ML21264A077
| ML21264A077 | |
| Person / Time | |
|---|---|
| Issue date: | 10/04/2021 |
| From: | Richard Ennis, Rodneshia Green, Metter D, Ouhib Z, Sheetz M Advisory Committee on the Medical Uses of Isotopes, NRC/NMSS/DMSST/MSEB |
| To: | |
| Daniel DiMarco | |
| References | |
| Download: ML21264A077 (2) | |
Text
U.S. Nuclear Regulatory Commission
Advisory Committee on the Medical Uses of Isotopes
Subcommittee on Medical Events
Subcommittee Final Report
Submitted On: October 4, 2021
Subcommittee Members: Mr. Richard Green, Dr. Ronald D. Ennis ( Chair), M.D., Dr. Darlene F.
Metter, Mr. Zoubir Ouhib, Mr. Michael Sheetz, Dr. Harvey Wolkov
Charge
The specific charge of this subcommittee is to annually review the medical events (MEs) with an eye to advising the Advisory Committee on the Medical Use of Is otopes and the U.S. Nuclear Regulatory Commission (NRC) about emerging trends needing regul atory attention.
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Background===
The subcommittee reviewed medical events from the Fiscal year 2 020 as part of its ongoing annual or biennial review.
Findings
The MEs during 2020 were similarly low as in years past. This issue regarding time outs and checklists as a method to minimize MEs was again noted. In the committees discussion regarding the category that it had previously called infrequen t/inexperience use the point was made that some of these events may be due to inattention at the time of the procedure rather than infrequent or inexperience use. So, this category has bee n renamed to highlight this ambiguity. The NRC has issued an Information Notice in 2019 advising the user community about these issues. https://www.nrc.gov/docs/ML1924/ML19240A450.pdf
The concern raised by this subcommittee last year that emerging, more complex, radiopharmaceuticals may lead to an increase in MEs was not see n. There was only one such event in 2020.
The MEs involving Y-90 microspheres continue to be the most com mon, although as a proportion of all such procedures an ME is very rare. The MEs occur with both Therasphere and Sirsphere, although more commonly with Therasphere, despite reportedly equal market share of the two products. Because of this, the subcommittee r ecommends the appointment of a subcommittee specifically focused on investigating the MEs as sociated with this therapy and to propose, in consultation with the vendors, methods to decrea se these MEs.
Concluding Remarks
The subcommittee looks forward to performing an in-depth trend analysis in 2022.
The subcommittee welcomes any comments and/or suggestions.
Respectfully Submitted, The Medical Event Subcommittee