January 25, 2017
The Society of Nuclear Medicine and Molecular Imaging submitted comments to the Nuclear Regulatory Commission (NRC) on training and experience requirements (T&E) in CFR 10 Part 35. The Advisory Committee on the Medical Use of Isotopes (ACMUI) of NRC originally began discussions on training and experience requirements in August 2015. The ACMUI subsequently formed a subgroup to address concerns over making changes to training and experience requirements for all modalities. SNMMI formed a task force as well to address the issue and determine if making any changes to the current requirements is warranted.
After a review of the T&E requirements, the society reiterated its position not to reduce the number of hours of training requirements for parenteral radionuclide therapies to any less than 700 hours. SNMMI feels a reduction of hours will significantly compromise the level of care for the patients receiving these treatments. The society believes training and experience is a complex component of clinical nuclear medicine practice, one that requires not only deep fundamental knowledge of radiation biology and radiation safety but also of indications, contraindications and safety precautions of these treatments. In addition, SNMMI feels that the administering physician needs to be fully prepared to handle any minor or major radiation spills that may have patient and health personnel safety implications as well as major regulatory implications at the local, state and federal levels.
SNMMI believes that the Authorized User requirement is not for a specific therapeutic agent; it applies to all parenterals now and in future.