Nuclear Medicine Clarification Act of 2025
The Nuclear Medicine Clarification Act of 2025 would require the Nuclear Regulatory Commission (NRC) to revise its medical-event reporting rules to specifically address unintended radiation exposure from extravasation during nuclear medicine procedures. Extravasation is when radiopharmaceuticals leak into surrounding tissue instead of remaining in the vein, potentially delivering higher, localized doses to tissue or skin. The bill adds new reporting thresholds: if a dose caused by extravasation exceeds 0.5 Sv (50 rem) to the most exposed 5 cubic centimeters of tissue during residence time, or 0.5 Sv (50 rem) to the most exposed 10 square centimeters of skin during residence time, it would be considered a medical event requiring reporting. The NRC must complete the regulatory revision within 120 days of enactment, and the revised rules would take effect 18 months after enactment. The aim is to strengthen patient safety and transparency around significant extravasation events in nuclear medicine.
Key Points
- 1Adds new criteria to medical-event reporting for nuclear medicine, specifically addressing extravasation.
- 2Thresholds: 0.5 Sv (50 rem) to the 5 cm³ of tissue with the highest dose, or 0.5 Sv (50 rem) to the contiguous 10 cm² of skin with the highest dose, during residence time.
- 3NRC must revise 10 CFR 35.3045(a)(1) to include these criteria within 120 days after enactment.
- 4The new reporting requirements become effective 18 months after enactment.
- 5The bill is titled the Nuclear Medicine Clarification Act of 2025 and aims to enhance patient safety and accountability in nuclear medicine procedures.