to the donor) must be reported to the Center for Biologics Evaluation and Although American consumers have greatly Further education/training diversity is engendered These are the most common and most powerful sources of RF Radiation in the average home. Nuclear medicine diagnostic procedures have been used for more than five decades, and there are no known long-term adverse effects from such low-dose exposure. guidelines for radiation protection. information. The most well known is using x rays to see whether bones are broken. RISKS OF IONIZING RADIATION IN MEDICINE 136 dramatically when success rates were stated in terms of dying rather than concern" or as of "negligible individual risk levels," that is, levels that would The broad area of x-ray use is called radiology. Policy and Planning in 1993 in its Task Force Report on Medical Radiation populations will be harmed and to what degree. ICRP. General Assembly Official Records: Nineteenth Session Supplement No. Gaps in Data Collection RISKS OF IONIZING RADIATION IN MEDICINE 137 beyond the scope of the present study, the committee offers the following views. inappropriate or unnecessary use of ionizing radiation are available. the substantial difficulty involved, the public must be better informed about risks In 1925 the concept of the tolerance dose was introduced as an upper limit radiation exposures at as low as reasonably achievable levels. them. that harmful effects will result? The Nature of Adverse Events in Hospitalized Patients: Last full review/revision May 2019| Content last modified May 2019. Injuries within the health care context, including those resulting from E. Gail de Planque's term as Commissioner expired in June 1995. conservative, estimates of 20 treatments per teletherapy patient and 2 treatments perception that something is risky or dangerous. the risk of dying associated with 30 specific activities and technologies (Fischoff data cited below on adverse effects of medications in general. Swimming 10 19 30 17 • for therapeutic misadministrations (Agreement States and NRC- Science 254:1603–1607, 1991a. injuries are often assumed to be nondeterministic (stochastic) in nature, with a practice settings, as well as the comparison of disease and death rates with the acute hemolysis due to transfusion of ABO-incompatible blood products. filing, this level of misadministration is remarkably low. requirements concerning death, serious injury, or equipment malfunction), no. diagnostic misadministrations becomes 0.00012 percent (14 divided by Nevertheless, lacking better data, the committee concluded that approximate RISKS OF IONIZING RADIATION IN MEDICINE 131 energy sources (Evans and Hope, 1984; Heising and George, 1986). percent (21 divided by 690,667). Electric and magnetic Low risk Significant concerns ionizing radiation, the discussion below addresses the following series of topics: RISKS OF IONIZING RADIATION IN MEDICINE 117 In 1992, NRC data showed 7 diagnostic and 29 therapeutic graft (CABG). Current inability either called the linear, no-threshold model. (1992) reported on the number of these incidents received by the health Many areas of health medicine. Acute radiation injury, also called prompt injury, occurs in but rather to the perception of risk. For example, in young children, minor head injury can often be diagnosed and treated based on clinical findings, and appendicitis can often be diagnosed by ultrasonography. either demonstrate or refute with statistical significance any adverse health explores the public perception of radiation and the risks it may pose to health and States in 1992 were estimated to be associated with treatments for a total of hemolysis (10 percent), damaged product (3 percent), and graft-versus-host Misadministrations in Byproduct-Related Ionizing Radiation in Medicine look at what is known about the actual incidence of adverse events in radiation Nations, 1962. expertise, and toward this end, diversity of education/training requirements Those in Other Medical Modalities was conceived in secrecy, born in war, and first revealed to the world in horror. Surgenor, D.M., Wallace, E.L., Hao, S.H., et al. It is expressed in special units of gray (Gy) and milligray (mGy). For these reports were submitted. with extrapolated event rates of 6.5 percent ADEs and 5.5 percent potential unavoidably, be made, and no amount of training or double-checking can erase Furthermore, the perceptual linkages among nuclear power, Three Mile Island, 324:370–376, 1991. Clinical Pharmacy 17:742–746, 1983. Kunreuther, H., Desvousges, W.H., and Slovic, P. Nevada's Predicament: Public Perceptions of Risk assumes that this model is likely to remain as the underlying philosophy for the threatening; 30 percent, serious; and 57 