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Dose considerations for alcohol-based hand rubs
Journal of Hospital Infection 95 (2017) 183e184 Available online at www.sciencedirect.com
Journal of Hospital Infection journal homepage: www.elsevierhealth.com/journals/jhin
Commentary
Dose considerations for alcohol-based hand rubs
Wilkinson et al. address an important topic in a very systematic way.1 They found that in hygienic hand disinfection an application time of alcohol-based hand rub (ABHR) of 20e30 s is considered acceptable among volunteers depending on the formulation, that it requires on average 1.5e2 mL to keep hands wet for this application time, and that the application of such a small volume usually fails to meet the EN 1500 efficacy criteria. Based on their findings they propose an additional test using volumes and times that are acceptable to the user. Products that fulfil the requirements of EN 1500 would be subjected to a further test using the same methodology but with the manufacturer’s recommended volume and time of application (not less than 30 s), with the test product compared with the reference alcohol applied in the same manner. This additional test would establish that a given product that passes EN 1500 also performs at least as well as the reference alcohol when compared at realistic contact times and volumes. We do agree that realistic contact times are critical for a product that is provided at the point of care, only a few seconds away from the patient, but how realistic is the recommendation of a specific dose for an AHBR? The authors themselves provide evidence that hand size varies between female and male volunteers. Would the recommended dose for female healthcare workers be smaller than for male healthcare workers? To add to the confusion, the Dutch CTGB (http://ctgb.nl/en/pesticides-database) recently published data for one product called ‘Deb instant foam’ (Reg. Nr. 2014-13) with three different package sizes including a pump for each of them. All three products apparently contain the same formulation but are approved (with specific pumps) with different volumes: a 400 mL bottle with a touch-free dispenser with 3.5 mL (five pushes), a 400 mL bottle with an ‘optidose pump’ with 3.0 mL (two pushes) and a 47 mL bottle with 3.2 mL (eight pushes). The application times for all products are 30 s. The approval by the authorities of a specific volume for each dispenser system may be in line with EU regulations but is not helpful for the variety of hands in healthcare and may cause confusion among users.
The proposal of Wilkinson et al. is to perform additional testing to show that a specific volume (e.g. 1.5 mL) of an ABHR that has passed the EN 1500 testing is non-inferior to the application of the same volume of the reference alcohol of EN 1500.1 We have two concerns in that respect: 1. The EN 1500 efficacy test can be performed in many different ways as well as 23 mL in 30 s, 22 mL in 215 s, or 23 mL in 220 s. There is no restriction on volume as long as the application time is between 30 and 60 s. The additional testing for formulations which are not effective enough with 3 mL for 30 s would be possible and would place these formulations on the same level as more efficacious AHBRs as long as the additional testing reveals non-inferiority to the small volume of reference alcohol. 2. The practical implications of the additional data are not entirely clear. For example, if an AHBR fulfils the EN 1500 efficacy requirement with 3 mL in 30 s and ‘fulfils’ the additional testing with 1.5 mL, what shall be the conclusion? Shall it be a general recommendation to use a volume of 1.5 mL on all hand sizes? Another example might be where an AHBR fails to fulfil the EN 1500 efficacy requirement with 3 mL, but fulfils it with 6 mL in 30 s. If it is then found to ‘fulfil’ the additional testing with 1.5 mL, what shall be the conclusion? Is the formulation now safe to be used with, for example, 1.5 mL after the additional testing? There could be serious implications for patient safety if small volumes of an AHBR with lower efficacy are applied on all sizes of hands. Another option to improve EN 1500 might be to measure hand size for each volunteer and determine the volume of ABHR for each volunteer which is necessary to keep hands wet for the required application time. By doing so, the final recommendation for application would be more realistic, and a single dose recommendation would no longer be necessary. Hand size among healthcare workers is so variable that it is difficult to recommend a specific standard volume for all healthcare workers, even if regulatory agencies insist on specific volumes. The typical recommendation to ‘keep hands wet for 30 s’ reflects clinical reality better so that a healthcare worker with small hands and dry skin may use 2 mL and a person with large hands and sweaty skin may use 6 mL irrespective of
http://dx.doi.org/10.1016/j.jhin.2016.12.021 0195-6701/ª 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.
184
Commentary / Journal of Hospital Infection 95 (2017) 183e184
any dispenser system. Might it be that allowing individual healthcare workers to apply a volume of ABHR that is appropriate to their hand size is a better strategy than defining a single volume that will be excessive for some or inadequate for others?
Reference 1. Wilkinson MAC, Ormandy K, Bradley CR, Fraise AP, Hines J. Dose considerations for alcohol based hand rubs. J Hosp Infect 2017;95: 175e182.
