ML20006B911
| ML20006B911 | |
| Person / Time | |
|---|---|
| Issue date: | 01/19/1990 |
| From: | Carr K NRC COMMISSION (OCM) |
| To: | Alazraki N AMERICAN COLLEGE OF NUCLEAR PHYSICIANS |
| Shared Package | |
| ML20006B912 | List: |
| References | |
| NUDOCS 9002060086 | |
| Download: ML20006B911 (2) | |
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' **%o hk UNITED STATES l
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NUCLEAR REGULATORY COMMISSION n
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j WASHINGTON, D. C. 20666
%Qg January 19, 1990 CHAIRMAN Naomi.P. Alazraki, M.D.
President-Elect,'SNM i
American College of Nuclear Physicians The Society of Nuclear Medicine 1101 Connecticut Avenue, NW Suite 700 Washington, D.C.
20036
Dear Dr. Alazraki:
I am responding to your letters of November 1,1989, and December 4,1989, regarding the nuclear medicine community's concerns about some> of the Nuclear Regulatory Commission's (NRC's) regulations for the medical use of byproduct 3
material.
I was pleased to meet with you in October to' discuss these matters, j
The.NRC is interested in your views and is working to improve our regulations '
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to ensure protection of the public health and safety while not impeding the
-l delivery of medical care.
I have noted the additional-facts and details you; submitted;in your letter regarding the safety record of the; nuclear medicine l
community, the risk-of nuclear medicine procedures, and existing programs for-quality control. This information will be part of the public record and will l
be considered by the NRC staff 1n developing and implementing: regulations for 1
the medical use of byproduct material.
1 We agree that the frequency of misadministration in nuclear medicine is rela-i tively low when compared to that;of other medical specialities. 'We also agree that mean excess doses of 100 mrem per diagnostic. misadministration and a collective dose of 100 rem per year due to all misadministrations in the diagnostic range do not represent a significant risk when viewed in broad terms. While the nuclear medicine community can be proud of its performance in protecting the public, neither the.NRC nor the medical community should.be-d complacent about this performance.
The average individual and collective doses due to misadministrations mask the significance of misadministrations to individuals.
For example, several times a year hospitals report that therapy 3
doses of iodine-131 are mistakenly given to patients scheduled for diagnostic-scans, and errors in sealed source and radiopharmaceutical therapy result in-excess doses on the order of-1000 rad to organs.
Fortunately, death'due to acute radiation effects caused by these types of errors is rare. However,. loss of organ. function and the need for compensatory medical therapy are not-uncommon and elevated doses associated with misadministrations unnecessarily increase the risk of-latent cancers in patients.
1 I/
9002060086 900119 PDR COMMS NRCC CORRESPONDENCE PDC
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Naomi P. Alazraki, M.D. '!
The types of errors which cause misadministrations appear to be avoidable.
The intent of the proposed medical quality assurance rule is to ensure that all-medical programs using NRC-licensed materials have in place procedures to avoid or mitigate the consequences of the types oT human errors which lead to mis-admir.istrations. These quality assurance procedures should be consistent with-good medical-practice and easily incorporated into routine operating proce-dures. We are seeking the advice and assistance of the medical community to t'
achieve this objective.
We do not understand your comments that radiographers are the sole cause of accidents that result in doses on the order of 100 rem and that they are hardly-regulated at all. Licenses authorizing industrial radiography are specific-licenses, not general licenses.
Industrial radiographers are governed by regulations which are at least as comprehensive as those pertaining to nuclear i
medicine. Radiography operations are inspected by NRC at least once each year and have been the subject of numerous NRC enforcement actions. Also, signifi-cant overexposures are not limited to industrial radiography.
As mentioned,-
medical therapy utilizing byproduct material has resulted in misadminstrations producing doses of 100 rem or greater than that prescribed.
If you mean physicians performing x-ray fluoroscopy, they are regulated by the States, not l
the NRC.
I appreciate your offer to work with the NRC to develop improved regulations, L-training materials to reduce the chance of misadministrations and improve radiation safety practices, and a Visiting Fellows Program. Although the Visiting Fellows Program is still in the conceptual stage, the Commission encouraged staff to pursue potential assignments for Visiting Fellows-in areas of emerging medical technologies and procedures where the Commission needs to concentrate efforts to ensure that regulations are adequate for future medical applications.
In addition, the Comission encouraged staff to pursue' offers from key medical use organizations to make available short-term sabbatical positions for NRC staff to enhance our understanding of the regulated-community. The staff looks forward te working with you and the Society of-Nuclear Medicine in-developing and implementing the Visiting Fellows Program.
Sincerely, a.: W Kenneth M. Carr i
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