FDA Regs for Fluoro -Reply

[Kathleen Kaufman <KKAUFMAN@dhs.co.la.ca.us>]

There are two different requirements, based on when the equipment
was manufactured. If manufactured before May 19, 1995, it cannot
exceed 5 R/m if the unit has hi-level (HL), unless you are in HL. Once in
HL, there is no limit. If the unit is manufactured on or after May 19, 1995,
it must have AEC to exceed 5 R/m, i.e., can go to 10 R/m, but there is a
20 R/m limit when in HL (except for those exceptions you noted).
The reason for all this is because under the older regs, since the unit
was restricted to 5 R/m, it simply forced the user to go into HL, & the
patient most likely got more dose than they might have needed had they
been allowed to go to 10 R/m. Also, some of the exposure rates in HL
were REALLY high ( we once measured one @ 119 R/m), & so it was
thought prudent to put a limit on HL.

kkaufman@dhs.co.la.ca.us


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