Executive Director of Teen Cancer America

Diagnostic nuclear medicine imaging procedures (PET/CT and SPECT scans) are an essential component of modern healthcare, with nearly 30 million injections of radioactive drugs (radiopharmaceuticals) administered annually. Medical professionals use these scans to diagnose cancer, heart, brain, and many other diseases to determine the optimal course of treatment and then measure their effectiveness.

However, mistakes can happen. Radiopharmaceuticals can be injected or extravasated into the patient’s arm tissue instead of completely into the vein. Radioactive extravasations can lead to pain and damage to underlying tissue, possible short-term visible skin damage, and possible long-term secondary cancer. It is estimated that nearly five million patients are extravasated annually. Most go undetected. No extravasations are good, but large ones can really matter.

The isotopes attached to these drugs are precisely measured to yield the best diagnostic results. Improper administration of these drugs can compromise the resulting images. Therefore, patients who are extravasated may not receive a correct diagnosis, the most appropriate course of treatment for their specific condition, or proper assessments of treatment progress.

Clinicians currently are not required to report these errors to the U.S. Nuclear Regulatory Commission (NRC), the agency in charge of overseeing the medical use of certain radiation. Even worse, there is no requirement to tell the patient in question that he or she has been extravasated. Ironically, if a radioactive drug is inadvertently spilled onto a patient and exceeds a certain radiation exposure, that incident must be reported to NRC and the patient – yet if 100 X the radiation is injected into a patient, no report is required.

Patients for Safer Nuclear Medicine (PSNM) is committed to changing this anti-patient policy. More than 500,000 extravasations each year merit reporting to the NRC. Evidence suggests that requiring reporting would quickly drive hospitals to reduce the number of large extravasations to fewer than 3,000 annually. Unfortunately, the NRC seems more concerned with protecting those who cause extravasation rather than protecting patients.

In December 2022, NRC accepted a petition for rulemaking to close a regulatory loophole that has exempted all extravasations (even extremely large ones) from reporting for 43 years. But rather than requiring reporting of large extravasations like any other accidental exposure, the NRC published a draft proposed rule. This proposal puts the onus on patients to report extravasations to the nuclear medicine physician responsible for the extravasation, who then uses subjective criteria to decide whether to report the event or not.

“Extravasations require quick identification, followed by mitigating the radiation exposure to the patient, assessing the severity of the extravasation, and ultimately, reporting the event if the exposure is large”

This proposal falls woefully short in protecting patients, who are not told they were extravasated but are expected to self-diagnose and then return to the physician responsible to request a report. This can be costly and time-consuming for patients who may be coping with debilitating illnesses and who don’t need additional stress and harm. These vulnerable patients deserve better protection, and that is why PSNM was created.

While our coalition does everything in its power to convince the NRC that current policy is harming patients, how can you protect yourself and your patients from extravasation? Make the following requests of your nuclear center a day before the scan:

• Use infrared vein-finding tools or an ultrasound device to gain venous access for the injection or demand the IV team gain venous access.

• Monitor the injection with the latest technology or make sure there is an image of the injection site to ensure the radioactive drug was injected properly. A black spot will appear at or near the injection site if an extravasation has occurred.

If there is radiation left at the injection site:

• Ask how much radiation is there, ensuring a note is in your medical record. Extravasation symptoms vary and take weeks, months, or years to develop. There may not be visible signs of underlying tissue injury. Ask for written information to help identify symptoms.

• Inform your care team so that together, they can assess the impact and make appropriate decisions on whether to repeat the procedure.

• Send a copy of your image to PSNM.

Patients must know they can trust medical providers to offer safe and effective nuclear medicine procedures that ensure accurate diagnosis and treatment. When mistakes are made, there should be accountability that also encourages systemic improvements. Without that level of accountability, patients are unnecessarily at risk.

NRC can fix this problem with a simple change. Extravasations require quick identification, followed by mitigating the radiation exposure to the patient, assessing the severity of the extravasation, and ultimately, reporting the event if the exposure is large. We encourage professionals, patients, caregivers, and advocates to call on NRC for action to substantially reduce extravasations, minimize patient harm and improve care.