FDA Regs for Fluoro

[Chris Alston <alstonc@odrge.odr.georgetown.edu>]

>Subject:      FDA Regs for Fluoro
>To: MEDPHYS@LISTS.WAYNE.EDU
>
>I have been reviewing 21CFR1020 (FDA rules on X-ray equipment) because
>the State of Ohio has incorporated these rules as the standards for
>QA/QC.  While reviewing part 32 on fluoroscopes I succeeded in
>confusing myself.  (Please hold your applause until the end.)  Part
>32(c)(1) seems to say that if a fluoroscope has automatic exposure
>rate control (AERC) its output is limited to 10 R/min at the patient.
> If, in addition, the fluoroscope has a high-level control, the output
>is restricted to 5 R/min at the patient except when the high-level
>control is in operation.  No limit is put on the exposure rate from
>the high-level control.
>
>Further down, Part 32(e) states that if a fluoroscope is capable of
>being operated at a rate greater than 5 R/min it must be equipped
>with AERC, in which case the output is limited to 10 R/min.  The
>output can go higher (apparently without limit) if images or made on
>film from the II or if a pulsed mode is used for video imaging.  If
>an optional high-level control is used the output is limited to 20
>R/min.
>
>Part 32(e) is the part I'm familiar with.  But how do I interpret
>Part 32(c)?  Are the two really at odds with each other or did I miss
>something?
>
>                    *****
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Chris Alston
alstonc@odrge.odr.georgetown.edu
I am not here a representative of my employer.

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