Dr. Clifford Gevirtz: There are two key points of <USP 797> that are not evidence-based.
1. The one-hour rule is not based on bacteriology results; it is a consensus approach by the committee that made <USP 797>. Please note that there were no anesthesiologists on that committee.
2. The observation that multiple entries versus single entry is irrelevant in the presence of bacteriostatic medication is a clinical truism. However, the FDA begs to differ. They state that if the label says “single patient use only,” then the container may be entered only once for a single patient. Their focus is on the labeling and not on clinical experience. The staff at CMS, similarly, have their own focus and anesthesia providers are now clearly in the crosshairs. However, the danger of non-compliance seems to far outweigh what is clinically reasonable.
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