1
Introduction

In November 1992, a misadministration1 of radiation to a patient in Indiana, Pennsylvania, preceded a week-long series in the December 1992 Cleveland Plain Dealer entitled "Lethal Doses: Radiation That Kills." In response, Senator John C. Glenn (then chairman of the Governmental Affairs Committee) announced a congressional investigation into radiation medicine. This sequence of events influenced the U.S. Nuclear Regulatory Commission (NRC) in seeking both an internal review of its Medical Use Program and an external review from the National Academy of Sciences' Institute of Medicine (IOM).

The NRC, pursuant to the Atomic Energy Act of 1954 (AEA), 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

1  

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. A misadministration may also be the administration of a correct dosage, but of the wrong substance, or to the wrong patient. (For the full definition of misadministration, see 10 CFR 35.2 in Appendix D.)

2  

The "AEA" abbreviation, as it appears throughout the report, refers to the 1954 act, as amended, unless otherwise noted.

3  

The NRC regulates "reactor-generated byproduct material." Byproduct material consists of radionuclides produced during the process of nuclear reactor generation. Although much of this material is considered waste and must be properly disposed of, quantities of certain byproduct radionuclides are marketed for use to various industries, including the health care industry. Throughout this report such reactor-generated material will typically be referred to as "byproduct material" or "byproducts." The radiation source involved in the Indiana, Pennsylvania, case was a reactor-generated byproduct.



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Radiation in Medicine: A Need for Regulatory Reform 1 Introduction In November 1992, a misadministration1 of radiation to a patient in Indiana, Pennsylvania, preceded a week-long series in the December 1992 Cleveland Plain Dealer entitled "Lethal Doses: Radiation That Kills." In response, Senator John C. Glenn (then chairman of the Governmental Affairs Committee) announced a congressional investigation into radiation medicine. This sequence of events influenced the U.S. Nuclear Regulatory Commission (NRC) in seeking both an internal review of its Medical Use Program and an external review from the National Academy of Sciences' Institute of Medicine (IOM). The NRC, pursuant to the Atomic Energy Act of 1954 (AEA), 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 1   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. A misadministration may also be the administration of a correct dosage, but of the wrong substance, or to the wrong patient. (For the full definition of misadministration, see 10 CFR 35.2 in Appendix D.) 2   The "AEA" abbreviation, as it appears throughout the report, refers to the 1954 act, as amended, unless otherwise noted. 3   The NRC regulates "reactor-generated byproduct material." Byproduct material consists of radionuclides produced during the process of nuclear reactor generation. Although much of this material is considered waste and must be properly disposed of, quantities of certain byproduct radionuclides are marketed for use to various industries, including the health care industry. Throughout this report such reactor-generated material will typically be referred to as "byproduct material" or "byproducts." The radiation source involved in the Indiana, Pennsylvania, case was a reactor-generated byproduct.

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Radiation in Medicine: A Need for Regulatory Reform Medical Use Program to regulate the use of byproduct material in medicine. The review of this program is the subject of the NRC's charge to the IOM. Byproduct materials include such radionuclides as cobalt-60, iodine-131, iodine-125, and iridium-192, all of which are used for diagnosis and treatment of cancer. They are sources of ionizing radiation and, as such, pose risks to health and safety that sources of nonionizing radiation do not.4 Radiation is ionizing when it dislocates electrons from atoms to produce positive ions and free electrons. (Nonionizing radiation pertains to other types of electromagnetic radiation at wavelengths that do not cause ionization, such as those used in magnetic resonance imaging, microwaves, and radar). Byproduct material is not the only source of ionizing radiation; other sources are radioactive materials that occur naturally or are accelerator produced, and radiation (not materials) produced by x-ray machines and particle accelerators. 5 In examining the existing NRC Medical Use Program, the IOM Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission compared the program not only with the regulation of sources of medically used ionizing radiation other than reactor-generated byproduct material but also with the regulation of medicine in general. The scope of this comparison was occasioned by an awareness of problems among the NRC, Congress, the states, and the regulated community that the entire regulatory system needed to be examined. In particular, a major question for the IOM committee was whether the scientific data on risks associated with reactor-generated byproduct material used in radiation medicine justify the extent to which it is regulated compared to other sources of radiation in medicine and to medicine in general. ERRORS AND SUCCESSES, BENEFITS AND PROBLEMS OF RADIATION MEDICINE The Indiana, Pennsylvania, incident—one of the precipitating factors in the NRC's decision to seek an independent review of its Medical Use Program—involved Sara Mildred Colgan, an 82-year-old woman who had worked most of her life as a physical therapist at a home for disabled children before retiring in the mid-1970s. In October 1991, she was diagnosed with cancer. 4   This is not to imply that there is no controversy or doubt concerning the possible effects of nonionizing radiation. 5   Naturally occurring and accelerator-produced radioactive materials are collectively referred to as "NARM" to distinguish them from reactor-generated byproduct materials. The term "radionuclide" refers to both NARM and reactor-generated byproducts.

