American College of Radiology White Paper on Radiation Dose in Medicine
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American College of Radiology White Paper on Radiation Dose in Medicine E. Stephen Amis, Jr, MDa, Priscilla F. Butler, MSb, Kimberly E. Applegate, MDc, Steven B. Birnbaum, MDd, Libby F. Brateman, PhDe, James M. Hevezi, PhDf, Fred A. Mettler, MDg, Richard L. Morin, PhDh, Michael J. Pentecost, MDi, Geoffrey G. Smith, MDj, Keith J. Strauss, MSk, Robert K. Zeman, MDl The benefits of diagnostic imaging are immense and have revolutionized the practice of medicine. The increased sophistication and clinical efficacy of imaging have resulted in its dramatic growth over the past quarter century. Although data derived from the atomic bomb survivors in Japan and other events suggest that the expanding use of imaging modalities using ionizing radiation may eventually result in an increased incidence of cancer in the exposed population, this problem can likely be minimized by preventing the inappropriate use of such imaging and by optimizing studies that are performed to obtain the best image quality with the lowest radiation dose. The ACR, which has been an advocate for radiation safety since its inception in 1924, convened the ACR Blue Ribbon Panel on Radiation Dose in Medicine to address these issues. This white paper details a proposed action plan for the college derived from the deliberations of that panel. Key Words: Radiation dose, radiation safety, radiation risk, radiation exposure, radiations, exposure to patients and personnel J Am Coll Radiol 2007;4:272-284. Copyright © 2007 American College of Radiology INTRODUCTION lution of imaging has also resulted in a significant increase in the population’s cumulative exposure to Ionizing radiation has been used for diagnostic pur- ionizing radiation. Will this cause an increased inci- poses in medicine for more than a century. The bene- dence of cancer years down the line? Although the fits are immense and certainly exceed the risks. The answer to that question is currently under debate, the more recent development of remarkable equipment presumption is that it will. such as multidetector row computed tomography and Consequently, there is increasing international and the increased utilization of x-ray and nuclear medicine federal interest in, and scrutiny of, radiation dose from imaging studies have improved the lives of our patients imaging procedures. Although there has been recent and, along with other new modalities, revolutionized widespread interest in patient safety issues [1], the the practice of medicine. However, this dramatic evo- possible hazards associated with radiation exposure generally have not been brought into clear focus by the a Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY. public or members of the medical community other b American College of Radiology, Reston, Va. than radiologists. The ACR, pursuing its commitment c Riley Hospital for Children, Indianapolis, Ind. to radiation safety, currently supports the following d Associated Radiologists, P.A., Nashua, NH. activities: accreditation programs, practice guidelines e University of Florida College of Medicine, Gainesville, Fla. and technical standards [2], Appropriateness Crite- f g South Texas Radio Surgery Associates, San Antonio, Tex. ria® [3], a dose index registry (in progress), educa- New Mexico Federal Regional Medical Center, Albuquerque, NM. h tional programs, the RadiologyInfo public informa- Mayo Clinic Jacksonville, Jacksonville, Fla. i tion Web site (jointly developed with the Radiological Kaiser Permanente, Washington, DC. j Society of North America [RSNA]) [4], collaborations Casper Medical Imaging, Casper, Wyo. k with government and legislators on safety issues, and Children’s Hospital Boston, Boston, Mass. l research activities such as the ACR Imaging Network George Washington University, Washington, DC. Corresponding author and reprints: Priscilla F. Butler, MS, American Col- (ACRIN)®. To further enhance radiology’s leadership lege of Radiology, 1891 Preston White Drive, Reston, VA 20191; e-mail: role in the arena of patient safety, the chairman of the pbutler@acr.org. ACR Board of Chancellors convened the ACR Blue 272 © 2007 American College of Radiology 0091-2182/07/$32.00 ● DOI 10.1016/j.jacr.2007.03.002
Amis et al/Radiation Dose in Medicine 273 Table 1. Growth of computed tomography (CT) mSv for a single study [15-18], and some patients have and nuclear medicine examinations in the United multiple studies; thus, it would not be uncommon for States (approximate) [5-8] a patient’s estimated exposure to exceed 50 mSv. In Examination 1980 2005 further validation of this concern, the International CT 3,000,000 60,000,000 Commission on Radiological Protection has reported Nuclear medicine 7,000,000 20,000,000 that CT doses can indeed approach or exceed levels that have been shown to result in an increase in cancer [19]. Although there are currently no data showing that Ribbon Panel on Radiation Dose in Medicine to assess high-dose medical diagnostic studies such as com- the current situation and to develop an action plan for puted tomography and nuclear medicine have actually the ACR that would further protect patients and in- increased the incidence of cancer, a 2004 study (using form the public. Panel members included private prac- survey data from 1991 to 1996) suggested that medi- tice and academic diagnostic radiologists, medical cal exposure might be responsible for approximately physicists, representatives of industry and regulatory 1% of the cancer in the United States [20]. This rate groups, and a patient advocate. This white paper is the result of the panel’s deliberations. can be expected to increase on the basis of the higher number of examinations performed today. On the SCOPE OF THE PROBLEM other hand, as the use of medical radiation has in- creased, the incidence of some cancers has actually Over the past quarter century, there has been a rapid decreased. For example, lung cancer is decreasing in growth in both the number of diagnostic x-ray exam- men because of smoking cessation, and breast cancer is inations and the introduction of newer, very valuable, leveling off [21], possibly because of less estrogen use. but also relatively high-dose technologies (see Table 1 Does this mean that current radiation exposure can be [5-8]). In 1987, medical x-rays and nuclear medicine neglected? The answer is no. Radiation-induced