NRC Meeting to Discuss Radiopharmaceutical Extravasation

The U.S. Nuclear Regulatory Commission (NRC) convened a public meeting May 24 to discuss preliminary proposed language and questions for stakeholders regarding the agency’s ongoing “extravasation” rulemaking. During the meeting, the American College of Radiology® (ACR®) urged NRC to work with experts, drug manufacturers, payers, accreditors and healthcare agencies to understand and avoid conflicts with medically standard injection safety practices.

In 2020, a device company petitioned the NRC to, in effect, require controversial injection site measurements and extravasation dose estimations for compliance with NRC Medical Event reporting under 10 CFR 35.3045. The company offers proprietary devices and software-as-a-service for related purposes. U.S. experts unaffiliated with the company’s campaign opposed the petition on medical, scientific and policy grounds.

Following a multi-year evaluation by the agency and its federal advisory committee, the NRC Commissioners voted unanimously to mandate reporting of radiopharmaceutical extravasations “requiring medical attention for a suspected radiation injury,” but stopped short of necessitating or promoting specific products or third-party services. The intent was to focus regulatory attention on radiation safety significance and outcomes. That rulemaking is underway, with a proposed rule planned for 2024.

Members interested in providing ACR with patient care perspectives on NRC’s questions can contact Michael Peters, ACR Senior Government Affairs Director. Stakeholders can also submit written comments directly to NRC via the instructions in the corresponding Federal Register notice.