Healthcare Personnel Handwash Research Articles

Comparative Recovery of Serratia marcescens Using Bags versus Gloves as Described in ASTM E1174-21 Health Care Personnel Handwash Method.

The ASTM E1174-21 Health Care Personnel Handwash method is prescribed by the U.S. Food and Drug Administration (FDA) to demonstrate the efficacy of antiseptic handwashing products. The standardized method allows for marker bacteria to be collected from the hands by using either a bag or a glove. Two recent studies utilizing the different collection methods testing the same product showed substantial differences in results. We sponsored two independent studies to compare the bag and glove collection methods following contamination with Serratia marcescens. Overall, there was no difference between collection methods for bacteria recovered (P = 0.603). The distribution of recovery for the bag method was slightly less variable than for the glove method. Statistical differences were observed within each lab based on the collection day. The day-to-day variability is critical to consider for future multiple-day studies. Additionally, hand size appears to impact recovery, especially for the glove method, with both small and medium hand sizes resulting in higher recovery than large and extralarge hand sizes (P = 0.015), whereas hand size did not impact recovery with the bag method (P = 0.315). While it appears that both the bag and glove methods can be used, our findings suggest that gloves may not be the best option for subjects with large to extra-large hands. Additional work looking at bacterial recovery following product treatment is warranted to understand the impact of large hands in the bag versus glove recovery method. IMPORTANCE Antiseptic hand wash products are evaluated using the standard ASTM E1174-21 to demonstrate their antibacterial efficacy. Often products are tested at multiple labs, and the need to understand variables that may play a role in the outcome of the study is important. This work allows us to evaluate the impact that the two collection methods, bags and gloves, have on bacteria recovery. If differences are observed, standardization to one method may be critical to ensure similar test results when planning studies at multiple labs.

Randomized controlled trial evaluating the antimicrobial efficacy of chlorhexidine gluconate and para-chloro-meta-xylenol handwash formulations in real-world doses

Chlorhexidine gluconate-based soaps have become the gold standard for handwashing in critical care settings and para-chloro-meta-xylenol is an effective alternative antibacterial active ingredient. This study benchmarked 2 novel foaming handwashes, compared to a bland soap for antimicrobial effectiveness using the health care personnel handwash method at realistic soap doses (0.9 mL and 2.0 mL). To our knowledge, this is the first published efficacy study on realistic soap doses. Both soaps met Food and Drug Administration success criteria.

Micrograph Analysis of Disinfectants on Escherichia Coli

RESULTS: Two of the six studies showed a reduction in HAIs with the addition of an alcohol sanitizer, three studies showed no additional benefit, and one study showed that the addition of alcohol sanitizers significantly increased nosocomial infections. The two studies where alcohol showed a benefit were conducted with a PCMX control. In one of the studies where the authors concluded no difference, the raw data showed a 27% increase in HAIs with alcohol. In another, alcohol increased infections over the baseline in 4 of 6 categories studied. LESSON LEARNED: Alcohol sanitizers have not been conclusively demonstrated to reduce HAIs over handwashing, and have never shown superiority over a top-tier handwash. The failure to reduce HAIs, despite increasing compliance, may be due to the lack of persistent activity. As the FDA Monograph states, “Persistence, defined as prolonged activity, is a valuable attribute that assures antimicrobial activity during the interval between washings, and is important to a safe and effective healthcare personnel handwash.”

Comparative efficacy of commercially available alcohol-based hand rubs and World Health Organization-recommended hand rubs: Formulation matters

Use of alcohol-based hand rubs (ABHRs) effectively reduces transmission of pathogenic microorganisms. However, the impact of alcohol concentration and format on product efficacy is currently being debated. Two novel ABHR formulations containing 70% ethanol were evaluated according to American Society for Testing and Materials E1174 (Health Care Personnel Handwash [HCPHW]) and European Norm (EN) 1500 global standards. Additionally, using E1174, the efficacy of these formulations was compared head-to-head against 7 representative commercially available ABHRs and 2 World Health Organization recommended formulations containing alcohol concentrations of 60% to 90%. The novel ABHR formulations met efficacy requirements for both HCPHW and EN 1500 when tested at application volumes typically used in these methods. Moreover, these formulations met HCPHW requirements when tested at a more realistic 2-mL product application. In contrast, the commercial ABHRs and World Health Organization formulations failed to meet HCPHW requirements using a 2-mL application. Importantly, product performance did not correlate with alcohol concentration. Product formulation can greatly influence the overall antimicrobial efficacy of ABHRs and is a more important factor than alcohol concentration alone. Two novel ABHRs based on 70% ethanol have been formulated to meet global efficacy standards when tested at volumes more representative of normal product use in health care environments.

