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

radbloom at comcast.net radbloom at comcast.net
Wed Feb 29 16:53:53 CST 2012



I agree with you regarding the confusion of the next step.  It's not clear to me that the attending physician necessarily needs to confirm the identity of radioactive material and quantify an intake; it seems likely that continued bioassay monitoring would occur by the person responsible for the radioactive material, because that person is responsible to quantify the dose.  I think clever lawyers could argue either side of the case as to whether or not FDA approval is required for any followup "medical" (but wouldn't this also be necessitated-by-regulation) bioassay , and I feel like I should do a bit of research before I do too much guessing.  :) 


I would think there would be similar issues in industrial hygiene, as well as in the analyses for toxic substances.  Maybe a radiochemist or hospital-associated list member will offer their thoughts about what protocols and approvals might currently be in place in the medical setting.  

Cindy Bloom 


----- Original Message -----

From: "Clayton J Bradt" <CJB01 at health.state.ny.us> 
To: radbloom at comcast.net 
Cc: radsafe at health.phys.iit.edu 
Sent: Wednesday, February 29, 2012 2:32:36 PM 
Subject: Radiation Bio-Assay - Are or Should Methods be        FDA Approved? 

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. 
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. 

Clayton J. Bradt 
Principal Radiophysicist 
NYS Dept. of Health 
Biggs Laboratory, Room D486A 
Empire State Plaza 
Albany, NY 12201-0509 


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