The new NRC regulations under 10 CFR Part 35 (Medical Use of Byproduct Material) became effective October 24, 2002, and govern the medical use and licensing of byproduct materials across the spectrum of diagnostic practice. The revised rule is intended to be less prescriptive than the current rule. The most significant change, according to Siegel, is "a new emphasis on risk-informed, performance-based approaches that focus not on procedures but on outcomes." Since the first use of nuclear medicine in the United States in the 1940s, more than one-third of a billion doses have been administered to patients, with unparalleled safety and almost no adverse events. In structuring the new regulations, the NRC took this low risk into account by eliminating or decreasing the prescriptiveness of the regulations that apply to diagnostic nuclear medicine. Instead, the NRC is relying on a performance-based approach that emphasizes not a step-by-step adherence to "best practices" but a consistent level of performance outcomes by institutions at which nuclear medicine is practiced.
"With this changed focus, we knew that it would be useful for practitioners to have a stand-alone document that suggests appropriate operating policies and sample procedures for compliance with the revised Part 35 and with other NRC regulations," says Siegel, who is chair of t
Contact: Becky Haines
Society of Nuclear Medicine