Re: FDA Regs for Fluoro

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

>The citation you spoke ofis 21CFR1020 "32(c)" and 32(e)".  I believe
>the first part has a typo and is actually 32(d), "Entrance exposure
>rates"? 32(c) is "Activation of tube", the deadman activation reg.
>
>The confusion may be due to the fact that 1020.32(d) applies to equipment
>manufactured BEFORE May 19, 1995 and 1020.32(e) applies to equipment
>manufactured on and AFTER May 19, 1995.  So the date of manufacturer
>determines which set of regs apply.
>
>An interesting question thus presents itself as to what do we as
>physicists require in our testing of existing installed equipment?  This
>will depend in large part on what your state requires.  Pennsylvania is
>about to publish requirements that the outputs be effectively consistent
>with 1020.32(e) regardless of when the unit was manufactured.  They can do
>this since the FDA regulates the SALE of equipment, but the state can
>regulate the use of the equipment.  At least that is my understanding.  In
>my opinion, it makes sense to have the same limit for all fluoro
>equipment regardless of the date of manufacturer.  This means that older
>equipment would need to be lowered to 20 R/min in high level mode and
>could now go to 10 R/min when high level is not activated.  I personally
>haven't run into a case yet where the older equipment couldn't be turned
>down to comply with this. I'd be interested in hearing what others
>have found or think about this.
>
>Dan Beideck
>beideckd@wpo.auhs.edu
>
>
>> Steve Cartwright wrote:
>
>> 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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