I work in nuclear medicine

Please consider making some or all of the following three points to the NRC in addition to answering any or all of the NRC’s specific Public Comment questions.

Please use your own words; the NRC will ignore repetitive, verbatim comments.

Point 1 – NRC should protect patients

  • Licensees employ many quality measures to help ensure the accuracy of the dose delivered to our patients. However, an extravasation can significantly and adversely affect the accuracy of the delivered dose.
  • Now that tools are available to help improve the accuracy of administrations, the injection process itself can be included in our overall quality procedures.
  • Reducing nuclear medicine extravasations is a tangible quality effort that improves patient care.
  • With the expected growth in volume of radio-therapies, solving the extravasations problem is important for the practice of nuclear medicine and for patients.
  • Misadministration of radiopharmaceuticals should not be considered a practice of medicine issue because there is no medical benefit to the patient from being unintentionally irradiated.
  • Licensees want to provide our patients the highest quality care. Transparency leads to improvement.
  • 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.

Point 2 – Patients and their doctors need to know

  • Extravasations can irradiate my patients 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.
  • Complete patient history is important for care decisions
    Radiation biological effects from extravasations may not show up for years.
  • Current procedure guidelines require physician reporting of abnormal findings and issues that affect diagnostic imaging.

Point 3 – NRC needs to follow the evidence

  • Clinical evidence shows that extravasations are a frequent occurrence, that they harm patients, and that they can be improved. NRC should be aware of these facts and eliminate the exemption policy accordingly.

The following section details the NRC’s specific Public Comments questions and provides points for you to consider in your response.

Feel free to answer as many questions as you wish, but please use your own words; the NRC will ignore repetitive, verbatim comments.

NRC Topic: Injection Quality Monitoring

Q1: How frequently does radiopharmaceutical extravasation occur?

Licensees know that spilling radiotracer on a patient is reportable if it results in 0.5 Sv dose to tissue or skin. Events like that rarely happen, so obviously event frequency is not a factor in whether an event is reportable.

Centers that are not monitoring extravasations cannot really know their frequency. Additionally, retrospectively reviewing images will underestimate the frequency since most nuclear medicine images do not include the injection site. Sometimes technologists will even cover the arm with lead or make sure it is outside of the imaging field-of-view so that the extravasation is not visible in the image.

Centers who know they extravasate but have not published their findings will not likely admit it in a public forum. However, if the NRC reviews the 2008 and 2009 ACMUI transcripts or the 9 peer-reviewed studies from 13 centers over the last 10 years, they will find that extravasations are a frequent occurrence.

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.”

Some reportable medical events may not directly cause patient harm at all. For instance, if Y-90 microspheres are under-injected by 20%, it is reportable.

Over 50 peer-reviewed papers discuss the harmful effects of extravasations. There is no published literature indicating that extravasations do not harm patients. Even though licensees are not required to report or track extravasations, a review of the FDA Adverse event database and the EU Vigilance database reveals that 55 patients have been harmed.

On the NRC website is the “Guide for Diagnostic Nuclear Medicine.” This paper, authored by the leaders of nuclear medicine, states that tissue dose greater than 1.0 Sv leads to adverse tissue reactions. The petition cites many cases of doses greater than 1.0 Sv.

It is well understood that the skin may not show any evidence of an underlying extravasation at all or it may take 1-3 days for reddening to happen. Additionally, the injury to the extravasated tissue will take months to years to develop.

Licensees do not routinely perform dosimetry on extravasated patients or follow them afterwards. So, it is difficult to know if patients’ tissue has been harmed; however, extravasations compromise image quality and invalidate quantification. These compromised images are often used for diagnosis or treatment assessment. A therapy infusion that is extravasated could also harm patients by altering the dose delivery.

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?

Please answer based on your facility’s practices.

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.

Licensees want to do the best job that they can, but we need feedback in order to improve our administration techniques. No one in nuclear medicine wants to extravasate a patient.

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?

Without a mandate, many centers will not correct this issue. If a mandate is not needed, then why is the extravasation rate so high today?

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?

Monitoring injection quality and improving administration technique will lead to high-value, patient-centric care.

All situations that can lead to reportable medical events are taken very seriously. However, without a reporting requirement, we can’t justify the cost to monitor injections and follow extravasated patients—even though doing so would improve patient health and safety.

Patients need to know when they have been irradiated at high levels. These extravasations may negatively affect their treatment and patients should be followed for delayed radiation injuries. This is no different from fluoroscopy-guided intervention patients who are followed when they receive high radiation exposures.

Reducing extravasations could reduce the cost of providing care by not having to repeat imaging procedures that were impacted by extravasation.

The burden associated with monitoring can be minimal. Radiotherapeutics are rarely extravasated. These same results can be achieved for diagnostic administrations. Any additional time spent ensuring administrations are done properly will benefit the patient and their care.

Reducing extravasations will result in no or very minimal additional burden for reporting. Only centers that refuse to fix their extravasation problem will be burdened.

When extravasations are suspected, medical procedures already require clinicians to image the injection site. Performing dosimetry on these patients will require an additional 3-5 minutes. The reporting burden for these cases is no different from the reporting burden associated with other medical events that exceed 0.5 Sv dose equivalent to tissue.

If extravasations rarely happen, then providing clarity in Subpart M that significant extravasations should be reported will not be a burden on the nuclear medicine community.

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)?

The NRC 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 the NRC.

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. A spill of a diagnostic radiotracer onto a patient is reportable if it exceeded the reporting threshold—there is no leeway given based on type of radiopharmaceutical in that case.

Contrary to commonly held beliefs, extravasation of a diagnostic positron emitter can provide higher equivalent dose than the same volume of a beta emitting therapeutic.

Extravasating 1 mCi of diagnostic 18F-FDG in 5 cc of tissue may result in approximately 0.8 Sv equivalent self-dose. The same activity of therapeutic Lu177-DOTATATE may result in 0.4 Sv or less.