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Radiation in Medicine: A Need for Regulatory Reform
In December 1989, New York State's health department began mandatory reporting of blood transfusion incidents, accidents, and errors. Linden et al. (1992) reported on the number of these incidents received by the health department from January 1, 1990, through October 31, 1991, and found a total of 104 significant transfusion errors, of which 54 (52 percent) involved the transfusion of incompatible red cells. There were three reported fatal errors (2 per million red cell transfusions).
Comparison of Risks in the Use of Ionizing Radiation in Medicinewith Those in Other Medical Modalities
The data reviewed above suggest that the rates of errors in other areas of medicine may exceed those of radiation medicine as reported. Readers are cautioned, however, that no comprehensive raw data are available to make exact comparisons.
In 1993, in a memorandum to NRC's John Glenn, Myron Pollycove, M.D., of the NRC prepared a comparison of the relative risks of radiation therapy, surgery general anesthesia, and chemotherapy (Pollycove, 1993). Pollycove concluded that the actual mortality rates for these health care interventions for five selected cancers far exceeded the mortality from radiation therapy misadministrations. Left untreated, the mortality for these various cancers is much higher than the treatment mortalities, a comparison that does underline the need to weigh the threats of disease against the risks associated with therapy that uses ionizing radiation. Furthermore, these comparisons do relate to quite incommensurate types of adverse events and types of hazards.
In a presentation to this committee, Dr. E. Gail de Planque, NRC Commissioner,5 observed that the death rates for cancer patients receiving surgery range from 1 to 23 percent, depending on the type of cancer and surgery involved. The risk of dying from chemotherapy is about 1 percent, and anesthesia carries a mortality risk of about 0.1 percent. Of greatest import for this comparison, Dr. de Planque cited a risk of death from correctly administered radiation therapy from byproduct materials at 1 percent, whereas the additional risk from misadministration of byproduct materials is only 0.0006 percent. She concluded that "even if all misadministrations were successfully eliminated—so that, as an incoming cancer patient about to undergo radiation therapy, I could be positively assured that my therapy would be properly administered—my risk of death due to the procedure itself would remain essentially unchanged, or about 1%" (de Planque, 1994).6
Dr. E. Gail de Planque's term as Commissioner expired in June 1995.
Dr. de Planque's calculations are based on NRC data, which calculate that therapeutic misadministrations of byproduct material occur at a rate of 40 per 100,000 administrations. Of those 40 misadministrations, 30 will result in significant side effects, or morbidity, and 0.6 will result in death. Dr. de Planque also notes that, unless the misadministration results in a particularly high dose, it may be difficult to connect the misadministration with subsequent morbidity or mortality.