Advancement of the standard in vivo hand rub test methods: a critical comparison of the health care personnel handwash (ASTM E1174) and the hygiene handrub (EN1500)

Recognized standards for evaluating alcohol based hand rubs (ABHR) differ significantly in methodology and success criteria. Hand hygiene authorities including the WHO and U.S. CDC have recognized inherent weaknesses calling out the need for improved in vivo efficacy methods.

In vivo Efficacy of Novel Alcohol-Based Hand Rubs Utilizing the Standard Test Method ASTM E 2755 to Represent In-Use Conditions

The current U.S. standard for evaluating the in vivo activity of alcohol-based hand rubs (ABHR) is the Health Care Personnel Hand Wash (HCPHW) method, ASTM E 1174. The HCPHW method was developed for the evaluation of hand wash products and does not reflect the in-use conditions of ABHR. ASTM E 2755, a recently approved Standard Test Method specifically designed for evaluation of hand rubs, is more reflective of normal use conditions.

In Vitro Skin Comparison of Alcohol and Non-Alcohol Hand Sanitizers

Methods: Three commercial products were evaluated: two recently introduced novel ABHRs, Product A (70% v/v ethanol gel) and Product B (70% v/v ethanol foam); and Product C, an ABHR gel (85% w/w ethanol (90% v/v)). WHOrecommended hand rub formulations were included as benchmarks: WHO-EtOH (80% v/v ethanol) and WHO-IPA (75% v/v isopropanol). Test articles were evaluated on the hands of adult subjects at a 2 ml dose using the Health Care Personnel Handwash (HCPHW) method according to US FDA requirements. Log reductions from baseline were calculated after one and ten product applications. Statistical analysis was conducted using one-way ANOVA (a50.05).

Development of a health care personnel handwash with 6-hour persistence

Health care handwashes/sanitizers help prevent the spread of infection. Many are alcohol-based, providing immediate microbial kill. Few contain persistence factors for residual antimicrobial effects. We conducted multiple studies on Viacydin-Containing Alcohol Sanitizer (VCAS) to evaluate antimicrobial properties and skin friendliness. The potential of VCAS to cause use related skin problems was examined by repeated applications over a 3-week period. Excessive handwashing compared effects of VCAS on the skin barrier with that of other handwash products. Antimicrobial range, immediate kill rates, and resistance development were assessed as was the potential for continued antimicrobial activity over an extended period following product use. Our data showed the VCAS formula has broad, rapid antimicrobial efficacy without promoting microbial resistance. VCAS is mild to skin. Antimicrobial persistence testing showed that VCAS remained effective up to 6 hours postapplication. VCAS was superior to or at parity with on-market products, exhibited substantial residual effects and persistence up to 6 hours, and was safe and well tolerated. These results provide strong evidence for the value of VCAS to help prevent and eliminate pathogen contamination of the hands.

Investigation of <i>in Vitro</i> and <i>in Vivo</i> Efficacy of a Novel Alcohol Based Hand Rub, MR06B7

Alcohol based hand rubs have been used for hand hygiene in health-care settings. Compared with hand scrubbing, using suitable alcohol based hand rub provides several advantages like usability in a ward with no tap, requiring less time and mildly-irritating. Alcohol provides immediate activity, but poor virucidal activity against certain viruses including norovirus. It is important to develop further improved alcohol based hand rubs which have characteristics of sufficient effectiveness, skin-safe and extended spectrum to non-enveloped viruses for infection control. In the study, in vitro microbicidal evaluations and in vivo efficacy evaluation study were investigated to clarify the characteristics of a novel hand antiseptic MR06B7 composed of additives with synergetic activities. MR06B7 showed bactericidal activity of more than 5 Log(10) reduction within 15 sec against 20 challenged strains. MR06B7 also demonstrated potent fungicidal activities at exposure time of 30 sec (more than 4 Log(10) reduction). Against all test viruses including non-enveloped viruses (adenovirus, feline calicivirus, murine norovirus and poliovirus), MR06B7 had excellent virucidal activity to reduce the titer of viability to the limit of detection within 30 sec exposure (more than 4 Log(10) reduction), whereas 83%(v/v) ethanol indicated the inadequate effectiveness. On the clinical study conducted in accordance with standard method for Healthcare Personnel Handwash of American Society for Testing and Materials, MR06B7 showed excellent immediate antimicrobial activity. The result surpassed the critical indices set forth in the FDA's Tentative Final Monograph. These findings suggest MR06B7 which satisfies most requirements of efficacy qualifications including potent virucidal activity against non-enveloped viruses may contribute to accomplish advanced infection control in clinical practice.

