Nuclear Medicine Clarification Act of 2025 | ChamberLight
Bills · HR 2541
IN COMMITTEE· 119TH CONGRESS
House BillHR 2541Health
Nuclear Medicine Clarification Act of 2025
INTRO APR 1· LAST ACTION APR 1
READING
1MIN
COSPONSORS
8BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8
Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law
WHAT THE BILL DOES
AI-written
This bill matters because it directly addresses patient safety in nuclear medicine procedures. When radioactive materials are injected or administered, there's always a small risk of the material leaking outside the intended area, known as extravasation. While often minor, severe extravasations can cause significant localized radiation exposure and potential harm to tissues. Currently, not all such incidents might be consistently reported as "medical events" under existing regulations.
If this bill becomes law, it clarifies and expands the types of unintended radiation exposures that must be reported to the federal government. This means there would be a more complete record of these incidents, which can help regulators and medical facilities identify patterns, improve training, and develop better safety measures to prevent future harm. Without this bill, some significant extravasation events might continue to go unreported at the federal level, potentially obscuring the full scope of patient risks.
KEY PROVISIONS
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PROVISION 01
The bill requires the Nuclear Regulatory Commission (NRC) to update its existing rules regarding "medical event" reporting within 120 days of the bill becoming law.
This provision is significant because it forces a specific regulatory change rather than merely recommending it.
PROVISION 02
The new rule specifies that unintended radiation doses due to "extravasation" (leaking radioactive material outside the intended area) must be reported if they exceed certain thresholds for deep tissue or skin exposure.
This provision is significant as it closes a potential gap in reporting and ensures specific types of accidental exposures are tracked.
PROVISION 03
The bill defines specific radiation dose limits (0.5 Sv or 50 rem to a 5 cubic cm volume of tissue, or 0.5 Sv or 50 rem to 10 square cm of skin) that trigger the reporting requirement for extravasation events.
These specific thresholds are significant because they provide clear, quantifiable standards for reporting, reducing ambiguity for medical facilities.
PROVISION 04
The revised regulations will take effect 18 months after the bill is enacted, giving the NRC and medical facilities time to implement the changes.
This provision is significant because it provides a clear timeline for compliance, balancing the need for safety with practical implementation challenges.
This bill matters because it directly addresses patient safety in nuclear medicine procedures. When radioactive materials are injected or administered, there's always a small risk of the material leaking outside the intended area, known as extravasation. While often minor, severe extravasations can cause significant localized radiation exposure and potential harm to tissues. Currently, not all such incidents might be consistently reported as "medical events" under existing regulations.
If this bill becomes law, it clarifies and expands the types of unintended radiation exposures that must be reported to the federal government. This means there would be a more complete record of these incidents, which can help regulators and medical facilities identify patterns, improve training, and develop better safety measures to prevent future harm. Without this bill, some significant extravasation events might continue to go unreported at the federal level, potentially obscuring the full scope of patient risks.
KEY PROVISIONS
AI-extracted
high
The bill requires the Nuclear Regulatory Commission (NRC) to update its existing rules regarding "medical event" reporting within 120 days of the bill becoming law.
This provision is significant because it forces a specific regulatory change rather than merely recommending it.
high
The new rule specifies that unintended radiation doses due to "extravasation" (leaking radioactive material outside the intended area) must be reported if they exceed certain thresholds for deep tissue or skin exposure.
This provision is significant as it closes a potential gap in reporting and ensures specific types of accidental exposures are tracked.
med
The bill defines specific radiation dose limits (0.5 Sv or 50 rem to a 5 cubic cm volume of tissue, or 0.5 Sv or 50 rem to 10 square cm of skin) that trigger the reporting requirement for extravasation events.
These specific thresholds are significant because they provide clear, quantifiable standards for reporting, reducing ambiguity for medical facilities.
med
The revised regulations will take effect 18 months after the bill is enacted, giving the NRC and medical facilities time to implement the changes.
This provision is significant because it provides a clear timeline for compliance, balancing the need for safety with practical implementation challenges.
Not later than 120 days after the date of enactment of this Act.
Nuclear Regulatory Commission required to revise regulations (10 CFR 35.3045(a)(1)).
18 months after the date of enactment of this Act.
The revised regulations become effective.
GLOSSARY
AI-written
Nuclear Regulatory Commission (NRC)
A U.S. government agency that regulates commercial nuclear power plants and other uses of nuclear materials, including those in medicine, to protect public health and safety.
Nuclear Medicine Procedures
Medical tests or treatments that use small amounts of radioactive materials, called radiopharmaceuticals, to diagnose or treat diseases by showing how organs and tissues are functioning.
Extravasation
The accidental leakage of a substance, such as a radioactive drug, from a blood vessel or the intended injection site into the surrounding tissues.
Dose Equivalent
A measure of the biological effect of radiation on tissue, taking into account the type of radiation and its potential for harm. Measured in sieverts (Sv) or rem.
Shallow Dose Equivalent
A measure of the radiation dose absorbed by the skin, specifically referring to the dose at a shallow depth below the skin's surface.
Residence Time
The total time that a radioactive substance remains in a specific organ or tissue within the body.
Medical Event Reporting
ACTION TIMELINE
2 EVENTS
APR 1, 25
Introduced in House
INTROREFERRAL
APR 1, 25
Referred to the House Committee on Energy and Commerce.
The process by which medical facilities are required to inform a regulatory body, like the NRC, about significant errors or unintended incidents involving radiation or radioactive materials during medical procedures.
