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• W2007758273 abstract "We appreciate the interest in our recent manuscript and in particular the attention given to the details of the methodology used to evaluate the in vivo efficacy of alcohol-based handrub (ABHR) formulations.1Edmonds S. Macinga D. Mays-Suko P. Duley C. Rutter J. Jarvis W. et al.Comparative efficacy of commercially available alcohol-based hand rubs and WHO-recommended hand rubs: formulation matters.Am J Infect Control. 2012; 40: 521-525Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar We agree with some points raised regarding the methods used in the manuscript and will address these concerns, while providing logic and evidence that the results and conclusions remain the same when the most recent American Society for Testing Methods (ASTM) methods are used. First, to address the rationale for method choice, test products were evaluated according to the Healthcare Personnel Handwash (HCPHW) method described by the Food and Drug Administration (FDA) in the 1994 Tentative Final Monograph for Healthcare Antiseptic Drug Products.2Food and Drug AdministrationTentative final monograph for healthcare antiseptic drug products: proposed rule.Federal Register. 1994; 59: 31441-31452Google Scholar In the manuscript, we referenced the method as the 1996 version of ASTM E1174, which follows the same procedure. Products were evaluated by the FDA HCPHW method because it remains today the only method accepted by the US FDA for validating the in vivo efficacy of ABHR products sold in the United States. It is, therefore, the only appropriate method for evaluating the ability of ABHRs to meet FDA efficacy requirements. It is important to note the FDA requires ABHR efficacy be evaluated after a single product use and after 10 consecutive product usage cycles.2Food and Drug AdministrationTentative final monograph for healthcare antiseptic drug products: proposed rule.Federal Register. 1994; 59: 31441-31452Google Scholar This is an absolute requirement and is included in the monograph to ensure products remain efficacious under high-frequency use typical of health care environments. It cannot be simply dismissed as “irrelevant” as suggested in the letter. As our results demonstrated, many ABHRs meet the FDA’s requirements after 1 application but fail to meet after 10 applications when tested at realistic doses.1Edmonds S. Macinga D. Mays-Suko P. Duley C. Rutter J. Jarvis W. et al.Comparative efficacy of commercially available alcohol-based hand rubs and WHO-recommended hand rubs: formulation matters.Am J Infect Control. 2012; 40: 521-525Abstract Full Text Full Text PDF PubMed Scopus (39) Google ScholarWe fully recognize the limitations of the FDA HCPHW method, the 2006 version of E1174, and EN1500 and have previously published on this topic.3Macinga D. Beausoleil C. Campbell E. Mulberry G. Brady A. Edmonds S. et al.The quest for a realistic in vivo test method for antimicrobial hand-rub agents. part 2: introduction of a low-volume hand contamination procedure.Appl Environ Microbiol. 2011; 77: 8588-8594Crossref PubMed Scopus (15) Google Scholar The 2006 version of ASTM E1174 is not “state of the art,” despite the assertion to the contrary in the letter. Although improvements have been made since the 1996 version, high soil load and hand wetness at the time of product application still remain a challenge. In 2010, ASTM International approved a standard test method, E2755-10, specifically designed to evaluate the efficacy of ABHR.4ASTM International. E-2755–10. Standard test method for determining the bacteria-eliminating effectiveness of hand sanitizer formulations using hands of adults. West Conshohocken [PA]: ATSM International; 2010.Google Scholar E2755 is a major improvement over E1174, greatly reducing soil load build-up and wetness on hands and enabling evaluation of ABHR under conditions more closely representing in use conditions. Furthermore, ASTM has recently re-approved E1174, which when published in 2013, will recommend use of E 2755-10 for evaluating the efficacy of ABHRs.In their letter the authors imply that use of E1174-06 instead of the FDA HCPHW method would have provided different results because of a more timely neutralization in E1174-06. This is not the case because test products A and B from our publication have also been evaluated according to E1174-06 at a 2-mL application volume and achieved log10 reductions of 2.84 and 3.40 after application 1 and 4.01 and 4.91 after application 10, respectively.5BioScience Laboratories, Bozeman, MT. Study 120404–101, October 4, 2012. Data on file at GOJO Industries, Inc.Google Scholar These results exceed the FDA’s efficacy requirements and are consistent with the data shown in Table 4 of our publication.1Edmonds S. Macinga D. Mays-Suko P. Duley C. Rutter J. Jarvis W. et al.Comparative efficacy of commercially available alcohol-based hand rubs and WHO-recommended hand rubs: formulation matters.Am J Infect Control. 