The US Nuclear Regulatory Commission’s (NRC’s) Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a meeting on March 30 to discuss a variety of topics of interest, including recent trends in radiopharmaceuticals, the scope of “patient intervention” as occurrences that are not Medical Events. Below are some items of potential interest from these discussions.
The NRC’s Office of Nuclear Reactor Regulation and Office of Nuclear Material Safety and Safety and Safeguards recently issued two Information Notices (INs) in response to medical events arising from the administration of radiopharmaceuticals.
The first IN alerts medical-use licensees to four strontium (Sr)-82/rubidium (Rb)-82 generator elution events that resulted in patients receiving concentrations of Sr-82 and Sr-85 in excess of regulatory requirements. The IN describes four separate events in which approximately 90 patients were administered Rb-82 chloride for cardiac imaging that contained Sr-82 and Sr-85 concentrations in excess of the regulatory limits identified in 10 CFR § 35.204. In evaluating these events, the NRC found that: