[Intl_DxMedPhys] [EXTERNAL] Re: Fluoro minimum SSD

Thu Oct 16 15:56:55 EDT 2025

Hi Ashley,

I've encountered this issue during a state inspection about 10 years ago at my previous institution. We had numerous Siemens Artis systems, and the "short" collimator cover was the preferred choice by the clinical team. As you correctly noted, the large covers are the only ones that provide the required minimum SSD of 38 cm. However, both the FDA and the state of Ohio have an exemption for certain surgical procedures, as others have already pointed out.

To clearly document a clinical need, we had the interventional services sign off on a statement indicating that for any given procedure they perform, they might need to acquire images at angles or views where the large collimator covers could be prohibitive. Additionally, it's important to note that, for many interventional systems, the covers cannot be swapped during or even between procedures on systems that have 3D capabilities because the 3D calibration requires input of the collimator type used as part of the calibration process. Since 3D calibration takes about 8 hours, it's not feasible to continually swap the covers and redo calibrations.

Producing a document of need from the physician leads for the applicable services, along with your X-ray QA (or radiation safety) committee review and approval, should satisfy any reasonable regulator (yes, they do exist, most just want to see that the issue has been considered and treated, though nothing is a guarantee).

That having been said, we more recently had two Siemens Artis MP rooms which had the short covers installed. We cannot make the same arguments about the clinical procedures done in those rooms, so we had those covers changed to the larger ones.

All the best,
Kevin

[The Ohio State University]
Kevin Wunderle, PhD, FAAPM, FACR
Professor, Department of Radiology
Diagnostic Medical Physicist
395 W. 12th Avenue,
Floor 4, Room 424
Columbus, OH, 43210
216-245-5513 Mobile
kevin.wunderle at osumc.edu<mailto:kevin.wunderle at osumc.edu>

From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces+kevin.wunderle=osumc.edu at lists.osu.edu> On Behalf Of Ryan Fisher via Intl_dxmedphys_wd_osu_list
Sent: Thursday, October 16, 2025 3:05 PM
To: Timmerman,Michael <Michael.Timmerman at SanfordHealth.org>; William Sensakovic <wfsensak at outlook.com>; DxMedPhys List <intl_dxmedphys_wd_osu_list at lists.osu.edu> <intl_dxmedphys_wd_osu_list at lists.osu.edu>
Subject: Re: [Intl_DxMedPhys] [EXTERNAL] Re: Fluoro minimum SSD

Devil’s advocate: technically they did provide a means to limit the SSD to not less than 38cm. The FDA doesn’t say you have to actually use it… From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces@ lists. osu. edu> On Behalf
Devil’s advocate: technically they did provide a means to limit the SSD to not less than 38cm. The FDA doesn’t say you have to actually use it…

From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu>> On Behalf Of Timmerman, Michael via Intl_dxmedphys_wd_osu_list
Sent: Thursday, October 16, 2025 2:26 PM
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Subject: Re: [Intl_DxMedPhys] [EXTERNAL] Re: Fluoro minimum SSD

STOP!
THIS IS AN EXTERNAL EMAIL
This email was originated outside of the MetroHealth System
Take a 3-second pause and ask yourself the following questions:
1. Who is sending me this email? Do I know who this is?
2. Am I expecting this email? Is this out of the ordinary?
3. Why is there a link in the email? Do I trust this link?
THINK
Before You
Click the Link
The FDA regulations does give an exception for “specific surgical applications” allowing an SSD of no shorter than 20 cm. I see this more often with portables – physicians tend to hate the cone and we do need to justify that
The FDA regulations does give an exception for “specific surgical applications” allowing an SSD of no shorter than 20 cm. I see this more often with portables – physicians tend to hate the cone and we do need to justify that this meets the regulatory requirements as a “specific surgical application.”

1020.32(g)

Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 20 cm. When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 1020.30(h)<https://urldefense.com/v3/__https:/www.ecfr.gov/current/title-21/section-1020.30*p-1020.30(h)__;Iw!!KGKeukY!2otpcVX0QEXAZwi9zFcUcQ1STKqiIhUYMHdJoUqj6M2YT2HBVjiViVX9ENIF31qcX0iN6Vhg0kixFTuX4RProOA9ynySNB_0iAATt2cu2MA-EoBYPRWIeOz4$>.

Best,

Mike
________________________________________
Mike Timmerman, MS, DABR
Diagnostic Medical Physicist
Sanford Health – Sioux Falls Region
Mobile: (541) 213-1075
[Icon    Description automatically generated with medium confidence]

From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces+michael.timmerman=sanfordhealth.org at lists.osu.edu<mailto:intl_dxmedphys_wd_osu_list-bounces+michael.timmerman=sanfordhealth.org at lists.osu.edu>> On Behalf Of William Sensakovic via Intl_dxmedphys_wd_osu_list
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Subject: [EXTERNAL] Re: [Intl_DxMedPhys] Fluoro minimum SSD

The cfr seems pretty clear that 30cm is only for portables. Are you comfortable sharing the vendor? Small and new vendors often save money by not hiring experts in informatics nor regulations. Had this experience before, though not for the cone
The cfr seems pretty clear that 30cm is only for portables. Are you comfortable sharing the vendor? Small and new vendors often save money by not hiring experts in informatics nor regulations. Had this experience before, though not for the cone size. They basically just want to make a mark quickly and get bought out by one of the big boys. Curious if this is an established vendor or small start up.
Best,
Bill

William F. Sensakovic, PhD, MRSC(MRSE), FAAPM
Chair and Assoc. Prof., Mayo Clinic (Arizona)
Founder, Telerad Physics Teaching, LLC
Twitter: @wfsensak
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From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu<mailto: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<mailto:intl_dxmedphys_wd_osu_list at lists.osu.edu>>
Sent: Thursday, October 16, 2025 11:04 AM
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Subject: [Intl_DxMedPhys] Fluoro minimum SSD

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<mailto:attao at emplifyhealth.org>

(w) 608-775-2078

(c) 507-398-1561

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