can- studies contributed less than 15% of the average yearly cers typically do not occur until 1 or 2 decades or radiation exposure received by the US population; the longer after exposure. Thus, any increase in cancer large majority was attributable to radon and other occurrence due to burgeoning medical exposures in natural sources [9]. Two decades later, because of the the past 2 decades, as is the case for CT and nuclear dramatic increase in the number of diagnostic exami- medicine studies, may not be expected to be evident nations performed each year as well as the higher doses for many years. In addition, because radiation is a associated with these examinations, this fraction has relatively weak carcinogen, it is difficult to isolate ra- most likely increased. diation-induced cancers (1/1,000 per 10-mSv effec- Before a new technology or procedure that uses tive dose) that are superimposed on the normal back- ionizing radiation is introduced, there should be gen- ground risk for other cancers (approximately 40% of eral agreement that the benefits exceed the risks and the population will be diagnosed as having cancer at that an attempt has been made to reduce the potential risks as low as practicable [10]. Ionizing radiation, some point in their lives) [22]. especially at high doses, has long been known to in- To put the issue in perspective, the current annual crease the risk for developing cancer. In fact, x-rays collective dose estimate from medical exposure in the have recently been officially classified as a “carcino- United States has been calculated as roughly equiva- gen” by the World Health Organization’s Interna- lent to the total worldwide collective dose generated tional Agency for Research on Cancer [11], the by the nuclear catastrophe at Chernobyl [23,24]. Agency for Toxic Substances and Disease Registry of Therefore, one can assume, using International Com- the Centers for Disease Control and Prevention [12], mission on Radiological Protection [25] risk factors and the National Institute of Environmental Health and other data cited above, that this annual collective Sciences [13]. The most comprehensive epidemiologic dose may likely result in an increase in the incidence of study supporting the carcinogenic effect of radiation is imaging-related cancer in the US population in the that of the atomic bomb survivors in Japan. The data not-too-distant future. from this study show a statistically significant increase The preceding information poses many challenges in cancer at dose estimates in excess of 50 mSv [14]. for referring physicians, radiologists, radiologic tech- Whether there is a cancer risk at lower doses remains nologists, medical physicists, equipment vendors, reg- controversial. It is worth noting that many computed ulators, and patients. Subsequent sections in this tomographic (CT) scans and nuclear medicine studies white paper recommend actions the ACR should take have effective dose estimates in the range of 10 to 25 to manage this potential problem.
274 Journal of the American College of Radiology/ Vol. 4 No. 5 May 2007 MEASUREMENTS calculations currently provide only an estimate for a single anatomic model. Furthermore, when estimating Recommendations population doses, these calculated values are multi- ● The ACR should adopt the policy of expressing quanti- plied again by weighting factors [25] that change as tative radiation dose values as dose estimates and replace scientific and professional organizations do their best the term dose with dose estimate as ACR publications are to examine past exposures and subsequent biologic revised. effects. Hence, it is important to understand that the ● The ACR should support the development of a national reported numerical values for individual radiation database for radiation dose indices to address the actual doses may vary by factors of 5 to 10 depending on range of exposures for x-ray examinations. individual patients and the manner of image acquisi- tion. Although there is little doubt that the absorbed There are references to radiation dose and radiation radiation dose for an abdominal CT examination is exposure throughout this paper. It is critical for the larger than that for a radiograph of the ankle, the reader to understand the terminology, especially as it precise numeric quantity (particularly for an individ- pertains to the difference between the easily measured ual) is quite problematic. Therefore, the ACR should radiation exposure from the various imaging modali- adopt a policy of expressing quantitative values regard- ties and the actual amount of radiation absorbed by a ing radiation dose as “dose estimates.” Furthermore, patient. in future ACR publications, the term dose should be The determination of ionizing radiation dose to a replaced with dose estimate. living human from an x-ray examination or nuclear For population exposure measurements, a range of medicine study is very complex. Even during radiation values would more accurately describe the situation. oncology treatment, the radiation dose is actually Currently, there are few data on which to base such measured only in extreme cases. This never occurs in estimations. However, with the growing applications diagnostic imaging. To determine the absorbed radia- of digital imaging, such data can now be easily ac- tion dose, the initial x-ray beam exposure and the quired. Digital x-ray imaging systems, such as com- absorption in each organ must be known. It is the puted radiography, digital radiography, and com- latter quantity that complicates this determination. puted tomography provide an index related to the This absorption is dependent on the amount and amount of radiation that was generated to form an properties of each tissue encountered by the x-ray image. Currently, these quantities are either displayed beam, and these parameters vary widely among pa- tients. The situation is further complicated because it at the operator’s console or embedded with the image is not practical to insert radiation detectors into each itself. If these data were to be extracted and a central organ of every patient. database established for dose indices as a function of For x-ray examinations, the radiation dose is esti- patient parameters (eg, gender, age, size) and exami- mated by a calculation that involves an actual physical nation type (eg, lateral lumbar spine, pelvic computed measurement multiplied by various factors (Table 2): tomography), the