Nuclear Medicine Clarification Act of 2025
Summary
What This Bill Does
The Nuclear Medicine Clarification Act directs the Nuclear Regulatory Commission to revise 10 CFR 35.3045(a)(1) within 120 days. The revision must add a medical event reporting trigger for a dose due to extravasation that exceeds 0.5 Sv, or 50 rem, to either the 5 cubic centimeters of tissue receiving the highest absorbed dose during residence time or the contiguous 10 square centimeters of skin receiving the highest shallow dose equivalent during residence time. The revision takes effect 18 months after enactment. Extravasation occurs when injected radioactive material leaks into tissue rather than staying in the intended vascular path, so the bill makes significant unintended localized irradiation reportable.
Who Benefits and How
Nuclear medicine patients benefit because significant extravasation-related radiation injuries become reportable medical events. Patient safety advocates benefit from clearer NRC data on unintended localized irradiation during radiopharmaceutical procedures. Hospitals using radioactive materials benefit from a defined threshold for when extravasation must be treated as a reportable event. Referring clinicians benefit from better visibility into safety events that may affect patient follow-up.
Who Bears the Burden and How
NRC regulators must revise 10 CFR 35.3045(a)(1) within 120 days and implement the new reporting trigger. Nuclear medicine licensees must track and report extravasation events above the specified tissue or skin dose thresholds. Radiology and nuclear medicine departments may face additional documentation, dosimetry, quality assurance, and incident reporting work. Hospitals with reportable events face regulatory review and possible reputational consequences.
Key Provisions
- Requires NRC to revise medical-event reporting rules within 120 days.
- Adds reporting for extravasation doses above 0.5 Sv to the highest-dose 5 cubic centimeters of tissue.
- Adds reporting for extravasation doses above 0.5 Sv shallow dose equivalent to 10 square centimeters of skin.
- Delays the revision's effective date until 18 months after enactment.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Requires the Nuclear Regulatory Commission to revise medical-event reporting rules so unintended irradiation from extravasation above 0.5 Sv to a small tissue or skin area is reportable, with the rule effective 18 months after enactment.
Key Policy Areas
Health Care, Nuclear Medicine, Patient Safety
Primary Purpose
Requires the Nuclear Regulatory Commission to revise medical-event reporting rules so unintended irradiation from extravasation above 0.5 Sv to a small tissue or skin area is reportable, with the rule effective 18 months after enactment.
Policy Domains
Resolution provisions
Identified Gains
- Nuclear medicine patients
- Patient safety advocates
- Hospitals using radioactive materials
- Referring clinicians
Identified Costs
- Nuclear Regulatory Commission
- Nuclear medicine licensees
- Radiology departments
- Hospitals with reportable events
Sponsors
Legislative Progress
In CommitteeMr. Davis of North Carolina (for himself, Mr. Griffith, and …
Referred to the House Committee on Energy and Commerce.
Introduced in House
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Nuclear medicine licensees, Nuclear medicine patients, Patient safety advocates
Positive-direction: Nuclear medicine patients, Patient safety advocates
Negative-direction: Nuclear medicine licensees
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology