Move Towards Making Extravasations a Reportable Event?

Sharon Worcester, MA

February 02, 2023

At present, when patients undergoing scans receive an injection of a radiopharmaceutical that goes wrong ― and the radioactive material is injected into the skin or soft tissue rather than directly into the vein ― medical staff do not need to report the incident. Even though the misplaced radioactive material, known as an extravasation, may cause harm, this is not currently identified as a reportable medical event.

That could change.

The US Nuclear Regulatory Commission (NRC) has said that it will reconsider its policy on the reporting of extravasations, according to a proposed rule announced in December 2022.

The decision to consider making extravasations a reportable event initially drew praise from the Patients for Safer Nuclear Medicine (PSNM), an advocacy group of more than 30 nonprofit organizations that has petitioned the NRC for the rule change.

However, the coalition reversed course in a January 9 letter expressing disappointment with certain details of the NRC proposal.

At issue is a plan to place the responsibility for reporting upon affected patients, according to the letter to the NRC from PSNM spokesperson Mary Ajango.

The NRC currently exempts diagnostic extravasations from medical event reporting on the basis of a regulatory policy established in 1980. As reported previously by Medscape Medical News, the agency has long resisted pressure to change the policy, repeatedly voting to retain the reporting exemption as recommended by its Advisory Committee on the Medical Use of Isotopes.

The turnabout follows a formal petition for rulemaking filed by Lucerno Dynamics, maker of a commercially available device to detect extravasations.

Lucerno called on the NRC to "prioritize patient safety [and] transparency" by updating its "1980 policy that allows nuclear injection errors to remain hidden."

The NRC solicited public comments on the petition and subsequently issued the proposed rule change.

As written, the proposed rule does little to address patient safety and ensure scan integrity, which can be compromised when extravasations occur, said Ajango.

"While acknowledging that the reporting exemption for extravasations is no longer supportable, you are initiating a rulemaking that would place responsibility for identifying a radiation safety–significant extravasation on the patient," she wrote on behalf of PSNM. "You are asking patients to detect radiation injury when clinicians themselves often disagree on how injury should be identified. You are asking patients to monitor themselves for months or years while waiting for an injury to present itself, rather than emphasizing the need for providers to identify and mitigate extravasations when they occur.

"There is only one way to interpret the NRC's staff requirements memo: the patient's voice matters less than the industry that the NRC regulates," she continued.

Without proper education, patients may not recognize an extravasation when it occurs, Ajango explained in an interview.

"Oftentimes when it happens, they experience pain or irritation, and they may think it was just a painful needle stick, but even then, they probably don't realize that nuclear, radiated material was injected into their tissue vs their vein," she told Medscape Medical News.

Furthermore, reactions may not occur immediately. Darker skin color could reduce the ability to recognize a reaction ― another concern she raised on behalf of PSNM. In her letter, she highlighted "a failure to seriously consider the impact [of the NRC plan] on healthcare inequities.

"The techniques that most nuclear medicine providers use to gain vascular access are woefully out of date and they fail to consider how skin color impacts the ability to find a vein," she wrote.

PSNM asked the NRC to issue immediate interim guidance that would require that patients be informed if they experience a radiation safety- and procedure-significant extravasation; that they be provided with clear information on identifying symptoms of extravasation injury; and that they be given written instructions explaining what action must be taken in the event that they experience extravasation symptoms.

PSNM subsequently shared a request for corrections to certain statements from medical staff on which the NRC relied in its decision-making process and which the petitioner deems incomplete, misleading, or incorrect.

Ajango said PSNM has not received a response to the letter.

An NRC public affairs representative told Medscape Medical News that he had not seen the letter but said the proposed rule will be available for public comment, thereby "allowing opportunities for the public and medical field to weigh in."

The NRC spokesperson also pointed out that the Commission has directed staff to "continue to explore approaches that would reduce the reliance on patient reporting."

Action on the proposed rule can be monitored by searching for Docket ID NRC-2022-0218 on the Federal rulemaking website,

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at or on Twitter: @SW_MedReporter.

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