[Intl_DxMedPhys] Fluoro minimum SSD

[Tao, Ashley T]

Thanks - in my case FDA and state regs are consistent with one another.  just not sure why the vendor provides a cover that is not compliant with the regs.

________________________________
From: Lemieux, Bryan P. <bryan.lemieux at uky.edu>
Sent: Thursday, October 16, 2025 1:22 PM
To: Tao, Ashley T <attao at emplifyhealth.org>; DxMedPhys List <intl_dxmedphys_wd_osu_list at lists.osu.edu> <intl_dxmedphys_wd_osu_list at lists.osu.edu>
Subject: Re: Fluoro minimum SSD

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This comes from 21 CFR 1020 in the FDA regs.  There is an out under certain situations.

when there is a conflict between FDA and state regs for equipment performance , my state usually defers to the FDA as the federal regulator.

I would compare your state and federal language and then reassess.  If you go with alternate procedures, be sure to educate the operators on the inverse square effects on entrance dose possible from use of a shorter cone/separator as well as any inaccuracies introduced with respect to display values and likely ESE where the patient entrance surface actually would be on the system.

Bryan Lemieux MS CHP DABMP
Associate Chief - Radiation Safety
Radiation Safety Officer
UK HealthCare
Lexington KY
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From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu> on behalf of Tao, Ashley T via Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list at lists.osu.edu>
Sent: Thursday, October 16, 2025 2:03:59 PM
To: DxMedPhys List <intl_dxmedphys_wd_osu_list at lists.osu.edu> <intl_dxmedphys_wd_osu_list at lists.osu.edu>
Subject: [Intl_DxMedPhys] Fluoro minimum SSD

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Hey all, We recently had a stationary c-arm unit installed and it came with a short and tall cover. The short cover provides a minimum SSD of 30cm whereas the tall cover provides a minimum SSD of 38cm. The manufacturer said their customers typically
Hey all,
We recently had a stationary c-arm unit installed and it came with a short and tall cover. The short cover provides a minimum SSD of 30cm whereas the tall cover provides a minimum SSD of 38cm. The manufacturer said their customers typically install the short cover because that's what the providers prefer. It gives them more flexibility with angles. Sure enough, that's what our providers wanted.

Both 21 CFR and state of wisconsin says that the minimum SSD for stationary fluoroscopes must be 38 cm, but the short cover does not meet this requirement. Curious if anyone else has dealt with this. Their FSE says that the customer has the choice of which cover they want to use. I have asked for feedback from the manufacturer but have not yet received a response.  Before I upset my providers by making them switch to the tall cover, is there something in the regs that I'm not seeing that allows them to use the 30 cm SSD? Would anyone know why they offer the short cover if fed and state requirements require 38 cm?

Thanks
Ashley



Ashley Tao, PhD, DABR, MRSE (MRSC™)

Lead Diagnostic Medical Physicist

Radiation Safety Officer

Emplify Health by Gundersen

1900 South Ave

Mail Stop H01-016

La Crosse, WI 54601

attao at emplifyhealth.org

(w) 608-775-2078

(c) 507-398-1561

[cid:5b82ed84-b2b6-4d2b-a120-c256a8ee62df]


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