relative range of radiation doses could be analyzed. The feasibility of such a database is Dose Estimate ⫽ Radiation Measurement ⫻ Factors. currently being examined by the ACR, and continued The various factors [25-29] are generated by Monte support of this initiative is essential. The value of such Carlo simulations [29] using mathematical represen- a database lies in its ability to demonstrate changes in tations of the human body. Although the latest re- dose indices due to technologic advances and practice search work in this area seeks to provide closer repre- modifications. These trends would be useful to advi- sentations for the range of body sizes [30-32], these sory radiation safety agencies as well as to individual Table 2. Radiation quantities and units Quantity Unit Determination Exposure Coulomb per kilogram (C/kg), roentgen (R) Measurement Dose Gray (Gy), rad Multiply exposure by f-factor or a conversion factor Equivalent dose Sievert (Sv), rem Multiply dose by a quality factor Effective dose Sv, rem Multiply equivalent dose by a tissue weighting factor
Amis et al/Radiation Dose in Medicine 275 practices wishing to compare their own doses against Liaison Committee on Medical Education, the accred- established benchmarks. iting body for medical schools, with a proposal to incorporate such a requirement into the standards that REFERRING PHYSICIANS schools must meet for accreditation. The Association of American Medical Colleges may prove an effective Recommendations ally in accomplishing this goal. Furthermore, the ACR should offer to develop learning materials on radiation ● The ACR should work to convince the Liaison Commit- dose in medicine and should approach the Alliance of tee on Medical Education and the Association of Amer- Medical Student Educators in Radiology for input in ican Medical Colleges of the need for a standard meth- support of this initiative. odology of introducing medical students to radiation The issue of radiation exposure associated with di- exposure in medical imaging and offer to prepare learn- agnostic imaging should be reinforced for nonradiol- ing materials in support of this initiative. ogy residents during their postgraduate years. Al- ● The ACR should work with the American Medical Asso- though core competencies for residents typically ciation to ensure the wide dissemination and enactment address patient safety issues, they generally lack the of its Council Report on Diagnostic Radiation Exposure. ● The ACR should request that the Council of Medical curriculum content specific to radiation safety. Aca- Specialty Societies (CMSS) address the critical issue of demic practices should be encouraged to provide ap- radiation exposure during medical imaging with its propriate guidance for nonradiology house staff re- member societies. garding both the risks associated with radiation and ● The ACR should add relative radiation dose levels to its the appropriate clinical indications for imaging in an Appropriateness Criteria® and work to ensure that the effort to develop knowledgeable referral patterns on Appropriateness Criteria can be integrated into physician the part of these physicians as they enter practice. order entry systems for real-time guidance in ordering Education regarding the risks of radiation exposure imaging examinations. provides a good foundation for physicians as they con- ● The ACR should sponsor a summit meeting with leaders sider imaging preferences, but it is always beneficial to from emergency medicine to discuss developing consen- reinforce theory with tangible information. The ACR sus guidelines for imaging common conditions for which Appropriateness Criteria® [33,34] offers an important computed tomography may be overutilized. decision-making framework for radiologists, referring physicians, and trainees at all levels. Incorporating Although some referring physicians are very knowl- relative radiation dose levels into these guidelines will edgeable regarding radiation safety issues and incorpo- produce a powerful tool for influencing the proper rate such information into their imaging decisions, utilization of imaging examinations, based not only on others have had little or no training in radiation expo- efficacy but also on potential radiation exposure of the sure and do not routinely consider this factor when patient. The ACR should enact this revision and work ordering imaging examinations. Furthermore, non- to ensure that the Appropriateness Criteria are in a physician health care providers (eg, physician assis- compatible electronic format that would allow them tants, nurse practitioners) may be granted the author- to be used within, or linked to, hospital information ity to order imaging studies, and their ordering systems and physician order entry systems. By promi- patterns are likely to reflect the behavior of their su- nently displaying the relative radiation exposure level pervising physicians. Subsequent references to refer- for a particular examination during order entry, a cli- ring physicians in this paper assume that their imaging nician may be steered toward an imaging regimen that preferences would likely be reflected in those they minimizes radiation. Furthermore, the display of the supervise. appropriateness rating for an examination (on a scale Educating future referring physicians on radiation of 1 to 9, with 9 being the most appropriate) at the exposure to patients during diagnostic imaging must time of order entry is designed to influence an order- begin during medical school. Radiology clerkships, in ing physician to choose the most efficacious examina- which students can be easily introduced to radiation tion for a given clinical condition. It is likely, though safety issues, are not required by all medical schools. A not proved, that more appropriate utilization of imag- more practical solution might include integrating ing will reduce overall radiation exposure of patients. mandatory material on radiation safety into the gen- When imaging guidelines such as those just described eral curriculum. The method of instruction, clerkship, are built into order entry systems, regularly posting or general curriculum is not as important as the goal of individual physician ordering patterns (both appropri- inculcating the awareness of radiation exposure in stu- ate and inappropriate) may positively influence physi- dents during training. The ACR should approach the cian ordering behavior through peer pressure.
