March 04, 2021

ACR Urges NRC Chairman to Elevate ACMUI Recommendations

The American College of Radiology® (ACR®) congratulated the new Nuclear Regulatory Commission (NRC) Chairman, Christopher T. Hanson, on his recent appointment and recommended that the agency elevate the recommendations of medical use experts on key issues of concern in a letter sent March 2, 2021.

Among many other responsibilities in the reactor, waste and industrial domains, the NRC regulates medical uses of radioactive materials. This includes licensing provider facilities and setting minimum eligibility requirements for physician Authorized Users (AUs) and certain other personnel. This also includes collecting data on reported Medical Events indicating problems with a facility’s use of radioactive materials. The agency is advised on these matters by the Advisory Committee on the Medical Uses of Isotopes (ACMUI), which includes relevant physician subspecialists, medical physicists and other representatives with real-world expertise.

The ACMUI’s influence on NRC policymaking with respect to the most important issues to the medical licensee community has significantly waned in recent years. Following years of evaluations, and against the evidence-informed recommendations of the ACMUI, the NRC drafted a rulemaking plan to deregulate AU eligibility such that advanced radiopharmaceutical therapies could be administered by referring clinicians without radiations safety expertise. This plan has been under consideration by the NRC Commissioners for approximately 14 months, and it is unknown how the agency’s leadership will ultimately vote on the issue.

The NRC also elevated an effort by the vendor of an injection site-monitoring device to require novel dosimetry and reporting of certain nuclear medicine agent infiltrations/extravasations as a Medical Event—a designation with serious public reporting consequences for radiology providers, referring providers and patients typically reserved for avoidable errors (wrong patient, dose, site, etc.). The effects would include an imposition into practice of medicine and significant clinical, financial, professional and medicolegal consequences. The agency has not yet rendered a decision on the vendor’s request.

The ACR letter to the new NRC Chairman reiterated previous ACR positions on these two issues and suggested ways to appropriately elevate the ACMUI so the medical licensee community’s expertise is adequately represented in agency decision making.