G. Kampfa,* J. Grayb a Institut fu¨r Hygiene und Umweltmedizin, Ernst-Moritz-ArndtUniversita¨t Greifswald, Greifswald, Germany b
Birmingham Children’s Hospital, Birmingham, UK
* Corresponding author. E-mail address: [email protected] (G. Kampf). Available online 5 January 2017
Journal of Hospital Infection journal homepage: www.elsevierhealth.com/journals/jhin
Commentary
Dose considerations for alcohol-based hand rubs
Wilkinson et al. address an important topic in a very systematic way.1 They found that in hygienic hand disinfection an application time of alcohol-based hand rub (ABHR) of 20e30 s is considered acceptable among volunteers depending on the formulation, that it requires on average 1.5e2 mL to keep hands wet for this application time, and that the application of such a small volume usually fails to meet the EN 1500 efficacy criteria. Based on their findings they propose an additional test using volumes and times that are acceptable to the user. Products that fulfil the requirements of EN 1500 would be subjected to a further test using the same methodology but with the manufacturer’s recommended volume and time of application (not less than 30 s), with the test product compared with the reference alcohol applied in the same manner. This additional test would establish that a given product that passes EN 1500 also performs at least as well as the reference alcohol when compared at realistic contact times and volumes. We do agree that realistic contact times are critical for a product that is provided at the point of care, only a few seconds away from the patient, but how realistic is the recommendation of a specific dose for an AHBR? The authors themselves provide evidence that hand size varies between female and male volunteers. Would the recommended dose for female healthcare workers be smaller than for male healthcare workers? To add to the confusion, the Dutch CTGB (http://ctgb.nl/en/pesticides-database) recently published data for one product called ‘Deb instant foam’ (Reg. Nr. 2014-13) with three different package sizes including a pump for each of them. All three products apparently contain the same formulation but are approved (with specific pumps) with different volumes: a 400 mL bottle with a touch-free dispenser with 3.5 mL (five pushes), a 400 mL bottle with an ‘optidose pump’ with 3.0 mL (two pushes) and a 47 mL bottle with 3.2 mL (eight pushes). The application times for all products are 30 s. The approval by the authorities of a specific volume for each dispenser system may be in line with EU regulations but is not helpful for the variety of hands in healthcare and may cause confusion among users.
The proposal of Wilkinson et al. is to perform additional testing to show that a specific volume (e.g. 1.5 mL) of an ABHR that has passed the EN 1500 testing is non-inferior to the application of the same volume of the reference alcohol of EN 1500.1 We have two concerns in that respect: 1. The EN 1500 efficacy test can be performed in many different ways as well as 23 mL in 30 s, 22 mL in 215 s, or 23 mL in 220 s. There is no restriction on volume as long as the application time is between 30 and 60 s. The additional testing for formulations which are not effective enough with 3 mL for 30 s would be possible and would place these formulations on the same level as more efficacious AHBRs as long as the additional testing reveals non-inferiority to the small volume of reference alcohol. 2. The practical implications of the additional data are not entirely clear. For example, if an AHBR fulfils the EN 1500 efficacy requirement with 3 mL in 30 s and ‘fulfils’ the additional testing with 1.5 mL, what shall be the conclusion? Shall it be a general recommendation to use a volume of 1.5 mL on all hand sizes? Another example might be where an AHBR fails to fulfil the EN 1500 efficacy requirement with 3 mL, but fulfils it with 6 mL in 30 s. If it is then found to ‘fulfil’ the additional testing with 1.5 mL, what shall be the conclusion? Is the formulation now safe to be used with, for example, 1.5 mL after the additional testing? There could be serious implications for patient safety if small volumes of an AHBR with lower efficacy are applied on all sizes of hands. Another option to improve EN 1500 might be to measure hand size for each volunteer and determine the volume of ABHR for each volunteer which is necessary to keep hands wet for the required application time. By doing so, the final recommendation for application would be more realistic, and a single dose recommendation would no longer be necessary. Hand size among healthcare workers is so variable that it is difficult to recommend a specific standard volume for all healthcare workers, even if regulatory agencies insist on specific volumes. The typical recommendation to ‘keep hands wet for 30 s’ reflects clinical reality better so that a healthcare worker with small hands and dry skin may use 2 mL and a person with large hands and sweaty skin may use 6 mL irrespective of
http://dx.doi.org/10.1016/j.jhin.2016.12.021 0195-6701/ª 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.
184
Commentary / Journal of Hospital Infection 95 (2017) 183e184
any dispenser system. Might it be that allowing individual healthcare workers to apply a volume of ABHR that is appropriate to their hand size is a better strategy than defining a single volume that will be excessive for some or inadequate for others?
Reference 1. Wilkinson MAC, Ormandy K, Bradley CR, Fraise AP, Hines J. Dose considerations for alcohol based hand rubs. J Hosp Infect 2017;95: 175e182.
G. Kampfa,* J. Grayb a Institut fu¨r Hygiene und Umweltmedizin, Ernst-Moritz-ArndtUniversita¨t Greifswald, Greifswald, Germany b
Birmingham Children’s Hospital, Birmingham, UK
* Corresponding author. E-mail address: [email protected] (G. Kampf). Available online 5 January 2017