ML20126C339
| ML20126C339 | |
| Person / Time | |
|---|---|
| Issue date: | 07/02/1982 |
| From: | Jennifer Davis NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Michelson C NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| Shared Package | |
| ML20126C180 | List:
|
| References | |
| FOIA-84-720 NUDOCS 8506140387 | |
| Download: ML20126C339 (1) | |
Text
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!!EMORAfiDUM FOR:
Carlyle Michelson, Director Office of Analysis and Evaluation of Operational Data s
FROM:
John G. Davis, Director Office of tiuclear Material Safety and Safeguards
SUBJECT:
10DIllE-125 SEALED SOURCE LEAKAGE ItiCIDEtiTS Thank you for your memorandum dated May 25, 1982, suggesting that there may be a generic problem associated with the use of iodine-125 seeds in cancer patient therapy.
Enclosed is a copy of a memorandum which I have received from Dick Cunningham, providing his assessment of the problem and outlining actions we plan to take to resolve this issue.
. With regard to your specific recosaendations, we are coordinating with IE in preparing a second information notice, and we are taking steps to obtain a medical consultant to assist in our evaluation. After we have obtained the consultant's report and any 3M conaents, we will complete our in-house evaluation of what additional requirements, if any, should be imposed upon 3M and/or the medical licensees.
Thank you for your assistance in this matter.
(Signed) John G. Davis John G. Davis, Director Office of Huclear Material Safety and Safeguards
Enclosure:
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JUN 3 01932 HEHORAtIDUM FOR:
John G. Davis, Director Office of Nuclear Material Safety and Safeguards Richard E. Cunningham, Director FR0H:
Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards AE00 REVIEW OF 10 DINE-125 SOURCE LEAKAGE INCIDENTS
SUBJECT:
We have reviewed the AE00 report enclosed with Mr. Michelson's memorandum 25,1982, discussing iodine-125 sealed sourt,e leakage incidents.
dated llay As discussed in the AEOD report, HMSS wrote to 3M in July,1981 concerning the leakage incidents, and as a result 3M added a warning notice for users To our knowledge, no incidents have been identified of the iodine-125 seeds.
since the warning notice was added. However, it is entirely possible that In any incidents have occurred, but were not recognized by the licensees.
case, we still consider this to be an unresolved problem.
Our preliminary evaluation is as follows:
The fod'ne-125 seeds are inherently fragile, and the leaks 1.
However, we have not were prcbably caused by rough handling.
ruled our. the possibility that a manufacturing defect is involved.
We agree with AE0D that the test data provided by 3M is not con-clusive.
The seeds may need to be inherently fragile, in order to be 2.
Therefore, if 3M is mquired to make the medically effective.
seeds stronger, the medical effectiveness could be reduced.
A leaking seed can deliver a dose of up to 100 rads to the cancer 3.
patient's thyroid. This potential risk must be balanced against the nadical benefit of the cancer therapy. There is also the risk of laboratory contamination prior to implantation of the seeds.
For perspective, a diagnostic thyroid scan using I-131 delivers 65 to 4.
90 rads to the thyroid. Treatment of hyperthyroidism involves doses in excess of 1000 rads to the thymid.
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In order to resolve these issues. we plan to take the following actions:
1.
As recomended by AEOD, we will coordinate with IE to develop 5
a supplemental information notice for medical licensees.
2.
We will inform 3M of our preliminary evaluation, and request sup-I plemental information and cocinents as to their evaluation of the problem.
3.
As suggested by AEOD. we will ical consultant to assist in our independent evaluation MM in rse us s available to prov'de th.s ass' stance.
$spresentlyundercontract to NRC as a consultant in se s'cs.
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4 After obtaining appropriate infonnation and recournendations, we will complete our risk / benefit analysis, and identify what h
requirements if any, should be imposed upon 3M and/or medical licensees.
We anticipate that the IE information notice will be sent to ifcensees within 30 days, and that input can be obtained from 3M and our consultant within 60-90 days. Within 30 days thereafter, we should be able to identify the requiremen$
h which should b d if any. However, this schedule depends on our ability to us ithin current limits placed on " full time equivalents".
Original Signed 'tiy l
Richard E. Cunningham Richard E. Cunningham, Director Division of Fuel Cycle and Haterial Safety i
Office of Nuclear Material Safety and Safeguards H
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