Following public comments in response to a petition that the U.S. Nuclear Regulatory Commission (NRC) revise its policy that exempts nuclear medicine injection extravasations from medical event reporting, the NRC has published an announcement in the December 30, 2022 Federal Register reporting it will evaluate the current requirements and guidance for reporting of such extravasations as medical events. In other words, the NRC is announcing the beginning of a new rule making process.
The petition requested that the NRC amend its regulations in part 35 of title 10 of the Code of Federal Regulations, “Medical Use of Byproduct Material,” to require reporting of certain nuclear medicine injection extravasations as medical events. Extravasation is the infiltration of injected fluid into the tissue surrounding a vein or artery. Extravasation is an occurrence that is not limited to the administration of radiopharmaceuticals.
On September 15, 2020, the NRC requested comments from the public on the petition and posed eight specific questions to gain information on the scope of and basis for the issues raised by the petition. The NRC received 488 public comment submissions. Eighty-eight submissions generally supported the petition, while 396 submitters generally wrote in opposition. Various medical societies, and leading members of the nuclear medicine and radiology communities indicated their views that generally there is no clinical data that diagnostic radiopharmaceutical extravasation is a patient safety issue.
The NRC noted that under its current practice of excluding extravasations from medical event reporting, extravasations that result in suspected radiation injury, or even those that meet the NRC's public health and safety significance criteria for an abnormal occurrence, are not required to be reported to the NRC. After reviewing the comments submitted to them, the NRC concluded it should reconsider via a rulemaking process the Commission's 1980 decision to exclude extravasations from medical event reporting, particularly given the evolution of nuclear medicine since its earlier decision more than 40 years ago.
The commission acknowledges the potential burdens to monitoring and reporting extravasations if it begins to require reporting. It acknowledged this by citing a comment that 14 million diagnostic procedures are performed annually. If there is a 1 percent extravasation rate, then the result would be 140,000 medical events to report annually.
Needless to say, a change in NRC medical event reporting to include extravasations will have serious administrative consequences. We will need to monitor this activity carefully.