A recent action by the U.S. Nuclear Regulatory Commission (NRC) should have protected patients who are inadvertently exposed to potentially high doses of radiation due to faulty injections or infusions. But it instead preferentially protects the nuclear medicine practitioners who are subject to its regulations and oversight.
At issue is the NRC’s policy that exempts practitioners of nuclear medicine — clinicians who use radioactive pharmaceuticals to diagnose or treat disease — from having to report when they mistakenly inject radiopharmaceuticals into a patient’s tissue rather than into a vein as intended. These errors, called extravasations or infiltrations, can affect the procedure and expose healthy tissue to potentially high doses of radiation.
Exposure to radiation is subject to the NRC’s risk-informed, objective, and dose-based reporting requirements for nuclear reactor workers, and in every medical context except mismanaged injections.
Since 1980, based on the belief that extravasations are “virtually impossible to avoid,” the NRC specifically exempts nuclear medicine practitioners from reporting extravasations.
In previous First Opinion essays, we wrote that these episodes of accidental irradiation are actually almost entirely preventable and therefore should be reported to the NRC if they meet medical event criteria. We also pointed out that the NRC’s prevarication on this issue raises serious concern that the agency has been influenced by the nuclear medicine practitioners whom NRC is supposed to regulate.
A petition filed by a medical device company in May 2020 challenged the NRC to eliminate the reporting exemption policy and treat radionuclide extravasations like any other medical event. We supported this effort, along with patients, radiation safety experts, and other stakeholders.
The NRC quietly released its decision to accept the petition in the Federal Register between Christmas and New Year’s Day, when patients, lawmakers, and the public had their attention diverted elsewhere. In accepting the petition, the NRC acknowledged that its current policy is outdated and should be reconsidered; and that both diagnostic and therapeutic extravasations can harm patients, happen frequently, and can exceed current reporting thresholds. The commission also stated that reporting would lead nuclear medicine practitioners to reduce the occurrence of extravasations, increase transparency, and take steps to improve patient care.
Of interest, the NRC estimated that approximately 28,000 people receive large extravasations that result in radiation doses that exceed reporting levels each year. Its decision concluded that rulemaking to change the exemption was warranted.
Then, after conceding that the petition’s evidentiary basis to close the reporting loophole was accurate, the commission endorsed a nonsensical and illogical reporting criterion for extravasations. A requirement memo directed NRC staff to “amend the NRC’s regulations to mandate medical event reporting of extravasations that require medical attention for a suspected radiation injury” [emphasis ours]. The injury information was not included in the Federal Register petition announcement but rather in the requirement memo and the Commissioner’s Notation Vote comments entered in the NRC’s document system later that same day.
The five NRC commissioners ignored their predecessors’ decision (on page 31703) that clinically detectable injury to a patient’s tissue was an unacceptable reporting criterion. They also ignored an existing NRC radiation protection policy that people do not have to be harmed before practitioners have to report a radiation safety event. And they rejected the NRC’s existing objective, dose-based reporting threshold used for all other medical events since 2002 when pressure from physicians and Congress forced the NRC to adopt a more risk-informed threshold for medical event reporting. (At that time, nuclear medicine practitioners had insisted that diagnostic procedures using radioactive substances are very low risk, use very low levels of radiation, and did not need to be reported.)
It is true that radionuclide imaging procedures use very low levels of radiation, and that these procedures are very low risk. That said, even a low level of radioactivity mistakenly placed in a small amount of tissue can deliver a high dose of radiation to that tissue and exceed the reporting threshold, and therefore warrants reporting.
Even though the petition presented clear evidence that such high, reportable radiation doses occur, the Society of Nuclear Medicine and Molecular Imaging, the American College of Radiology, and the NRC’s Advisory Committee on the Medical Uses of Isotopes — which is composed of nuclear medicine practitioners — still resisted reporting extravasations. The commissioners, at the expense of patient safety, ignored NRC policies in their Notation Vote comments and adopted the societies’ and nuclear medicine practitioners’ recommendation for a unique reporting criterion (see pages 68 to 69). The commissioners placed the responsibility on patients, who must demonstrate harm that would require medical attention to initiate reporting.
Consider what this means in practice. A nuclear medicine procedure is one of many that patients undergo as part of their cancer or cardiology or other care. A patient, needing a diagnostic scan that requires a radioactive tracer, is never told that the injection mistakenly entered the wrong tissue, does not fully understand the properties of the radiopharmaceutical, is unaware of the symptoms of excessive radiation, and does not know that it can take weeks, months, or years before effects manifest themselves. Yet the patient must somehow independently determine that tissue underneath their skin has been damaged, schedule and pay for a visit with the physician responsible for the error, and convince that physician the injury resulted from the nuclear medicine procedure that likely occurred months earlier.
The recommendation made by the Society of Nuclear Medicine and Molecular Imaging, the American College of Radiology, and the Advisory Committee on the Medical Uses of Radiation that the NRC adopted is designed to minimize extravasation reporting, rather than extravasation occurrence.
After reviewing the Federal Register and Notation Vote comments, a coalition called Patients for Safer Nuclear Medicine realized that the 57-month rulemaking process led by NRC staff was more concerned with input from physicians than the people it should have been protecting. The coalition (which we are not affiliated with) expressed disappointment in the commissioners and called on them to require nuclear medicine practitioners to notify their patients right away when a large extravasation occurs and to measure the amount of radiation left in the tissue near the injection site (almost always the arm). Patients want clear, simple information to identify potential symptoms of radiation injury and clear instructions on what to do if they experience such symptoms.
Those are reasonable requests the NRC should grant without delay. But in the end, it is not the role of patients to provide quality control for radioactive drug misadministration by practitioners weeks, months, or years after the event. Monitoring the quality of these procedures at the time of administration, performing immediate mitigation — such as dispersing the radiation into a larger volume of tissue by flushing the vein and surrounding tissue with saline, adding a warm compress to the site, massaging to increase blood flow to area — for inadvertent high radiation exposures, and reporting these events are the responsibility of nuclear medicine practitioners, not patients.
Given the NRC’s backdoor action, Congress must step in and side with patients and patient safety by ensuring that the NRC holds nuclear medicine practitioners accountable to the reporting threshold they lobbied for in 2002. We urge Congressional committees of jurisdiction to hold hearings on this issue and establish how the NRC commissioners reached such a flawed conclusion after accepting the evidence in the petition.
Simple, targeted legislation clarifying that extravasations resulting in irradiation above existing risk-informed dose limits must be reported should doubtless earn bipartisan support.
Daniel Fass is a radiation oncologist at South County Health in Rhode Island, CEO of Medpark U.S., and an assistant professor at Weill Medical College of Cornell University. David Townsend is a fellow of the Institute of Electrical and Electronics Engineers, a co-inventor of the PET/CT scanner, and a pioneer of three-dimensional reconstruction algorithms for PET.
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