Formal education, certification and on-the-job training contribute to the expertise of a healthcare professional. These dedicated staff members use many sources of scientifically based information to develop interventions that improve the quality of patient care. Many professionals may not be aware that there is another source of information to add to their list of resources — some manufacturers conduct research and make reports available on the testing of their products.
Recently, infection control professionals have adopted “zero tolerance” toward healthcare-associated infections (HAIs) in their programs as the most important initiative to improve the quality of patient care. One way that healthcare workers can contribute to the success of this initiative is by increasing and maintaining their compliance with good hand hygiene practices.
Professional hand hygiene products, especially alcohol handrubs, should be regarded as a “must have” element of hand hygiene programs. The time has come to recognize that professional-grade alcohol handrub products used in the healthcare environment can be differentiated from consumer or household-grade alcohol handrubs. Household alcohol handrubs are not necessarily developed to meet the antimicrobial performance standards of a healthcare personnel handwash (HCPH) as proposed by the Food and Drug Administration (FDA) and may not be as effective when used multiple times over the course of a day. Typical household alcohol rubs may also irritate the skin after multiple applications because of inadequate concentrations of emollients and skin conditioners. This can make compliance with hand hygiene practices difficult.
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?
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.
These performance standards were originally written for wash-off hand hygiene products and there has been an ongoing debate as to whether leave-on hand hygiene products such as alcohol handrubs can meet these standards.
To investigate the theory that leave-on hand hygiene products are unable to meet the FDA performance standards, a professional-grade isopropyl alcohol handrub was tested in a clinical HCPH study utilizing the FDA testing methodology. The professional-grade isopropyl alcohol handrub not only met the HCPH standard, but exceeded it by achieving a 4.1 log10 reduction after the first wash and a 4.4 log10 reduction after the 10th. Table 1 shows the results of the professional-grade isopropyl alcohol handrub for the first, third, seventh, and 10th contamination/application cycles compared to the proposed FDA performance standards.
In a previously published article, a household-grade ethyl alcohol handrub was tested in a clinical study using a modified version of a HCPH study by the American Society for Testing and Materials Standard Method E11794-94.2 The test product achieved a 3.9 log10 reduction after the first wash, but failed to meet FDA’s 10th wash requirement by achieving only a 2.1 log10 reduction. Figure 1 portrays the HCPH results of the professional-grade and household-grade alcohol handrubs in comparison to FDA’s performance criteria for a HCPH product.
Although FDA does not cite performance standards for the third and tenth contamination/wash cycles in the HCPH study, it should be noted that the household-grade ethyl alcohol handrub results demonstrated a decreasing effectiveness at reducing the number of organisms from the third application through the tenth application. It could be interpreted that the product becomes less effective the more it is used.
This reduction in activity may have little relevance when these products are used occasionally in the household. However, in the healthcare environment, professionals may need to use an alcohol hand sanitizer many times in an hour. In these situations, it is imperative to have the same antimicrobial efficacy at the 10th use as there is at the first use. The professional-grade isopropyl alcohol handrub demonstrated its ability to maintain its antimicrobial efficacy from the first application to the 10th application.
The Mildness Factor
Many healthcare workers express concern that alcohol handrubs will have a drying and damaging effect on their skin. Professional-grade alcohol handrubs are formulated to provide superior antimicrobial efficacy and at the same time to be mild to the skin. Mildness is usually defined in terms of what it is not: a mild product is not harsh and irritating. After multiple uses, a mild product does not allow rapid transepidermal water loss from the skin and helps maintain the natural moisture of the skin.
The professional-grade isopropyl alcohol handrub was tested for its capability of maintaining skin hydration in a clinical study called a forearm controlled application test (FCAT), along with a household-grade ethyl alcohol handrub. In this one-day study, technicians applied the two test products to marked sites on the forearms of human volunteers. Skin hydration was evaluated prior to the application of the test products (baseline) and at one and two hours after one application of each product. The professional-grade isopropyl alcohol handrub demonstrated an increase in skin hydration for up to two hours after one application. There was a loss of skin hydration at both one and two hours after the application of the household-grade ethyl alcohol handrub. Figure 2 illustrates the results of the study.
The Moisturizing Factor
A professional-grade alcohol handrub can enhance skin health by adding moisture to the skin. The professional-grade isopropyl alcohol handrub was tested in a second FCAT clinical study for its moisturizing capability competing with skin lotions commonly used in healthcare facilities. During the one-day treatment phase, trained technicians applied the test products twice to one of five sites designated on the forearms of the volunteers. One hour after application, evaluations of the moisture added to the skin were conducted. The results demonstrated that the professional-grade isopropyl alcohol handrub contributed significant moisturization to the skin that was comparable or superior to the skin care lotions. See Figure 3 for results.
Professional is as Professional Does
Professional healthcare workers need to protect their patients and themselves over the course of a workday against pathogenic microorganisms that are present in healthcare facilities today. They also need to protect their skin from the potentially harsh effects of repeated hand decontamination required for proper compliance to protocols. A professional-grade hand hygiene product that meets FDA performance standards can provide superior antimicrobial efficacy and can also provide mildness and moisturization to promote good skin health. There is scientific evidence available that differentiates professional and household alcohol handrubs. Now that you know the difference, ask to see it for your hand hygiene products and make an educated decision for your facility.ICT
Jeanne Medvick, BAMT (ASCP), MBA, is group manager of clinical studies for STERIS Corporation. She is responsible for clinical evaluations related to skin care products. She has more than 25 years of experience in infection prevention and control, both in microbiology research and as an infection control professional. Over the years, Medvick has presented at many local and national continuing education offerings for professional healthcare organizations. Her areas of expertise include infection prevention and control trends and practices (such as strategies for preventingand controlling antimicrobial resistance), improving hand hygiene compliance, maintaining skin health, and disinfection and sterilization issues. She has been an active member of the Association for Professionals in Infection Control and Epidemiology (APIC) since 1980 and has served in many capacities including as president of the Pittsburgh APIC chapter. She currently belongs to the Greater St. Louis APICchapter and is a longstanding member of the Association of Clinical Research Professionals.
1. Food and Drug Administration. Topical antimicrobial drug products for over-the-counter human use: tentative final monograph for health care antiseptic drug products-proposed rule. Federal Register, Parts 333 and 369, Vol. 59, No.116, June 17, 1994; pp. 31402-31452.
2. Fendler EJ, Ali Y, Hammond, BS, Lyons MK, Kelly MB, Vowell, NA. The impact of hand sanitizer use on infection rates in an extended care facility. Am. J. Infect. Control. 2002; 30:226-33.