SNMMI Submits Comments to NRC on Patient Release, Injection Extravasations

September 7, 2023

In the past few weeks, SNMMI has submitted comments to the Nuclear Regulatory Commission (NRC) on several important issues.

Patient Release. On August 20, SNMMI expressed several concerns to NRC about its draft regulatory guide on “Release of Patients  Administered Radioactive Materials.” The primary point related to the proposed occupancy factor, which is four times more restrictive than the previous guidance; SNMMI believes the current 0.25 occupancy factor is safe and realistic. The increase is an “unnecessary hurdle” that would ultimately affect patient access to life-saving nuclear medicine therapies. Read more here.

Injection Extravasations. On September 1, SNMMI provided comments to the NRC on rulemaking on the reporting of nuclear medicine injection extravasations as medical events. The letter referenced two new studies that demonstrate both the infrequency and lack of severity of extravasations in nuclear medicine. “Clearly, it’s essential to minimize and work to prevent serious extravasation events, but accurate estimates of both frequency and severity are an important factor when deciding whether there is an immediate need for regulatory measures,” said SNMMI President Helen Nadel, MD, FRCPC, ABR, ABNM, FACNM, FSNMMI.

The letter went on to address 14 specific points and questions brought up by the NRC. Read the full letter here