August 19, 2021

NRC Releases Preliminary Evaluation Report of "Extravasation" Issue

The U.S. Nuclear Regulatory Commission (NRC) recently released a preliminary evaluation report and corresponding advisory committee recommendations regarding reporting of certain extravasations to federal and state radiation protection agencies. This issue was raised in a petition for rulemaking (PRM-35-22) filed by the vendor of an injection site monitoring system asking NRC to require reporting of certain nuclear medicine injection extravasations as medical events (MEs).

Historically, the NRC has exempted all extravasations from reporting requirements under 10 CFR 35.3045 as the intended purpose of the ME mechanism is to capture actionable reports of preventable errors. The vendor requested the long-standing policy be revisited and that NRC require reporting of extravasation resulting in shallow/localized dose equivalent exceeding 50 rem (0.5 Sv). This type of dose-based reporting threshold would necessitate nuclear medicine providers use novel injection site monitoring systems and contested, nonstandard dosimetry to determine if the ME reporting threshold is reached during infiltrations.

The NRC report explained the background of the issue and identified several options for how to potentially proceed, including maintaining the current exemption policy, requiring qualitative reporting, or requiring some type of quantitative reporting threshold. The NRC staff have not determined which option they will eventually recommend to the agency’s leadership.

The NRC’s federal advisory committee of independent medical experts — the Advisory Committee for the Medical Uses of Isotopes (ACMUI) — previously recommended reporting of extremely rare extravasations that resulted in physician-determined, unintentional permanent functional damage to an organ or a physiological system, per existing regulations in 10 CFR 35.3045(b). In the latest document, a subcommittee of the ACMUI recommended modifying the ACMUI position to support ME reporting of any radiation-caused skin damage requiring medical attention. The ACMUI will meet Sept. 2 to publicly discuss the latest document.

The American College of Radiology® (ACR®) is currently considering the options identified by NRC as well as the details of the modified ACMUI subcommittee recommendation. If you have questions or would like more information, contact Michael Peters, Director of ACR Government Affairs.