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ACMUI Backs SNMMI's Recommendations on Extravasation Reporting
September 3, 2021
Yesterday, the Advisory Committee for the Medical Uses of Isotopes (ACMUI) Subcommittee on Extravasations reviewed and provided further recommendations on the Nuclear Regulatory Commission (NRC) Staff Preliminary Evaluation of Radiopharmaceutical Extravasation and Medical Event Reporting in a public meeting. In anticipation of the meeting, SNMMI provided public comment. The Society has been working for close to a year on this very important issue, which has the potential to negatively impact the future of nuclear medicine.
On September 15, 2020, the NRC requested comments from the public on whether additional rulemaking is needed to require reporting of certain nuclear medicine injection extravasations as medical events. SNMMI, the American College of Nuclear Medicine (ACNM), and the American Society of Nuclear Cardiology (ASNC) released the following statement. We later submitted comments in November 2020, which may be found here.
In our most recent comments, we supported non-dose-based reporting options found in both NRC staff and ACMUI draft reports. Although we preferred a lower regulatory reporting requirement (Option 6), as extravasations pose an extremely low patient safety risk, we made the following recommendations to the Subcommittee's preferred option (Option 4).
Option 4 would require reporting if “a patient requires medical attention due to skin damage near the administration site, and the damage is determined to be caused by radiation.”
- The phrase “medical attention” is ambiguous. Taken to the extreme, “medical attention” could conceivably include basic IV access care (e.g., compresses, etc.) for temporary injection site bruising, erythema or swelling. If Option 4 is to be seen as a viable option, the manner and intensity of “medical attention” that would trigger medical event reporting requirements must be clearly defined.
- The injury assessor should be a physician with radiation medicine expertise (i.e., an Authorized User [AU] or AU-eligible physician) who can differentiate normal injection site changes from radiation-caused damage. Option 6 would provide for this physician determination of harm standard, whereas Option 4 does not specify the qualifications for the “radiation damage assessors.”
We are pleased that the Subcommittee supported our recommendations to tailor Option 4 more narrowly to the needs of the nuclear medicine community, and we look forward to the final report.