The U.S. Nuclear Regulatory Commission (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) approved a report May 27, recommending changes to the definition of abnormal occurrence (AO). Specifically, the ACMUI supported NRC proposals to limit the AO definition to medically significant incidents.
The NRC is required by law to report AOs to Congress on an annual basis. AOs are defined in law as “an unscheduled incident or event which the NRC determines to be significant from the standpoint of public health or safety.” NRC policies include further specifications for AOs, including incidents that result in a dose that is at least 50 percent greater than prescribed; wrong radiopharmaceutical, route of administration or treatment mode; leaking source; and wrong patient.
Over the years, the NRC’s AO criteria has led to conservative overrepresentation of medical uses in its annual reports to Congress as compared to NRC’s other regulated industries. On average, 12 medical use AOs are reported each year, and the ACMUI estimated that more than 95% of total AOs since 2017 were medical use-related. Most of the reported AOs from the medical industry do not meet the significance standard described in the law.
The overreporting of medical use AOs inaccurately suggests to policymakers that the medical domain is problematic relative to NRC’s other regulated industries, ultimately leading to misinformed policy positions. For example, a recent lobbying effort by an injection monitoring device vendor to require nuclear medicine injection extravasation to be quantified and reported to NRC under 10 CFR 35.3045 has generated significant interest on Capitol Hill despite widespread opposition from experts.
Previous attempts by NRC to modify the AO definition were unsuccessful in reducing the number of insignificant medical use AOs. The ACMUI’s report is a continuation of a multi-year effort by NRC to address this issue. The agency now is considering changes to the AO definition that would necessitate harm, among other requirements, for elevating certain medical events to AO status. The ACMUI report generally supported the NRC’s proposal.
For more information about the AO definition and recommended changes, please email Michael Peters, 新澳门六合彩官网 Director of Legislative and Regulatory Affairs, at mpeters@acr.org.