ML20046D066
| ML20046D066 | |
| Person / Time | |
|---|---|
| Issue date: | 07/21/1993 |
| From: | Siegel B NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20046D057 | List: |
| References | |
| NACMUI, NUDOCS 9308160092 | |
| Download: ML20046D066 (3) | |
Text
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tg NUCLEAR REGULATORY COMMISSION "q s,4 wasmNGTON, D C. 20555 @ 01 MEMORANDUM FOR:
Carl J. Paperiello, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Barry A. Siegel, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes
SUBJECT:
SUMMARY
REPORT - MEETING 0F THE ADVISORY COMMITTEE ON THE MEDICAL USES OF IS0 TOPES, JULY 8, 1993 The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held a special teleconference meeting on July 8, 1993.
Committee members who took part via telephone included:
Barry A. Siegel, M.D., Chairman Peter R. Almond, Ph.D.
Judith I. Brown Melvin L. Griem, M.D.
Joan A. McKeown Carol S. Marcus, Ph.D., M.D.
For FDA:
David H. Woodbury, M.D., FDA [via telephone]
Donald R. Hamilton [present]
Present were: John E. Glenn, Ph.D, Nuclear Regulatory Commission (NRC),
(Designated Federal Official for the panel), and Larry W. Camper, Section Leader, Medical and Academic Section, NRC, and Richard Vollmer, Director of Policy and Planning, NRC.
John E. Glenn, Ph.D., opened the meeting at 11:40 a.m.
Richard Vollmer of the NRC's Office of Policy and Planning initiated.the discussion and provided background information to the ACMUI. He indicated that the Senate Committee on Governmental Affairs met on May 6,1993, to consider the allocation of regulatory responsibility for the medical uses of ionizing radiation.
This Committee requested a report from the Commission that would delineate the options for improving the current regulatory program.
Chairman Selin committed to provide a preliminary report by August 6, 1993.
Accordingly, a task force consisting chiefly of NRC staff, but including liaison representation from FDA, was convened to develop this-report for the Commission.
The task force was charged by the Commission with the principal objective of characterizing the problem, to the fullest extent possible, based on currently available information. The task force also was asked to identify those legislative and regulatory options worthy of careful evaluation and to.
identify the data base that would be necessary for a critical evaluation of 93081o0092 930721 PDR ADVCM NACMUI PDR
t Carl J. Paperiello 2
those options. Mr. Vollmer further indicated that the object of this preliminary effort was not to recommend specific, final solutions to any perceived problems. Rather, the Commission had instructed that recommendation of solutions should be delayed until completion of the independent assessment of the medical use program to be performed by the National Academy of I
Sciences.
Mr. Vollmer stated that what the task force seeks from the ACMUI is its views on the characterization of the issues as presented in the task force's draft document, entitled " Issues Relative to Radiation Safety in the Medical Uses of lonizing Radiation."
I During the ensuing discussion, the ACMUI did not provide commentary on each and every item in the draft list of issues compiled by the task force.
l Rather, the ACMUI focused its attention on the following issues.
The Health and Safety implications of Radiation use in Medicine. and Data Base Needed to Assess These Implications.
It was the nearly unanimous consensus of the ACMUI that the wisest thing the task force could recommend would be a critical scientific evaluation of adverse events in all areas of nodicine in order to determine whether adverse events associated _with uses of ionizing radiation in medicine warrant more
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regulation, less regulation, or about the same level of regulation for nuclear medicine and radiation oncology as for the rest of medicine.
Getting better data to characterize the problem should be the highest priority and should be done before the other issues are addressed.
The ACMUI recommended that the i
National Academy of Sciences would be the best organization to perform such a study, which should be accomplished independently of any particular Federal agency.
Ms. Brown, while agreeing with the need for better data, cautioned that getting such data would be difficult given the wide variability in data i
collection by the states. Accordingly, she favored requiring that the reporting by the Agreement States of misadministrations in a form compatible with NRC regulations should be accomplished before 1995. Dr. Almond noted i
that the evaluation of the problem does not require every bit of data from both NRC-regulated and Agreement states; sampling methods are available that will allow for statistically reliable conclusions without access to all data.
Ms. Brown further dissented by indicating her concern that comparing outcome and injuries in nuclear medicine and radiation oncology with those occurring in other areas of medical practice does not seem a useful exercise; the goal i
of regulatory agencies should be to achieve high quality in all areas of medical care. Other Committee members retorted that the regulatory approach cannot ignore costs and, thus, comparative data were appropriate to insure wise allocation of the nation's limited resources for healthcare.
Uniformity i
The ACHUI expressed the general consensus that uniform national standards for i
radiation protection were appropriate, but uniform prescriptive regulations l
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Carl J. Paperiello 3
governing medical practice were unnecessary and would limit medical flexibility. There also was consensus that, if there were uniformity by way of a single national regulatory authority, such authority should be vested within a department or agency that has responsibility for regulation of all medicine and not within an agency that has " tunnel vision" as a consequence of its narrowly constructed responsibilities for radiation safety.
Lack of a global medical perspective has the potential to result in increasing and inappropriate over-regulation of nuclear medicine and radiation oncology without clear benefit to the general public welfare.
Ms. Brown dissented and advocated the need for a single national regulatory authority in order to allow for concentration of the highest level of expertise within a single organization and to allow for easiest access of the general public to such expertise.
Trainina and Exoerience The ACMUI recommended that the task force study the minutes and transcript of the Committee's May, 1993 meeting. At that meeting, the ACMUI discussed the need for a " paradigm shift" in the approach to establishing training and experience criteria for licensure and in validating the training and experience of authorized users.
The Committee reiterated its belief that the focus of the NRC and States with respect to licensure for use of ionizing radiation in medicine should be radiation safety, and that training and experience criteria should be closely linked to the type of use of ionizing radiation and hazard posed by such use to patients, occupational workers, and members of the general public.
Communication
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The Committee agreed that the task force had identified the appropriate issues in this area, and that it would be hard to argue against the need for improved communication.
Written comments submitted to Dr. Siegel by several ACMUI members prior to the teleconference were accepted into the record.
Dr. Glenn invited other Ccmmittee members to submit supplementary written comments.
Dr. Glenn declared that the meeting was closed at 1:15 p.m.
d MD Barry A. Siegel, M.D., Chairman Zl $ (y (%3 (Da'te)