The United States Nuclear Regulatory Commission (NRC) released a request for public comments on a petition for rulemaking asking the agency to require reporting of certain nuclear medicine injection extravasations as Medical Events (MEs) under 10 CFR 35.3045. Currently, the NRC encourages — but does not require — use of quality assurance tools and technologies to ensure radioactive materials are administered as intended, and extravasation has generally been viewed by the agency as a practice of medicine issue.
The petitioner — a manufacturer of an infiltration detection/measurement system — specifically requested that extravasations resulting in a localized dose equivalent exceeding 50 rem (0.5 Sv) be subject to ME reporting requirements. Compliance with the petitioner’s requested change would presumably mandate the use of certain technologies during relevant administrations.
The American College of Radiology® (ACR®) Commission on Government Relations-Federal Regulatory Committee and Commission on Medical Physics-Government Relations Committee are currently reviewing the issue and compiling input. ACR members with an interest are encouraged to review NRC’s short list of questions and email feedback to the ACR Director of Legislative and Regulatory Affairs, Michael Peters, at mpeters@acr.org. All member feedback will help inform future comment development efforts of the ACR.