Re: [FDA] Radiation-Induced Skin Injuries from Fluoroscopy

[John Moulder <jmoulder@post.its.mcw.edu>]

> > FDA has received a number of reports of serious radiation- 
> > induced skin injuries resulting from prolonged fluoroscopic 
> > imaging during interventional therapeutic procedures. 

I talked earlier today to someone who was involved in one of these incidents.  
In their case it was a malfuntion of the unit which resulted in a dramatic 
increase in dose rate.  

Sorry, I don't know enough about the engineering to understand the details, 
but it had to do with the "pulse mode" failing.  Fortunately, the tube blew 
soon afterwards, so only one patient was overdosed.

The dose was medically serious -- high enough to produce a substantial skin 
reaction (moist desquamation to be precise).  They're gestimating the skin 
entrance dose at 15 Gy, but from my experience with radiation-induced skin 
reactions in animals, they may be underestimating.

Naturally, they're not talking on the record to anyone but the FDA and the 
company who made the unit (and probably their lawyers), and don't want to be 
identified by name or institution.

But if you've got a fluoro unit that could fail in a manner like this, maybe 
you should talk to the FDA.
John Moulder (jmoulder@its.mcw.edu)
Radiation Biology Group
Medical College of Wisconsin