Impact of Delays between the Clinical and Laboratory Standards Institute (CLSI) and the Food and Drug Administration (FDA) Revising Interpretive Criteria for Carbapenem-Resistant Enterobacteriaceae (CRE).

Bartsch SM1, Huang SS2, Wong KF3, Slayton RB4, McKinnell JA5, Sahm DF6, Kazmierczak K6, Mueller LE1, Jernigan JA4, Lee BY7.

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Abstract

Delays often occur between CLSI and FDA revisions of antimicrobial interpretive criteria. Using our RHEA simulation model, we found the 32-month delay in changing CRE breakpoints might have resulted in 1,821 additional carriers in Orange County, CA that could have been avoided by identifying CRE and initiating contact precautions. Policy makers should aim to minimize the delay in the adoption of new breakpoints for antimicrobials for emerging pathogens where containment of spread is paramount, with delays under 1.5 years being ideal.