Extravasation rulemaking to dominate ACMUI public meeting June 17

Nuclear medicine injection extravasations and medical events will be the focus of the Advisory Committee on the Medical Uses of Isotopes (ACMUI)'s public teleconference on June 17.

ACMUI's report on the draft proposed rule and associated draft implementation guidance for reporting nuclear medicine injection extravasations as medical events addresses anticipated U.S. Nuclear Regulatory Commission (NRC) rulemaking. Extravasations have never been required to be reported, NRC's senior health physicist Cindy Flannery said June 11 during a regulatory session at the Society of Nuclear Medicine and Molecular Imaging's (SNMMI) recent meeting in Toronto.

The proposed rule is not available for public comment yet; however, during the session, some attendees offered comments. Ben Greenspan, MD, of VA Augusta (GA) Health, said he has never seen a patient harmed by a diagnostic extravasation or infiltration, and the claim that thousands of patients are being injured is "just not right. I hope you won't make that a medical event because that would be ridiculous. For us to have to stop for every injection and measure, it would be a huge waste of time."

The proposed extravasation rule avoids having a minimum dose threshold; "instead, it's worded in a way that it would have to result in a radiation injury." That might do away with diagnostic concerns, Flannery noted.

Attendee Robert Naylor, associate radiation safety officer at Dana-Farber Cancer Institute in Boston, raised a question about the rise of alpha-emitting radiopharmaceuticals, asking what the expectation is for "detectability of extravasations in the moment given that the range of the alpha particles involved in tissue would typically not lend itself to detectability and given that not all alpha-emitting radionuclides have subsequent beta- or gamma-emitting daughter products."

Flannery responded that the focus is on radiation injury, retrospectively, and that has to be determined by an authorized user physician.

"That's the focus rather than doing a measurement and taking that measurement and determining a dose," she said.

Materials for review prior to the ACMUI meeting became available Wednesday via the NRC website. The ACMUI meeting will take place from 2 p.m. to 4 p.m. Eastern time. Details for joining can be found here.

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