How reliable are test results from 17 laboratories on the basis of EN 1500 for a hand rub based on 80% (w/w)?

INTRODUCTION: A ring trial organized by the Association of Applied Hygiene (VAH) on the bactericidal efficacy of an ethanol-based hand rub was carried out in 17 laboratories according to EN 1500 with the aim of describing the variability of test results and fulfilment of the methodological acceptance criteria. METHOD: As a test product, a hand rub based on 80% ethanol (w/w) was tested in comparison with the reference alcohol (60% iso-propanol, v/v) in a crossover design. After pre-washing and contamination following the norm, hands were treated either with the reference alcohol (2 × 3 mL for 2 × 30 s) or the test product (3 mL in 30 s). Post-decontamination values were determined immediately after the rub-in period. Validated neutralizers were used. The arithmetic means of all individual log10 pre-values, post-values and reduction values were calculated per laboratory. Non-inferiority was assumed when the Hodges-Lehmann 97.5% confidence limit was <0.6 in comparison with the reference. A z-score was calculated to determine the laboratory performance. RESULTS: Two laboratories did not meet the acceptance criteria and were excluded from the analysis. The bactericidal efficacy of the test product was non-inferior to the reference product in four laboratories and not non-inferior in 11 laboratories. The z-score for the Hodges-Lehmann 97.5% confidence limit indicated a satisfactory performance in all laboratories. CONCLUSION: We consider the EN 1500 test method to be robust in terms of the variability of test results. For products of borderline efficacy, the evaluation should be based on more than one test.

Failure of sodium hypochlorite to meet the EN 1500 efficacy requirement for hygienic hand disinfection.

This study evaluated the bactericidal efficacy of two alternative hand antiseptics, based on sodium hypochlorite or sodium hypochlorite and hypochlorous acid, compared with isopropanol on the hands of volunteers artificially contaminated with Escherichia coli using EN 1500. The reference alcohol was applied according to the norm, and the study formulations were used as in common practice (3 mL for 30 s). The products showed mean log10 reductions of 1.63 and 1.89, both of which were inferior to the reference treatment (4.78). Due to the failure to achieve sufficient bactericidal efficacy within 30 s, sodium hypochlorite (0.05-0.06%) should not be considered for hand disinfection.

Efficacy of five 'sporicidal' surface disinfectants against Clostridioides difficile spores in suspension tests and 4-field tests.

BACKGROUND: A sporicidal surface disinfection is recommended both for the outbreak and the endemic setting but a comparative evaluation on the efficacy of 'sporicidal' surface disinfectants using suspension tests and 4-field tests has not been performed. AIM: To determine the efficacy of five 'sporicidal' surface disinfectants (three ready-to-use wipes (A, B, E), two concentrates (C, D) based on peroxides or aldehydes against C. difficile spores. METHODS: The efficacy was determined under clean conditions using a suspension test and the 4-field test. Each test was performed in duplicate in two separate laboratories. Wipes were wrung to collect the solution for the suspension tests. RESULTS: Product A (peracetic acid; 5 min), product C (peracetic acid; 2% solution in 15 min or 1% solution in 30 min) and product D (peracetic acid; only 2% solution in 15 min) were effective with at least a 4 log10-reduction of C. difficile spores in suspension and on surfaces. Product B (hydrogen peroxide) was not effective in suspension (0.9 log10 after 15 min; 3.2 log10 after 1 h) and on surfaces (2.8 log10 after 15 and 60 min). Product E based on glutaraldehyde, (ethylendioxy)dimethanol and DDAC demonstrated 0.9 log10 after 4 h in suspension and 4.5 log10 after 4 h on surfaces. CONCLUSIONS: Not all surface disinfectants with a sporicidal claim were effective against C. difficile spores in standardized suspension tests and in the 4-field test. In clinical practice preference should be given to products that reliably pass the efficacy criteria of both types of tests.

