''It would be beneficial for one organization to have regulatory power for all sources of internally administered ionizing radiation. Placing all ionizing radiation (external and internal) under one agency would be a mistake. … Issues [surrounding] externally administered radiation are different and tend to be device related far more than internally administered radiation" (RSNA).
Finally, one group believed that the regulation should be expanded to incorporate nonionizing radiation. "Have a single agency … include the regulation of practices that involve nonionizing radiation used in medicine, such as ultrasonography and MRI [magnetic resonance imaging" (ASRT).
There was a cry for uniformity. What specifically ought to be uniform was not entirely clear. There also appeared to be no consensus as to how that uniformity is to be achieved.
Question 4 (N = 28)
Do you believe that the current regulatory framework pertaining to the medical uses of ionizing radiation reflects the actual risks associated with various diagnostic and therapeutic applications?
In response to this question we received 28 replies: 18 from professional associations, societies, and industry; 7 from states; and 3 from miscellaneous sources. There was widespread consensus that the current regulatory framework is too elaborate, expensive, and time intensive relative to the actual risks associated with diagnostic applications. "Clinical benefits of radiation exposure greatly outweigh the risks" (HPS). Several respondents indicated that the actual risks related to diagnostic applications are many orders of magnitude less than the risks of other treatment modalities, such as administration of drugs, anesthesia, and medical/surgical procedures that are unregulated: "Misadministrations occur at much higher rates in these disciplines, but since these areas do not have attending regulatory agencies the degree of their regulation is much less" (ACR). "Patients perceive that risks that are important enough to get the federal government involved are greater than risks which do not require any government agency oversight or regulation" (ABNM). "Compared with therapeutic and diagnostic interventions in traditional medicine, the adverse events in nuclear medicine are few and of limited medical consequence" (Syncor).
Several respondents noted that the regulatory structure should distinguish between the risks of therapeutic and diagnostic applications in ionizing radiation. "Levels of radiation received by a patient undergoing diagnostic procedures are significantly lower than the levels for therapeutic procedures. The current level of regulation, however, is virtually the same" (Syncor). "The current framework reflects the risk associated with therapeutic uses but overestimates and overcontrols diagnostic uses" (ARRS).
Risk was also addressed in the context of education and training of personnel involved in performing diagnostic and therapeutic applications of radiation in medicine. It was noted that the existing regulatory framework does not "address