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Radiation in Medicine: A Need for Regulatory Reform On November 16, 1992, Ms. Colgan was being treated for anal carcinoma with a form of radiation therapy called high dose rate brachytherapy at the Indiana Regional Cancer Center. Before the treatment, doctors had placed into her tumor five catheters that were to remain for subsequent treatments. During the treatment, high-intensity radioactive iridium-192 sources were placed sequentially into each of the catheters by a remotely controlled Omnitron 2000 after loader. Iridium-192 is a reactor-generated radionuclide. At the end of the treatment, radiation therapists believed that the source had been retracted. A radiation monitor in the treatment room indicated that excessive levels of radiation existed, but despite the availability of a portable survey instrument, no one surveyed Ms. Colgan's radiation levels. The staff assumed that the area radiation monitor was malfunctioning, as there had been prior false alarms. The control console of the Omnitron 2000 after loader indicated "safe," leading the staff to believe that the source material not only had been removed from Ms. Colgan's body but also had been fully retracted into the lead shield. Although proper staff radiation safety training and the discrepancy between the monitor alarm and the control panel should have elicited a response, three therapists and Ms. Colgan's attending physician all failed to act. One therapist simply unplugged and reset the monitor. In reality, the wire that connected the iridium-192 source to the catheter had broken, leaving the source in one of the catheters in the patient. Ms. Colgan returned to her nursing home. On November 20, four days after her treatment, the source-containing catheter came loose and fell out. Nursing home personnel, unaware that the catheter contained radioactive material, placed it in a medical biohazards bag and into storage. Ms. Colgan died the next day, it was later determined, from the radiation misadministration. Between November 16 and November 25, 1992, residents, employees, and visitors to the nursing home were unknowingly exposed to radiation from the source, first while it was lodged in Ms. Colgan's body and subsequently from within the biohazards bag. Other persons exposed included employees and patients at the cancer center who came near Ms. Colgan during the time she awaited transfer back to the nursing home after her treatment and the ambulance staff who returned her there. On Friday, November 27, a trailer loaded with medical waste, including waste from Ms. Colgan's nursing home, drove to a medical waste incinerator in Warren, Ohio. 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. Colgan's nursing home (NRC, 1993). This unusual case is commonly referred to as the "Indiana, Pennsylvania, incident." Other adverse events involving radiation in medicine are not confined to the loss of byproducts in a patient's body. In the past, errors have been made in the calibration of teletherapy machines that use radioactive cobalt and in the