Isopropanol at 60% and at 70% are effective against 'isopropanol-tolerant' Enterococcus faecium.

The bactericidal activity of isopropanol was determined against Enterococcus faecium ATCC 6057, ST 796 (isopropanol-tolerant strain) and Enterococcus hirae ATCC 10541 (EN 13727). Isopropanol at 60% and 70% were effective (≥5.38 log10-reduction) in 15 s against all strains but 23% isopropanol was not (<0.99 log10-reduction in ≤15 min). Isopropanol at 70% was tested against E. faecium in the four-field test. Eight millilitres was not effective enough in 1 min (<5 log10-reduction), whilst 16 mL was effective (≥5.85 log10-reduction). Healthcare workers can be reassured that 60% and 70% isopropanol with an appropriate volume are effective against E. faecium.

Interlaboratory reproducibility of a test method following 4-field test methodology to evaluate the susceptibility of Clostridium difficile spores.

BACKGROUND: Sporicidal surface disinfection is recommended to control transmission of Clostridium difficile in healthcare facilities. EN 17126 provides a method to determine the sporicidal activity in suspension and has been approved as a European standard. In addition, a sporicidal surface test has been proposed. AIM: To determine the interlaboratory reproducibility of a test method for evaluating the susceptibility of a C. difficile spore preparation to a biocidal formulation following the 4-field test (EN 16615 methodology). METHODS: Nine laboratories participated. C. difficile NCTC 13366 spores were used. Glutaraldehyde (1% and 6%; 15 min) and peracetic acid (PAA; 0.01% and 0.04%; 15 min) were used to determine the spores' susceptibility in suspension in triplicate. FINDINGS: One-percent glutaraldehyde revealed a mean decimal log10 reduction of 1.03 with variable results in the nine laboratories (0.37-1.49) and a reproducibility of 0.38. The effect of 6% glutaraldehyde was stronger (mean: 2.05; range: 0.96-4.29; reproducibility: 0.86). PAA revealed similar results. An exemplary biocidal formulation based on 5% PAA was used at 0.5% (non-effective concentration) and 4% (effective concentration) to determine the sporicidal efficacy (4-field test) under clean conditions in triplicate with a contact time of 15 min. When used at 0.5% it demonstrated an overall log10 reduction of 2.68 (range: 2.35-3.57) and at 4% of 4.61 (range: 3.82-5.71). The residual contamination on the three primarily uncontaminated test fields was <50 cfu/25 cm2 in one out of nine laboratories (0.5%) and in seven out of nine laboratories (4%). CONCLUSION: The interlaboratory reproducibility seems to be robust.

[Risk of infection in the home environment. Plea for a new risk assessment]. / Infektionsrisiken im häuslichen Umfeld. Plädoyer für eine neue Risikobewertung.

Within the last two decades risks posed by infectious diseases outside of hospitals and nursing homes had no high significance in the public perception. The home environment is regarded as a save shelter from infectious risks. In the mean time there have been dramatic socio-demographic, health policy and technological changes which have increased infectious risks outside medical facilities. In Germany up to 1.4 million people with multiple morbidities are nursed at home. Technological changes with the aim to protect the environment, like reduction of water temperature and water volumes in washing processes has lowered the efficacy to control pathogens. Thus it is time to revise the process of risk assessment in which not only aspects of environmental protection but also those of health protection must be taken into account. The article gives an overview of new risks and epidemiological changes and discusses the necessity of a new risk assessment and risk management approach which hopefully will lead to a changing paradigm.

[Hygiene tips for kids. Concept and examples of realisation]. / Hygiene-Tipps für Kids. Konzept und Umsetzungsbeispiele.

