January 2, 2023 — The federal agency that oversees the administration of nuclear medicine has announced that it will reconsider its policy affecting extravasation, in a decision praised by the Patients for Safer Nuclear Medicine Coalition.
As part of a ruling issued this month, the Nuclear Regulatory Commission (NRC) will commence the rulemaking process regarding large extravasation reporting. Extravasation occurs when radiopharmaceutical materials used for nuclear medicine scans or therapies are injected into skin or soft tissue instead of a vein. Extravasation can not only cause pain and visible skin damage by leaving radiation in the tissue but can also compromise the images used to determine the best course of treatment or the treatment itself.
Specifically, the NRC acknowledges that the “radiation safety impact of some extravasations can be severe enough to warrant regulatory action, and reporting and tracking these incidents is of interest,” adding that "improvements in training, skill, and tools could help reduce the prevalence of extravasations."
It is estimated that an extravasation occurs in hundreds of patients every day in the U.S. However, an exact count is impossible. The current regulations enacted in 1980 do not require providers to notify the NRC - or even the patient - when any extravasation occurs, not even large extravasations.
“We are pleased to note that the NRC agrees with the coalition and recognizes that the current extravasation policy puts patients at unnecessary risk of serious harm,” says Patients for Safer Nuclear Medicine spokesperson Mary Ajango. “When administered properly, nuclear medicine is vital in determining the best course of treatment for patients. However, scans must first be accurate and safe, and patients have a right to know as soon as possible when their own body has been extravasated.”
Patients for Safer Nuclear Medicine, which includes 30 non-profit patient organizations, will closely monitor the proceedings as the NRC rulemaking process commences.
“It is obvious that current policy is woefully out of date. Extravasation reporting will encourage providers to proactively deploy quality improvement programs aimed at prevention while also increasing transparency,” Ajango says. “The NRC has a clear opportunity to prioritize the health and safety of patients over the interests of those the NRC is charged with regulating.”
For more information: https://www.nrc.gov/