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Radiation in Medicine: A Need for Regulatory Reform
would be more cost effective and would assure greater patient/staff safety (NEMA, ABR, Washington, New York, North Carolina; see synopsis of question #3 for elaboration of this issue).
Although some respondents noted inconsistency among the states, several other respondents believed that the regulatory responsibility for ionizing radiation in medicine should be shifted to the states or the states in conjunction with the federal government. "A uniform regulatory structure that would be more cost-effective and assure greater patient/employee safety would be achieved by state regulation and inspection of all sources of ionizing radiation based on conformity with minimum basic national regulatory safeguards" (ABNM). "Federal standards need to be developed in full consultation with the states and involvement by the public and regulated community. [A] State agency should have flexibility to develop a regulatory program consistent with federal standards which reflects local needs and conditions" (New York).
A different approach was proposed by the American College of Medical Physics (ACMP). The ACMP suggested that regulatory agencies should revise their programs to require adequate facility design for safe operation, adequate staffing with required qualifications (certification/licensure), and standards of practice following established QA protocols developed by relevant professional/scientific organizations. ACMP proposes that periodic inspections should be performed by a small team of experts to evaluate both physical and clinical aspects of the program and that "the regulatory agency" should require compliance with the recommendations of the site team. ACMP did not specifically identify the regulatory agency. Finally, the ASRT stated that the regulations need to address the credentialing of technologists.
A few respondents stated that NRC's scope of control should not be expanded and in certain instances should be reduced (Du Pont Merck, Illinois, Washington, Florida) or that insufficient data are available to justify fundamental changes in the structure (ASTRO). Illinois asserted that the federal agencies should respect efforts of the states and professional societies in regulating the practice of medicine and that the federal government should only require each state to have a radiation regulation program that has all the basic components necessary to implement the equivalent of the model state statutes provided by the CRCPD licensing state program. The American Medical Association recommended that the NRC work in conjunction with the private sector and other government agencies.
Various respondents noted the omission of federal requirements for x-ray programs that include linear accelerators (Kentucky).
The majority believed that the existing regulatory structure adequately protects the public's health and safety, but there was sentiment that the cost/benefit ratio is disproportionate and should be reevaluated. Opinions varied as to whether a single federal agency should regulate all of ionizing radiation in medicine or whether this responsibility should be transferred to the states under a national set of performance standards (see question #3 for further discussion).