Not all Alcohol-Based Hand Rubs are Equal

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Factors to Consider When Choosing Alcohol-Based Hand Rubs (ABHR) for Your Healthcare Facility writes Elizabeth De Nardo, PhD and Christine Claighen, BSC, Biotechnology.

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Hand Hygiene is one of the most important actions Healthcare Workers (HCWs) can take to reduce the transmission of pathogens that may cause disease. However, hand hygiene compliance average rates have been around 40%, in healthcare settings throughout the world (WHO, 2009).
Many factors play a role in hand hygiene compliance rates but choosing the correct hand hygiene products and user acceptance are major determinants of improving hand hygiene compliance by HCWs (Larson, et al. 2006; WHO, 2009).
Selecting an appropriate antiseptic hand rub is an important decision to make because the clinical effectiveness of Alcohol Based Hand Rubs (ABHR) in reducing Healthcare Associated Infections (HAIs) is a result of several components including: product formulation, antimicrobial efficacy and hand hygiene compliance by the HCWs (Fig.1).
Figure 1 shows that the ability to achieve clinical benefit from ABHR is directly dependent on both the antimicrobial efficacy of the product and hand hygiene compliance. Efficacy and compliance are influenced by several components including: product formulation, dispensing system, and compliance programs.
Although costs of the product are always part of the selection process, a risk/benefits analysis should be conducted and the costs associated with treating preventable HAIs should be considered. A product with undesirable characteristics may discourage hand hygiene among staff, resulting in poor compliance with all of the costs that this incurs in terms of infectious complications (Larson et al., 2006).
Currently in the market we find several hand antiseptics containing different antimicrobial active ingredients, such as alcohol, quartenarium compounds, and others. However, alcohol is the active ingredient of choice for antiseptics hand rubs by leading health organizations such as World Health Organization (WHO); Center for Disease Control and Prevention (CDC) based upon an abundance of scientific evidences of its efficacy (WHO, 2009). Therefore, this article will focus solely on Alcohol Based Hand Rubs (ABHR) and describes main factors to consider when selecting for your health care facility. Those include: antimicrobial efficacy, product formulation, skin tolerance, and user acceptance.
1. Antimicrobial Efficacy of ABHR
The antimicrobial properties and efficacy of ABHR selection should be reviewed prior to engaging staff for end users acceptance and skin tolerance.
With the exception of non-medicated soaps, every new formulation for hand antisepsis must be tested by the manufacturer to demonstrate that it meets the agreed efficacy performance standard. The formulation with all its ingredients should be evaluated to ensure that humectants or rehydrating chemicals added to ensure better skin tolerance do not in any way compromise its antimicrobial action (WHO, 2009).
ABHR are widely accepted in the majority of countries falling under a variety of regulatory schemes, unique to each country or region in which they are marketed. In Australia if an ABHR only claims to be effective against bacteria then it is considered a cosmetic and is regulated under NICNAS. If the ABHR claims to be effective against bacteria and more such as fungi, viruses, yeast, etc, it is then considered a drug regulated by the Therapeutic Goods Administration (TGA) under the OTC (over the counter sector).
Regulatory Agencies in general require both in vitro and in vivo antimicrobial efficacy testing of the finished product. In vitro testing is used to demonstrate the speed of kill and the spectrum of activity of products. In vivo laboratory studies using human subjects are designed to mimic the hospital setting and serve as surrogates for clinical efficacy (WHO, 2009).
1.1. Protocols used for Testing the Antimicrobial Efficacy
Although many methodologies are available to perform the in vitro and in vivo tests the two most accepted protocols are the ASTM which refer to the standards of ASTM International (formerly, the American Society for Testing and Materials) mostly used in the U.S. and the European Committee for Standardization (CEN) adopted by most of the European countries. Australia TGA accepts protocols from both organizations (ASTM International, 2006, Comité Européen de Normalisation, 1997).
1.1.1. In Vitro Testing
In vitro tests are performed in laboratory, under a controlled environment and a battery of 25 or more pathogens of public health concern, mainly bacteria, are exposed to the formulation for 15 a 30 seconds. A minimum of 3 to 4 log reduction (99.9 to 99.99%) is expected. Results from the in vitro tests do not always predict the in vivo tests results (Edmonds et al., 2011).
1.1.2. In Vivo Testing
Currently two standard test methods: ASTM E1174 and EN1500 are accepted in most countries. The choice of which depends on the particular country in which the product is to be marketed. Australia TGA accepts both protocols. Both tests measure the reduction of a transient marker organism (Serratia marcescens for ASTM E1174 and Escherichia coli for EN1500) on the hands of adult subjects.
1.2. Formulation Matters not Alcohol Concentration
The antimicrobial activity of alcohols results from their ability to denature proteins. Alcohol solutions containing a range of 60–90% alcohol content is most effective and recommended by leading Health Care Organizations (Boyce et al, 2002, WHO, 2009).
However, formulations that contain more alcohol concentration do not mean they have better antimicrobial efficacy. Formulation as a whole is more important than alcohol concentration.
Recent studies (Edmonds et al., 2011 and 2012) comparing the in vivo efficacy of several ABHR containing different alcohol concentration showed that antimicrobial efficacy does not correlate with alcohol concentration (Fig. 2); more alcohol is not always better. In addition, those studies also show that product format (gel and foam) does not impact efficacy. Gel and foam have the same in vivo efficacy.
Figure 2. Bacteria log reduction (in vivo test- ASTM E1174) of several ABHR containing different alcohol concentrations (Edmonds, et al., 2011)
Figure 2 illustrates the influence that product formulation can have on in vivo efficacy. Two 70% formulations (Products C and D) performed statistically superior at application 1 and 10 than another 70% formulation (Product B) indicating that alcohol concentration does not drive antimicrobial efficacy. Furthermore, some 70% formulations (Products C and D) perform significantly better than higher alcohol formulations (Products E and F). Some 70% formulations (Products C and D) perform significantly better than higher alcohol formulations. These data clearly demonstrate that product formulation is a key driver of product efficacy, regardless of alcohol concentration (Edmonds et al., 2011 and 2012).
ABHR are complex formulations, combining alcohol with various ingredients to create specific attributes including skin tolerance, skin moisturisation, aesthetic properties (e.g. skin feel, fragrance, etc.); and to enable specific delivery formats to effectively deliver the active ingredient. These additional ingredients can in some cases improve or inhibit the formulation’s antimicrobial efficacy (Edmonds et al., 2012). Therefore, not all ABHR are equal. Formulations matter for antimicrobial efficacy (Fig.3).
Figure 3 illustrates that formulation as a whole has impact on the antimicrobial efficacy, skin tolerance and end user acceptance.
As Figure 3 shows, the whole formulation (active plus inactive ingredients) has influence not only on the antimicrobial efficacy, but also on the skin tolerance and end user acceptance of the product. This knowledge should be taken into consideration during the selection process.
1.2.1 Suggested questions / data required from the product manufactures regarding antimicrobial efficacy:

