[Intl_DxMedPhys] NRC and Extravasation

[Steiner, Joseph [BSD]]

Hi Bill

Short answer: Still waiting

Long answer:

The nuclear medicine clarification act was annoyingly re-introduced in the House April of 2025. Currently only 8 co-sponsors. Hopefully will die without going to committee like the prior iterations. (https://urldefense.com/v3/__https://www.congress.gov/bill/119th-congress/house-bill/2541__;!!KGKeukY!ykueaspLYklTTdf6w29d7heEv2ucUD5TIKoB8C-oKiVRjNRf3e5MMProg6LP57W1m9_X20gQObyWjeXCDL8-QmyTwD9DCAGS85cPOmOdYNV7R_1XvyulLl0$ )

The NRC is still undergoing rulemaking on this. They are supposed to be done by Spring 2026, but this date keeps getting pushed back (it was supposed to be done Spring 2025 in the fall of 2024). You can read the details here: https://urldefense.com/v3/__https://www.nrc.gov/materials/miau/med-use-toolkit/reporting-nuclear-medicine-injection-extravasations__;!!KGKeukY!ykueaspLYklTTdf6w29d7heEv2ucUD5TIKoB8C-oKiVRjNRf3e5MMProg6LP57W1m9_X20gQObyWjeXCDL8-QmyTwD9DCAGS85cPOmOdYNV7R_1XCpDndF0$ .

Per the federal register, the last time extravasation was mentioned was 8/12/2025 and it just points back to the new proposed rule from summer 2024 (see NRC link above)

So, the date this will be implemented (changes to 10 CFR § 35.3045) is still not known, nor is the exact change in regulation (to me at least, if others have more detail, I’d be very interested)

Currently the NRC has signaled they will NOT be using dosimetric thresholds to determine if an extrav is a medical event. Their language is (from 2024): The proposed rule would amend 10 CFR Part 35 to require reporting of certain nuclear medicine injection extravasations as medical events. Specifically, the staff is proposing that licensees report to the NRC "[t]he administration of byproduct material that results or has the potential to result in a radiation injury from an extravasation, as determined by a physician.”

Much more reasonable than the HR bill linked above (>500 mSv  to 50 cc tissue or >500 mSv to 10 cm^2 skin) but “potential to result in a radiation injury” is still a bit dangerous in my opinion, even if determined by a physician, and I hope they don’t include that part.

Thanks
Joe

From: Intl_dxmedphys_wd_osu_list <intl_dxmedphys_wd_osu_list-bounces at lists.osu.edu> On Behalf Of William Sensakovic via Intl_dxmedphys_wd_osu_list
Sent: Thursday, January 29, 2026 6:21 PM
To: intl_dxmedphys_wd_osu_list at lists.osu.edu
Subject: [EXTERNAL] [Intl_DxMedPhys] NRC and Extravasation

Hello, Quick question regarding regs. Where do things currently stand with the proposed change to cfr35 regarding extravasations as medical events? I remember the comment period and do not see it in the current reg, but cannot remember if a
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Hello, Quick question regarding regs. Where do things currently stand with the proposed change to cfr35 regarding extravasations as medical events? I remember the comment period and do not see it in the current reg, but cannot remember if a
Hello,
Quick question regarding regs. Where do things currently stand with the proposed change to cfr35 regarding extravasations as medical events? I remember the comment period and do not see it in the current reg, but cannot remember if a final outcome occurred. Was it voted down? Is it still to be voted on? Did it pass and slated to be implemented?
Thanks,
Bill

William F. Sensakovic, PhD, MRSC(MRSE), FAAPM
Chair and Assoc. Prof., Mayo Clinic (Arizona)
Founder, Telerad Physics Teaching, LLC
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