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.

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

Annually

18.5M
nuclear medicine injections
15.2%
published extravasation rate
2.8M
affected patients
500K+
significant extravasations*

*Company estimates based on 20,000+ monitored injections

Extravasations can harm patients

(watch video)

Extravasations can compromise patient care

Extravasations can unintentionally irradiate patient tissue with high doses

Food and Drug Administration and
Nuclear Regulatory Commission regulate nuclear medicine

FDA

Approves radiopharmaceuticals and nuclear medicine equipment

NRC

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.”
This is a relatively simple issue to resolve, since the NRC’s 1980 policy on extravasation was based on assumptions that are no longer valid. The NRC could easily update and fix that policy today with a stroke of the pen.
Dr. Darrell Fisher
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

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

Dose Equivalent – 31,300 mSv

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!

Requiring reporting would be a small step for hospitals to implement but a big step toward improving patient care. Read more

David Townsend

Co-inventor of the PET/CT Scanner

Serious extravasations should not be automatically exempted from medical event reporting requirements. Read more

Dr. Darrell Fisher

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

Getting the image right matters to my treatment plan and my life. Read more

Pam Kohl

Patient

Injection of a radiopharmaceutical into an unintended tissue… should be reported upon occurrence. Read more

OAS

Organization of Agreement States

Infiltrated injections are much more common in nuclear medicine than most people realize, and this is a fixable problem. Read more

Dr. Dan Sullivan

Former Director of the National Cancer Institute’s Cancer Imaging Program

We call on the NRC to grant the petition for rulemaking NRC-2020-0141. Read more

United States Congress

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.

Laura Weil

NRC’s Advisory Committee on the Medical Uses of Isotopes patient advocate representative