US regulators considering changes to long-standing extravasation reporting requirements
The organization overseeing radioactive isotope use in the U.S. is considering changes to a long-standing policy that exempts providers from reporting extravasations.
The U.S. Nuclear Regulatory Commission released a preliminary report July 30 detailing potential options for disclosing when radiopharmaceuticals are inadvertently injected into patients’ tissue instead of their veins. NRC’s Advisory Committee for the Medical Uses of Isotopes Subcommittee on Extravasation also relayed its own suggestions.
There are six options within the documents, ranging from no action to required reporting for events that exceed a localized dose equivalent to 50 rem (0.5 Sv).
The NRC said it’s weighing the options but has not determined which it will be recommending to agency leadership. The ACMUI subcommittee, meanwhile, supports reporting any radiation-caused skin damage requiring medical attention, known as option 4.
According to the report, that includes events that meet the 10 Gy (1,000 rad) dose threshold requirement for abnormal occurrences. As it stands, these extravasations and those that cause patient harm don’t need to be reported to federal and state radiation protection agencies.
“At this time, the subcommittee has decided that the best regulatory strategy with regard to extravasation is to focus on qualitative consequences of radiation-induced injury,” subcommittee Chair Melissa Martin wrote, referring to option 4. “This would provide NRC with information on the types of radiation injuries caused by extravasation, and the frequency of such injuries. The subcommittee recognizes the challenges associated with a qualitative reporting standard but believes that this strikes the best balance between radiation safety, patient harm and complex dosimetry.”
Extravasation reporting has been a hotly debated topic as of late.
Cary, North Carolina-based Lucerno Dynamics filed a petition last year that would require the quantification and reporting of certain extravasations. The firm, which sells a device used to monitor injection quality, has argued there is plenty of evidence showing extravasations can and have caused patient harm and should be reported.
At the same time, imaging groups such as the American College of Radiology and Society of Nuclear Medicine and Molecular Imaging argue otherwise.
SNMMI past-President Alan Packard, PhD, went as far as to say the organization “firmly believes that extravasation of diagnostic radiopharmaceuticals is not a patient safety issue,” he told Health Imaging in June.
Read the NRC’s entire report and subcommittee’s corresponding recommendations here. Read the ACR’s Aug. 19 news update on the topic here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.