276 Journal of the American College of Radiology/ Vol. 4 No. 5 May 2007 There are other ways in which the ACR can raise and tive process should be extended to include other redirect awareness of referring physicians regarding the specialties. relative radiation doses associated with various imaging examinations and the risks associated with diagnostic radiation exposure. The ACR should approach the RADIOLOGISTS American Medical Association, as a follow-up to its Council Report on Diagnostic Radiation Exposure [35], Recommendations with an offer to develop collaborative programs or Web content directed at nonradiologist physicians. The ● The ACR should support the current multiorganiza- Council of Medical Specialty Societies is another organi- tional effort to improve radiology resident training in zation that could provide an appropriate venue for rais- medical physics. ing the awareness of referring physicians about imaging- ● The ACR should include additional questions on radia- related radiation exposure of patients. The CMSS vision tion safety and patient dose in its Annual In-Training calls for convening specialty societies to identify critical Examination. issues, defining common policies and positions, and in- ● The ACR should request that the American Board of fluencing decisions in the best interest of the public [36]. Radiology consider requiring at least 1 self-assessment The ACR, which is a member in good standing of module on patient safety, to include radiation dose, every CMSS, should request that CMSS make its other mem- 10 years as an integral part of the maintenance of certifi- cation. ber societies aware of this increasingly urgent problem. ● The ACR should develop and implement maximum ra- Influencing referral patterns from emergency depart- diation dose estimate pass/fail criteria for the ACR CT ments, for example, poses a major challenge. Patients Accreditation Program. arriving at emergency departments are acutely ill or in- ● The ACR should review and update the CT Accredita- jured, may have incomplete medical records, and may tion Program’s recommended scanning protocols on a not be able to communicate their medical histories accu- routine basis and make them available on its Web site. rately. The Emergency Medical Treatment and Labor ● The ACR should request that the editor of the Journal of Act (part of the Consolidated Omnibus Budget Recon- the American College of Radiology (JACR) add a monthly ciliation Act of 1986) [37] requires that any patient who column on patient safety (to include radiation exposure comes to an emergency department be provided with “an issues). appropriate medical screening examination” to deter- ● The ACR should create a prominent safety link on its mine if the patient is suffering from an emergency med- Web site’s home page to facilitate access to this informa- ical condition. If such a condition is present, the institu- tion and to demonstrate the priority given to patient tion has the duty to treat the patient. Emergency safety. department physicians are aware that computed tomog- ● The ACR should include in its Practice Guidelines and raphy can provide quick, reliable answers to many clini- Technical Standards additional considerations for special cal questions. The Emergency Medical Treatment and radiosensitive populations, such as children and pregnant Labor Act and other concerns regarding medical liability, and potentially pregnant women. along with the known clinical efficacy of CT scans, have ● The ACR should encourage radiology practices to record been significant drivers of CT referrals. all fluoroscopy times, compare them with benchmarks, and evaluate outliers as part of ongoing quality assurance Merely providing educational programs for emer- programs. gency physicians regarding the radiation risks associated ● The ACR should encourage radiology practices to define with computed tomography is likely to do little to alter a surveillance mechanism to identify patients with high their referral patterns. Rather, the ACR should proac- cumulative radiation doses due to repeated imaging. tively sponsor a summit meeting between leaders of ra- diology and emergency medicine to address the growing issue of increasing radiation exposure to patients due to It has been suggested that radiologists embody 3 prin- the overutilization of medical imaging. This group cipal attributes: clinical acumen, mastery of technology, should discuss developing consensus statements and and dedication to safety and quality [38]. A compelling guidelines for evaluating common clinical presentations, argument exists that mastery of imaging technology is the such as suspected pulmonary embolism or ureteral calcu- linchpin to these attributes, and that one cannot master lus, and for reviewing a patient’s history to identify ex- the technology without learning the principles and appli- cessive imaging that may have unnecessarily resulted in cations of the physics underlying the technology. It is high levels of radiation exposure. Such consensus guide- then essential that all radiologists continually refresh lines could be powerful tools for improving the appro- their knowledge regarding the basics of radiation safety priate utilization of imaging. If successful, this collabora- to be able to effectively apply them when imaging and
Amis et al/Radiation Dose in Medicine 277 when consulting with their patients and referring physi- nificantly reduce radiation exposure. The Committee on cians. CT Accreditation currently provides recommended To ensure that every radiologist is committed to the scanning protocols as part of the accreditation program. safe practice of radiology, especially in the daily applica- The committee should review and update these routinely tion of radiation safety principles, a more standardized and post them on the ACR’s Web site. approach to physics education at the resident level is More information on general patient safety, as well as necessary. The panel was pleased to learn that the Amer- radiation safety, needs to be made available to the prac- ican Association of Physicists in Medicine (AAPM) held ticing diagnostic radiologist. The aim of the JACR is to a forum on physics education in January 2006, to address “fill the need for information on clinical parameters, the issue [39]. The RSNA sponsored a multiorganiza- practice management, education, health policy, and re- tional follow-up meeting in February 2007. The draft search on radiology health services” [43]. In keeping curriculum being considered by the participants in this with this mission, the ACR should request that the educational initiative covers radiation safety in detail. editor of JACR add a monthly column on patient Definitive planning is under way for improving training safety (to include radiation exposure issues) in the in medical physics by strengthening residency program journal. Because JACR is widely read by ACR mem- accreditation requirements, linking physics topics to pro- bers, this column could provide an effective vehicle for fessional certification examinations, and reinforcing clin- keeping the issue of radiation dose squarely in front of ically relevant physics issues through continuing educa- practicing radiologists. tion and the maintenance of certification. The panel fully Although the ACR’s Web site allows members and endorses this process as a means of better incorporating other interested parties access to many resources related the tenets of radiation safety into the training of all radi- to patient safety (eg, Practice Guidelines and Technical ology residents. To supplement these efforts, the ACR Standards [2], a magnetic resonance imaging safety white