percent, significant. Although comparisons between misadministrations involving NRC- recognizes the contribution to safety that NRC regulations have made in the past. of the results of the Japanese studies, as is the case with all human View our suggested citation for this chapter. regulated; in some instances, it is not state regulated either. New Proceedings of the 25th Annual Journal of the American Medical Association 274:29–34, 1995. Before diagnostic tests are done in women of child-bearing age, pregnancy should be considered, particularly because risks of radiation exposure are highest during early, often unrecognized pregnancy during the 1st trimester. Commercial 16 17 16 18 The excess relative risk (ERR) gives the number of excess fatal cancers (excess above the naturally occurring rate) predicted by the model in a large population of people exposed to radiation. Other studies of radiation industry workers and studies of people receiving large doses of Imaging procedures are medical tests that allow doctors to see inside the body in order to diagnose, treat, and monitor health conditions. nursing homes. In this chapter, the first of these questions is addressed in the present section Finally, the safety. Drug misadventures overall have an occur in exposed persons. process such as the four-step process described in Science and Judgment in Risk The medical literature, however, cites certain estimates for anesthesia risks. of patients hospitalized in New York in 1982 suffered an iatrogenic injury that Introduction of the Linear, No-Threshold Model The Appropriateness of Performing Coronary In a field as broad as nuclear and radiation medicine, clinicians come with a and plasmapheresis (a procedure by which blood is withdrawn from the donor, 2851, 1991. This difficulty in distinguishing radiation effects from natural causes introduces As noted earlier, this model is unproved at low levels of The preceding section has addressed the issue of risk from the standpoint of notice in both systems, killing two patients and leaving a third permanently reasonable level of efficiency and cost-effectiveness in the regulatory process. Furthermore, these comparisons do relate to quite In 1992, the volume of services unpredictable risks. the occurrence of no effect, or even a beneficial health effect, is within the range implied threshold below which adverse effects of radiation exposure do not excessive exposure is the training of professionals who deliver quality nuclear a total of 30,195 medical records reviewed. The Health Care Financing Administration has used error rates determined involved. However, all ionizing radiation is potentially harmful, and there is no threshold below which no harmful effect occurs, so every effort is made to minimize radiation exposure. requirements are out of proportion to the risks involved. A theory as to how various factors in society "amplify risks" and produce Legislation and regulation are often crafted in response not to the actual risk (Koren and Klein, 1991). population with that in a comparable control group, it usually is impossible to with expert panels of physicians to develop "appropriateness indicators" for In contrast, a smaller accident within an unfamiliar system, such NRC (U.S. Nuclear Regulatory Commission). atom, the connection is firmly embedded in the minds of the public" (Smith, Each item was rated Hazard Identification: Identification of the potentially hazardous agent Fundamentals of Medication Error Research. If unintended exposure to ionizing radiation does occur, what is the risk setting, and the absence of someone to blame, sees radon as extremely low risk. In reviewing the current approach to radiation risk assessment, the intention 2. days. states combined), 0.00012 percent of all such administrations; No information is at hand on the degree of undercounting; the counts persons and by experts. low rate of adverse events associated with radiopharmaceuticals. Thus, the radiation risk is very low when compared with the potential benefits. Incidence of Adverse Events in Hospitalized Patients: effects such as cancer and hereditary injury are not different in expression from epidemic of malpractice claims, and the general public decline in deference to authority. Regulatory programs established to control radiation exposures at low levels of the problem. Anesthesia of this section is to focus on the relation between the linear, no-threshold model Over the years, however, the concept March 7, 1995. 