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Joseph Ring, Government Relations Committee Chair

The Health Physics Society (HPS) Government Relations Committee and Medical Health Physics Section provided a response to the Nuclear Regulatory Commission's (NRC) request for comment on "Reporting Nuclear Medicine Injection Extravasations as Medical Events," Docket ID NRC-2020-0141 on 14 October 2020. The document is available on the Government Relations Program website: HPS Public Comments.

In summary, the comment says the HPS does not believe the infiltration/extravasation of radiopharmaceuticals should be classified as a medical event. Infiltration of a portion of the radiopharmaceutical is often unavoidable and there is little evidence that infiltration of radiopharmaceuticals carries any health consequences for the patient or the general public.

Monitoring the rate of extravasations is a medical issue that is overseen by the institution's quality management program. Additional regulatory action would only add regulatory burden without an improvement for patient radiological health and safety.

Requiring monitoring and review of extravasations is fundamentally different from the majority of NRC-specified medical events that can be attributed to failures that are readily preventable. The NRC has used reporting of medical events to evaluate if there is a breakdown in the licensee's program or if there was a generic issue that should be reported to other licensees that could reduce the likelihood of other medical events and enhanced radiological safety. Extravasations frequently occur in intravenous injections and are almost impossible to prevent, which makes the proposed classification inconsistent with the purpose of a medical event.

If the NRC decides to classify extravasation as a medical event, the focus should be on therapy administrations where there is a potential for tissue reactions. The criteria should consider that infiltration and extravasation occur at some frequency regardless of interventions and quality initiatives. The potential evaluation criteria should be similar to how the medical community handles fluoroscopic skin injury (The Joint Commission. Sentinel Event Alert 47: Radiation Risks of Diagnostic Imaging and Fluoroscopy).