2012; 40: 521-525Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar Four additional ABHR products, containing ethanol at 70% vol/vol or higher were also tested, and each failed to achieve a 3-log reduction at application 10. These data demonstrate that the superior efficacy of products A and B reported in our publication is not an artifact of delayed sampling or a lack of neutralization. In addition, we presented data at the 2012 APIC Annual Conference demonstrating that products A and B exhibit a similar level of efficacy when tested according to either the FDA HCPHW method, E1174-06, or E2755-10.6Edmonds S, Macinga D, Paulson D. The influence of ABHR product format on in vivo efficacy: a meta-analysis. American Professionals in Infection Control (APIC) Annual Educational Conference, San Antonio, June 2012.Google ScholarAdditionally, in the letter the authors speculate that an inactive ingredient (caprylyl glycol) contributed to the efficacy of products A and B, which they suggest continued to kill bacteria after the alcohol evaporated from the hands and before the product was neutralized. Although we agree that caprylyl glycol has been demonstrated to enhance the activity of alcohol, the amount of caprylyl glycol in products A and B is well below the concentration required to exhibit bactericidal activity. However, because the authors suggest the 15-second time kill study was insufficient to prove the lack of bactericidal activity, we have performed an additional study, extending the contact time to 5 minutes (the maximum time allowed after product has dried before sampling according to the FDA HCPHW method). In this test, a vehicle formulation containing caprylyl glycol, but lacking ethanol, exhibited no bactericidal activity against Serratia marcescens (ATCC 14756) and Staphylococcus aureus (ATCC 33591).7GOJO Industries Microbiology Laboratory, Akron, OH. Study TK010913 January 2013. Data on file at GOJO Industries, Inc.Google Scholar These data further demonstrate that the activity of products A and B in our study were not overestimated by continued bactericidal activity of inactive ingredients after the alcohol evaporated.Finally, the US FDA has concluded that the effective concentration range for ethanol is from 60% to 95% by volume.2Food and Drug AdministrationTentative final monograph for healthcare antiseptic drug products: proposed rule.Federal Register. 1994; 59: 31441-31452Google Scholar However, the FDA requires each product formulation be tested to ensure the antimicrobial activity of the alcohol is not compromised. The results of our study demonstrate product formulation, and not alcohol concentration, is the critical driver of ABHR efficacy. Even when products A and B are excluded from the analysis in our original publication, there is no relationship between alcohol concentration and efficacy. Whereas previous studies have observed such a relationship, these studies were performed using unformulated, alcohol-in-water solutions that are inappropriate for use in health care.8Rotter M. Koller W. Kundi M. Usability of three alcohols for a standard disinfection method to be employed for the evaluation of procedures for the hygienic disinfection of hands (author’s translation).Zentralbl Bakteriol Orig B. 1977; 164: 428-438PubMed Google Scholar Furthermore, the relevance of these studies is questionable because hands were rinsed with water to stop the action of alcohol after a prescribed “contact time.” This step biases the data because the evaporation rate of alcohol is dependent on alcohol concentration. To perform an unbiased evaluation of the influence of alcohol concentration on efficacy, test formulations need to be rubbed in until dry. We have published such a study using E2755 and found no correlation between alcohol concentration and efficacy.3Macinga D. Beausoleil C. Campbell E. Mulberry G. Brady A. Edmonds S. et al.The quest for a realistic in vivo test method for antimicrobial hand-rub agents. part 2: introduction of a low-volume hand contamination procedure.Appl Environ Microbiol. 2011; 77: 8588-8594Crossref PubMed Scopus (15) Google ScholarIn conclusion, products were evaluated according to the method required by the US FDA for validating ABHR efficacy. The results of the study demonstrate ABHR formulation has a strong influence on a product’s antimicrobial performance and ability to meet FDA efficacy requirements, particularly after repeated product use, which is relevant, realistic, and critical in health care environments. Further evidence has been presented herein to demonstrate similar results are observed and lead to the same conclusion when the current ASTM methods are used. We agree the HCPHW methodology has limitations and have been on the forefront of developing improved methods that more closely reflect ABHR use conditions. However, until the FDA adopts such methods, it is not up to the manufacturer to decide what method is most appropriate for validating efficacy or whether to ignore the FDA efficacy requirements after repeated use. It is the responsibility of the manufacturer to ensure that ABHR products meet FDA efficacy requirements every time the product is used throughout the day, not just after the first use. We appreciate the interest in our recent manuscript and in particular the attention given to the details of the methodology used to evaluate the in vivo efficacy of alcohol-based handrub (ABHR) formulations.1Edmonds S. Macinga D. Mays-Suko P. Duley C. Rutter J. Jarvis W. et al.Comparative efficacy of commercially available alcohol-based hand rubs and WHO-recommended hand rubs: formulation matters.Am J Infect Control. 