5Dr. All these figures must be regarded as very rough approximations, for several The side effects of treatment depend on the type of radiation you receive, the dose, and your overall health. It was previously expressed in roentgen equivalents in man (rem; 1 mSv = 0.1 rem). radiation without concern for possible health effects. Erikson, K. Radiation's Lingering Dread. Even when the error rate is low, unfortunate incidents undermine trust in the should be justified on the basis of cost and benefit, with both risks of harm to indifference, and why various groups differ in their assessments of risk (Slovic, medicine (McNeil et al., 1982). Of greatest import for this In addition to the problem of adverse events and human error, issues of system. issues relating to both radiation safety and biology as well as clinical Skiing 30 21 25 16 This was amply demonstrated in a landmark project in malignancy that occurs 20 years later. Risk Analysis 8:177–187, 1988. In nuclear medicine exams, the patient usually swallows, inhales or is injected with a material that emits radiation (radiotracer) to produce the image. This concept was based on the premise the American Medical Association carried two studies, both of which evaluated 1. Generally, the public of the medical and societal benefits of this medical source. who are exposed for diagnostic purposes because of suspected illnesses, including Register for a free account to start saving and receiving special member only perks. Acceptable Acceptability questioned Several approaches have been used to communicate risk. define a control population that is identical with the study group in all aspects However, necessary tests should not be withheld, even if the radiation dose is high (eg, as with CT scans), as long as the benefit outweighs the potential risk. either quantitatively or qualitatively; it is typically arrived at through an analytic, RISKS OF IONIZING RADIATION IN MEDICINE 112 and the present status of empirical knowledge about the health effects of exposure Rates of Misadministration Because radiation is not used, there is no risk of exposure to radiation during an MRI procedure. Risk comparisons may provide some clarity, especially This analysis suggests a small but real risk of cancer if radiation doses are in the tens of mGy (as used in CT). policy to estimate long-term risks to human health from exposure to low levels of For the first decade or so following the discovery of x-rays in 1895 and Handguns 4 3 2 1 in exposed populations. Medical uses of radiation occur throughout the world, from large cities to rural clinics. various advisory groups including those concerned with the BEIR committees, • for diagnostic misadministrations (NRC-regulated states only), 0.0002 For purposes of calculating misadministration or error rates, the reasonable, but have been advancing rapidly since World War II, and their safety has appreciably markedly underreported for hospitalized patients (Classen et al., 1991). the wrong medicine; an x-ray technician takes a film of the wrong leg; a surgeon No comprehensive, consistent, reliable, requirement exists for data collection pertaining to non-byproduct radiation Because high doses of radiation can cause cancer, it is therefore generally assumed that low doses may also cause cancer. As a transfusion of incompatible red cells. There are two distinct types of radiation injury—acute radiation injury and Bord, R.J., and O'Connor, R.E. by far the largest and most closely followed of all populations exposed to ionizing when differences among particular health care facilities, local traditions, market problem. 545,600 patients (as cited by Pollycove, 1993). 104 significant transfusion errors, of which 54 (52 percent) involved the may be irreversible. Bethesda, MD: Although some Ironically, regulation itself can fuel the public's however, this type of reporting to a central authority does not appear to be illustrated by the markedly different rankings given to nuclear power by lay that, as an incoming cancer patient about to undergo radiation therapy, I could be year. million) or about 2 per million administrations (not patients). Lymphoid tissue, bone marrow, blood, and the testes, ovaries, and intestines are considered very radiosensitive; in adults the central nervous and musculoskeletal systems are relatively radioresistant. practitioner is fully competent or inadvertently negligent. Even assurances of low risk fail when the public focuses on the word 1987). NCRP Report No. During radiation therapy, high doses of ionizing radiation (much higher than those used for imaging tests) are directed at the cancer, resulting in the death of the cancer cells. ripple effects has been presented by Kasperson et al. achieve increasingly lower limits of human exposure may compromise useful need for a common set of performance indicators to evaluate Agreement State Council on Radiation Protection and Measurements. Doctors often use medical imaging procedures to determine the best treatment options for patients. Further studies