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Radiation in Medicine: A Need for Regulatory Reform disposal of those machines and sources. Furthermore, adverse events occur with ionizing radiation in which byproducts play no role at all. Design problems in linear accelerators (another source of radioactive materials and radiation) have led to serious patient overdoses in a limited number of cases because of a failure to measure accurately the output of the machine. In another case, problems with software control of the machines allowed delivery of excessive doses to a few patients. Furthermore, the occasional adverse event occurs not only during the treatment of cancer. Large doses of ionizing radiation are delivered during diagnosis with fluoroscopy equipment and may cause unnecessary exposure of the operator and the patient. Mistakes may be made in the dosage of diagnostic, systemically administered radionuclides. Beyond this, the quality of radiography may be inferior, necessitating second or third exposures to diagnostic radiation. Such inferior radiography, for example, led first to voluntary and now to congressionally mandated control of the quality of mammography for the detection of breast cancer. 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. The number of favorable outcomes from radiation therapy far exceeds the number of problematic outcomes; good patient outcomes are the norm for most radiation therapy procedures. As an example, in June 1991, a 30-year-old pregnant woman who was both deaf and mute was diagnosed with a melanoma, which put her in danger of losing her eye. As a photographer, she depended on her vision. Doctors offered her the choice of either removal of her eyeball or insertion of a radioactive iodine-125 ocular plaque. In an effort to save her sight, she underwent placement of the plaque. The plaque delivered 10,000 cGy (centigray) to the apex of the tumor and was removed after 129.2 hours. Because of the shielding of the plaque holding the radioactive source and because of iodine-125's weak emission of gamma rays, most of the radiation emanating from the plaque was absorbed locally, posing no risk of exposure to her fetus or to her health care providers. Four years later, the photographer and her child are alive and well. Her vision is 20/20 on the right and 20/60 on the left. Another example of success involves a 42-year-old woman who was found to have a carcinoma of the cervix. A hysterectomy was attempted, but because of positive pelvic lymph nodes, the procedure was not completed. She was treated with linear accelerator external beam irradiation followed by an interstitial iridium-192 implant in the cervix, which delivered 3,500 cGy over four days. She has been disease-free for at least two years with normal sexual function and no apparent bowel or bladder complications.

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Radiation in Medicine: A Need for Regulatory Reform The foregoing discussion of successes and benefits of the uses of radiation in medicine helps to put the Indiana, Pennsylvania, incident in perspective. Nonetheless, that case presents in microcosm many of the complex questions that prompted the IOM study of the NRC's Medical Use Program. Could appropriate public policy have prevented the mishaps that occurred during Ms. Colgan's treatment? Does response to the incident by several federal agencies indicate proper regulatory coverage or regulatory fragmentation and, if the latter, which agency should have taken the lead? Should the federal government have been involved at all, or could a state authority have handled the incident? Would stricter regulations have had any effect, or could regulation instead be loosened without more such mishaps? Indeed, what should be expected from regulations? Can adverse events ever be eliminated entirely? Even the strict regulations, both state and federal, in place in Pennsylvania at the time of this incident did not prevent the human error that caused Ms. Colgan's death. In sum, the Indiana, Pennsylvania, case crystallized the need for a reexamination of the regulation of radiation medicine. 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 10 percent7 of ionizing radiation procedures used for medical purposes. The NRC's Medical Use Program is a minor part of its regulatory responsibilities; it accounts for about 1 percent of the total NRC budget. More than 80 percent of the time and energy of the NRC's employees—and $512 million of its approximately 6   The Atomic Energy Commission was originally authorized to regulate nuclear reactors pursuant to the AEA. The NRC, established in 1974, currently has the authority for nuclear reactors. 7   This percentage of procedures is derived from the information provided in Chapter 2 about procedures in radiation medicine that involve byproduct materials. These data reveal that there are about 800 diagnostic radiology procedures using x-rays per 1,000 population. Thus, more than 200 million x-ray procedures are carried out annually. In radiotherapy, about 500,000 patients are treated with an average of 20 treatments or a total of 10 million treatments. Of these, no more than 20 percent involve byproducts. Eight million nuclear medicine procedures are performed each year, most of which involve byproducts. Thus, of a total of 218 million procedures per year, only 10 million involve byproduct materials, clearly less than 10 percent of the procedures.

