[ RadSafe ] Radiation Bio-Assay - Are or Should Methods be FDA Approved?

[Clayton J Bradt]

Yes, Cindy I agree, but let's take your scenario to the next step:

Once the screening is done and it is determined that an intake is likely 
to have occurred and medical evaluation is needed, what does the attending 
physician do to confirm the identity of the radioactive material and 
quantify the intake? What tests does the physician order? If samples of 
tissue or excreta are taken and sent to a lab for analysis are the 
reagents, processes, and protocols used to do the analysis required to be 
FDA approved? The results will be used to determine a course of medical 
treatment. Now if the physician did the analysis himself there would be no 
issue - it's the practice of medicine and is not regulated (except by 
malpractice lawyers). But if it is an outside lab or even a lab in the 
attending's hospital that does the analysis, it is not obvious to me 
whether or who regulates.


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I guess I would argue that in most cases the purpose of bioassay is for 
regulatory compliance , i.e., to provide assurance that regulatory limits 
are not exceeded.? This would be similar to the use of external dosimetry 
.? In both examples, when regulatory limits are far exceeded, it might be 
appropriate to suggest medical surveillance/intervention and at that time, 
further testing might fall into the FDA's purview.? I would also argue 
that emergency screening is done not to cure, mitigate, treat or prevent 
disease, but to determine if further?evaluation, e.g., a medical 
evaluation is warranted. 
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Clayton J. Bradt
Principal Radiophysicist
NYS Dept. of Health
Biggs Laboratory, Room D486A
Empire State Plaza
Albany, NY 12201-0509

518-474-1993