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Objectives.To evaluate the reproducibility and workability of the in vivo test model of the European test standard EN 12791 regarding the effectiveness of surgical hand antiseptics and, as a secondary objective, to evaluate the power of the model to discriminate between the effectiveness of various formulations of surgical hand antiseptics.Design.Prospective, randomized, multicenter study with a Latin square design.Setting.Five laboratories at 2 universities, 2 disinfectant manufacturers, and 1 private testing institution.Participants.Twenty healthy adults in each laboratory.Intervention.Surgical hand antisepsis was performed by scrubbing with chlorhexidine gluconate 4% detergent (CHG) or by rubbing the hands with propan-2-OL (70% by volume; Iso 70) or ethanol 85% (E 85); rubbing the hands and forearms for 3 minutes with propan-1-OL (N 60) was used as the reference disinfection procedure. We deliberately chose to use these antiseptics at the given concentrations because they were intended to cover the range of typical antiseptics submitted for approval according to EN 12791.Methods.In once-weekly tests, the immediate effects of the 4 antiseptics were established according to the method laid down in EN 12791 by assessing the release of skin flora from the fingertips as viable bacteria counts per milliliter of sampling fluids before treatment and viable bacteria counts immediately after treatment, separately for both hands, such that after 4 weeks each volunteer had used every formulation once.Results.The mean log reduction factor (RF) for the release of bacterial skin flora (the log RF was calculated as the log count before treatment minus the log count after treatment) and corresponding standard deviations for the 4 hand antisepsis formulations were as follows: for CHG, 1.1 ± 0.3 colony-forming units (cfu) per milliliter of sampled fluid; for Iso 70, 1.7 ± 0.3 cfu/mL; for E 85, 2.1 ± 0.3 cfu/mL; and for N 60, 2.4 ± 0.4 cfu/mL. The differences between these values proved significant (PPP>.01). Relating the log RF values of the other 3 formulations to those of the reference formulation (N 60) abolished differences between laboratories (P = .16); in addition, the interclass correlation coefficient decreased from 9.1% to 4.5%. With 20 volunteers, a minimum difference of 0.47 log between the mean log RFs of the reference formulation and an inferior test formulation will be detected as significant at an α of .05 (1-sided) and a 1 — β value of .8.Conclusion.The test method described in EN 12791 yielded the same conclusion on the effectiveness of the tested formulations in every laboratory and proved, therefore, reproducible and workable.

Background Alcohol-based hand rubs (ABHR) range in alcohol concentration from 60-95% and are available in a variety of delivery formats, such as rinses, gels, and foams. Recent studies suggest that some ABHR foams dry too slowly, thereby encouraging the use of inadequate volumes. This study investigates the influence of product volume, delivery format, and alcohol concentration on dry-time and antimicrobial efficacy of ABHR foams, gels and rinses. Methods ABHR dry-times were measured using volunteers to determine the influences of product volume, delivery format, and alcohol concentration. ABHR efficacies were evaluated according to the European Standard for Hygienic Hand Disinfection (EN 1500) using 3-mL application volumes rubbed for 30 s, and additionally, using volumes of the products determined to rub dry in 30 s. Results Volumes of six ABHR determined to rub dry in 30 s ranged from 1.7 mL to 2.1 mL, and the rate of drying varied significantly between products. ABHR dry-times increased linearly with application volume and decreased linearly with increasing alcohol concentration, but were not significantly influenced by product format. An ABHR foam (70% EtOH), rinse (80% EtOH), and gel (90% EtOH) each met EN 1500 efficacy requirements when tested at a volume of 3 mL, but failed when tested at volumes that dried in 30 s. Conclusions Application volume is the primary driver of ABHR dry-time and efficacy, whereas delivery format does not significantly influence either. Although products with greater alcohol concentration dry more quickly, volumes required to meet EN 1500 can take longer than 30 s to dry, even when alcohol concentration is as high as 90%. Future studies are needed to better understand application volumes actually used by healthcare workers in practice, and to understand the clinical efficacy of ABHR at such volumes. Electronic supplementary material The online version of this article (doi:10.1186/1471-2334-14-511) contains supplementary material, which is available to authorized users.