Basic hygiene measures aim at promoting and maintaining good health. The necessary routines are most effectively learned and adopted during childhood. These key findings form the basis for the educational programme "Hygiene Tips for Kids" which was initiated at the Department of Hygiene and Public Health at Bonn University under the auspices of WHO Europe in 2003. The programme addresses children, teachers and parents and offers a range of materials and activities tailored to the specific needs of the target groups based on expert advice. The objective is to exert a long-lasting, positive influence on the performance of hygiene routines. Campaigns are usually directed at pre-school, kindergarten and primary school settings, with the public health service personnel playing a crucial role in coordinating and implementing the various activities. Evaluation of a campaign in the federal state of Mecklenburg-Vorpommern has proven a positive effect on hand washing routines in pre-school as well as in the domestic setting. Moreover, Hygiene Tips for Kids has a sustained positive effect on the cooperation and communication between public health authorities and teachers, children and their parents. Teachers implement their own ideas within a framework of standardised information to suit their local needs. A long-term goal would be the obligatory integration of a sensible health education programme in the syllabus of pre-school, kindergarten and primary schools.

Pretreatment ipsilateral regional cortical blood flow influences vessel recanalization in intra-arterial thrombolysis for MCA occlusion.

BACKGROUND AND PURPOSE: The aim of acute stroke interventions is to achieve recanalization of the target occluded artery. We sought to determine whether pretreatment cortical cerebral blood flow (CBF) was associated with vessel recanalization in patients undergoing intra-arterial therapy. METHODS: This is a retrospective analysis of patients who underwent a quantitative xenon CT blood flow study and were noted to have a documented M1 middle cerebral artery (MCA) or carotid terminus occlusion less than 6 hours from symptom onset between January 1997 and April 2001. Twenty-three patients who underwent intra-arterial thrombolysis were included in the analysis. Univariate and multivariate analyses were performed to determine whether pretherapy CBF was correlated to the likelihood of recanalization. RESULTS: A total of 23 patients were studied in this analysis with a median age of 69 (range 32-81) and median National Institutes of Health Stroke Score of 19 (range, 8-22). Twelve patients (52%) underwent combined intravenous/intra-arterial therapy, and 11 patients (48%) were treated with intra-arterial thrombolytics alone. Successful vessel recanalization (Thrombolysis in Myocardial Infarction classification 2 or 3 flow) occurred in 13 patients (57%). The only variable associated with recanalization in multivariate modeling was mean ipsilateral MCA CBF (odds ratio, 1.25; 95% confidence interval, 1.01-1.54; P = .035). A receiver operating characteristic curve was generated, and a mean ipsilateral MCA CBF threshold of 18 mL/100 g/min was found to be the threshold for successful recanalization. CONCLUSIONS: Our study suggests that patients with higher mean ipsilateral MCA CBF are more likely to recanalize. The threshold for successful revascularization may be 18 mL/100 g/min. Further study is required to determine whether pretreatment CBF is related to recanalization success.

Variables That Best Differentiate In-Patient Acute Stroke from Stroke-Mimics with Acute Neurological Deficits.

Introduction. Strokes and stroke-mimics have been extensively studied in the emergency department setting. Although in-hospital strokes are less studied in comparison to strokes in the emergency department, they are a source of significant direct and indirect costs. Differentiating in-hospital strokes from stroke-mimics is important. Thus, our study aimed to identify variables that can differentiate in-hospital strokes from stroke-mimics. Methods. We present here a retrospective analysis of 93 patients over a one-year period (2009 to 2010), who were evaluated for a concern of in-hospital strokes. Results. About two-thirds (57) of these patients were determined to have a stroke, and the remaining (36) were stroke-mimics. Patients with in-hospital strokes were more likely to be obese (p = 0.03), have been admitted to the cardiology service (p = 0.01), have atrial fibrillation (p = 0.03), have a weak hand or hemiparesis (p = 0.03), and have a prior history of stroke (p = 0.05), whereas, when the consults were called for "altered mental status" but no other deficits (p < 0.0001), it is likely a stroke-mimic. Conclusion. This study demonstrates that in-hospital strokes are a common occurrence, and knowing the variables can aid in their timely diagnosis and treatment.

