The bipartisan leadership of the U.S. Nuclear Regulatory Commission (NRC) in favor of from NRC medical team staff, federal advisory committee members and radiation experts to use harm-based reporting — not dose estimate-based reporting — of certain nuclear medicine (NM) agent extravasations as Medical Events. The NRC’s Medical Event reporting mechanism facilitates case-specific analyses by NRC staff and advisors of significant errors or permanent harms during medical uses of radiological material. Phenomena that can occur inside the body without administration error, such as shunting, seed migration and extravasation, are generally excluded.
The NRC broadly defines extravasation as the infiltration of injected fluid into the tissue surrounding a vein or artery. Extravasation is a known potential with any type of intravenous (IV) drug or media and is primarily influenced by patient-specific characteristics and conditions. Some IV drugs and media (e.g., certain chemotherapeutic compounds and large fluid volume infusions) have a much higher potential for tissue injury if extravasated. By contrast, most NM imaging agents are administered in very small volumes of solutions with inert chemical properties unlikely to cause injury. When traces of NM agents extravasate, these typically resolve spontaneously within minutes via reabsorption into the venous and lymphatic systems without injuring tissue or negating the corresponding medical procedure.
A device company that sells related devices and software-as-a-service filed a petition with the NRC in 2020 urging the agency to require novel measurements and dose estimate-based reporting of extravasations (PRM-35-22). The petition raised the collective eyebrows of government watchdogs and stakeholder groups including the 黑料网® (黑料网®) and other national medical associations. If implemented, it would have severely impacted patient access and cost by making novel products and controversial methods of dose estimation a requisite part of approximately 20 million IV administrations annually. It would have inexplicably rendered the consequence of an insignificant extravasation occurrence the same as a healthcare provider administering treatment to the wrong patient or injecting the wrong drug. The petition also could have resulted in nationwide reliance on a single-source vendor for compliance systems and services, likely to result in canceled imaging and therapy procedures, wasted NM agent doses, and adversely affected patients during supply or service disruptions.
The 黑料网 applauds the NRC for appropriately and independently evaluating the company’s petition and choosing to implement a risk-informed approach that focuses on significance and patient safety.
For more information, please contact Michael Peters, 黑料网 Senior Government Affairs Director.