This Act updates Nuclear Regulatory Commission reporting requirements for medical events involving unintended radiation doses resulting from extravasation during nuclear medicine procedures.
Donald Davis
Representative
NC-1
The Nuclear Medicine Clarification Act of 2025 directs the Nuclear Regulatory Commission (NRC) to update regulations regarding medical event reporting for accidental radiation exposure. Specifically, it mandates reporting if a radiation dose resulting from an extravasation exceeds defined thresholds in the most highly irradiated tissue or skin. This ensures clearer reporting standards for unintended irradiation events in nuclear medicine.
New Law Sets Specific 0.5 Sv Dose Threshold for Reporting Accidental Radiation Leaks in Medical Procedures
The Nuclear Medicine Clarification Act of 2025 is all about dialing in the safety rules for medical procedures that use radioactive materials. Specifically, Section 2 updates the criteria for when a hospital or clinic has to report an accidental radiation exposure—what the regulators call a “medical event.” This isn't about broad policy changes; it’s a technical move to make the reporting thresholds clearer and more quantitative for a specific type of accident.
The key change centers on a phenomenon called "extravasation," which is when the radioactive drug leaks out of the vein and into the surrounding tissue during an injection. Under the current rules, reporting this kind of accident can sometimes be ambiguous. This Act tells the Nuclear Regulatory Commission (NRC) to update its regulations within 120 days to require a report if that leaked dose exceeds a very specific threshold: 0.5 Sieverts (Sv). This 0.5 Sv limit applies either to the 5 cubic centimeters of tissue that got the highest dose, or to the 10 square centimeters of skin that absorbed the most radiation.
Think of it this way: The NRC is moving from a somewhat qualitative rule to a hard, measurable line in the sand. For the medical facilities, this means less guesswork about whether an incident is reportable. If a technician is administering a nuclear medicine treatment and a little bit of the fluid leaks, they now have a clear, objective measurement—that 0.5 Sv threshold—to determine if they need to file a formal report. This clarity is a win for compliance, making it easier for hospitals to follow the rules and ensuring that only incidents above a certain severity level trigger the regulatory process.
While the NRC has four months to write the new rule, the actual requirement for reporting these specific extravasation doses won't kick in immediately. The bill grants an 18-month grace period from the date the Act becomes law before medical facilities must start using the new 0.5 Sv reporting standard. This lengthy delay gives hospitals, clinics, and equipment manufacturers plenty of time to update their protocols, train staff, and ensure they have the proper dosimetry equipment to measure these highly localized doses accurately.