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Radiation in Medicine: A Need for Regulatory Reform $525.6 million budget—is spent regulating nuclear power plants. The overwhelming majority of the NRC's professional staff are not health professionals (the staff's expertise is oriented toward technical and engineering skills). The staff of the Nuclear Medicine Safety and Safeguards division of the NRC has no full-time physicians and presently but one medical consultant. Until 1946, when Congress first enacted the AEA, virtually all regulation of radioactive material, none of which was reactor-generated, took place at the state level.8 The AEA provided the Atomic Energy Commission (AEC) authority to regulate possession and use of certain artificial materials for the first time. The AEC's jurisdiction covered radiation and radiation sources (nuclides) produced by nuclear reactors; it did not extend to naturally occurring and accelerator-produced material (NARM) or to machine-produced radiation. The AEA designated the AEC as the agency responsible for establishing a licensing and inspection program for radioactive materials produced in reactors and not used in nuclear weapons or production of electricity. In 1974, the Energy Reorganization Act split the functions of the AEC in two. Congress determined that it was in the public interest for the AEC licensing and related regulatory functions to be separated from the performance of the other AEC functions, and it created the Nuclear Regulatory Commission to do that job. As part of that job, the NRC is responsible for regulating the medical (diagnostic and therapeutic) use of byproduct materials and protecting the public from undue risks attendant upon their use in health care applications. Thus, the NRC regulates the medical use of reactor-generated radionuclides under the auspices of a long succession of legislation and regulatory rules that date back about a half century and that include the Agreement State Program established in 1959. Through this program, the NRC discharges its responsibility in two ways: (1) direct regulation of affected institutions (in the case of 21 NRC-regulated or Non-Agreement States), or (2) through formal agreements with state governors (in the case of the remaining 29 Agreement States).9 The NRC's Medical Use Program, which applies to both the 21 NRC-regulated states and the 29 Agreement States, involves the following responsibilities and activities: (a) registering facilities; (b) registering physicians; (c) annual reporting by each facility; (d) setting criteria for determining misadministration of byproduct materials in medical use; (e) reporting misadministrations promptly; (f) conducting 8   Public Law 79-585, 60 Stat. 755 (1946). 9   Federal Register (FR) 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). The NRC directly regulates administration of byproduct material or radiation from such material in 22 (now 21) states, the District of Columbia, the Commonwealth of Puerto Rico, and various territories, for about 2,000 civilian and military hospitals and clinics. See 56 Fed. Reg. (July 25, 1991) at p. 34104.

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Radiation in Medicine: A Need for Regulatory Reform provider inspections; and (g) applying a system of sanctions for infractions of its regulations. Two categories of radiation medicine are subject to NRC regulation. The first category is nuclear medicine, which uses radioactive drugs (typically containing very small amounts of radioactive materials) primarily for diagnostic purposes but sometimes for therapy, most often for disease of the thyroid gland. The second is radiation therapy as a primary treatment of cancer. 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. According to 1992 data, about half of approximately 1.1 million new cancer cases were treated with some type of radiation therapy. Of these treatments, sealed sources made from reactor-generated byproduct material were used in no more than 25 percent (Selin, 1993); the other 75 percent of radiation treatments stemmed primarily from external beams of x-rays and electrons produced in linear accelerators, and it included a small number of treatments with charged particles and neutrons. This proportionality within cancer treatments, coupled with the very high proportions of the population receiving diagnostic procedures that do not involve byproducts, shows that a vast portion of the use of radiation in medicine is not regulated by the NRC (as noted earlier and in footnote 7). Assuring the safe use of these preponderant and non-byproduct-related materials has fallen to a wide variety of local, state, and federal agencies; despite attempts at federal coordination, the regulation of these sources is fragmented. Evolution of Federal and State Regulatory Programs In 1967 the U.S. Public Health Service established the National Center for Radiologic Health, which later became the Bureau of Radiologic Health (BRH) of the Food and Drug Administration (FDA). By 1968, Congress, realizing that non-byproduct material was not in any way supervised or regulated, passed the Radiation Control for Health Safety (RCHS) act, which established performance standards for devices that emit ionizing radiation. It also directed the Secretary of Health, Education and Welfare to establish and conduct a radiation control program. Although the RCHS act was initially passed in order to control radiation from color television, it included x-ray machines for diagnosis, treatment, research, and education. In 1976 Congress passed the Medical Device Amendment, under which the Bureau of Medical Devices was established to implement the programs created under the 1968 RCHS Act. In 1982 the BRH and the Bureau of Medical Devices

