I am a clinician outside of nuclear medicine

Point 1 – NRC should protect patients

• Clinicians count on NRC policies to protect their patient when radiation is being used medically.
• 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

• 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.
• Referring physicians have a need to know about issues that could affect patient care.
• Complete patient history is important for care decisions
  Radiation biological effects from extravasations may not show up for years.

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.

NRC Topic: Injection Quality Monitoring

Q1: How frequently does radiopharmaceutical extravasation occur?

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?

Medical literature suggests that diagnostic extravasations happen at least 15% of the time, centers do not routinely monitor extravasations, and injection sites are rarely in the field of view.

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

Just like many metrics in medicine, if you do not track issues, then you can’t know their frequency or impact.

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

Many of the nuclear medicine images do not include the injection site. Without monitoring the quality of the injection, it will be difficult for anyone to know the true frequency of extravasations.

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

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.

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. Quality improvement should be part of a medical practice’s culture.

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?

Patients and treating physicians expect nuclear medicine procedures to be done properly. A reduction in the incidence of extravasation would provide higher confidence in the results of nuclear medicine imaging.

Patients and treating physicians need to know when patients 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.

Many nuclear medicine/radiology colleagues say extravasations never happen. If this is the case, making extravasations reportable will not be a regulatory burden.

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?

It does not matter to a patient whether the high dose from an extravasation results from a diagnostic or therapeutic radiopharmaceutical.

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.