Today more and more thermo-labile medical devices are applied, which have to be decontaminated with low-temperature sterilization methods. One method under development is the low-temperature plasma. For the comparability of the antimicrobial efficacy of two low-temperature plasma setups in fine-lumen polytetrafluoroethylene (PTFE) tubes, independent of performer, round robin tests with Bacillus atrophaeus and Geobacillus stearothermophilus spores loaded with 0.3% BSA were done. All in all six test series were necessary to standardize the process and to achieve comparability, reproducibility, and microbiological variability. The results provide new evidence to the importance of standardization in microbiological investigations in terms of decontamination. This new tool is useable for established and new decontamination and sterilization equipment.

The efficacy of disinfectants is verified on the basis of the results of test methods that have undergone continuous change in line with new scientific insights. To begin with, the prime focus was on the relevance of practical measures: germ carriers were contaminated with, for example, the sputum of patients suffering from tuberculosis or with stools, while the data provided on the recoverable bacteria following exposure were very imprecise since they were based on subjective evaluation – using different methods for the various countries. With the development of the quantitative suspension test various factors of influence were analyzed for the first time and the concept of reduction factors with logarithmic units was introduced. Today, such insights are viewed as something to be taken for granted in all European and international standards. European standardization orchestrated by the European Commission received important impetus from one scientist: H. Reber. An important aspect here was that the European standards introduced and recognized in principle a separation of the methods into “in-vitro tests” and “tests conducted under everyday practice conditions”. The increasingly more precise test methods have, on the other hand, soon revealed shortcomings in the disinfectant performance of even commonly used and hitherto accepted products. This gave rise to tests with a lower margin of error and with quantitative requirements. It is only by having a uniform overview that it is possible to detect and eliminate such shortcomings. The closure of several Hygiene Institutes at German and Austrian universities and the ongoing confinement of this discipline (infection control) to microbiology have additionally meant that already today there is a shortage of infection control experts who have a holistic view of matters and are able to spearhead further development of test methods. Without experts capable of taking a holistic view of matters, it will not be possible to create an atmosphere conducive to the development, and evaluation, of test methods, as needed for quality assurance. The less often disinfectants are evaluated by competent specialists, the greater is the risk that dangers are not recognized and countered.

Background Some national hospital hygiene societies in Europe such as the French society for hospital hygiene (SFHH) have positive lists of disinfectants. Few hand disinfectants with a rather low concentration of ethanol are listed by one society as effective for hygienic hand disinfection with 3 mL in 30 s including a virucidal activity in 30 s or 60 s, but published data allow having doubts. We have therefore evaluated the efficacy of three commonly used hand disinfectants according to EN 1500 and EN 14476. Methods Products 1 (Aniosgel 85 NPC) and 2 (Aniosrub 85 NPC) were based on 70% ethanol, product 3 (ClinoGel derma+) on 60% ethanol and 15% isopropanol (all w/w). They were tested in 3 laboratories according to EN 1500. Three mL were applied for 30 s and compared to the reference treatment of 2 × 3 mL applications of isopropanol 60% (v/v), on hands artificially contaminated with Escherichia coli. Each laboratory used a cross-over design against the reference alcohol with 15 or 20 volunteers. The virucidal activity of the products was evaluated (EN 14476) in one laboratory against adenovirus and poliovirus in different concentrations (80%, 90%, 97%), with different organic loads (none; clean conditions; phosphate-buffered saline) for up to 3 min. Results Product 1 revealed a mean log10-reduction of 3.87 ± 0.79 (laboratory 1) and 4.38 ± 0.87 (laboratory 2) which was significantly lower compared to the reference procedure (4.62 ± 0.89 and 5.00 ± 0.87). In laboratory 3 product 1 was inferior to the reference disinfection (4.06 ± 0.86 versus 4.99 ± 0.90). Product 2 revealed similar results. Product 3 fulfilled the requirements in one laboratory but failed in the two other. None of the three products was able to reduce viral infectivity of both adenovirus and poliovirus by 4 log10 steps in 3 min according to EN 14476. Conclusions Efficacy data mentioned in a positive list published by a society for hospital hygiene should still be regarded with caution if they quite obviously contradict published data on the same or similar products.