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Radiation in Medicine: A Need for Regulatory Reform TABLE 1.1 Ionizing Radiation in Medicine Subject to NRC Regulation Not Subject to NRC Regulation Reactor-generated byproduct material Naturally occurring radioactive material Reactors Accelerator-produced radioactive material   Machine-produced radiation   X-ray machines   Particle accelerators   • Cyclotrons   • Linear accelerators merged to form the new Center for Devices and Radiologic Health within the FDA. In related activities, the Department of Health and Human Services published in 1985 ''Standards for the Accreditation of Education and General Programs for and the Credentialing of Radiologic Personnel." These regulations were not binding except in federal facilities, but they were advisory to the states. While all of this was occurring at the federal level, the states—spurred by (a) the initial Agreement State Program,10 (b) the need to implement procedures for licensing and regulating the use of ionizing radiation in medicine, and (c) the BRH—voluntarily began to expand their own state radiation health programs. These were usually within the state departments of health. Essentially all the states now have such programs, which are coordinated by the Conference of Radiation Control Program Directors (CRCPD). This group has encouraged the adoption of uniform regulations in the various states and has promulgated regulations that cover all of the uses of ionizing radiation in medicine. Only a portion of the activities of these state programs are federally mandated through the Agreement State Program. The majority of users regulated by the states are involved with other sources of ionizing radiation. THE INSTITUTE OF MEDICINE STUDY As described above, the Indiana, Pennsylvania, incident preceded a weeklong series in the Cleveland Plain Dealer and was followed by Senator Glenn's announcement that he would begin an investigation into radiation medicine. The Senate Committee on Governmental Affairs held a hearing on the regulation of medical radiation on May 6, 1993, to determine the extent of the NRC's authority and to explore the precautions and measures the states take to protect their citizens. The Senate committee also sought to determine the extent to which federal 10   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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Radiation in Medicine: A Need for Regulatory Reform agencies tracked and recorded the kinds of errors and problems illustrated by the Indiana, Pennsylvania, case. At the May 6 hearing, Chairman Glenn questioned whether federal and state regulations on medical radiation adequately protected public health and the rights of those who may be put at risk. 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, 11 stated that the NRC had studied the issues of regulatory coverage of all radiation therapy treatment across the country. In response to Senator Glenn's request to expedite the NRC's consideration of these issues, Chairman Selin promised to provide the committee with a preliminary report on medical radiation protection in three months. After the hearing, an NRC task force was formed, with FDA representation, and it submitted its report to the NRC commissioners on September 15, 1993. That report examined issues and options pertaining to radiation protection of the public health and safety from all medical sources of ionizing radiation: machine-produced; NARM; and byproduct material, the only source regulated by the NRC. The above sequence of events influenced the NRC's decision to seek an external review that would complement an internal management review. According to an internal memorandum the outside study was intended to examine "the basic regulatory rules, policies, practices and procedures to assess whether our current framework for medical use of byproduct material is appropriate to fulfill our statutory responsibilities for public health and safety" (Chilk, 1992). In the winter of 1992–1993, the NRC approached the IOM regarding a study to review and evaluate its Medical Use Program. NRC discussions with IOM senior staff over a period of several months in 1993 led to agreement on the key issues to be examined. The IOM study officially began on January 2, 1994. The NRC Request to the IOM and the Committee Charge In its formal request to the IOM to conduct a detailed independent review and make recommendations for needed changes, the NRC defined three major goals: examine the broad policy issues that underlie the regulation of medical uses of radioisotopes (radionuclides); 11   Ivan Selin resigned his position as chairman of the NRC on March 14, 1995, effective July 1, 1995.

