Evaluation of the bactericidal effect of five products for surgical hand disinfection according to prEN 12054 and prEN 12791

Marchetti, Maria Gabriella; Kampf, Günter; Finzi, G; Salvatorelli, G

doi:10.1016/s0195-6701(03)00039-2

Cited by 74 publications

(42 citation statements)

References 15 publications

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“…A single, 3-minute application of the product tested in the present study has been shown to meet EN 12791 requirements. 25 Kampf et al 7 showed that even a 1.5-minute application of this product sufficed to meet these requirements in a group of 18-20 healthy volunteers. The Kampf et al study, 7 however, did not reflect the application of the test product under actual operating room conditions, because disinfection entailed rubbing both hands up to the wrists only.…”

Section: Discussionmentioning

confidence: 99%

“…25 Very recently, a 90-second application of Sterillium classic pure was proven to be at least as effective as the 3-minute reference disinfection procedure for healthy volunteers under rigorous experimental conditions in the laboratory. 7 Since 1995, surgical hand antisepsis involving a 3-minute application of Sterillium classic pure has been the standard procedure at the University Hospital Basel (Basel, Switzerland).…”

Section: Infect Control Hosp Epidemiol 2009; 30:420-426mentioning

confidence: 99%

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Surgical Hand Antisepsis With Alcohol-Based Hand Rub Comparison of Effectiveness After 1.5 and 3 Minutes of Application

Weber

Reck

Neff

et al. 2009

Infect. Control Hosp. Epidemiol.

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Objective.Research has shown 1.5 minutes of surgical hand antisepsis with alcohol-based hand rub to be at least as effective under experimental conditions as the 3-minute reference disinfection recommended by European Norm 12791. The aim of the present study was to validate the effectiveness of 1.5 minutes of surgical hand antisepsis in a clinical setting by comparing the effectiveness of 1.5- and 3-minute applications of alcohol-based hand rub (45% vol/vol 2-propanol, 30% vol/vol 1-propanol, and 0.2% mecetronium ethylsulphate).Design.Prospective crossover trial in which each surgeon served as his or her own control, with individual randomization to the 1.5-or the 3-minute group during the first part of the trial.Setting.Basel University Hospital, Switzerland.Participants.Thirty-two surgeons with different levels of postdoctoral training.Methods.We measured the bactericidal effectiveness of 1.5 minutes and 3 minutes of surgical hand antisepsis with alcohol-based hand rub by assessing the mean (± SD) log10 number of colony-forming units before the application of hand rub (baseline), after the application of hand rub (immediate effect), and after surgery (sustained effect) so as to follow European Norm 12791 as closely as possible.Results.The immediate mean (± SD) log10 reduction in colony-forming units (cfu) was 2.66 ±1.13 log10 cfu for the 1.5-minute group and 3.01 ±1.06 log10 cfu for the 3-minute group (P = .204). Similarly, there was no statistically significant difference between the 2 groups with respect to the sustained effect; the mean ( ± SD) log10 increase in bacterial density during surgery was 1.08 ± 1.13 log10 cfu for the 1.5-minute group and 0.95 ± 1.27 log10 cfu for the 3-minute group (P = .708). No adverse effects were recorded.Conclusion.In this clinical trial, surgical hand antisepsis with alcohol-based hand rub resulted in a similar bacterial reduction, regardless of whether it was applied for 3 or 1.5 minutes, which confirms experimental data generated with healthy volunteers.

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Section: Discussionmentioning

confidence: 99%

Section: Infect Control Hosp Epidemiol 2009; 30:420-426mentioning

confidence: 99%

Surgical Hand Antisepsis With Alcohol-Based Hand Rub Comparison of Effectiveness After 1.5 and 3 Minutes of Application

Weber

Reck

Neff

et al. 2009

Infect. Control Hosp. Epidemiol.

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“…A surgical scrub based on 4% chlorhexidine gluconate, for example, met both the European requirements (22) and the U.S. requirements (24). A surgical scrub based on 7.5% povidone iodine, however, failed to pass the European efficacy requirements (22).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Two Methods of Determining the Efficacies of Two Alcohol-Based Hand Rubs for Surgical Hand Antisepsis

