ML20236T765

Summarizes Comments Received from Advisory Committee on Medical Uses of Isotopes on Misadministrations Package. Comments Made in Ref to 870102 Mailing

ML20236T765
Person / Time
Issue date:	07/15/1987
From:	Mcelroy N NRC
To:	NRC
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References
FRN-52FR36942, RULE-PR-35 AC65-1-034, AC65-1-34, NUDOCS 8712020078
Download: ML20236T765 (1)

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90/2 36 Summary of comments received from members of the Advisory Committee on the Medical Uses of Isotopes on the Misadministration package. The comments, submitted by letter or telephone, were made in reference to a mailing made January 2,1987.

1. Some of the suggested doses in the eirly discussion text do not apply to certain diseases. A lawyer could use this to generate a lawsuit. You should see the recent RSHA publication on treatment planning for additional guidance.

The number of cobalt patients isprobably 75k each year, and a total of 400k radiation treatment patients each year. Brachytherapy is on the rise. Precision of 10% in calculating brachytherapy doses is difficult at best. Independent measurements of treatment doses will add to cost. Consider other units for measuring source strength. Who is finally responsible for treatment planning; section 35.43 may cloud this. The remainder of the regulatory text seems to be all right.

2. Lawyers will love this, but that is unavoidable. You should use a standard definition for negligence because that is what we are dealing with here. A uniform chart may help. Note that 10 and 20% criteria are silly because you ,

can't describe a set of isodose curves with a single number. '

3. I am concerned with the interpretation and implementation of this. For checking dose calculations, there must be an acceptance / rejection criterion.

New personnel will be needed and may not be available in small hospitals. I have reservations about this. The government will be telling people exactly what to do. Next there will be Federal prescriptions.

4. Small users may have trouble complying with this. There should be a good cost /

benefit basis for this. Expand the scope of the " unusual configuration" text, and clarify what you mean by independent check. There must be a prescription before tharapy is administered. Checks of brachytherapy implants are almost impossible to do, especially for I-125 seeds. A three-point check may suffice.

The 20% and 50% triggers for dose calculation checks are reasonable. Beware that manual checks of calculations are less sophisticated than computer checks, for example a 20% lung correction factor, and corrections for body slope, bone density, and field shape.

5. It doesn't seem necessary to have two individuals make physical measurements of patients. For low dose prescriptions, the 20% check criterion may be unworkable.

A dose calculation for temporary brachytherapy implants is reasonable, but not for permanent implants. It is rare that two people would not be able to check calculations due to pressing medcal need. Clarify what you mean by measuring system. Is it a second in-house system, or an independent outside system.

Thermoluminescent dosimeters in tissue-equivalent material by mail would be an appropriate answer.

This summary was prepared July 15, 1987.

m Norman L. McElroy g20go78871201 -

3,5 ,52FR36942 PDR

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