have an objective method to assess AU competency and the need for broader stakeholder engagement in crafting training and education requirements. Moreover, the subcommittee noted the importance of having the NRC conduct ongoing monitoring for potential AU shortages, including collecting data on the geographic distribution and practice patterns of AUs.
State regulators also are evaluating training and experience issues for specific emerging or evolving modalities. The Conference of Radiation Control Program Directors (CRCPD) H-45 Task Force currently is looking at use of electronically-generated low-energy radiation sources (ELS) used for treatment of skin cancers. This work group hopes to provide guidance to states that are seeing increased use of these devices within their jurisdictions.
Regulators are challenged to provide patient access to therapies, while ensuring the safe use of devices and administration of therapies. Training and education requirements for providers authorized to administer these therapies is key.
We will continue to provide updates on training and education regulatory issues. Contact Richard Martin, JD, AAPM's Government Relations Program Manager, at firstname.lastname@example.org if you have any questions or concerns.
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