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Radiation in Medicine: A Need for Regulatory Reform
BENEFITS OF IONIZING RADIATION
Diagnostic and therapeutic clinical applications of ionizing radiation range from simple procedures like taking a chest x-ray to the complex regimens used to treat a brain tumor. Each of these applications benefits patients.
The diagnostic uses of ionizing radiation are classified under two basic headings: radiology and nuclear medicine. In radiology, the radiation administered is external to the patient; in nuclear medicine, it is internal. Ionizing radiation applied for therapeutic purposes is also typically classified into categories based on whether the source of the radiation is external or internal to the patient. These areas are called radiation oncology and teletherapy (external sources), brachytherapy (internal), and therapeutic nuclear medicine (internal).
The committee recognizes both the tremendous benefits derived from the use of ionizing radiation in medicine and its potential for harm. The committee's goal is to promote the benefits while advocating a regulatory structure that adequately protects the health and safety of patients, health care workers, and the public. An important component to this balance is patient access to radiation medicine. Fewer people will benefit if regulation makes radiation medicine needlessly expensive or less accessible to patients. Regulatory steps that lower the probability of risk only slightly, if at all, but seriously affect access to services through significant increases in cost or in the distance from patient populations should be foregone. The committee has identified and proposes to eliminate regulations that result in added costs but achieve little, if any, reduction in risk or added benefit for a patient's outcome and well-being or that of health care personnel.
THE REGULATORY FRAMEWORK
Regulatory authority over ionizing radiation in medicine is widely dispersed among several government agencies at the federal, state, and local levels. Among the federal agencies with oversight, the NRC has regulatory authority over the use of byproduct materials in medicine. The Food and Drug Administration (FDA) in the Department of Health and Human Services (DHHS) oversees the approval of radiation-producing devices and radiopharmaceuticals. In addition to the NRC, the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration, and the Department of Energy oversee exposure standards for the public and for workers. The transportation of radionuclides is regulated by another federal agency, the Department of Transportation (DOT). In some cases, regulatory standards, though crafted at the federal level, are administered by the states, as with the NRC's Agreement State Program (described below).