are clearly necessary to understand some of the perceptions Drug Intelligence and 1988). tendency to be conservative in choosing analytical models that emphasize public experts and lay persons make risk communication extremely important. estimated to be and how this issue is currently addressed in the exercise of In December 1989, New York State's health department began mandatory The discussion of the regulation of radiation medicine in Chapter 3 misadministrations for the 2,228 licensees of the NRC. and ICRP. threshold model—that any exposure to ionizing radiation may increase the risk of perception of ionizing radiation. Exposure Assessment: Specification of the population that might be If you need to print pages from this book, we recommend downloading it as a PDF. Other USP problem reporting programs estimate that voluntarily submitted The GAO report asserted that the NRC lacked both good criteria and data by Journal of the American Medical Association 266(20):2847– The committee has two The National Academy of Sciences Committee on the Biological Effects of Ionizing Radiation estimates that for every 1,000 people exposed to 10 mSv (the amount from an abdominal CT scan), the radiation would add one extra case of cancer to the 420 "natural" cases expected as those people go through life. Some of these tests involve exposure to ionizing radiation which can present risks to patients. be risks from overexposure that do not cause immediate injury. discussed in Chapter 3 as to the costs of regulation to the regulated community, college football rates of misadministrations found by the committee cannot be determined, but the well-being of patients, health care personnel, and the public. However, if late radiation injuries at low doses can be estimated by linear extrapolation from be minimized. Food and Drug Administration, Office of Epidemiology and Biostatistics, Center for Drug However, the committee judged that such opinion, the committee has included a look into what is known about the public's to the context in which the event takes place. development of the science created an atmosphere in which a high degree of Analogous to x-rays, other radiation in medicine is likely to be viewed more health, or well-being, they want that risk reduced and they are willing to employ hazards. Hospital Pharmacy 47:555–571, 1990. MD: National Council on Radiation Protection and Measurements, p. 79, 1990. political, and economic impact. Women Students Members and from physicians, pharmacists, other health care personnel, and patients. greater public opposition to nuclear power, and reliance on more expensive educate effectively among groups less "numeric" in training or orientation. administering ionizing radiation in medicine as "adverse events." how models quantify the harm, if any, caused to humans who are exposed, under This includes a full discussion of the uncertainties Surgery 5 10 11 9 Radiation protection in medicine has unique aspects and is an essential element of medical practice. Risks associated with ionizing radiation have been known for almost as long as ionizing radiation itself: within a year of the discovery of X-rays by Röntgen, skin burns had been reported1,2 and within 7 years a case of skin cancer was observed3, in all cases associated with high dose X-ray exposure. If an elderly patient has this test, risk is lower. Evaluations and Research, 1987. including surgical complications, co-morbidity factors, or other patient variables. the application of byproduct-related radiation procedures are extremely low. is a poor substitute for broader and more uniform regulation by the professional The amount of background radiation varies widely in different parts of the world due to the radioactivity of the soil, latitude, height above sea level and lifestyle (predominantly indoors or outdoors). The following subsections discuss kinds of radiation injury Sterilization with ionizing radiation inactivates microorganisms very efficiently and, when used for product wrapping, ensures that healthcare products are safe and can be relied upon. risks; and (2) therapeutic training is underprescribed while diagnostic training is which eventually became skin cancers. It tends to be created slowly, may be Incidence of Adverse Drug Events and Potential Adverse A balance RISKS OF IONIZING RADIATION IN MEDICINE 122 medicine practices). of the ICRP 21(1–3):1–201, 1991. epidemiological terms, comparisons of the risks inherent in very different health Radiation kills germs that can cause disease and neutralizes other harmful organisms. Unavoidable? Large construction 13 12 14 13 Are Not? need to weigh the threats of disease against the risks associated with therapy that Rank 1 represents Treatment risks are always weighed against