1. Ask for in vivo results, they are the best to show the antimicrobial efficacy of the product. Don’t be fooled by 99.999999 % of the in vitro results;


2. Ask for the type of protocol/ methodology used for testing the in vivo efficacy: ASTM E1174 and EN1500 are the global standards protocols. Different protocols to assess efficacy can show different results;


3. If ASTM E1174 was used request data on the volume of the product used to meet the criteria. Some products require unreasonably large volumes to meet test requirements. However, large volumes of the product is not used typically in healthcare facilities and not desired by HCW because of the long time it takes to dry on hands (Macinga, et al., 2012).

Summary

• Recommendation of types of data to ask from product manufacturers has been proposed.


• ABHR are complex formulations, combining ethyl alcohol with various ingredients to create specific attributes including antimicrobial efficacy, skin tolerance and aesthetic properties (e.g. skin feel, fragrance, etc.) that contribute to the end user experience / acceptance of the product leading to improve or inhibit hand hygiene compliance in health care facilities.


• The process of selecting ABHR for your facility is such an important decision to make because the clinical effectiveness of those products in reducing Healthcare Associated Infections (HAIs) is a result of several components including: product formulation, antimicrobial efficacy and end user acceptance of the product the HCWs.


• There are still many false beliefs among HCWs about the effect of ABHR may have on the skin.


• Although costs of the product are always part of the selection process, a risk / benefits analyses should be conducted and the costs associated with treating preventable HAIs should be considered.

About the Authors
Elizabeth De Nardo is a Senior Scientist with GOJO Industries. Dr De Nardo holds a PhD in Biology/ Microbiology with a major in Virology. She has conducted extensive research in virology and is responsible for the technical information process at GOJO which results in her interfacing with numerous key customers as a technical liaison giving information about the science behind the formulations. She has more than 15 years of academia experience and 8 years of industry experience working in the Hand Hygiene arena. She has given many presentations at scientific conferences and has published several research articles in her field of expertise.
E denardoe@gojo.com
W www.gojo.com
Christine Claighen is the Regulatory and Scientific Manager, Australasia with BSC majoring in Biotechnology and Microbiology. Christine’s role allows her to liaise face to face with Infection Controllers in the industry to assist with some clinical matters, discuss formulations and best solutions. Christine is recognized by the Stamford Who’s who as a technical professional with 15 years of industry practice in Microbiology, Manufacturing, Quality and Regulatory Affairs in the pharmaceutical and Medical Devices industry.
Regulatory & Scientific Manager- Australasia
E christine.claighen@gojo.com.au
 
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