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 the Joint Government Relations Committee of the SNM and the American College of Nuclear Physicians. Working closely with representatives from the NRC, Siegel compiled this useful resource that covers all pertinent regulations, addresses compliance concerns and standards, and provides operating policies and procedures and "At a Glance" and summary features. "The book is intended to serve as a useful bridge between the new regulations and nuclear medicine practitioners who want to ensure continued compliance and thereby maintain the security and safe use of licensed materials in clinical and research settings," says Siegel.
The NRC released a separate guidance volume on October 20 as Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses (NUREG-1556, Volume 9; available at www.nrc.gov). This guidance is intended to outline one means of acceptable compliance but is not intended to be the only means of satisfying the new requirements. Because most nuclear medicine departments do not have the resources to develop custom operating procedures, the NRC guidance is often followed. The SNM volume offers, for the first time, alternate guidance devised by nuclear medicine professionals specifically for the needs of nuclear medicine departments. "We believed that it was important to create guidance that directly addressed the detailed information that diagnostic nuclear medicine professionals would need to know in practicing under the new regulations," says Siegel. The SNM book includes chapters on training and experience, the license application process, license amendment and renewal, and a detailed chapter that offers a point-by-point guide to setting up and implementing an effective radiation protection program.
"For all diagnostic nuclear medicine practitioners, the primary and paramount focus remains on the accurate, timely, and safe diagnosis of illness and disease," says Siegel. Compliance with changing federal regulations and increased familiarity with the implications of these regulations will assure both practitioners and patients of adequate and effective radiation safety practices. The SNM is currently consulting with NRC staff on the preparation of a companion Guide to Therapeutic Nuclear Medicine, to be published in 2003.
The Society of Nuclear Medicine is an international scientific and professional organization with more than 14,000 members dedicated to promoting the science, technology, and practical applications of nuclear medicine
The Guide for Diagnostic Nuclear Medicine is available from the SNM at www.snm.org via the on line Service Center (click on Shop SNM). The SNM is currently working with the NRC to make the document freely available to the nuclear medicine community.