2012; 40: 521-525Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar We agree with some points raised regarding the methods used in the manuscript and will address these concerns, while providing logic and evidence that the results and conclusions remain the same when the most recent American Society for Testing Methods (ASTM) methods are used. First, to address the rationale for method choice, test products were evaluated according to the Healthcare Personnel Handwash (HCPHW) method described by the Food and Drug Administration (FDA) in the 1994 Tentative Final Monograph for Healthcare Antiseptic Drug Products.2Food and Drug AdministrationTentative final monograph for healthcare antiseptic drug products: proposed rule.Federal Register. 1994; 59: 31441-31452Google Scholar In the manuscript, we referenced the method as the 1996 version of ASTM E1174, which follows the same procedure. Products were evaluated by the FDA HCPHW method because it remains today the only method accepted by the US FDA for validating the in vivo efficacy of ABHR products sold in the United States. It is, therefore, the only appropriate method for evaluating the ability of ABHRs to meet FDA efficacy requirements. It is important to note the FDA requires ABHR efficacy be evaluated after a single product use and after 10 consecutive product usage cycles.2Food and Drug AdministrationTentative final monograph for healthcare antiseptic drug products: proposed rule.Federal Register. 1994; 59: 31441-31452Google Scholar This is an absolute requirement and is included in the monograph to ensure products remain efficacious under high-frequency use typical of health care environments. It cannot be simply dismissed as “irrelevant” as suggested in the letter. As our results demonstrated, many ABHRs meet the FDA’s requirements after 1 application but fail to meet after 10 applications when tested at realistic doses.1Edmonds S. Macinga D. Mays-Suko P. Duley C. Rutter J. Jarvis W. et al.Comparative efficacy of commercially available alcohol-based hand rubs and WHO-recommended hand rubs: formulation matters.Am J Infect Control. 2012; 40: 521-525Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar We fully recognize the limitations of the FDA HCPHW method, the 2006 version of E1174, and EN1500 and have previously published on this topic.3Macinga D. Beausoleil C. Campbell E. Mulberry G. Brady A. Edmonds S. et al.The quest for a realistic in vivo test method for antimicrobial hand-rub agents. part 2: introduction of a low-volume hand contamination procedure.Appl Environ Microbiol. 2011; 77: 8588-8594Crossref PubMed Scopus (15) Google Scholar The 2006 version of ASTM E1174 is not “state of the art,” despite the assertion to the contrary in the letter. Although improvements have been made since the 1996 version, high soil load and hand wetness at the time of product application still remain a challenge. In 2010, ASTM International approved a standard test method, E2755-10, specifically designed to evaluate the efficacy of ABHR.4ASTM International. E-2755–10. Standard test method for determining the bacteria-eliminating effectiveness of hand sanitizer formulations using hands of adults. West Conshohocken [PA]: ATSM International; 2010.Google Scholar E2755 is a major improvement over E1174, greatly reducing soil load build-up and wetness on hands and enabling evaluation of ABHR under conditions more closely representing in use conditions. Furthermore, ASTM has recently re-approved E1174, which when published in 2013, will recommend use of E 2755-10 for evaluating the efficacy of ABHRs. In their letter the authors imply that use of E1174-06 instead of the FDA HCPHW method would have provided different results because of a more timely neutralization in E1174-06. This is not the case because test products A and B from our publication have also been evaluated according to E1174-06 at a 2-mL application volume and achieved log10 reductions of 2.84 and 3.40 after application 1 and 4.01 and 4.91 after application 10, respectively.5BioScience Laboratories, Bozeman, MT. Study 120404–101, October 4, 2012. Data on file at GOJO Industries, Inc.Google Scholar These results exceed the FDA’s efficacy requirements and are consistent with the data shown in Table 4 of our publication.1Edmonds S. Macinga D. Mays-Suko P. Duley C. Rutter J. Jarvis W. et al.Comparative efficacy of commercially available alcohol-based hand rubs and WHO-recommended hand rubs: formulation matters.Am J Infect Control. 