The U.S. Nuclear Regulatory Commission (NRC) recently approved rulemaking that would add performance-based requirements for rubidium-82 generators.
In addition to voting on training and experience requirements for authorized users, the NRC approved the modernization of Part 35 of its Code of Federal Regulations, according to the Society of Nuclear Medicine and Molecular Imaging (SNMMI).
The commission voted to establish performance-based requirements for emerging medical technologies, focusing on radiation safety for workers, patients, and the general public, the SNMMI said. Performance-based requirements for rubidium-82 generators, gravitational synchrotron radiation units, and Y-90 microspheres will also be developed.
In its current iteration, Part 35 doesn't specifically address rubidium-82 generators, which produce a PET radiopharmaceutical. The commission has previously relied on enforcement discretion in this area, according to the SNMMI.
The society said it's looking forward to attending stakeholder calls and participating in the comment process.
