Evaluation of the Regulatory Paradigm for Testing Antimicrobials for Use in Clinical Settings

On December 16, 2013, the Food and Drug Administration proposed a rule that would require manufacturers to provide more evidence to demonstrate the effectiveness of antibacterial soaps.  The laboratory tests used to evaluate the effectiveness of antibacterial soaps do not directly take into account the effect of a product on infection rates.  Similarly, manufacturers of antimicrobials for use in hospitals, which are under the jurisdiction of the U.S. Environmental Protection Agency, are not currently required to conduct studies that directly test the ability of an antimicrobial to be clinically beneficial.  Furthermore, there are no detailed standards in place to guide approval of antimicrobial products for healthcare settings.  A hospital environment can be a short-term or a long-term home for many immunocompromised patients including children and elderly who can be exposed to healthcare-associated infections (HAIs).  Antimicrobial products play an important role in preventing HAIs, however, an antimicrobial product that kills pathogens in vitro does not necessarily translate into decreasing the incidence of HAIs in humans.  Differences between how the Environmental Protection Agency (EPA) and the public interpret the use of “antimicrobial” is exemplified in the registration of copper as the first “antimicrobial surface.”  Here, we summarize the regulatory paradigm that was used to register copper as an antimicrobial surface under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  We also provide an analysis of the current guidelines in action for hospital cleaning practices as well as an analysis of the differences between clinical and environmental use of the term “antimicrobial.”  We recommend employing a standardized efficacy testing protocol specifically designed for surfaces and not just conventional antimicrobial agents that is based on stringent, evidence-based hospital cleaning standards. We conclude that the selection of antimicrobials in infection control practice in hospital settings should be based upon the best evidence available.