On average, every 56 seconds in the United States, a nuclear medicine patient is significantly extravasated.
It could be you, a family member, or a friend.
We need your help to fix this patient safety issue.
- Learn more below
- Submit your comments to the Nuclear Regulatory Commission (NRC)
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Extravasations are circled in red
An extravasation is the misadministration of a radioactive drug
For nuclear medicine procedures, a technologist injects/infuses a radioactive drug (radiopharmaceutical) into a patient’s venous system. An extravasation, also known as an infiltration, occurs when some or all of the radiopharmaceutical is inadvertently delivered into the patient’s tissue rather than their vein. Extravasations occur frequently at many nuclear medicine centers and negatively affect patient safety and care.
1,500+ patients experience significant extravasations every day
*Company estimates based on 20,000+ monitored injections
Extravasations can harm patients
Extravasations can compromise patient care
- Diagnostic extravasation: results in misinterpretation of medical images
- Therapy extravasation: prevents the delivery of the prescribed radioactive treatment
Food and Drug Administration and
Nuclear Regulatory Commission regulate nuclear medicine
Approves radiopharmaceuticals and nuclear medicine equipment
Assures the proper medical use of
radiopharmaceuticals and protects patients from unnecessary radiation
40-year-old NRC policy fails to protect the safety of patients
May 1980 NRC actions
- established misadministration reporting regulations
- exempted extravasation from reporting
- exemption is an internal policy (not a regulation)
- policy based on belief that extravasations occur frequently and are “virtually impossible to avoid.”
Extravasations are NOT virtually impossible to avoid
Chemotherapy and contrast CT administrations are similar to those in nuclear medicine. In the 1990s and 2000s, chemotherapy and contrast CT extravasation rates were significantly improved because of quality improvement projects.
In 2019, the world’s largest nuclear medicine injection quality improvement project was published. It demonstrated that nuclear medicine centers can also significantly improve their extravasation rates. The NRC is now aware of all of these results.
The NRC exemption policy results in the following paradox:
a radiation spill ON a patient is reportable, but an extravasation INTO the patient is not
A proper radiopharmaceutical injection irradiates patient’s tissue with a harmless dose of ~1 millisievert (mSv).
The NRC has established 500 mSv as the reporting limit for misadministrations.
An accidental radiopharmaceutical spill ON the patient which exceeds 500 mSv exposure to patient tissue is reportable. However, an extravasation INTO the patient is not reportable….even when the tissue dose far exceeds 500 mSv.
Extravasations can grossly exceed NRC limits
Therapy extravasations are well-known to exceed the NRC reporting limit and have resulted in patient harm.
Diagnostic extravasations can also exceed 500 mSv – Lucerno has shared 36 examples with the NRC. Few patients, if any, are informed when this happens to them.
MDP Bone Scan Patient
Lucerno petitions NRC to change regulation
After 18 months of effort to address the 1980 policy, Lucerno officially petitioned the NRC to eliminate the extravasation reporting exemption. The public will be able to comment on the petition.
Supporting the petition puts you in great company!
Serious extravasations should not be automatically exempted from medical event reporting requirements. Read more
Nuclear medicine physicist with Versant Medical Physics and Radiation Safety, who previously served on the NRC’s Advisory Committee on the Medical Uses of Isotopes (ACMUI) as patient advocate representative
Infiltrated injections are much more common in nuclear medicine than most people realize, and this is a fixable problem. Read more
Former Director of the National Cancer Institute’s Cancer Imaging Program
The extravasation exemption in the 1980 language is unnecessary. Only rare gross discrepancies in delivered dose or tissue exposure would be reportable, and this member believes that those rare instances should be reported just as any other misadministration of such magnitude would be reported as medical events….this member believes that the current specific exclusion of extravasation is inconsistent with other regulations and is unwarranted.
NRC’s Advisory Committee on the Medical Uses of Isotopes patient advocate representative