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Radiation in Medicine: A Need for Regulatory Reform study the overall levels of risk associated with the use of ionizing radiation in medicine, assessing (a) the error rates and consequences of the use of byproduct materials in comparison to other medical interventions, and (b) the frequency and consequences of byproduct misadministrations compared to properly conducted administrations; and assess the current statutory or regulatory framework for regulation of the medical uses of byproduct materials. The NRC also asked that the IOM provide recommendations on two major issues: a uniform national approach to the regulation of ionizing radiation in all medical applications, including consideration of how the regulatory authority and responsibility for medical devices sold in interstate commerce for application of radiation to human beings should be allocated among the federal government agencies and between the federal and state governments; and appropriate criteria for measuring the effectiveness of the regulatory programs to protect public health and safety. In response to the NRC's request, the IOM appointed a 16-member interdisciplinary committee chaired by Charles E. Putman of Duke University. The committee membership represented a broad range of expertise in the following areas: medicine (diagnostic radiology, nuclear medicine, radiation oncology, and nuclear cardiology); health physics; economics; quality of care; biostatistics; public health; nursing; law; ethics; regulatory matters; and public policy analysis. In approaching its task, the IOM committee generally accepted the NRC charge as just outlined. The broad policy issues included the adequacy of the 1979 Medical Use Policy Statement and the consistency of NRC regulations and guidance with: the extent of the NRC's responsibility to the patient involved in a misadministration, including that of a federal regulatory requirement for patient notification by the physician; the appropriate role of the NRC medical consultant and the Medical Use Program; and the NRC regulatory policy and whether it could more effectively promote better patient care and safer medical use of radionuclides. With respect to the third goal, the committee determined that a critical assessment of the current framework for the regulation of the medical uses of byproduct must include the appropriateness of the statutory framework—both federal and state—for regulation of both (a) the medical uses of byproduct material and (b) other sources of ionizing radiation used in the medical context. The

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Radiation in Medicine: A Need for Regulatory Reform committee also noted that the NRC is concerned with the appropriateness of the regulatory relationships that exist among the NRC, the Agreement States, the FDA, and various state boards. Especially important is the complicated relationship between the FDA's Center for Devices and Radiologic Health and the NRC. 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. The committee thoroughly reviewed all available information about the Medical Use Program and had extensive discussions throughout its deliberations about the existing system, the accuracy of data, and the effectiveness of the program. Meetings The committee held six meetings, which generally were open to the public; all open sessions were attended by representatives of the sponsor. The first meeting was devoted to organizational matters and planning of the entire study; a briefing by the NRC staff was an integral part of this meeting. Subsequent meetings were concerned with review of background materials, further in-depth briefings by NRC representatives, presentations from outside experts, discussion of issues and information gathered during the various study activities, and early formulation of committee conclusions. The last two meetings were devoted chiefly to discussion of the committee's findings, conclusions, and recommendations and to the production and review of the committee's report. Public Hearing In conjunction with the third meeting, the IOM convened a public hearing to clarify issues and to bring in a broad spectrum of experts and interested parties from professional organizations, industry, and the public. One hundred and thirty-nine societies, organizations, and agencies were invited to submit written testimony and to request an opportunity to give an oral statement. They were also asked to share the invitation letter with any other entity that might be interested. The committee received written testimony from 38 organizations, and 15 respondents requested an opportunity for oral presentation at the meeting. Lists of those organizations that were invited to participate, those that presented statements to the committee, and those that submitted written responses can be found in Appendix H.

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Radiation in Medicine: A Need for Regulatory Reform Technical Panel One technical panel, which included outside experts and representatives from professional societies, focused on quality of care issues generally and the NRC's "quality management (QM) rule" specifically. Quality of care issues (both processes of care and patient outcomes such as mortality and morbidity) in situations involving radionuclides and in circumstances involving other high-technology diagnostic and therapeutic interventions were discussed at a specially convened meeting (see Appendix I for a list of participants). Commissioned Papers The committee commissioned several background or technical papers, to supplement the fact-finding it pursued through workshops and site visits (titles and authors of papers can be found in Appendix J). The topics of these background documents included regulatory issues, risk estimation pertaining to low-level radiation exposure, history of radiation medicine, misadministrations, and perception of risk. Site Visits Groups of three or four committee members and one or two IOM staff made four regional site visits to state regulatory agencies and to major facilities or institutions that use radionuclides. Each site visit involved visits to multiple hospital, county, and state offices and meetings with individual practitioners. Two site visits took place in Agreement States (Georgia and California) and two in Non-Agreement States (Minnesota and Massachusetts12). The site visits were intended to provide representative information from across the nation, and the data gathered from them are not to be regarded as a systematic or comprehensive basis for quantitative analysis. Professional Meetings Attendance by appropriate study staff or committee members at selected professional meetings in 1994 and 1995 provided additional background information and facilitated briefings about the project. 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 Measurements, 12   Massachusetts is in the process of becoming an Agreement State.

