As regulators weigh revising nuclear medicine reporting rules, imaging advocates and others take sides – Health Imaging

Radiopharmaceuticals inadvertently injected into tissue rather than veins can harm patients and should fall under required national reporting guidelines, researchers urged Monday in Frontiers in Medicine. But the call has drawn criticism from some imaging advocates.

A 1980 policy from the Nuclear Regulatory Commission, which oversees radioactive isotope use in the U.S., currently exempts providers from reporting these medical events, known as extravasations.

But the NRC is currently reviewing a petition filed last year by Lucerno Dynamicsa Cary, North Carolina, company that sells a device used to monitor injection qualitythat would require quantification and reporting of certain extravasations.

In this context, authors of the current study reviewed adverse event databases on the topic, pointing to 38 examples listing diagnostic radiopharmaceutical extravasation as a factor in such events, according to Dustin Osborne, with the Radiology Department at the University of Tennessee Graduate School of Medicine, and colleagues.

While some questions remain, they claim their research points to new hypotheses related to inadvertent injections.

Our findings suggest that significant extravasations can or have caused patient harm and can irradiate patients' tissue with doses that exceed medical event reporting limits and deterministic effect thresholds, they added June 28. Therefore, diagnostic radiopharmaceutical injections should be monitored, and dosimetry of extravasated tissue should be performed in certain cases where thresholds are thought to have been exceeded.

Importantly, four of the seven authors are employed by Lucerno Dynamics.

Following last years petition, the NRC opened a comment period garnering nearly 400 responses. Many, including the NRC's Advisory Committee on the Medical Uses of Isotopes, supported the claim that there is no clinical data suggesting radiopharmaceutical extravasation is a patient safety issue.

A number of medical societies and organizations hold a similar sentiment, including the American College of Radiology.

In a statement sent to Health Imaging on Tuesday, the ACR said NRCs medical event requirements are a serious regulatory mechanism, adding reporting isnt meant to gather inconsequential data.

Therefore, the ACR is on recordalongside hundreds of medical and scientific stakeholdersas opposed to the companys (Lucerno Dynamics)petition, the college said over email. We support the NRCs medical advisory committee recommendations that infiltrations reported to NRC as medical events be limited to rare, outlier extravasations that result in actual harm.

The Society of Nuclear Medicine and Molecular Imaging offered its own comment Tuesday.

SNMMI firmly believes that extravasation of diagnostic radiopharmaceuticals is not a patient safety issue, past President Alan Packard, PhD, told Health Imaging over email. On those rare occasions when a significant extravasation occurs, it is managed under existing procedures under the direction of the authorized user.

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As regulators weigh revising nuclear medicine reporting rules, imaging advocates and others take sides - Health Imaging