Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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1 Introduction
1 Introduction
Pages 23-38
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From page 23... ...
, as amended,2 is responsible for the regulation of nuclear reactors and reactor-generated byproduct material.3 As part of this broad responsibility, the NRC instituted its ~ A misadministration is defined by the Nuclear Regulatory Commission, generally, as the administration of some radioactive substance in an amount that exceeds by a certain percentage the prescribed dosage. The percentage calculation depends upon the substance in question.
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4 This is not to imply that there is no controversy or doubt concerning the possible effects of nonionizing radiation. s Naturally occurring and accelerator-produced radioactive materials are collectively referred to as "NARM" to distinguish them from reactor-generated byproduct materials.
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At this facility, monitors identified radiation emanating from the trailer. On December 1, a subsequent search identified a name found with the biohazards bag waste and traced it back to Ms.
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Finally, before the advent of byproduct materials and their eventual replacement of most radium sources, there was a long history of the occasional loss of radium sources during brachytherapy. Such adverse events have the capacity, as demonstrated by the Indiana, Pennsylvania, incident, to overshadow the millions of success stories that result from radiation medicine.
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From page 27... ...
It also led naturally to an examination of radiation safety and the appropriate standards for medical and radiation safety protection practice, including not only the proper education for all health care personnel but also ongoing training that reinforces that education. THE CURRENT REGULATORY SYSTEM The NRC Medical Use Program The NRC, subject to the AEA, is responsible for regulation of nuclear reactors; the regulation of byproduct material used in medicine derives from this broader responsibility.6 Byproduct material accounts for approximately l(i percent7 of ionizing radiation procedures used for medical purposes.
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From page 28... ...
announcement RIN 3150-AC65, on the Quality Management Program and Misadministrations of the NRC Final Rule, indicates that 28 (now 29) states have entered agreements to regulate the use of byproduct material and that they currently issue licenses and otherwise regulate about 4,000 institutions (clinics, hospitals, and physicians in private practice)
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This treatment modality requires much larger amounts of radioactive materials than diagnostic procedures. Regulation of Other Sources Because the radiation subject to NRC jurisdiction originates in nuclear reactors, the NRC is called on to regulate only a small portion of the field of radiation medicine.
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The Senate committee also sought to determine the extent to which fed ~° Congress amended the AEA in 1959 to establish the Agreement States Program for the regulation and monitoring of the use of byproduct materials. Kentucky became the first Agreement State under this program in 1962.
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Although the Cleveland Plain Dealer series had triggered this particular hearing, the Senator noted the committee's long-standing interest in the role of federal and state agencies that regulate medical radiation and its concern that regulation of medical radiation was scattered, fragmented, and seriously inconsistent. Ivan Selin, then chairman of the NRC,~i stated that the NRC had studied the issues of regulatory coverage of all radiation therapy treatment across the country.
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assess the current statutory or regulatory framework for regulation of the medical uses of byproduct materials. Issues: The NRC also asked that the IOM provide recommendations on two major 1.
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Elements of the Study To carry out its charge, the IOM study committee conducted a series of meetings, held a public hearing, convened a technical panel, commissioned several papers, organized site visits, and sent representatives to relevant professional conferences. Committee meetings, information collected by the staff, and commissioned papers provided essential information about the NRC's Medical Use Program, its origin, and legislative mandate.
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Among the specific meetings attended were those of the American College of Nuclear Physicians, American College of Radiology, American Roentgen Ray Society, American Society for [therapeutic Radiology and Oncology, Association of Health Services Research, Association of University Radiologists, Conference of Radiation Control Program Directors, Isotopics, National Council on Radiation Protection and Meas i2 Massachusetts is in the process of becoming an Agreement State.
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From page 35... ...
Chapter 2, "Clinical Applications of Ionizing Radiation", surveys the wide array of clinical applications of ionizing radiation, grouping them into diagnostic uses and therapeutic uses. The discussion addresses the types and volume of procedures performed and the institutions and personnel engaged in the use of ionizing radiation medicine.
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At present, however, reactor-generated byproduct materials are much more stringently regulated (at the federal level) than are naturally occuring and accelerator-produced materials (NARM)
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This creates an intrinsic conflict of interest for the agency. Another internal conflict arises from the tension between health care providers, who desire latitude to exercise judgment in using radioactive byproduct materials in medicine and freedom from burdensome and detailed reporting procedures, and society and its elected officials, who desire absolute assurance concerning monitoring and safety in the medical use of byproduct radioactive material.
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From page 38... ...
To date the federal role has been uneven and divided; much of the current supervision of educational requirements in the use of ionizing radiation, other than the minority of incidents in which byproduct material is used in Non-Agreement States, falls to the states themselves. The chapters that follow give in detail the basis for these introductory observations and make recommendations as to ways in which the regulation of ionizing radiation in medicine may be made more uniform and more responsive to the actual risks involved.
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