Real Benefits of Hand Hygiene Product Foaming Technology

BACKGROUND/OBJECTIVES: Healthcare workers are choosing foamed hand hygiene products because of their ease of use and free-rinsing characteristics. Unfortunately, foamed products can sometimes be less mild most likely due to poor surfactant selection. Hand hygiene products that cause skin irritation and dryness might deter healthcare workers from complying with good hand hygiene practices as outlined in the Guideline for Hand Hygiene in Health-Care Settings. The true benefit of foam technology is that it can provide extremely mild routine and antiseptic cleansers when formulated with the appropriate choice of surfactant ingredients and increased levels of moisturizing agents. Furthermore, increasing mildness in hand hygiene products does not necessarily interfere with their antimicrobial efficacy. To compare mildness and efficacy of foamed hand hygiene products containing various surfactant systems. METHODS: To determine efficacy, a randomized, double-blinded healthcare personnel handwash (HCPH) study was designed based on the procedures described in the Tentative Final Monograph for Healthcare Antiseptic Drug Products (TFM). Serratia marcescens was applied to the subjects' hands prior to washing with a 0.75% triclosan foamed hand hygiene product or a positive control (4% chlorhexidine gluconate). The contamination/wash cycle was repeated 10 times. Log reduction was determined after cycles 1, 3, 7, and 10. A randomized, double-blinded forearm controlled application test (FCAT) study was designed to determine the effects of the foamed products on the moisture and barrier properties of the skin. Visual appearance, transepidermal water loss, and skin hydration were evaluated at baseline and after five days of treatment. RESULTS: In the HCPH study, the mild surfactant containing triclosan foam demonstrated a 2.81 log10 reduction after wash 1 and a 3.03 log10 reduction after wash 10 (p = 0.0001). Even with this demonstrated activity, the mild antimicrobial product minimized the drying effects of water when measured using a corneometer. The mildest routine product demonstrated increased moisture versus water alone. Additionally, the routine foaming product demonstrated no significant difference in moisture (p = 0.0250) compared to an untreated site. CONCLUSIONS: These data demonstrate that well formulated foaming hand hygiene products can be mild and in the case of antiseptic foam products can also meet the TFM criteria for a HCPH. Employee. STERIS Corporation BACKGROUND/OBJECTIVES: Healthcare workers are choosing foamed hand hygiene products because of their ease of use and free-rinsing characteristics. Unfortunately, foamed products can sometimes be less mild most likely due to poor surfactant selection. Hand hygiene products that cause skin irritation and dryness might deter healthcare workers from complying with good hand hygiene practices as outlined in the Guideline for Hand Hygiene in Health-Care Settings. The true benefit of foam technology is that it can provide extremely mild routine and antiseptic cleansers when formulated with the appropriate choice of surfactant ingredients and increased levels of moisturizing agents. Furthermore, increasing mildness in hand hygiene products does not necessarily interfere with their antimicrobial efficacy. To compare mildness and efficacy of foamed hand hygiene products containing various surfactant systems. METHODS: To determine efficacy, a randomized, double-blinded healthcare personnel handwash (HCPH) study was designed based on the procedures described in the Tentative Final Monograph for Healthcare Antiseptic Drug Products (TFM). Serratia marcescens was applied to the subjects' hands prior to washing with a 0.75% triclosan foamed hand hygiene product or a positive control (4% chlorhexidine gluconate). The contamination/wash cycle was repeated 10 times. Log reduction was determined after cycles 1, 3, 7, and 10. A randomized, double-blinded forearm controlled application test (FCAT) study was designed to determine the effects of the foamed products on the moisture and barrier properties of the skin. Visual appearance, transepidermal water loss, and skin hydration were evaluated at baseline and after five days of treatment. RESULTS: In the HCPH study, the mild surfactant containing triclosan foam demonstrated a 2.81 log10 reduction after wash 1 and a 3.03 log10 reduction after wash 10 (p = 0.0001). Even with this demonstrated activity, the mild antimicrobial product minimized the drying effects of water when measured using a corneometer. The mildest routine product demonstrated increased moisture versus water alone. Additionally, the routine foaming product demonstrated no significant difference in moisture (p = 0.0250) compared to an untreated site. CONCLUSIONS: These data demonstrate that well formulated foaming hand hygiene products can be mild and in the case of antiseptic foam products can also meet the TFM criteria for a HCPH. Employee. STERIS Corporation

Novel characteristics of a 60% isopropanol hand rub formulated to meet tentative final monograph healthcare personnel handwash criteria

