Government agencies responsible for protecting the public from negligence and harm must act with independence and integrity and resist undue influence from those they are charged with overseeing. When they fail to do this, “regulatory capture” — advancing the commercial or political concerns of special interest groups that dominate an industry or sector instead of the public interest — can occur.
The results of regulatory capture can be catastrophic, like the Federal Aviation Administration (FAA)’s oversight failure of the Boeing 737 MAX, with corrective actions that were too late to avoid disaster and hundreds of deaths.
As a radiation oncologist keenly interested in patient safety, I am concerned that the U.S. Nuclear Regulatory Commission (NRC) faces an FAA moment of regulatory capture.
At issue is the commission’s medical event reporting requirements, which require that nuclear medicine providers disclose unintentional irradiation of patient skin or tissue above a radiation dose threshold of 0.5 Sieverts. That is about 500 times the radiation dose the skin or tissue would normally receive in a nuclear medicine imaging procedure.
Radiopharmaceuticals are radioactive drugs used mostly for imaging among people with, or suspected of having, cancer, heart disease, and neurologic problems. These drugs are generally injected into a vein and circulate through the blood to reach their intended targets, which “light up” on PET or SPECT scanners.
Forty years ago — that’s almost a lifetime ago with regard to medical advances — on advice from the nuclear medicine practitioners it regulates, the NRC implemented a policy exempting extravasations — radiopharmaceutical injections inadvertently delivered into a patient’s tissue rather than into the intended vein — from being reported to patients, referring physicians, state regulators, and the NRC itself, no matter how high a radiation dose the patient received.
That policy results in irrational and inconsistent application of criteria for medical event reporting. Today, a provider must report if a radiopharmaceutical has leaked onto a patient’s skin or clothing during a nuclear medicine procedure, but does not have to report if a radiopharmaceutical has leaked into a patient’s arm tissue.
In November 2019, some of a radiopharmaceutical leaked onto a patient’s skin, resulting in an estimated skin dose of 7 Sieverts (14 times the reporting limit and 7,000 times the dose the skin should have received), and therefore was required to be reported to the NRC. Since it takes time for ionizing radiation to cause visible harm, skin injury developed four days later. An extravasation of the same radiopharmaceutical into a patient’s arm was presented at a recent Health Physics Society meeting. In this case, clinicians estimated that all of the radiopharmaceutical may have ended up in the patient’s arm tissue. Yet, this mishandling of a radiopharmaceutical was deemed not reportable, even though a reasonable estimate of the dose to the patient’s tissue exceeded 100 Sieverts.
For the past 41 years, the NRC’s own Advisory Committee on the Medical Uses of Isotopes, which is populated by nuclear medicine professionals, has sought to protect this reporting exemption.
In 2008 and 2009, the NRC specifically asked the committee if the exemption should continue. A transcript (see page 170) of the meeting where this was discussed shows that committee members knew that some patients were receiving high doses of radiation as a result of human error. Referring to an example where a patient might receive a dose six to 10 times the reporting threshold, an advisory committee member expressed concerns about extra work like this:
“Now if we consider this as a medical event, if we go through all the procedures and identify whatever- 3 or 4 or 5 [sieverts]- the patient will have to be informed; the physician have to be informed, blah blah blah [sic], and then – you have to go into all the reporting mechanisms. And therefore, I am thoroughly against this being reported as a medical event.”
Minutes later, the group voted unanimously to recommend that the NRC retain the exemption, and it complied.
That recommendation was not based on science, but on convenience. Like Boeing and the FAA, faced with a danger to the public, industry and regulators knowingly looked the other way.
In 2019, a medical device company that provides an approach to help identify extravasations shared new evidence with the NRC and its advisory committee regarding the loophole. Again the committee recommended no action, despite dissent from the patient advocate on the committee, who wrote that there is no justification for treating an extravasation that exceeds reporting limits differently than other medical events.
In 2020, the company filed a petition for rulemaking that officially asked the NRC to close the extravasation loophole and to treat significant extravasations the same as other medical events. The petition presents substantive and convincing evidence that the loophole is unjustified, that radiation exposure by extravasations can exceed current reporting limits, and that they can be avoided. This petition is publicly supported by the Organization of Agreement States (the NRC’s regulatory partner in 39 states); physicians; experts in physics, radiation biology, vascular access, and imaging; patients; and patient advocacy groups. The International Atomic Energy Agency also recommends monitoring, documenting, and reporting significant extravasations.
In considering the petition, the NRC’s medical staff appears to be tilting toward favoring the opinions of the nuclear medicine practitioners the staff is supposed to be overseeing. In advance of a September 2021 public meeting, the NRC gave its Advisory Committee on the Medical Uses of Isotopes and affiliated medical societies 132 days to study preliminary NRC findings and offered six potential options for how to address extravasations and prepare their responses. The NRC medical staff opened public review of its preliminary findings for just 20 days.
My analysis shows that the NRC findings predominantly parrot positions of the advisory committee and affiliated societies, such as requiring patients to determine whether a procedure was done correctly; requiring reporting only if a patient experiences permanent functional damage; or taking no action whatsoever.
Rather than trying to minimize, if not prevent, the dangers of extravasation, the NRC and the industry it regulates appear to be more concerned with minimizing reporting.
Requiring providers to report significant extravasations will drive improvement. Centers that routinely expose patients to high doses of radiation will be demonstrating they are having trouble handling radiopharmaceuticals and need to improve. Patients need to know which centers struggle in delivering radiopharmaceuticals.
As an oncologist for nearly 40 years, I rely on PET imaging to plan treatments for my patients. I understand that the benefits of nuclear medicine procedures for my patients far outweigh the associated risks when the radiopharmaceutical is delivered properly. But significant extravasations alter the risk profile and patients deserve to know that every aspect of their treatment — including radiopharmaceutical injections and imaging — is performed safely and properly and they will be informed if an error occurs.
The NRC should base its actions on scientific evidence and patient safety, not on the nuclear medicine community’s desire to avoid oversight. After 41 years, it is time for the NRC to close this unjustifiable loophole and safely land this plane.
Daniel Fass is radiation oncologist, CEO of Medpark U.S., and an assistant professor at Weill Medical College of Cornell University.
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