December 02, 2020

ACR Recommends NRC Denial of Device Manufacturer’s Extravasation Petition

The American College of Radiology® (ACR®) filed comments with the United States Nuclear Regulatory Commission (NRC) on Nov. 30, 2020 recommending denial of a petition for rulemaking (PRM-35-22) filed by a device vendor requesting that the agency require reporting of certain nuclear medicine injection infiltrations/extravasations as “medical events.” Historically, the NRC has exempted infiltration/extravasation from medical event requirements due to the general insignificance and unavoidability of these occurrences.

The requested change in the petition—which was filed by the vendor of a novel injection site monitor and corresponding dosimetry service—would require quantification of infiltrations to determine if the medical event threshold has been reached. NRC medical events have stringent reporting requirements under 10 CFR 35.3045, including 24-hour early notifications of referring physicians and patients as well as requisite filing of detailed reports with referring physicians and regulators within 15 days. Medical event data is documented in a federal database and is broadly understood to indicate potential problems in a facility’s use of radioactive materials. There are administrative burdens, medicolegal implications, professional pressures, and numerous other unintended consequences of 10 CFR 35.3045, and thus the focus of NRC’s requirements is usually on completely preventable provider errors, such as wrong site, wrong patient, wrong dose, and so on.

The ACR and all other relevant provider organizations recommended against the manufacturer’s petition due to the unavoidability of infiltration during typical intravenous administrations, the usual insignificance of these occurrences from a radiation safety perspective, the downstream consequences on providers and patients of medical event regulations, the financial conflict of interest of the petitioner, and because the change would be a burdensome imposition into the practice of medicine without regulatory justification or an offsetting radiation protection benefit.

Despite opposition from healthcare providers, the North Carolina-based vendor has obtained support from North Carolina Congressmen David Price, George Holding and G. K. Butterfield, who jointly sent NRC a letter in June 2020 controversially stating that nuclear medicine injection infiltration is “avoidable” and harmful.

The NRC will convene a public workshop on the manufacturer’s extravasation petition on Dec. 8, from 2 to 4pm ET. Registration is required, and participation by interested ACR members is encouraged.