should include additional questions on radiation safety paper [44], accreditation guidance [45]), these resources and patient dose in the ACR Annual In-Training Exam- are scattered throughout the site and may not be readily ination. apparent. The ACR should create a prominent safety link The maintenance of certification in radiology, admin- on its Web site’s home page to facilitate finding all ACR istered by the American Board of Radiology, requires safety information. This link would also serve to demon- completion of a minimum of 20 self-assessment modules strate the priority the ACR places on patient safety. during each 10-year recertification period [40]. In light There are special patient populations, notably chil- of the above comments regarding physics education and dren and pregnant and potentially pregnant women, that the need to continually reinforce the lessons learned, it radiology departments and organizations should target seems reasonable for the ACR to approach the American for additional radiation protection. The ACR is currently Board of Radiology with the request that diplomates be developing a practice guideline for appropriate screening required to complete at least 1 module addressing patient for pregnancy before radiology testing that uses ionizing safety, including material specific to radiation dose, radiation. Because children have greater risks from ion- among the 20 needed every 10 years. izing radiation than adults, the ACR should also develop Since its development, the ACR CT Accreditation additional practice guidelines and technical standards to Program [41] has been attracting a steadily increasing protect them. number of practices to seek accreditation. This is occur- Although the ACR plans to be a resource for imple- ring for several reasons, including: the desire for a public menting many new programs designed to help protect display of practice excellence, as a marketing strategy, patients, it is incumbent on radiology practices and de- and to meet the requirements that some payers impose partments to accept responsibility for minimizing radia- for reimbursement. The program has gathered credible tion dose. In this regard, increased oversight of fluoros- data on the range of radiation exposure factors associated copy time will promote acute awareness of radiation with various CT examinations and therefore is able to exposure levels. Although the ACR currently recom- define good practice regarding radiation exposure [42]. mends that radiation dose-related information or fluoro- The ACR should now take this a step further and imple- scopic exposure times be recorded in patients’ medical ment maximum radiation dose estimate pass/fail criteria records for procedures involving more than 10 minutes for its CT Accreditation Program. of fluoroscopic exposure [46], it should now encourage Default settings and vendor-supplied protocols for practices to record actual fluoroscopy time for all fluoro- computed tomography may be designed to provide op- scopic procedures. The fluoroscopy time for various pro- timal imaging quality. However, it is often the case that cedures (eg, upper gastrointestinal, pediatric voiding cys- sufficient image quality for the examination may be tourethrography, diagnostic angiography) should then maintained by using alternative protocols that also sig- be compared with benchmark figures, such as those pub-
278 Journal of the American College of Radiology/ Vol. 4 No. 5 May 2007 lished by the AAPM [47]. More complete patient radia- that a duplicate or questionably indicated examination tion dose data should be recorded for all high-dose inter- has been ordered for a patient or that a patient has un- ventional procedures, such as embolizations, transjugular dergone multiple similar examinations. An alert technol- intrahepatic portosystemic shunts, and arterial angio- ogist should notify the radiologist in such a case and plasty or stent placement anywhere in the abdomen and thereby possibly avoid exposing the patient to unneces- pelvis [48]. Excessive exposure times and doses should sary radiation. warrant further evaluation as part of practices’ quality Technologists are responsible for determining the assurance programs and Joint Commission sentinel event need for additional radiation safety actions before a radi- policy [49]. ation exposure. Considerations include the identification One of the more important processes that can be im- of high-risk patients (ie, children and pregnant or poten- plemented in any radiology practice, whether outpatient tially pregnant women) and the imaging of body parts in or hospital based, is review of the imaging histories of all which sensitive tissues (ie, fetus, thyroid, breasts, bone patients presenting for studies. For example, it is not marrow, gastrointestinal tract, gonads, and eyes) might uncommon since the advent of noncontrast computed be irradiated. For such patients, technologists may need tomography for evaluating patients with suspected ure- to use individualized shielding or collimation; for others, teral calculus to find patients who have had multiple technologists may need to consult with radiologists about scans over a period of months or years. In some of these substituting lower dose examinations (eg, fewer images cases, and at least on some occasions, the combination of or radiography instead of computed tomography). In a kidney, ureter, and bladder radiograph (KUB), and addition, technologists are responsible for limiting radi- ultrasound might also be diagnostically effective and ation exposure to patients by ensuring that proper pro- therefore provide a safer imaging regimen. Routine re- cedures and techniques are followed to prevent the need views of patients’ detailed imaging histories will alert for repeated imaging because of suboptimal image qual- radiologists that such alternatives should be considered. ity. However, the imaging records must be scrupulously re- It is generally accepted that technologists are appropri- viewed to identify these patients. The ACR should en- ately trained and expected by radiology practices to per- courage practices to make this review a standardized ele- form the functions described above. To enhance perfor- ment of practice policy. mance in this arena, the ACR should encourage practices to provide regular in-service training in radiation safety TECHNOLOGISTS issues for their technologists and to make sure they know to communicate any related problems to radiologists for Recommendations resolution. ● The ACR should encourage radiology practices to pro- Patient exposure considerations are more critical in vide in-service training on radiation safety issues for their computed tomography and nuclear medicine because the technologists on a regular basis. doses are typically much higher than for radiographic or ● The ACR should phase in the requirement that at least fluoroscopic procedures. To produce high-quality im- 1 technologist per accredited CT site hold the American ages with the lowest possible patient doses, CT technol- Registry of Radiologic Technologists advanced registry in ogists need to understand and use well-established pro- computed tomography and that at least 1 technologist tocols. In nuclear medicine, there has been increasing per accredited nuclear medicine site hold the advanced complexity of cardiac procedures and positron emission registry in nuclear medicine or certification by the Nu- tomographic examinations. Such examinations require clear Medicine Technology Certification Board. more expertise on the part of technologists. Therefore, ● The ACR should continue to support the Consistency, both CT and nuclear medicine technologists