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Is Your Alcohol Handrub as Professional as You Are?

Jeanne Medvick, BAMT (ASCP), MBA
05/19/2008
Continued from page 1

Many professional-grade hand hygiene products are formulated to meet FDA performance standards, to be effective against pathogenic microorganisms present in healthcare facilities, and to be mild to the skin after repeated uses. Are you sure that the alcohol handrub you use in your facility makes the professional grade?

Antimicrobial Efficacy

A professional-grade antiseptic hand hygiene product must be able to provide broad-spectrum, fast-acting antimicrobial efficacy against the pathogenic organisms that constitute a threat to both patients and healthcare workers. By meeting the FDA proposed performance standards for a HCPH, a product provides evidence of optimum antimicrobial performance. The FDA published the proposed performance standards for the HCPH claim in 1994.1 A hand hygiene product can only claim to be a HCPH if it is tested in an in vivo clinical study with human volunteers. The volunteers’ hands are contaminated with a uniform number of bacteria (Serratia marcescens is used). The hands are then sampled to obtain the baseline number of organisms recovered from the hands. The volunteers then undergo 10 cycles of hand contamination followed by handrub application. The determination of the number of organisms killed by the test product is made after the first, third, seventh, and 10th contamination/application cycles. The product must demonstrate a two log10 reduction of the bacteria after the first wash and a three log10 reduction of the bacteria after the 10th wash to make a HCPH claim.

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