[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

RE: Fwd: Fluoroscopic abdomen phantom



We at FDA/CDRH are already contemplating regulations on fluoro dose 
rates (and other issues).  Some of the areas of consideration, which 
were discussed this spring at the meeting of the Technical Electronic 
Product Radiation Safety Standards Committee (TEPRSSC) are posted on the 
FDA web site at

    http://www.fda.gov/cdrh/teprssc.html

The stuff there is preliminary ideas and concepts.  Any input is 
welcome.  I'll serve as target.

We are getting too many reports of patients being injured (radiation 
burn) during fluoro (interventional) procedures.  see    

http://fda.gov/cdrh/radinj.html

The official change proposal is still being written, so input from the 
community is welcome.

Ed Tupin
RSO, Center for Devices and Radiological Health
Food and Drug Administration
EAT@cdrh.fda.gov
(301) 827-1230
Fax:  (301) 594-4760