should be Accuracy, Responsibility and Excellence in Medical Im- specially trained, as is currently required by the ACR’s aging and Radiation Therapy ACT (known as the CARE CT Accreditation Program and Nuclear Medicine Ac- bill). creditation Program. Furthermore, the ACR should phase in a requirement that at least 1 technologist per A radiologic technologist is typically the first, and may accredited CT site hold the American Registry of Radio- be the only, health care professional to interact with a logic Technologists advanced registry in computed to- patient presenting for a radiologic procedure. To re- mography and at least 1 technologist per accredited nu- spond to patients’ imaging-related questions, technolo- clear medicine site hold the advanced registry in nuclear gists need to be familiar with all components of the medicine or certification by the Nuclear Medicine Tech- particular examinations, including not only the technical nology Certification Board. aspects but also the associated radiation dose and risk. The American Society of Radiologic Technologists Furthermore, it may be a technologist who recognizes has supported the introduction of legislation in the US
Amis et al/Radiation Dose in Medicine 279 House of Representatives (HR 583, the Consistency, Although patients frequently want to know the radia- Accuracy, Responsibility and Excellence in Medical Im- tion “dose” they will receive during examinations, they aging and Radiation Therapy Act, known as the CARE are generally unfamiliar with radiation terminology and bill) [50] as a means of providing safer medical imaging may not understand the level of risk involved. Conse- examinations by setting federal standards for personnel quently, any dose estimates should include information who perform them. This bill specifically requires certifi- on comparative risks. An example of such comparative cation, licensure, testing, training, or experience for in- information is available on RadiologyInfo [53]. Patients dividuals who will be involved in performing medical should also be informed of the risks to their health should imaging services. The ACR should continue its current alternative examinations, or perhaps even no examina- support for this legislation. tion, be performed. A review of several patient support Web sites found little information on the benefits and risks associated PATIENTS with imaging examinations. That said, there are many patient advocacy groups (eg, the American Cancer Soci- Recommendations ety, the Susan G. Komen Foundation) with sincere in- terest in providing accurate information on various dis- ● The ACR should, in collaboration with the RSNA, install a prominent patient safety link on the RadiologyInfo eases. These groups are familiar with their constituencies home page and regularly review and update information and have well-established communication systems to on the Web site regarding the risks and benefits of imag- reach them. The ACR should work with such patient ing procedures. advocacy groups to improve availability and accessibility ● The ACR should install a prominent patient safety link of information on radiation exposure associated with on the ACRIN® home page that will lead patients to medical imaging. For example, direct links to Radiology- information on risks and benefits associated with partic- Info on appropriate advocacy Web sites would be of ipation in current ACRIN research protocols. significant benefit to patients. ● The ACR should work with patient advocacy organiza- tions to more effectively communicate the potential ra- diation risks and health benefits of imaging procedures. MEDICAL PHYSICISTS Recommendations Radiologists understand the potential dangers from ionizing radiation far better than patients do, yet not ● The ACR should work with the AAPM to develop a every radiologist provides a balanced assessment of the credentialing program for nonradiologist physicians who risks and benefits of imaging when patients undergo test- use fluoroscopy. ing [51]. It is incumbent on radiologists to assume the ● The ACR should task its Commission on Education and responsibility for their patients’ safety with regard to Commission on Medical Physics to develop more effec- radiation exposure. They should also educate their pa- tive teaching methodologies for medical physics in sup- tients on these issues so they may make informed deci- port of the AAPM-RSNA initiative on physics education sions about their health care. To facilitate this educa- for radiology residents. tional process, the ACR should continue collaborating ● The ACR should implement a periodic review and up- with the RSNA in reviewing and updating their cospon- date of its primer on radiation risk [54]. sored patient education Web site, RadiologyInfo [4], to make sure it includes current and understandable infor- Although much of the ACR’s effort regarding radi- mation on the risks and benefits of imaging procedures. ation safety is focused on computed tomography and This material should be easy to customize, download, nuclear medicine, other modalities such as fluoros- and print for use by practices and patients. The ACR copy also contribute to the public’s radiation burden. should advertise the availability of this resource to its Fluoroscopy is frequently performed outside radiology members. As with the ACR’s Web site, there should be a departments in cardiac catheterization laboratories, prominent patient safety link on the RadiologyInfo endoscopy suites, operating rooms, pain management home page allowing easy patient access to safety informa- clinics, and orthopedic procedure rooms. Medical tion for all types of imaging examinations. The ACR physicists need to routinely survey these systems to should work with the RSNA to accomplish this. In ad- ensure that they are producing acceptable image qual- dition, a safety link on the ACRIN Web site’s home page ity at the lowest possible dose. In addition, medical [52] should lead patients to easily understood informa- physicists, working with radiology practices and their tion on the risks and benefits associated with participa- facilities’ radiation safety officers, should implement tion in any of the current ACRIN protocols. programs for credentialing and monitoring the activ-
280 Journal of the American College of Radiology/ Vol. 4 No. 5 May 2007 ities of nonradiologist physicians using radiation. The tion, the Contrast Media Manual [57], is now in its purpose of these programs would be to maximize pa- fifth revision and has become an invaluable resource tient safety, not to limit the use of fluoroscopy, and for radiologists. they should therefore enjoy strong support by hospital administration. Such programs typically involve pre- VENDORS paring brief primers on radiation safety pertaining to fluoroscopy, administering tests on the material in the Recommendations primers that must be passed by physicians requesting ● The ACR should work with the National Electrical Man- such privileges, and awarding certificates document- ufacturers Association (NEMA) to encourage vendors to ing compliance with these educational requirements. ensure that their application specialists are familiar with This process should also be incorporated into the over- imaging protocols that emphasize the standard of as low all credentialing program of the hospital. Several in- as reasonably achievable for their new equipment. stitutions have already successfully implemented such ● The ACR should work with NEMA to encourage ven- programs [55,56]. Involving medical physicists in this dors to adopt a standardized approach describing expo- process is essential, and the AAPM is currently devel- sure indices