Radiation in Medicine A Need for Regulatory Reform (1996) / Chapter Skim
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Appendix H: Public Meeting Documents
Appendix H: Public Meeting Documents
Pages 259-280
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From page 259... ...
American Board of Internal Medicine 14. American Board of Nuclear Medicine (ABNM)
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American Radium Society 49. American Roentgen Ray Society (ARRS)
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Society of Nuclear Medicine (SNM)
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Veterans Administration RADIATION IN MEDICINE COM~TEE FOR REWEW AND EVALUATION OF THE MEDICAL USE PROGRAM OF THE NUCLEAR REGULATORY COMMISSION PUBLIC MEETING ANNOUNCEMENT AND REQUEST FOR WRITTEN TESTIMONY The Institute of Medicine (IOM) Committee for Review and Evaluation of the Medical Use Program of the Nuclear Regulatory Commission (NRC)
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Although a limited number of organizations will be invited to present oral testimony and to respond to the committee's questions, the committee urges you to submit written testimony, which will be given equal consideration to the oral testimony. One invitational session, a day long, will be convened in Washington, D.C.
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Who should bear the ultimate responsibility for devising appropriate quality assurance programs? Professional associations such as ICAHO, ACR, AAPM, etc.?
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American Association of Clinical Endocrinologists American Association ofPhysicistsin Medicine American Board of Nuclear Medicine American Board of Radiology American Brachytherapy Society American College of Medical Physics American College of Nuclear Physicians American College of Radiology ~ The organizations in italics presented oral testimony at the public hearing.
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Does the cumat regulatory structure pertaining to the medical uses of ionizing radiation provide adequate safeguards to protect the public's health and safety? If not, how might the respective roles of various Federal and State authorities be revised to assure greater patient safety and cost effectiveness?
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The current regulatory structure simply does not reflect this reality. Burdening health care providers with excessive regulation and diverting the time and efforts of highly compensated professional and technical personnel from patient care to regulatory compliance causes health care costs to escalate and impedes the delivery of effective care"(NYH-CMC)
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. The majority believed that the existing regulatory structure adequately protects the public's health and safety, but there was sentiment that the cost/benefit ratio is disproportionate and should be reevaluated.
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In response to this question we received 21 replies: 16 from professional associations, societies, and industry; 3 from states; and 2 from miscellaneous sources. Although there was no singular answer to this question, there seemed to be widespread agreement that the current regulatory structure was, as one association explained, "very expensive, time consuming and inhibitory" (ABNM)
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From page 270... ...
. "While the Quality Management rule codifies a concept that is already fairly well established, it also adds a significant paperwork burden for all licensees, keeps the regulator busy reviewing the accumulated paper rather than evaluating the actual radiation safety practice of the institution, and potentially generates civil penalties which distract the licensee from needed radiation safety improvements....
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From page 271... ...
Four stated there should be a single agency, but did not identify an existing one or state whether there should be a new one. One respondent said responsibility should be split between the FDA and the NRC, with the FDA regulating electronic product radiation and the NRC regulating all radioactive material used in medicine.
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From page 272... ...
In response to this question we received 28 replies: 18 from professional associations, societies, and industry; 7 from states; and 3 from miscellaneous sources. There was widespread consensus that the current regulatory framework is too elaborate, expensive, and time intensive relative to the actual risks associated with diagnostic applications.
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If not, why not? In response to this question we received 19 replies: 15 from professional associations, societies, and industry; 2 from states; and 2 from miscellaneous sources.
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From page 274... ...
In response to this question we received 26 replies: 18 from professional associations, societies, and industry; 5 from states, and 3 from miscellaneous sources. Although the response was not unanimous, there appeared to be overwhelming consensus that the various professional associations should be entrusted with the task of devising appropriate quality assurance programs.
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"The Boards of Medicine and the professional associations, with input solicited from the appropriate state and federal agencies, should bear ultimate responsibility for devising the appropriate quality assurance program" (CORAR)
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currently approved by the United States Department of Education." "Illinois requires minimum standards of education, including continuing education, for persons who perform medical radiography, nuclear medicine technology
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In addition, there are still 35 states which have no requirements for technologists who use radioactive materials and perform nuclear medicine procedures. While the Act describes minimum standards, there has been little guidance provided to the states on implementation of these standards." Question 10 (N = 24)
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From page 278... ...
However, the professional associations and accreditation bodies must have responsibility for establishing quality programs and local committees for local implementation" (ARRS)
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From page 279... ...
In response to this question we received 16 replies: 13 from professional associations, societies, and industry and 3 from the states.- The overwhelming number of respondents agreed that continuing education and in-house training were the best means of assuring a competent work force. A smaller number suggested that testing was also important.
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From page 280... ...
. "The needless over-regulation of medicine has become cumbersome, difficult for patients, and more expensive at no benefit to the patient or to the regulating agencies beyond the apparent self-serving need to perpetuate multiple agencies with ambiguous role and scope definition, unnecessary redundancy and predictable excessive delays, and increased costs" (ARRS)
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