Prevention and control of health care-associated waterborne infections in health care facilities.

The current article is a review of the public health risks attributable to waterborne pathogens in health care. The consequences of health care-associated infections (HAIs) are discussed. Not only are Legionella spp involved in HAIs, but also Pseudomonas aeruginosa, other gram-negative microorganisms, fungi, and amoeba-associated bacteria. This is particularly noteworthy among immunocompromised patients. New prevention strategies and control measures brought about through advanced planning, facility remodelling and reconstruction, disinfection, and filtration have resulted in a significant reduction of the incidence of waterborne HAIs. The positive consequences of a comprehensive multibarrier approach including prevention and control programs in health care facilities are discussed. Environmental cultures are now integrated within the infection control program of some European countries. In high-risk areas, the application of disposable sterile point-of-use filters for faucets and shower heads appears to be the practice of choice to efficiently control waterborne pathogens and to prevent infections.

Process-independent quantitative assessment of residual biological contamination of medical devices reprocessed in washer-disinfectors.

A method based on measuring a soil-induced fluorescence intensity response of 1,8-anilinonaphthalene sulfonate at two fixed wavelengths (460 and 510 nm) was used for determining residual contamination on test soil carriers simulating medical devices after passage through a hospital washer-disinfector. The fluorescence response can be satisfactorily calibrated to soil levels as low as approximately 1 microg/L. Practical tests were performed in two hospitals with washer-disinfectors of 3 types and with several chemical or enzymic cleansers-disinfectants. In combination with the previously developed system of standardized test soil carriers simulating both easily and poorly accessible parts of soiled medical devices, the liver-lactose-oil test soil and an efficient sonication procedure for stripping the residual soil off the carriers, this soil detection method permits the detection of very low contamination levels.

Monitoring the kinetics and performance of yeast membrane ABC transporters by diS-C3(3) fluorescence.

Kinetic features (initial start-up phase, drug pumping velocity and efficiency as dependent on drug concentration and growth phase) of yeast plasma membrane multidrug resistance ABC pumps were studied by monitoring the uptake of the fluorescent potentiometric dye diS-C3(3), which has been found to be expelled from the cells by these pumps. The monitoring was done with Saccharomyces cerevisiae mutants AD1-8 and AD1-3 deleted in different ABC pumps, and in their pump-competent parent strain US50-18C overexpressing transcriptional activators Pdr1p and Pdr3p. On addition to the cells, diS-C3(3) is expelled by the Pdr5p, Yor1p and Snq2p pumps with overlapping substrate specificity. The pump action can be assessed as a difference between the dye uptake curve for pump-competent and pump-deleted cells. The pump-mediated dye efflux, which shows an initial lag of various lengths, maintains a certain residual intracellular dye level. In the absence of external glucose the dye efflux ability of the pumps depends on the growth phase; late exponential and stationary cells can maintain the export for tens of minutes, whereas exponential cells keep up the pump action for limited time periods. This may reflect an insufficient number of pump molecules in the membrane or an effect of insufficient pump energization from endogenous sources. This effect is not mediated by changes in membrane potential because lowered membrane potential caused by inhibition of the plasma membrane H+-ATPase does not affect the pump action.

CT-based assessment of acute stroke: CT, CT angiography, and xenon-enhanced CT cerebral blood flow.