for computed radiography and digital radi- oping such a program. Therefore, the ACR should ography. offer to work with the AAPM on a model credentialing ● The ACR should continue working with NEMA to en- program that includes educational and testing materi- courage vendors to standardize digital equipment using als. Ideally, the program would be available through ionizing radiation so that it automatically captures com- the ACR’s Web site when complete so that ACR mem- plete dose information for each examination. bers could share it with their hospitals’ credentialing boards and encourage them to adopt the program. If The operational parameters of imaging devices should such a program is successful, it should be expanded to always be optimized to achieve patient doses that are as low credential physicians other than radiologists, radiation as reasonably achievable. Understanding the imaging de- oncologists, or nuclear medicine physicians who are mands of the multitude of clinical examinations for multi- responsible for the operation of CT or nuclear medi- ple sizes of patients, from neonates to large adults, is a chal- cine equipment in the hospital setting. lenge for vendors’ design engineers and physicists. For As mentioned previously in the section on radiolo- example, in the fluoroscopy mode of an interventional unit, gists, there is a current multiorganizational effort to voltage, tube current, pulse width, pulse rate, filter material improve the quality of physics education for radiology and thickness, focal spot size, exposure level at the image residents that the panel finds worthy of ACR support. receptor, field of view, and at least a half dozen image- A comprehensive curriculum on radiologic physics has processing parameters can affect not only image quality but been developed. In academic institutions with resi- also radiation dose. Although vendors automate many of dency programs, the responsibility for teaching this these parameter choices into a single default selection, this curriculum will belong in large part to medical physi- automation needs to be based on the need to minimize cists. For this initiative to succeed, the faculty must be radiation exposure as well as the desire to produce an opti- qualified and the material well structured. To this end, mized image. To address the safety concerns of a procedure, the ACR should task its Commission on Education appropriately trained radiologists and medical physicists and Commission on Medical Physics to develop and need to be involved in the selection of imaging parameters. disseminate effective teaching methodologies to med- Vendors typically accomplish this collaboration by intro- ical physicists to ensure that they present their courses ducing new equipment at designated clinical sites, often clearly, concisely, and in a clinically relevant manner. academic departments with which the vendors have formal Such an initiative will hopefully result in radiology research agreements. A review of several major computed residents’ discovering that instruction in medical tomography vendors’ Web sites found references to proto- physics is interesting and memorable, so that they will cols for reducing radiation dose in pediatric patients or dur- subsequently be able to apply the principles learned ing cardiac studies in all cases. throughout their careers. Too often, practicing radiologists unrealistically expect Because radiology technology and practice are still vendors’ application specialists to have “all the answers.” evolving, and more information on the risk of radia- Vendors need to continually train and update their applica- tion is constantly being reported, the ACR should task tion specialists to make sure that improved, validated pa- its Commission on Medical Physics to update the rameter choices are introduced to its entire customer base. 1996 primer on radiation risk [54] and keep this ma- To this end the ACR should work with NEMA to encour- terial current by creating a mechanism to regularly age vendors to ensure such preparation of their application review and update this document. A similar publica- specialists.
Amis et al/Radiation Dose in Medicine 281 Imaging equipment needs to display and record more Although there is a literal “alphabet soup” of regulatory information about patient dose. Although the US Food and agencies with some degree of responsibility over ionizing Drug Administration (FDA)-mandated display of radiation radiation, the FDA, the NRC, and individual state radio- air kerma rate and cumulative air kerma from new fluoro- logic health agencies have the primary responsibility for scopic equipment [58] was a good first step, a single, stan- medical radiation. dardized exposure indicator has not been adopted by ven- The FDA regulates the manufacturers of medical de- dors, particularly across digital radiographic and computed vices and other electronic products that emit radiation radiographic systems. This confuses imaging staff members, and has promulgated regulatory standards for medical prevents comparison of exposure indices among rooms or x-ray equipment safety and performance. In general, the institutions, and impedes image quality analysis. The FDA has no legislative authority to regulate the users of AAPM, with input from vendors, has drafted a standardized these devices, with the exception of facilities performing exposure indicator for digital radiographic equipment [59]. mammography (the Mammography Quality Standards An International Electrotechnical Commission standard is Act of 1992 [63] gave the FDA authority in this case). also being developed through user-vendor cooperation [60]. The FDA takes an active role in providing radiation The ACR should work with the NEMA to encourage adop- protection guidance through the Center for Devices and tion of this standard by all vendors. Radiological Health. For example, in 2001, in response The displayed radiation dose information should auto- to concerns in the pediatric radiology community, the matically be recorded without operator intervention to center issued a public health notification warning of the eliminate errors and incomplete records that may result potential risks of radiation-induced cancer from helical from the manual recording of this information. Interna- computed tomography in young patients [64]. tional standards that enable such automatic dose data pres- The NRC regulates the use of radioactive materials in ervation have already been issued for digital radiography and medicine, as well as for other applications, except in fluoroscopy [61] and will be issued for computed tomogra- so-called agreement states, where that regulatory author- phy in 2007 [62]. Vendors, radiologists, and medical phys- ity has been assumed by the state. The NRC and agree- icists have been collaborating on these standards. The ACR ment states need to continue focusing efforts on physician should work with the NEMA to ensure this collaboration and patient education concerning radiation exposure from continues. nuclear medicine procedures. Given the vital involvement of both the FDA and the NRC in minimizing unnecessary REGULATORY AGENCIES, ACCREDITING radiation exposure, the ACR should approach both organi- BODIES, AND THIRD-PARTY PAYERS zations seeking input on how it can better support their efforts. Recommendations State regulations on ionizing radiation are variable in scope and enforcement, with a traditional focus on radi- ● The ACR should approach the FDA and the US Nuclear ation-producing machines and radioactive materials. Al- Regulatory Commission (NRC) and seek input on how it can better support their efforts to minimize unnecessary though not a