Executive Director of Teen Cancer America

Simon Davies

Imagine you are in the doctor’s office to undergo a nuclear medicine imaging procedure like a PET/CT or SPECT scan. Sometime after the procedure is finished – perhaps weeks, months or even years later - you begin to feel pain in one arm. Or a strange sensation in the fingers on one hand. What could be wrong? For some reason you think back to the nuclear medicine procedure. Surely if a mistake was made, the medical team would have told me. What kind of mistake could happen during that procedure?

Unfortunately, a simple mistake can be made during the administration of the radioactive drug used to produce nuclear medicine images. And today, healthcare providers often don’t know when they make this mistake and when they do, they don’t have to tell the patient anything. That is why change needs to happen now in the nuclear medicine community.

Nearly 30 million diagnostic nuclear medicine imaging procedures, (PET/CT and SPECT scans) are administered annually. These procedures are incredibly valuable in diagnosing cancers, and heart and brain diseases. These typically low-risk scans help care teams diagnose diseases, determine the optimal course of treatment for each patient, and then measure their effectiveness.

However, as many as 5 million patients inadvertently get radioactive drugs (radiopharmaceuticals) injected or extravasated into arm tissue instead of completely into the vein. Hundreds of thousands are large extravasations. The results may include pain, nerve damage, and possibly visible skin damage and long-term secondary cancer.

“Nearly 30 million diagnostic nuclear medicine imaging procedures, (PET/CT and SPECT scans) are administered annually. These procedures are incredibly valuable in diagnosing cancers, and heart and brain diseases.”

More importantly, radioactive material is precisely measured to yield optimal diagnostic results. When an extravasation occurs, some of the radioactive material has been improperly administered. The Society of Nuclear Medicine states extravasations can compromise your images. These compromised images are used to guide your care.

You may wonder why so many extravasations occur. You are not alone. The simple answer is because no one must report this mistake. As a result, no one monitors this process. Because the nuclear medicine community uses radioactive isotopes, the U.S. Nuclear Regulatory Commission (NRC) has oversight for the proper use of this radiation. And while the NRC ensures that accidental radiation exposures like radiation spills need to be reported, there is no requirement to report an extravasation to the NRC. No matter how large the radiation exposure.

This extravasation reporting loophole has been in place for 43 years. This loophole is wrong and is bad for patients. That’s why the organization I represent is part of Patients for Safer Nuclear Medicine, a coalition that has been working hard for years to convince the NRC to require extravasation reporting like any other accidental exposure.

Last December, we thought we had succeeded. The NRC admitted the loophole had to go. But instead of treating extravasations like any other mistakes, the NRC proposed a new loophole. Rather than apply the same reporting rules for extravasations, the NRC is now proposing that patients self-diagnose an extravasation, then return to the physician responsible to request a report.

Can you imagine? Patients who may not know they are being injected with radiation, who will not know they were extravasated, and who are never told about symptoms of radiation damage, are given the burden of reporting. As a patient copes with a life-changing illness they must now take on the medical  establishment due to a medical error. Current policy puts the medical community ahead of the health and well-being of patients. That is why Patients for Safer Nuclear Medicine is in this fight.

While we continue to fight for transparency and systemic change at the NRC, there are steps you can take to protect yourself from a harmful extravasation. A day before your appointment, ask your nuclear center to do the following:

• Use infrared vein finding tools or an ultrasound device to help find the proper vein and proper location to gain venous access for the injection or use the local IV team to gain venous access.

• Monitor the injection 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, you have rights as a patient:

• Ask how much radiation is present, ensuring a note is included in your medical record.

• Extravasation symptoms can take as little as weeks, or as long as years to develop. There may not be visible signs of tissue injury. Ask for written information to help identify symptoms.

• Tell your care team about the situation to ensure the appropriate next steps are taken.

• Speak up and share your story! Send a copy of your image to www.safernuclearmedicine.org, and help us ensure that extravasations are reported as medical events.

The NRC has the ability to take a simple action that will protect patients and make measurable improvements in care: require extravasation reporting, just like any other radiation exposure. Every stakeholder – from patients to professionals – will benefit from quick identification of an extravasation, followed by mitigating the exposure, assessing the severity, and ultimately, reporting the event if the radiation exposure is large. It is estimated that such a regulatory change would cause the number of large extravasations to plummet to fewer than three thousand per year.

We encourage you to join us and make your voice heard. Together, we can drown out the voices of special interests in the nuclear medicine community standing in the way of progress, and demand the NRC put patients first.

Teen Cancer America is a member of Patients for Safer Nuclear Medicine, a coalition comprised of non-profit patient organizations advocating on behalf of patients nationwide.