2012; 40: 521-525Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar Four additional ABHR products, containing ethanol at 70% vol/vol or higher were also tested, and each failed to achieve a 3-log reduction at application 10. These data demonstrate that the superior efficacy of products A and B reported in our publication is not an artifact of delayed sampling or a lack of neutralization. In addition, we presented data at the 2012 APIC Annual Conference demonstrating that products A and B exhibit a similar level of efficacy when tested according to either the FDA HCPHW method, E1174-06, or E2755-10.6Edmonds S, Macinga D, Paulson D. The influence of ABHR product format on in vivo efficacy: a meta-analysis. American Professionals in Infection Control (APIC) Annual Educational Conference, San Antonio, June 2012.Google Scholar Additionally, in the letter the authors speculate that an inactive ingredient (caprylyl glycol) contributed to the efficacy of products A and B, which they suggest continued to kill bacteria after the alcohol evaporated from the hands and before the product was neutralized. Although we agree that caprylyl glycol has been demonstrated to enhance the activity of alcohol, the amount of caprylyl glycol in products A and B is well below the concentration required to exhibit bactericidal activity. However, because the authors suggest the 15-second time kill study was insufficient to prove the lack of bactericidal activity, we have performed an additional study, extending the contact time to 5 minutes (the maximum time allowed after product has dried before sampling according to the FDA HCPHW method). In this test, a vehicle formulation containing caprylyl glycol, but lacking ethanol, exhibited no bactericidal activity against Serratia marcescens (ATCC 14756) and Staphylococcus aureus (ATCC 33591).7GOJO Industries Microbiology Laboratory, Akron, OH. Study TK010913 January 2013. Data on file at GOJO Industries, Inc.Google Scholar These data further demonstrate that the activity of products A and B in our study were not overestimated by continued bactericidal activity of inactive ingredients after the alcohol evaporated. Finally, the US FDA has concluded that the effective concentration range for ethanol is from 60% to 95% by volume.2Food and Drug AdministrationTentative final monograph for healthcare antiseptic drug products: proposed rule.Federal Register. 1994; 59: 31441-31452Google Scholar However, the FDA requires each product formulation be tested to ensure the antimicrobial activity of the alcohol is not compromised. The results of our study demonstrate product formulation, and not alcohol concentration, is the critical driver of ABHR efficacy. Even when products A and B are excluded from the analysis in our original publication, there is no relationship between alcohol concentration and efficacy. Whereas previous studies have observed such a relationship, these studies were performed using unformulated, alcohol-in-water solutions that are inappropriate for use in health care.8Rotter M. Koller W. Kundi M. Usability of three alcohols for a standard disinfection method to be employed for the evaluation of procedures for the hygienic disinfection of hands (author’s translation).Zentralbl Bakteriol Orig B. 1977; 164: 428-438PubMed Google Scholar Furthermore, the relevance of these studies is questionable because hands were rinsed with water to stop the action of alcohol after a prescribed “contact time.” This step biases the data because the evaporation rate of alcohol is dependent on alcohol concentration. To perform an unbiased evaluation of the influence of alcohol concentration on efficacy, test formulations need to be rubbed in until dry. We have published such a study using E2755 and found no correlation between alcohol concentration and efficacy.3Macinga D. Beausoleil C. Campbell E. Mulberry G. Brady A. Edmonds S. et al.The quest for a realistic in vivo test method for antimicrobial hand-rub agents. part 2: introduction of a low-volume hand contamination procedure.Appl Environ Microbiol. 2011; 77: 8588-8594Crossref PubMed Scopus (15) Google Scholar In conclusion, products were evaluated according to the method required by the US FDA for validating ABHR efficacy. The results of the study demonstrate ABHR formulation has a strong influence on a product’s antimicrobial performance and ability to meet FDA efficacy requirements, particularly after repeated product use, which is relevant, realistic, and critical in health care environments. Further evidence has been presented herein to demonstrate similar results are observed and lead to the same conclusion when the current ASTM methods are used. We agree the HCPHW methodology has limitations and have been on the forefront of developing improved methods that more closely reflect ABHR use conditions. However, until the FDA adopts such methods, it is not up to the manufacturer to decide what method is most appropriate for validating efficacy or whether to ignore the FDA efficacy requirements after repeated use. It is the responsibility of the manufacturer to ensure that ABHR products meet FDA efficacy requirements every time the product is used throughout the day, not just after the first use. Comparative efficacy of commercially available alcohol-based hand rubs and World Health Organization-recommended hand rubsAmerican Journal of Infection ControlVol. 41Issue 5PreviewEdmonds et al conducted a comprehensive study leading to the following conclusion: Formulation matters.1 However, the study design suffers from limitations challenging the conclusions. Full-Text PDF" @default.
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• W2007758273 title "Reply to letter to the editor on “comparative efficacy of commercially available alcohol-based hand rubs and World Health Organization-recommended hand rubs”" @default.
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