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NRC proposes reporting extravasations as medical events

April 21, 2023

On April 19, 2023, the Nuclear Regulatory Commission released for public comment preliminary proposed rule language to add “the administration of byproduct material results in an extravasation that requires medical attention for a suspected radiation injury” under medical event reporting. The preliminary language includes the following:

  • Definitions of the following: “extravasation,” “medical attention” and “suspected radiation injury.”
  • Requirement for licensees to have written procedures on detection and reporting of extravasations.
  • The NRC is also seeking feedback on questions in the following areas: definitions, procedures and health care inequities.

Earlier this year, the NRC Commissioners directed staff to evaluate within the rulemaking process medical event reporting of extravasations that require medical attention for suspected radiation injury. NRC staff believes that a risk-informed medical event reporting requirement may be warranted to capture radiation-safety-significant extravasation events.

While ASTRO preferred no rulemaking on this issue, a risk-informed medical event reporting requirement is preferable to other dose-based options.

ASTRO will be commenting on the proposal, and public comments are due July 18, 2023.

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