Congressmen Davis, Griffith, and Cline Introduce Legislation to Protect Nuclear Medicine Patients

WASHINGTON, D.C. — Congressmen Don Davis (D-NC), Morgan Griffith (R-VA), and Ben Cline (R-VA) introduced the bipartisan H.R. 2541, the Nuclear Medicine Clarification Act of 2025, which would close a loophole that currently allows patients to be unintentionally exposed to high levels of radiation without reporting or disclosure. The legislation would improve care and ensure transparency for patients and simplify federal rules coming from the Nuclear Regulatory Commission (NRC).

“Patients deserve to have protections and transparency when undergoing treatment for serious health conditions,” said Congressman Davis. “Improving reporting for accidental radiation exposure is long overdue and we must restore the rights of the patients who place their trust in healthcare providers.”

“The Nuclear Medicine Clarification Act is about making sure patients are protected and federal agencies are doing what they’re supposed to do,” said Congressman Cline. “This bill brings clear direction to the NRC so that nuclear medicine procedures are carried out with the highest safety standards. I’m proud to join my colleagues to reintroduce this commonsense legislation that puts patient safety first and strengthens oversight without growing bureaucracy.”

“I am extremely pleased Reps. Davis, Griffith, and Cline have come together on this important patient safety and care issue,” said Dr.  Jackson W. Kiser, a Nuclear Medicine physician. “I have over a dozen published articles on this topic and have seen the impact that a large extravasation can have on a patient’s care. It is disturbing that in the year 2025 patients can be extravasated with large doses of radiation that affect their imaging or therapy procedure and may have skin and tissue implications. And it is unconscionable that patients are not told, and the NRC is not informed. I am pleased that Congress is stepping in to force the NRC to protect patients. NRC needs to make these incidents reportable like any other accidental exposure so my fellow physicians can get the support they need from their hospitals like I have to reduce the frequency and severity of these medical events.”

Background

Radiopharmaceutical extravasations are medical errors that occur when a radioactive drug is accidentally injected into the tissue rather than into the patient’s vein as intended. Large extravasations can cause tissue and skin damage and compromise the nuclear medicine procedure. However, since 1980, NRC rules have exempted all radiopharmaceutical extravasations from “medical event” reporting requirements, even if they result in radiation doses that were known to be incredibly dangerous, and even if they exceeded the level of radiation doses that NRC should have reported to Congress.

In 2022, NRC accepted a petition for rulemaking to close this outdated loophole. In 2024, NRC published a draft proposed rule to require reporting of extravasations that result in injury or have the potential to cause injury. The draft proposed rule is insufficient and uses a subjective standard to determine whether an event is reportable, which is contrary to every other radiation safety rule.

In response, the Nuclear Medicine Clarification Act would require NRC to treat extravasations like all other unintended irradiation.  If a dose threshold is exceeded, the incident must be reported. Doing so would improve safety and transparency for patients while simplifying rules for licensees.