regulatory agency, the CRCPD plays an radiation exposure. important role in the content of state regulations. This ● The ACR should continue working with the Conference nonprofit organization of state regulators serves as a of Radiation Control Program Directors (CRCPD) task “common forum for the many governmental radiation force developing the document “Suggested State Regula- protection agencies to communicate with each other and tions for Control of Radiation” and encourage its mem- to promote uniform radiation protection regulations and ber states to uniformly adopt appropriate regulations. activities” [65]. The ACR should continue working with ● The ACR should encourage the Joint Commission to the CRCPD to encourage its member states to adopt apply its existing credentialing and privileging standards appropriate regulations covered in its document “Sug- to nonradiologist physicians who wish to use fluoros- gested State Regulations for Control of Radiation.” In copy. addition, the CRCPD has a partnership with the FDA to ● The ACR should encourage third-party payers to develop periodically characterize radiation exposures to patients a process for identifying patients who have frequent im- from current diagnostic imaging procedures. This pro- aging examinations using ionizing radiation and to pro- gram, the Nationwide Evaluation of X-Ray Trends [15], vide feedback regarding these patients to their referring is partially funded by the ACR and has tracked x-ray physicians. exposure trends for the past 30 years. The ACR should continue its support of this program. In the United States, regulatory agencies, accrediting The Joint Commission (formerly the Joint Commis- bodies, and third-party payers all have important roles to sion on Accreditation of Healthcare Organizations) has play in reducing unnecessary radiation dose to patients. been active in the nationwide promulgation of extensive
282 Journal of the American College of Radiology/ Vol. 4 No. 5 May 2007 patient safety initiatives through its hospital accredita- (T. Dehn and F. Apgar, NIA, personal communication, tion process. However, it has not routinely addressed January 2007). Anthem also is exploring a pay-for-per- radiation safety or patient exposure issues occurring out- formance component of quality-based reimbursement side of radiology. A recently published Joint Commission for hospitals and providers centered around the setup and reviewable sentinel event, an estimated exposure of more maintenance of meaningful radiation safety programs than 15 Sv (1,500 rads) during fluoroscopy, is indicative focused on dose reduction in multidetector row com- of interest in this arena [49]. More oversight of radiation puted tomography (E. Malko and R. LaFleur, medical use at diagnostic levels might serve to prevent such an directors, Anthem New Hampshire Blue Cross Blue event. Just as its emphasis on hand washing has positively Shield, personal communication, 2006). To expand affected the rate of nosocomial infections, the Joint these programs beyond the current, somewhat isolated Commission, by further application of its current cre- regional efforts, the ACR should encourage third-party dentialing standard requiring relevant training to per- payers to develop a process, such as that planned by form a requested privilege [66], could help prevent the Anthem and the NIA, for identifying patients who have misuse of radiation in hospitals. Therefore, the ACR frequent imaging examinations using ionizing radiation should encourage the Joint Commission to apply this and to provide feedback regarding these patients to their standard during the accreditation process by requiring referring physicians. nonradiologist physicians who use fluoroscopy to be privileged to do so on the basis of documented training in the safety aspects of this procedure. A credentialing pro- CONCLUSIONS gram that could provide relevant training in the safe use Many questions remain unanswered regarding the fun- of fluoroscopy for nonradiologist physicians was de- damental mechanisms of radiation injury. Deoxyribonu- scribed above in the section on medical physicists. cleic acid breakage, chromosomal aberrations, and gene Third-party payers have played only a small active role mutations caused by radiation exposure, as well as the in reducing unnecessary radiation exposure until re- potential for deoxyribonucleic acid to repair itself be- cently. The efforts of third-party payers to control the tween radiation exposures, are important avenues for utilization of imaging have been primarily economic, further investigation. The intensive study of actual oc- first with the concept of requiring preauthorization for currences, such as workplace exposure of radiologists, the certain examinations and, more recently, with pay-for- long-term fate of patients treated with radiation therapy, performance incentives. Despite these measures, the and the events at Hiroshima, Nagasaki, and Chernobyl number of CT studies performed has risen significantly have provided some answers and form the basis for the over the past few years. At the national level, the Blue assumptions in this paper regarding the carcinogenic ef- Cross Blue Shield Association recently commissioned a fects of ionizing radiation. special report from its Technology Evaluation Commis- There is no question that the benefits of diagnostic sion titled Potential Health Risks Associated with Radia- imaging are immense. However, information gleaned tion Exposure from Diagnostic Imaging. On November 2, from the above events suggests that the rapid growth of 2006, the Medical Advisory Panel of the Blue Cross Blue CT and certain nuclear medicine studies over the past Shield Association approved publication of this report quarter century may result in an increased incidence of [67]. This report, now in draft form and due to be pub- radiation-related cancer in the not-too-distant future. lished in the near future, reviews the current literature Pending future studies that contradict this assumption, and issues nonbinding recommendations to the various there should be special attention paid to the practical state Blue Cross/Blue Shield plans (B. Rothenberg, se- suggestions set forth in this paper, such as education for nior scientist, Blue Cross Blue Shield Association, per- all stakeholders in the principles of radiation safety, the sonal communication, 2007). appropriate utilization of imaging to minimize any asso- There are, however, individual state health insurers ciated radiation risk, the standardization of radiation that have proactively implemented radiation safety pro- dose data to be archived during imaging for its ultimate grams. In the past year, Anthem Blue Cross/Blue Shield use in benchmarking good practice, and, finally, the of New Hampshire, Maine and Connecticut, in conjunc- identification and perhaps alternative imaging of patients tion with National Imaging Associates (NIA), has em- who may have already reached threshold levels of esti- barked on a comprehensive dose reduction initiative that mated exposure from diagnostic imaging. is scheduled for rollout in 2007. This program consists of The recommendations derived from the deliberations an educational component, available on the Anthem of the blue ribbon panel are felt to be feasible, apolitical, Web site [68], and a preauthorization tracking software and efficient methods to further minimize unnecessary system developed by the NIA, which identifies patients radiation exposure to patients. That said, there is little who have reached certain radiation exposure levels question that some of these recommendations, were they
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