As a community, we strive for cancer treatment and research that is data-driven, patient-centered, and that meets the highest standards of quality and safety. Yet, as physicians and advocates, we’ve become aware of a situation where these ambitions are not being met.
A 42-year-old regulatory loophole is preventing the reporting of significant nuclear scan medical events. A nuclear imaging procedure, such as a PET or bone scan, usually requires injecting a radioactive drug into a patient’s vein.
If much of that radiation is accidently injected into the patient’s tissue instead of their vein, hospitals and clinics do not need to report this event to anyone—not even to the patient or their treating physician.
This is true even when the radiation doses are so high that patients can develop tissue damage, including peeling and scarring, weeks or months later. Because of the DNA-damaging effects of radiation in the tracers, patients can also risk developing a new cancer months or years after a bad injection.
Worse still, we know as oncologists and patient advocates that these errors can affect cancer staging and treatment decisions. If a large dose of the injected radiation ends up in the arm, not circulating in the veins, then the radiation won’t reach its targets. Lower amounts of radiation reaching the target leads to low quality scans. Poor images can lead to improper diagnoses and assessments.
This is a serious quality and safety issue—and not a small one.
Millions of cancer patients (and patients with cardiac or neurological conditions) get nuclear medicine scans each year across the United States. And with the recent approval of exciting new radioactive cancer therapies, the number of people affected is growing rapidly.
Because there are no reporting requirements, and because most of these accidents go unnoticed without advanced technology monitoring at the injection site, we don’t have good data to know how many injection errors, or extravasations, occur. But estimates put the number of really large extravasations at about 500,000 every year in the United States. Half a million people at risk should concern us all.
Consider the experience of a patient we will call “Jane.” A stage IV metastatic breast cancer patient, Jane was extravasated last year while preparing for a bone scan.
She felt a sting in her arm, then a burn, and knew something was wrong. A long-time health care advocate, Jane knew enough to ask to see the scan of her arm. Sure enough, a large black circle appeared at the injection site.
Jane received no medical assistance at the time. For days, pain in her arm woke her during the night. She is not as concerned about a lasting injury as she is about the accuracy of her scans—which will help determine the length and quality of her life.
“Patients need transparency,” Jane said to us. “We have a right to know what happens to our own bodies.”
As a radiation oncologist, a medical oncologist, and a cancer patient advocate, we are speaking up for people like Jane by calling for the NRC to close their loophole.
While the U.S. Food and Drug Administration approves these radioactive scan tracers, the U.S. Nuclear Regulatory Commission (NRC) oversees their use.
The NRC approved the reporting exemption in 1980 based on bad information—a statement that extravasations were “virtually impossible to avoid” and thus nothing could be learned to prevent them from affecting other patients.
We know from research and experience that these errors can indeed be avoided with good training, tools, and safety protocols. And the Association for Vascular Access, a society of experts in intravenous injections, has made it clear to the NRC that extravasations are not virtually impossible to avoid.
We can, and should, do better. An extravasation that meets existing reporting thresholds should be identified and reported just like any other medical event. Bringing transparency to these significant extravasations will drive health care systems to provide their injecting technologists with the tools and training they need to prevent errors. Transparency also means that patients can get the data they need to care for themselves in case of an injury, and ensure they get a nuclear medicine scan they can trust.
All it would take is a simple NRC rule change.
Unfortunately, several medical societies are against reversing the reporting exemption. Recognizing that the NRC will want some action, they have suggested that patients should report extravasations.
This approach will help keep this issue hidden. Still others have actually stated that patients need not know when their tissue has been accidently exposed to large amounts of radiation and their images compromised.
This is worse. For the past 42 years, there has been no data, no accountability, and no improvement. How many cancer patients have been misdiagnosed or given the wrong treatment? This must change now.
The Patients for Safer Nuclear Medicine coalition is speaking up online and aiming to deliver 1,000 signatures to the NRC in May on a petition to correct their mistaken exemption and require reporting of significant extravasations.
Join us. As cancer physicians and advocates, you can become a member of our coalition, sign our petition, or take up this issue at your institution. Some health care systems, including Carilion Clinic in Virginia and the University of Tennessee Knoxville Cancer Center, are doing great work to identify and prevent extravasations and educate patients about risks. Good models of nuclear medicine quality and safety are out there.
It’s an exciting time to work in cancer care and research. With President Joe Biden’s Cancer Moonshot back in the headlines, and major advances in treatments, we can continue the remarkable progress we’ve made in reducing the burden of cancer.
A simple rule change would patch a big hole in our cancer patient safety net and help improve and extend—and perhaps save—lives.
