I am a regulator or government official

Point 1 – NRC should protect patients

• The petition is not asking the NRC to create a new reporting regulation specifically for extravasations. It is asking that extravasations be treated the same as all other medical events—if the dose exceeds 0.5 Sv to tissue or skin, it should be reportable.
• In the August 3, 2020 Federal Register (65 FR 47654) the NRC explains their current Medical Use Policy Statement. The NRC “has a role assuring accurate delivery of radiation doses and dosages to patients and has rejected the notion that NRC should not regulate patient radiation safety.”
• Extravasations are, by definition, the inaccurate delivery of radiation doses. Significant extravasations can harm patients.
• Extravasations are currently exempted from reporting as medical events because of the NRC 1980 policy, which we now know is incorrect. Therefore, extravasations should not be treated any differently than other medical events.
• The NRC is not meeting their own Medical Use Policy Statement—they need to make extravasations reportable events.
• Correcting the extravasation exemption would be consistent with the NRC radiation safety culture, of which 3 traits apply: problem identification and resolution, continuous learning, and questioning attitude.
• The FDA has a program to minimize unintentional radiation exposure to patients. The FDA is also represented on ACMUI. The FDA also has a database that captures extravasation adverse events. The NRC should coordinate with the FDA to reduce extravasations.
• The extravasation issue is fundamentally no different than the issue that led to the creation of the Mammography Quality Standards Act. NRC needs to act to fix this issue expeditiously.

Point 2 – Patients and their doctors need to know

• Extravasations can irradiate patients’ tissue with high doses and affect their care. Patients have a right to know when something goes wrong with their medical procedure.
• Many nuclear medicine patients are predisposed to an increased radiosensitivity at lower radiations doses due to factors like obesity, diabetes, and prescribed chemotherapy and other drugs.

Point 3 – NRC needs to follow the evidence

• The recommendations from the ACMUI are not based on scientific analysis of patient safety, but rather based on practitioner convenience.
• The NRC needs to follow the evidence and their own Medical Use Policy Statement and ensure extravasations that exceed medical event reporting limits are reported.

NRC Topic: Injection Quality Monitoring

Q1: How frequently does radiopharmaceutical extravasation occur?

Published literature indicates at least 15% of the time, but licensees say they rarely happen. If that’s the case, there should be no issue in removing the 1980 exemption policy. Even events that only occur rarely are reportable—extravasations should not be treated differently.

The frequency of the potential medical events should not dictate medical event reporting. Did the NRC consider the frequency of other types of medical events or occupational exposures when determining reporting requirements?

It is important to know when a medical event happens with licensees regardless of the frequency.

A review the 9 peer-reviewed studies from 13 centers over the last 10 years, indicates that extravasations are a frequent occurrence.

A review of the 2008 and 2009 ACMUI transcripts supports the medical literature. ACMUI members suggested extravasations happen all the time.

Centers who extravasate and have not published their findings will not be likely to admit it in a public forum.

A recent poster presented at a scientific session showed a major medical center extravasated 13% of their initial Lutathera therapy patients.

Q2: Do you know of any extravasations that have resulted in harm to patients? If so and without including information that could lead to the identification of the individual, describe the circumstances, type of effect harm, and the impacts.

A review of the NRC website indicates that medical event reporting does not necessarily indicate patient harm. Your website says “Medical event reporting may indicate potential problems in a medical facility’s use of radioactive materials. It does not necessarily result in harm to the patient.”

The petition and other communications with the NRC cite references to medical literature and cases that show patient harm. Additionally, the FDA has had adverse events reports associated with extravasations.

It is well understood that harm from radiation to tissue may not show up for months or years and the literature suggests that the nuclear medicine community does not routinely perform dosimetry or follow extravasated patients. Therefore, clinicians cannot know when their patients have been harmed.

The “Guide for Diagnostic Nuclear Medicine,” authored by leaders of nuclear medicine, states that tissue dose greater than 1 Sv leads to adverse tissue reactions. The petition cites many cases that exceed 1 Sv.

Q3: For medical use licensees, does your facility currently monitor for radiopharmaceutical extravasation? If so, why and how do you monitor? If not, why not?

N/A

Q4: Do you expect that monitoring for extravasation and reviewing the results would improve radiopharmaceutical administration techniques at medical use licensee facilities? If so, how? If not, why not?

Monitoring a process is the first step in understanding and improving the process.

Use of quality improvement processes has already been proven to reduce the frequency of extravasation in chemotherapy and contrast CT injections/infusions.

In 2019, the world’s largest nuclear medicine injection quality improvement project was published. It demonstrated that nuclear medicine centers who follow a quality improvement process significantly improved their extravasation rates.

The Mammography Quality Standards Act (MQSA) that Congress passed in the 1990’s ensured monitoring and improved mammography quality. The extravasation issue is no different.

Q5: Do you believe an NRC regulatory action requiring monitoring and review of extravasation would improve patient radiological health and safety? If so, how? If not, why not?

Regulatory action and public reporting will drive quality improvement efforts that will lead to reduced frequency.

50 peer-reviewed publications indicate how extravasation can negatively affect patient images and ensuing care. Reducing extravasations will reduce these negative effects.

The nuclear medicine community has stated that irradiating patient tissue with 1.0 Sv dose equivalent leads to adverse tissue reactions. Reducing extravasations will reduce the number of patients suffering from adverse tissue reactions.

NRC Topic: Medical Event Classification and Reporting Criteria

Q1: Are there any benefits, not related to medical techniques, to monitoring and reporting certain extravasations as medical events? What would be the burden associated with monitoring for and reporting certain extravasations as medical events?

Reporting extravasations will provide more confidence that licensees are properly handling radioactive materials.

The burden for reporting will depend on the frequency of extravasations that exceed 0.5 Sv dose equivalent. However, the frequency of reporting can be adjusted to minimize this burden. The petition suggests that a reporting grace period be instituted to allow centers to understand their extravasation problem and improve. This will also minimize reporting burden.

Once centers have corrected their extravasation issues, I would expect no significant additional burden due to reporting.

Q2: If the NRC were to require that licensees report certain extravasations as medical events (recorded in NMED), what reporting criteria should be used to provide the NRC data that can be used to identify problems, monitor trends, and ensure that the licensee takes corrective action(s)?

Regulators should collect similar data to that collected for other medical events. Extravasations that exceed 0.5 Sv to tissue should be reported.

The ratio of significant extravasations to administrations would provide important information for understanding how a facility administers radioactive material. Centers that are not improving their reportable extravasation ratio should warrant closer scrutiny by regulators.

Q3: If the NRC requires reporting of extravasations that meet medical event reporting criteria, should a distinction be made between reporting extravasations of diagnostic and therapeutic radiopharmaceuticals? If so, why? If not, why not?

The reporting requirement is equivalent dose to tissue or skin. Therefore, it doesn’t matter what type of radiopharmaceutical caused the event. If diagnostic radiation were spilled onto a patient, it would be reportable if it exceeded the reporting threshold.

The petition cites many cases of diagnostic extravasation which exceeded 0.5 Sv to tissue and references many therapeutic extravasations that must have exceeded the reporting limit. Both should be reported.