H.R.2541 - Nuclear Medicine Clarification Act of 2025 (119th Congress)
Summary
H.R.2541, the Nuclear Medicine Clarification Act of 2025, aims to revise Nuclear Regulatory Commission (NRC) regulations to enhance patient safety during nuclear medicine procedures. Specifically, it mandates the NRC to revise section 35.3045(a)(1) of title 10, Code of Federal Regulations, regarding medical event reporting of unintended irradiation. This revision focuses on reporting doses resulting from extravasation exceeding specified thresholds.
Expected Effects
The primary effect of this bill will be to require more stringent reporting of unintended radiation exposure during nuclear medicine procedures. This increased scrutiny is intended to improve patient safety by identifying and addressing potential issues in the administration of nuclear medicine. The revised regulations will take effect 18 months after the enactment of the Act, providing a transition period for implementation.
Potential Benefits
- Improved Patient Safety: The primary benefit is enhanced protection for patients undergoing nuclear medicine procedures by mandating reporting of specific radiation exposure events.
- Enhanced Regulatory Oversight: The bill strengthens the NRC's oversight capabilities, allowing for better monitoring and prevention of unintended radiation exposure.
- Increased Transparency: By requiring more detailed reporting, the bill promotes transparency in the administration of nuclear medicine.
- Standardized Reporting: The bill establishes clear thresholds for reporting radiation doses due to extravasation, ensuring consistency in reporting practices.
- Proactive Prevention: The data collected through enhanced reporting can be used to identify trends and implement preventative measures to reduce the risk of future incidents.
Potential Disadvantages
- Increased Administrative Burden: Healthcare facilities may face increased administrative burden due to the more stringent reporting requirements.
- Potential for Over-Reporting: The specific thresholds may lead to over-reporting of minor incidents, potentially overwhelming the NRC with data.
- Compliance Costs: Healthcare providers may incur costs associated with updating their procedures and training staff to comply with the new regulations.
- Delayed Implementation: The 18-month delay in the effective date could postpone the realization of the intended safety benefits.
- Unintended Consequences: The specific thresholds may not capture all clinically significant radiation exposure events, leading to a false sense of security.
Constitutional Alignment
The bill appears to align with the general welfare clause of the US Constitution, as it aims to protect the health and safety of individuals undergoing medical procedures. Congress has the power to regulate interstate commerce, which includes the regulation of nuclear materials and medical procedures involving radiation. Article 1, Section 8 grants Congress the power to make all laws which shall be necessary and proper for carrying into execution the foregoing powers, and all other powers vested by this Constitution in the government of the United States, or in any department or officer thereof.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).