The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Radiation in Medicine: A Need for Regulatory Reform
sources. There was widespread opinion that the current regulatory structure pertaining to the medical uses of ionizing radiation adequately protects the public's/worker's health and safety (ABNM, NEMA, Syncor, ACR, Mallinckrodt, CORAR, Texas, New York). Some believe it is adequate because "it is incidental to insuring public health and safety. Professional pride, peer pressure and legal implications of errors are more important factors than regulations" (AAPM).
Others asserted that the existing regulatory structure protects the public health and safety "with a level and degree of regulation that is often excessive to achieve the desired goal" (RSNA). The Society for Nuclear Medicine stated that the existing structure is not useful for protecting the public. "Excessive regulations are proving unnecessary, prescriptive, expensive and prohibitively burdensome to hospitals and physicians in private practice" (SNM). In view of these statements the American Roentgen Ray Society suggestion appears reasonable: "Validity of regulatory requirements must be re-evaluated and changed as appropriate."
The primary concern about the adequacy of the regulations focused on excessive paperwork, cost effectiveness, diagnosis and treatment of disease (ACNP, Illinois, RSNA, North Shore Hospital, Mallinckrodt, SNM). "Licensees are faced with ever increasing regulations that are costly to implement. NRC's licensing and annual fees have increased 1000% since Congress turned over full budget authority to the NRC through the collection of user fees … medical licensees are restricted in their ability to recoup costs" (ACR).
"In diagnostic nuclear medicine even a gross error has virtually no practical possibility of inducing a perceptible adverse health effect in the affected patient. The current regulatory structure simply does not reflect this reality. Burdening health care providers with excessive regulation and diverting the time and efforts of highly compensated professional and technical personnel from patient care to regulatory compliance causes health care costs to escalate and impedes the delivery of effective care"(NYH-CMC). "… [O]ften NRC's licensing requirements exceed the regulations promulgated in the CFR [Code of Federal Regulations] and add additional expense … large fees are not commensurate with services rendered" (SNM). The Society of Nuclear Medicine believes that "there is a loophole in the existing requirements under the Administrative Procedures Act that allows the NRC to bypass an accurate cost/benefit analysis for new regulations affecting medical licensees."
The distinction between diagnostic and therapeutic applications was noted in several instances. "The regulatory framework is inadequate relative to therapeutic applications"(NYH-CMC). In addition, the American College of Nuclear Physicians noted that the public is adequately protected but the patients are less so. "The patients are not as well protected as is desirable, but the situation is different with different types of ionizing radiation in medicine."
Several respondents stated they favored a single federal agency with authority to regulate ionizing radiation in medicine. They argue that a single agency