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Radiation in Medicine: A Need for Regulatory Reform Radiological Society of North America, Society of Medical Physics, and Society for Nuclear Medicine. Organization of the Report The Summary and Chapter 1 of the report provide an overview. Chapters 2 through 4 present essential background material. Chapters 5 and 6 present the committee's analysis, findings, conclusions, and recommendations. 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. It also describes the form that government control takes with respect to particular sources and uses of ionizing radiation. Chapter 3, "Regulation and Radiation Medicine", provides a comprehensive account of existing regulation, especially by the NRC and the FDA. It also discusses the history and social goals of regulation; the current regulatory framework, both federal and state; and the direct and indirect costs of regulation to the regulated community. Chapter 4, "Risks of Ionizing Radiation in Medicine", is a detailed examination of three aspects of the issue of risk: (1) risk assessment as a conceptual and methodological tool applied to radiation medicine; (2) actual and hypothetical risks determined to exist in the use of ionizing radiation in medicine; and (3) the public's perception of risk. Chapter 5, "Alternative Regulatory Systems", outlines the major alternative regulatory systems developed and considered by the committee and proposes the optimal alternative to supplant the existing regulatory structure. Chapter 6, "Findings, Conclusions, and Recommendations", presents the outcome of the committee's work to Congress, the NRC, and the CRCPD and states. Scope and Limitations of the Report All exposure to ionizing radiation has biological effects. Although it is used in industrial as well as medical settings, examining all ionizing radiation regardless of the context is certainly beyond the scope of this committee's charge. Nevertheless, the committee believes that ionizing radiation in all its uses should be scrutinized to determine whether centralizing its regulation is a viable option. The 1994 General Accounting Office report Nuclear Health and Safety: Consensus on Acceptable Radiation Risk to the Public Is Lacking (GAO, 1994) was reviewed by the committee. The report describes the existing federal regulatory regime for radiation as inconsistent, overlapping, and incomplete. After affirming that the GAO assessment of the disjointed federal regulatory system was valid, the committee focused on its more limited charge, turning its attention specifically to ionizing radiation in medicine.

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Radiation in Medicine: A Need for Regulatory Reform Much of the fractured nature of authority arises from the varied sources of and uses for radiation. This committee, however, sees much more similarity than difference between the subjects of these regulations. The risks of ionizing radiation are determined by the type of particle, energy level, and absorbed dose, not by the nature of the source. In medicine, both machine-produced radiation and radionuclides (natural and anthropogenic) are used in a variety of tasks, from diagnosis to treatment to research. As far as the patient is concerned, it makes little difference whether the source of the ionizing radiation is natural, a machine, or a reactor byproduct. Thus, protecting patients should be done uniformly and without undue variation solely on the basis of the source of the radiation. Similarly, all worker exposure to ionizing radiation must be scrutinized, regardless of the source. To be sure, differences exist between x-ray machines and accelerators (which can be shut off) and radioactive materials whether byproducts or accelerator produced. Because radioactive materials continue to generate ionizing radiation before and after treatment is administered, they must be watched carefully during shipment, storage, and disposal as well as during patient treatments. Nevertheless, similarities between the sources are much greater than the differences. At present, however, reactor-generated byproduct materials are much more stringently regulated (at the federal level) than are naturally occurring and accelerator-produced materials (NARM) or machine-produced radiation (regulated at the state level). The NRC asked the IOM to address the issue of appropriate criteria for measuring the effectiveness of the regulatory programs to protect public health and safety. The task of conceptualizing such criteria is extremely difficult and should not be underestimated. The committee determined that it did not possess the requisite expertise to undertake this task. In addition, those on the committee who were experts in regulation did not believe that the committee would make any headway in this area and recommended that it not be pursued. The discussion throughout this report focuses on "quality management" as the concept has been defined by the NRC and put into operational form through its QM rule. The committee recognized, however, that issues relating to the measurement and improvement of quality of health care go far beyond this narrow interpretation. Given the complexities of its charge, the committee opted not to examine issues relating to quality assurance in any detail, but it recognized that the NRC's approach was not consistent with contemporary efforts by health care institutions and plans to implement continuous quality improvement programs within their own facilities and by their own practitioners and members. It was beyond the scope of this committee's study and report to do a full-scale cost-benefit analysis on the medical uses of reactor-generated byproduct materials. Although the committee tried to follow the spirit of cost-benefit analysis, it did not attempt to translate the various effects into dollars. The committee believed recommendations could be made without this difficult step.