Kampf¹,

Ostermeyer²,

Heeg

et al. 2006

Appl Environ Microbiol

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The antimicrobial efficacies of preparations for surgical hand antisepsis can be determined according to a European standard (prEN 12791 [EN]) and a U.S. standard (tentative final monograph for health care antiseptic drug products [TFM]). The U.S. method differs in the product application mode (hands and lower forearms, versus hands only in EN), the number of applications (11 over 5 days, versus a single application in EN), the sampling times (0, 3, and 6 h after application, versus 0 and 3 h in EN), the sampling methods (glove juice versus fingertip sampling in EN), and the outcome requirements (absolute bacterial reduction factor [RF], versus noninferiority to reference treatment in EN). We have studied the efficacies of two hand rubs according to both methods. One hand rub was based on 80% ethanol and applied for 2 min, and the other one was based on 45% propan-2-ol, 30% propan-1-ol, and 0.2% mecetronium etilsulfate and applied for 1.5 min. The ethanol-based hand rub was equally effective as the 3-min reference disinfection of prEN 12791 in both the immediate (RFs, 2.97 ؎ 0.89 versus 2.92 ؎ 1.03, respectively) and sustained (RFs, 2.20 ؎ 1.07 versus 2.47 ؎ 1.25, respectively) effects. According to TFM, the immediate effects were 2.99 log 10 (day 1), 3.00 log 10 (day 2), and 3.43 log 10 (day 5), and bacterial counts were still below baseline after 6 h. The propanol-based hand rub was even more effective than the reference disinfection of prEN 12791 in both the immediate (RFs, 2.35 ؎ 0.99 versus 1.86 ؎ 0.87, respectively) and sustained (RFs, 2.17 ؎ 1.00 versus 1.50 ؎ 1.26, respectively) effects. According to TFM, the immediate effects were 2.82 log 10 (day 1), 3.29 log 10 (day 2), and 3.25 log 10 (day 5), and bacterial counts were still below baseline after 6 h. Some formulations have been reported to meet the efficacy requirements of one of the methods but not those of the other. That is why we conclude that, despite our results, meeting the efficacy requirements of one test method does not allow the claim that the requirements of the other test method are also met.

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“…This treatment was chosen as the treatment with the greatest effect on resident skin bacteria (18). The test principle of including a reference treatment has been used successfully in various studies in order to evaluate the comparative efficacies of various preparations for surgical hand disinfection (5,8,16). That is why we investigated whether the applied volume has any effect on the efficacy of the reference alcohol applied for surgical hand disinfection.…”

mentioning

confidence: 99%

Influence of Applied Volume on Efficacy of 3-Minute Surgical Reference Disinfection Method prEN 12791

Kampf

Ostermeyer

2004

Appl Environ Microbiol

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For assessment of the efficacy of surgical hand disinfection, European reference method prEN 12791 prescribes that the hands must be kept wet with the reference alcohol for 3 min regardless of the applied volume. The aim of this study was to determine whether the applied volume of the reference disinfectant n-propanol (60%, vol/vol) influences the effect on the resident hand flora. Ten experiments with 200 reference disinfections were analyzed. Hands were washed for 1 min with soap. The bacterial prevalue was obtained by rubbing fingertips in tryptic soy broth for 1 min. After this, each subject treated the hands with n-propanol (60%, vol/vol) by using as many portions as necessary to keep hands wet for a total of 3 min. Bacterial postvalues (immediate effect) were obtained for one hand, and the other hand was gloved for 3 h. After the gloves were taken off, a second postvalue was obtained (sustained effect). Most surgical reference disinfections (73%) were achieved with 9 ml of the reference alcohol, followed by 12 ml (24%) and 6 ml (3%). There was no significant difference between the mean log 10 reduction values for the three treatment groups, both in terms of the immediate effect (P ‫؍‬ 0.333, as determined by analysis of variance) and in terms of the sustained effect (P ‫؍‬ 0.442). A higher number of portions did not correlate with a higher reduction factor (for immediate effect, Pearson's correlation coefficient ‫؍‬ ؊0.028 [P ‫؍‬ 0.689]; for sustained effect, Pearson's correlation coefficient ‫؍‬ 0.059 [P ‫؍‬ 0.404]). If the hands were kept wet with the reference alcohol for the total application time, the applied volume could vary, but this did not alter the efficacy.

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Evaluation of the bactericidal effect of five products for surgical hand disinfection according to prEN 12054 and prEN 12791

Cited by 74 publications

References 15 publications

Surgical Hand Antisepsis With Alcohol-Based Hand Rub Comparison of Effectiveness After 1.5 and 3 Minutes of Application

Surgical Hand Antisepsis With Alcohol-Based Hand Rub Comparison of Effectiveness After 1.5 and 3 Minutes of Application

Evaluation of Two Methods of Determining the Efficacies of Two Alcohol-Based Hand Rubs for Surgical Hand Antisepsis

Influence of Applied Volume on Efficacy of 3-Minute Surgical Reference Disinfection Method prEN 12791

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