[ RadSafe ] Radiation Bio-Assay - Are or Should Methods be FDA Approved?
Clayton J Bradt
CJB01 at health.state.ny.us
Wed Feb 29 13:32:36 CST 2012
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
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