NRC Requests Comments on Additional Rulemaking for Extravasations

September 29, 2020

On September 15th, the U.S. Nuclear Regulatory Commission (NRC) requested comments from the public on whether additional rulemaking is needed to require reporting of certain nuclear medicine injection extravasations as medical events. After reviewing relevant literature and regulatory guidelines from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and NRC, SNMMI is preparing to comment. In the meantime, SNMMI, the American College of Nuclear Medicine (ACNM), and the American Society of Nuclear Cardiology (ASNC), release the following statement. If you would like to submit your own comment, please click here.

In summary, we believe that extravasations are best managed on an institutional level at the discretion of the authorized user and do not require additional NRC regulation. Furthermore, the Society recognizes the effect that extravasation of diagnostic radiopharmaceuticals may have on the quality of diagnostic images, particularly on quantitative studies, and is actively addressing this as the quality-control issue that it is, rather than a patient-safety issue. Accordingly, the SNMMI Technologist Section (TS) has adopted reduction of extravasations as an essential initiative of the TS Quality Committee.

If you would like to learn more about the NRC's current position on extravasations, you may register for the FDA/NRC Workshop on October 14th here. The workshop is an all-day virtual event titled "Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices." Registration for the event closes on October 9th.