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Radiation in Medicine: A Need for Regulatory Reform Nor did the committee's charge include an examination of the risks associated with various forms of therapeutic and diagnostic treatment of ionizing radiation in medicine. This issue extends beyond the scope and abilities of the committee, especially when considering the inability of the scientific community to come to any consensus on these matters. Furthermore, the committee's charge did not include an examination of the overuse of x-rays and radiation in other procedures. The current federal regulations attempt to address misadministrations, not overuse. Another consideration was the lack of complete, accurate data regarding the frequency of misadministrations (see Chapter 3). FDA regulations focus on medical device efficacy and devices that malfunction or cause serious injury or death—and not on administration of treatment, physician prescriptions, or other causes of misadministrations (except for the Mammography Quality Standards Act). Misadministration data are not maintained on linear accelerators (only data on serious malfunction of the machine are reported), and consequently there is no way of determining the role of misadministrations with respect to accelerators. Nor are there reliable data to assess the level of risk and effectiveness of regulatory programs for non-byproduct sources of radiation. Lastly, although this report critically examines several aspects of the NRC's regulatory and enforcement program, the committee recognizes that the NRC is in a very difficult situation. The NRC's programs reflect a federal legislative mandate that requires the NRC to be self-funded through dollars collected for licensure and inspection. 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. These are systemic conflicts over which the NRC has no control. CHAPTER SUMMARY Concern is widespread among the states, the Congress, the NRC, and the regulated community that the existing system for regulating radiation medicine needs to be rethought and reformulated. The overarching question on the part of the IOM committee was whether the scientific data on risks from radiation medicine justify the extensive regulatory system for byproduct materials currently in place, particularly when compared with the regulatory systems imposed upon non-byproduct radiation and on other modalities of medical care. Use of ionizing radiation in medicine, termed "radiation medicine" in the generic sense in this report, is extremely widespread, and it is of great benefit in the diagnosis and treatment of disease. It is also unevenly regulated. The hazards associated with the use of ionizing radiation must be balanced against both the

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Radiation in Medicine: A Need for Regulatory Reform benefits to the health of the population and the costs of regulation to society. The number of lethal or highly morbid adverse events appears to be small, at least as can be determined from the available information. The findings of the committee point to the need for improved databases on the actual incidence of adverse events and severe misadministrations. The apparent low incidence of adverse events suggests that the stringent NRC regulation of the practice of medicine may not be warranted. It is clear, however, that all uses of ionizing radiation call for some level of regulation and that this regulation needs to be made more consistent and coordinated. 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. REFERENCES Chilk, S.J. NRC Memorandum for James M. Taylor, Subject CHILK, Comis-92-026-Review of the Regulation of the Medical Use of Byproduct Material, December 21, 1992. GAO (General Accounting Office). Nuclear Health and Safety: Consensus on Acceptable Radiation Risk to the Public Is Lacking. RED-94-190. Washington, DC: General Accounting Office, 1994. NRC (U.S. Nuclear Regulatory Commission). Loss of an Iridium-1992 Source and Therapy Misadministration at Indiana Regional Cancer Center, Indiana, Pennsylvania, on November 16, 1992. NUREG 1480. Washington, DC: Nuclear Regulatory Commission, 1993. Selin, I. Statement Submitted by Chairman of the NRC to Committee on Governmental Affairs, U.S. Senate, 1993.