Impact of Delays between Clinical and Laboratory Standards Institute and Food and Drug Administration Revisions of Interpretive Criteria for Carbapenem-Resistant Enterobacteriaceae

Author:

Bartsch Sarah M.1,Huang Susan S.2,Wong Kim F.3,Slayton Rachel B.4,McKinnell James A.56,Sahm Daniel F.7,Kazmierczak Krystyna7,Mueller Leslie E.1,Jernigan John A.4,Lee Bruce Y.1

Affiliation:

1. Public Health Computational and Operations Research (PHICOR), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

2. Division of Infectious Diseases and Health Policy Research Institute, University of California—Irvine School of Medicine, Orange, California, USA

3. Center for Simulation and Modeling, University of Pittsburgh, Pittsburgh, Pennsylvania, USA

4. Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

5. Infectious Disease Clinical Outcomes Research Unit (ID-CORE), Los Angeles Biomedical Research Institute, Harbor–UCLA Medical Center, Torrance, California, USA

6. Torrance Memorial Medical Center, Torrance, California, USA

7. International Health Management Associates, Inc., Schaumburg, Illinois, USA

Abstract

ABSTRACT Delays often occur between CLSI and FDA revisions of antimicrobial interpretive criteria. Using our Regional Healthcare Ecosystem Analyst (RHEA) simulation model, we found that the 32-month delay in changing carbapenem-resistant Enterobacteriaceae (CRE) breakpoints might have resulted in 1,821 additional carriers in Orange County, CA, an outcome 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 against emerging pathogens when containment of spread is paramount; delays of <1.5 years are ideal.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference34 articles.

1. Emerging Resistance, New Antimicrobial Agents  …  but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape

2. Centers for Disease Control and Prevention. 2012. Guidance for control of carbapenem-resistant Enterobacteriaceae (CRE): 2012 CRE toolkit. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, Division of Healthcare Quality and Promotion, Atlanta, GA.

3. Centers for Disease Control and Prevention. 2013. Antibiotic resistance threats in the United States 2013. Centers for Disease Control and Prevention Atlanta GA. http://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf.

4. The Regional Healthcare Ecosystem Analyst (RHEA): a simulation modeling tool to assist infectious disease control in a health system

5. Simulation Shows Hospitals That Cooperate On Infection Control Obtain Better Results Than Hospitals Acting Alone

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