The Nuclear Regulatory Commission (NRC), the agency regulating the use of radioactive materials, recently announced their intention to update regulations to make some cases of radiopharmaceutical extravasations a medical event. Medical events are instances where errors occurred during the administration of radioactive materials requiring immediate reporting to the NRC. These errors must meet specific criteria set forth by the NRC to be considered a “medical event." An example would be administering a radiopharmaceutical to the wrong patient and that resulting dose differing substantially from what that patient should have received. Extravasation is the infiltration of injected fluid into the tissue surrounding a vein or artery. During the original drafting of regulations related to medical event reporting, extravasations were intentionally excluded from this requirement. At the time, the NRC stated, “extravasation frequently occurs in otherwise normal intravenous or intra-arterial injections. It is virtually impossible to avoid."
In 2020, the NRC was petitioned to reconsider their position. A subcommittee of medical professionals was formed to discuss the topic and requests for public comment were made. The requests for public comments included proposed options for how the NRC should proceed. Options ranged from taking no action to reporting all extravasations exceeding a dose threshold. After consideration of the subcommittee's findings and public comments, the NRC has decided to update their regulations to align with “Option 3" of the proposed options. Option 3 is a non-dose-based option requiring notification to the NRC if a radiopharmaceutical extravasation occurs, and the patient requires medical attention for suspected radiation injury as a result.
How does this affect the NIH community? While the time it takes to progress from proposed rulemaking to actual regulations can be long, it is best to be prepared for this inevitability. It would be prudent for clinical areas administering radiopharmaceuticals for either diagnostic and/or therapeutic purposes to evaluate extravasation policy and procedures and update them as needed to be ready for this upcoming regulatory change.
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