Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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Appendix L: Separate Statement
Appendix L: Separate Statement
Pages 290-298
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From page 290... ...
These events included a fatal radiation incident in Indiana, Pennsylvania, and a series of newspaper articles in the Cleveland Plain Dealer on the hazards of radiation medicine. In addition, during discussions between the NRC and the IOM, Senator John Glenn held a highly critical hearing on the NRC's regulation of nuclear medicine.
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From page 291... ...
Although I believe that the report describes the benefits associated with ionizing radiation, I remain concerned that the report does not detail the potential risks of radiation medicine as thoroughly as it might. I grant that we do not know with certainty the extent, if any, to which radiation medicine causes harm.
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From page 292... ...
COMPARING MISADMINISTRATION RATES AMONG MEDICAL MODALITIES Our report includes a lengthy discussion of misadministration rates and comparison of those in nuclear medicine to other medical modalities. Although I am open to the possibility that misadministration rates in nuclear medicine are lower than in other areas of medicine, I find the attempts to quantify the relative rates among medical modalities not to be helpful.3 Although our report acknowledges that in "statistical, clinical, and epidemiological terms, comparisons of the risks inherent in very different health care interventions can be problematic," it fails to emphasize the dramatically different methodologies used to collect data related to medical mistakes.4 One simply cannot draw meaningful quantitative conclusions from data drawn from such disparate sources.s Moreover, in making the case that misadministration rates in radiation medicine are lower than in other areas of medicine, the report recognizes that one of the essential reasons for these rates has been the existence of NRC regulations.
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From page 293... ...
or machine-produced ionizing radiation, such as x-rays.6 Second, byproduct materials are regulated in a more stringent fashion than are other forms of ionizing radiation. As noted elsewhere in this report, the NRC's primary focus is nuclear power in large reactors, and its enforcement approach with respect to nuclear medicine evidently borrows heavily from its comprehensive approach to regulating reactors.
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From page 294... ...
One needs to remember that the NRC has been accused of timidity as often, if not more so, as it has been charged with excessive zeal. Propriety of the NRC's Quality Management and Misadministration Reporting Rules The report takes sharp issue with two rules issued simultaneously in 1992 by the NRC.
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From page 295... ...
The NRC rule requires licensees to notify the agency when misadministrations occur and to explain how they occurred and what actions the licensee has taken to prevent recurrence. This rule is similar to rules at numerous agencies like the FDA, the Consumer Product Safety Commission, the Environmental Protection Agency, the National Highway Traffic Safety Administration, and others that require individuals and companies to share safety problems with bodies entrusted with the public's health.
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From page 296... ...
Instead of federal regulation, the report urges the establishment of a federal agency that would work with and coordinate efforts among the states and professional societies with respect to radiation safety. Among other things, such an agency would assist states in developing safety programs; investigate radiation accidents and issue reports about them; and help educate the public about the risks of radiation.
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From page 297... ...
However, one must take careful note of the following point: under the majonty's approach, if and when the federal Bully pulpit" agency is confronted by the failure of a state regulatory system or state licensing authorities to address a crisis involving the medical use of ionizing radiation, the federal agency will be without arty power to act to protect the public. So objectionable is federal authority to the committee members that they specifically eschew even a minuscule dollop of residual federal regulatory authonty.~4 I find this unacceptable.~S Regrettably, my experience with state authorities and professional medical societies does not leave me sanguine about their ability to deal with radiation hazards in a completely acceptable fashion.
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From page 298... ...
Second, although I salute the conclusion in this report that the medical uses of ionizing radiation should be treated in uniform fashion, I object to the uniformity envisioned in the report, to wit, a repeal of all federal authority over its medical uses. Instead, I favor a reexamination of ionizing radiation risks as a whole and an appropriate restructuring of regulatory approaches.
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