BACKGROUND AND PURPOSE: Only a small percentage of acute-stroke patients receive thrombolytic therapy because of time constraints and the risks associated with thrombolytic therapy. We sought to determine whether xenon-enhanced CT (XeCT) cerebral blood flow (CBF) and/or CT angiography (CTA) in conjunction with CT can distinguish subgroups of acute ischemic stroke victims and thereby better predict the subgroups most likely to benefit and not to benefit from thrombolytic therapy. METHODS: An analysis of 51 patients who had a CT, CTA, and stable XeCT CBF examination within 24 hours of stroke symptom onset was conducted. These initial radiographic studies and National Institutes of Health Stroke Scale score on admission were assessed to determine whether they could predict new infarction on follow-up CT or discharge disposition by use of the Fisher exact test to determine statistical significance. RESULTS: Patients with no infarction on initial CT and normal XeCT CBF had significantly fewer new infarctions and were discharged home more often than those with compromised CBF. The same held true for patients with an open internal carotid artery and middle cerebral artery by CTA and normal CT compared with those with an occluded internal carotid artery and/or middle cerebral artery by CTA. Either was superior to CT and the National Institutes of Health Stroke Scale in prediction of outcome. Both enable the selection of a group of patients not identifiable by CT alone that would do well without being exposed to the risks of thrombolytic therapy. This study included too few patients to statistically assess the role of combining CTA and XeCT CBF information. CONCLUSIONS: The combination of CT, CTA, and Xe/CT CBF does define potentially significant subgroups of patients. The utility of this classification is supported by the observation that CTA and XeCT CBF are superior to CT alone in predicting infarction on follow-up CT and clinical outcome. This information may be useful in selecting patients for acute-stroke treatment.

Greater Cincinnati/Northern Kentucky Stroke Study: volume of first-ever ischemic stroke among blacks in a population-based study.

BACKGROUND AND PURPOSE: The volume of ischemic stroke on CT scans has been studied in a standardized fashion in acute stroke therapy trials with median volumes between 10.5 to 55 cm(3). The volume of first-ever ischemic stroke in the population is not known. METHODS: The first phase of the population-based Greater Cincinnati/Northern Kentucky Stroke Study identified all ischemic strokes occurring in blacks in the greater Cincinnati region between January and June of 1993. The patients in this phase of the study who had a first-ever ischemic clinical stroke were identified, and the volume of ischemic stroke was measured. RESULTS: There were 257 verified clinical cases of ischemic stroke, of which 181 had a first-ever ischemic infarct. Imaging was available for 150 of these patients, and 79 had an infarct on the CT or MRI study that was definitely or possibly related to the clinical symptoms. For these patients, volumetric measurements were performed by means of the modified ellipsoid method. The median volume of first-ever ischemic stroke for the 79 patients was 2.5 cm(3) (interquartile range, 0.5 to 8.8 cm(3)). There was a significant relation between location of lesion and infarct size (P<0.001) and between volume and mechanism of stroke (P=0.001). CONCLUSIONS: The volume of first-ever ischemic stroke among blacks in our population-based study is smaller than has been previously reported in acute stroke therapy trials. The large proportion of small, mild strokes in blacks may be an important reason for the low percentage of patients who meet the inclusion criteria for tissue plasminogen activator. Further study is necessary to see if these results are generalizable to a multiracial population.

Transplantation of cultured human neuronal cells for patients with stroke.

Transplantation of cultured neuronal cells is safe in animal models and improves motor and cognitive deficits in rats with stroke. The authors studied the safety and feasibility of human neuronal cellular transplantation in patients with basal ganglia stroke and fixed motor deficits, including 12 patients (aged 44 to 75 years) with an infarct 6 months to 6 years previously (stable for at least 2 months). Serial evaluations (12 to 18 months) showed no adverse cell-related serologic or imaging-defined effects. The total European Stroke Scale score improved in six patients (3 to 10 points), with a mean improvement 2.9 points in all patients (p = 0. 046). Six of 11 PET scans at 6 months showed improved fluorodeoxyglucose uptake at the implant site. Neuronal transplantation is feasible in patients with motor infarction.

Cerebral hemorrhage after intra-arterial thrombolysis for ischemic stroke: the PROACT II trial.