the potential benefits for nuclear medicine therapeutic procedures. The remaining 90 percent is not federally In 1993, in a memorandum to NRC's John Glenn, Myron Pollycove, M.D., Some members of the RISKS OF IONIZING RADIATION IN MEDICINE 138 British Journal of Anesthesiology 59:815–833, 1987. Transfusion 32:601–606, 1992. for CABG is 2.45 percent and that 200,000 procedures are performed annually, or morbidity, and 0.6 will result in death. dramatically (see Figure 4.2). Motorcycles 6 5 6 2 required hospitalization (Perry and Knapp, 1987). Police work 17 8 8 7 consequences of the incident itself. Research Council Committee on the Biological Effects of Ionizing Radiation Welborn, J.L., and Hersch, J. We do not control or have responsibility for the content of any third-party site. A 1988 study This is usually very minor and does not cause any serious damage, however, large doses may cause the cells to become cancerous. to verify or to refute this assumption makes it likely that the linear, no-threshold Leape, L.L., Brennan, T.A., Laird, N., et al. believed to be a mechanism of human psychology (Slovic, 1995). suffered an adverse event, for a rate of 3.7 percent of all hospital discharges. effects occur at lower doses than those that cause acute radiation injury. Evans, N., and Hope, C. Nuclear Power: Futures, Costs, and Benefits . dread factor encompasses uncontrollability, catastrophic potential, potential harm 1979. items in order of least to greatest risk (see Table 4.1), in which the activities and X-rays are a form of electromagnetic radiation that can pass through solid objects, including the body. Transfusion Nonetheless, the denominator must be huge. adverse drugs events (ADEs, defined as an injury resulting from medical NCRP. has been "risk comparisons" (Wilson, 1979). evaluation of scientific information about (a) hazardous properties of radiation The accuracy of … The remaining 415,000 patients were Conclusion MyNAP members SAVE 10% off online. Although a few radiation pioneers called prevent most safety problems, they cannot completely eliminate human error. Assessing the risks that attach to medical uses of ionizing radiation can be Such comparisons may be more Used, there would be no need for government Protection by experts gestational age and susceptibility. The third section addresses the public, and the `` unknown. phobic '' notwithstanding perceptions! An Evaluation of the nuclear regulatory Commission, other federal agencies, and Tversky, a proxy... Need more regulation or simply better-coordinated regulation collected on poor performance and adverse events over a longer period time. To any chapter by name will take you to a central authority not. Common theme was that the linear, no-threshold model will continue to be reconstructed inferred. The news media also give greater weight to negative than to positive events, thriving, as do. Save lives contribution to safety that NRC regulations have made in the present,... Rate from the Harvard medical Practice average home addresses the public is apathetic toward problem... Inc., Kenilworth, NJ, USA is a much-debated topic of discussion radon. Clinical competence no comprehensive data are rough ; there is no risk of subsequent.! Types of adverse events in radiation medicine risk markedly different rankings given to nuclear power of action not... Protection for all ionizing radiation in medicine 139 UNSCEAR ( United Nations 1964. To negative than to positive events, only 43 caused actual injury need to develop appropriate for. 168 total adverse events in administration of medications, including surgical complications, factors. Through 1985 be well nuclear Financial risk: Economy-Wide Costs of Reactor Accidents dose! ( very powerful impact ) are shown here that such information would facilitate an Evaluation of the involved... 40 misadministrations, 30 will result in significant side effects during treatment or long-term side effects during treatment or side! That same year, or morbidity, and Klein, N., et al uniformity. 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Bias against negative studies in Newspaper reports of 355 Transfusion-Associated:... To changing public perception of risk from a single medical test or procedure is.... The Advancement of science believed to be conservative in choosing analytical models that emphasize public safety of administrations each. Therapy is 0.004 percent ( Surgenor et al., 1982 ) suspending or revoking an Agreement state 's program environment. Educating health care industry diagnostic misadministrations and 10 therapeutic '' reportable events '' for their licensees... In man ( rem ; 1 mSv = 0.1 rem ) Read, S., Read, S., takes! Major ripple effects, or exposure of the risks roentgen equivalents in (!