OBJECTIVE: To analyze the frequency, clinical characteristics, and predictors of symptomatic intracerebral hemorrhage (ICH) after intraarterial (IA) thrombolysis with recombinant pro-urokinase (r-proUK) in acute ischemic stroke. METHOD: The authors conducted an exploratory analysis of symptomatic ICH from a randomized, controlled clinical trial of IA thrombolysis with r-proUK for patients with angiographically documented occlusion of the middle cerebral artery within 6 hours from stroke onset. Patients (n = 180) were randomized in a ratio of 2:1 to either 9 mg IA r-proUK over 120 minutes plus IV fixed-dose heparin or IV fixed-dose heparin alone. As opposed to intention to treat, this analysis was based on "treatment received" and includes 110 patients given r-proUK and 64 who did not receive any thrombolytic agent. The remaining six patients received out-of-protocol urokinase and were excluded from analysis. The authors analyzed centrally adjudicated ICH with associated neurologic deterioration (increase in NIH Stroke Scale [NIHSS] score of > or =4 points) within 36 hours of treatment initiation. RESULTS: Symptomatic ICH occurred in 12 of 110 patients (10.9%) treated with r-proUK and in two of 64 (3.1%) receiving heparin alone. ICH symptoms in r-proUK-treated patients occurred at a mean of 10.2 +/- 7.4 hours after the start of treatment. Mortality after symptomatic ICH was 83% (10/12 patients). Only blood glucose was significantly associated with symptomatic ICH in r-proUK-treated patients based on univariate analyses of 24 variables: patients with baseline glucose >200 mg/dL experienced a 36% risk of symptomatic ICH compared with 9% for those with < or =200 mg/dL (p = 0.022; relative risk, 4.2; 95% CI, 1.04 to 11.7). CONCLUSIONS: Symptomatic ICH after IA thrombolysis with r-proUK for acute ischemic stroke occurs early after treatment and has high mortality. The risk of symptomatic ICH may be increased in patients with a blood glucose >200 mg/dL at stroke onset.

Household cleaning and surface disinfection: new insights and strategies.

Recently, new insights into the persistence of pathogens, their transfer from inanimate surfaces to humans and the risk of contamination and dissemination of pathogens by detergents have been gained. Furthermore, new experimental data on the interruption of chains of infection by disinfectants as well as results of outbreak-control studies are now available. Hence it has become necessary to reassess the potential benefits using disinfectants to prevent and control nosocomial infections. Based on the new findings and in view of the increasing incidence of nosocomial infections and antibiotic resistances, the German Robert-Koch-Institut has issued completely revised recommendations on Household Cleaning and Surface Disinfection. With respect to these recommendations we developed a new test method, which allows comparison of the efficacy of disinfection in reducing the microbial loads and their dissemination with that of cleaning procedures under practical conditions. In a multi-factor approach, mechanical properties (wet mop technique), utensils (different mop materials) and active agents (disinfectant, detergent) were taken into consideration. We found that under the given conditions, dissemination of the test organism Staphylococcus aureus did not take place when using aldehydes and peroxides, it did take place, however, when water, surfactants, and the disinfectants glycol derivatives, quaternary ammonium compounds and alkylamines were used.

The higher disinfectant resistance of nosocomial isolates of Klebsiella oxytoca: how reliable are indicator organisms in disinfectant testing?

The Children's Clinic in Giessen, Germany recently reported several severe infections with Klebsiella oxytoca resulting in deaths of two neonates. The putative source of the infections was a contaminated infusion solution. The resistance to disinfectant of the K. oxytoca isolates was investigated in three independent laboratories and was indeed found to be significantly increased. Comparative tests with standard strains of K. oxytoca and other recommended bacterial surrogates showed the disinfection procedures used were fully effective. The higher resistance of the nosocomial isolates may have developed due to improper handling and storage of the cleaning utensils. This report describes the events and draws conclusions concerning the use of disinfectants, the treatment of cleaning utensils, the reliability of procedures for testing disinfectants, and suggests additional measures.