BACKGROUND: A healthcare personnel handwash (HCPH) is defined in the Tentative Final Monograph for Healthcare Antiseptic Drug Products (TFM) as an antiseptic handwash that demonstrates a 2 log10 reduction of a marker organism, Serratia marcescens, after wash 1 and a 3 log10 reduction after wash 10. In addition to the rapid, broad-spectrum efficacy requirements, antiseptic handwash products should be formulated to maintain skin condition and should be well tolerated by users. Chlorhexidine gluconate (CHG)–containing antiseptic handwash products have been able to meet the TFM criteria, but other antiseptic ingredients, such as 60% isopropanol, when properly formulated, can also meet the TFM criteria while also providing excellent moisturization. OBJECTIVES: To evaluate the effectiveness of a 60% isopropanol hand rub in a HCPH clinical study and to evaluate the moisturizing properties in a forearm controlled application test (FCAT). METHODS: To determine efficacy, a randomized, double-blinded HCPH study was designed based on the procedures described in the TFM. Following a 1-week washout period, Serratia marcescens was applied to the subjects' hands followed by the application of the 60% isopropanol hand rub or the positive control (4% CHG). The contamination/application cycle was repeated 10 times. Reduction of the test organism was determined after cycles 1, 3, 7, and 10. A randomized, double-blinded FCAT study was designed to determine the moisturizing properties of the isopropanol hand rub versus skin lotions. The test products were applied twice, 30 minutes apart, to the subjects' forearms. Transepidermal water loss (TEWL) and skin hydration were evaluated at baseline, 1, 2, and 4 hours after the second applications. RESULTS: In the HCPH study, the 60% isopropanol hand rub exceeded the TFM criteria by achieving a 4.11 log10 reduction of the test organism from baseline after wash 1 and a 4.41log10 reduction after wash 10 (p = 0.0001). This compared to 2.42 log10 and 3.62 log10 reductions for the 4% CHG product. In the FCAT study, the 60% isopropanol hand rub significantly decreased transepidermal water loss (p = 0.0071) and significantly increased skin hydration (p = 0.0001). CONCLUSION: These data demonstrate that a well formulated 60% isopropanol hand rub can meet the TFM criteria for a HCPH and provide moisturizing properties comparable to typical hand lotions used in healthcare facilities. BACKGROUND: A healthcare personnel handwash (HCPH) is defined in the Tentative Final Monograph for Healthcare Antiseptic Drug Products (TFM) as an antiseptic handwash that demonstrates a 2 log10 reduction of a marker organism, Serratia marcescens, after wash 1 and a 3 log10 reduction after wash 10. In addition to the rapid, broad-spectrum efficacy requirements, antiseptic handwash products should be formulated to maintain skin condition and should be well tolerated by users. Chlorhexidine gluconate (CHG)–containing antiseptic handwash products have been able to meet the TFM criteria, but other antiseptic ingredients, such as 60% isopropanol, when properly formulated, can also meet the TFM criteria while also providing excellent moisturization. OBJECTIVES: To evaluate the effectiveness of a 60% isopropanol hand rub in a HCPH clinical study and to evaluate the moisturizing properties in a forearm controlled application test (FCAT). METHODS: To determine efficacy, a randomized, double-blinded HCPH study was designed based on the procedures described in the TFM. Following a 1-week washout period, Serratia marcescens was applied to the subjects' hands followed by the application of the 60% isopropanol hand rub or the positive control (4% CHG). The contamination/application cycle was repeated 10 times. Reduction of the test organism was determined after cycles 1, 3, 7, and 10. A randomized, double-blinded FCAT study was designed to determine the moisturizing properties of the isopropanol hand rub versus skin lotions. The test products were applied twice, 30 minutes apart, to the subjects' forearms. Transepidermal water loss (TEWL) and skin hydration were evaluated at baseline, 1, 2, and 4 hours after the second applications. RESULTS: In the HCPH study, the 60% isopropanol hand rub exceeded the TFM criteria by achieving a 4.11 log10 reduction of the test organism from baseline after wash 1 and a 4.41log10 reduction after wash 10 (p = 0.0001). This compared to 2.42 log10 and 3.62 log10 reductions for the 4% CHG product. In the FCAT study, the 60% isopropanol hand rub significantly decreased transepidermal water loss (p = 0.0071) and significantly increased skin hydration (p = 0.0001). CONCLUSION: These data demonstrate that a well formulated 60% isopropanol hand rub can meet the TFM criteria for a HCPH and provide moisturizing properties comparable to typical hand lotions used in healthcare facilities.

Effect of healthcare personnel handwash products on skin moisturization

BACKGROUND/OBJECTIVES: Alcohol-based hand-rub products are effective in helping healthcare personnel to reduce resident skin flora. Unfortunately, the frequent occupational use of alcohols is known to cause detrimental changes to the skin. In this study, a standard method for measuring skin moisturization was used to compare the moisturization capability of several formulations containing hand-health components. METHODS: Fifteen female subjects were subjected to a 6-day “wash out” period using a nonmoisturizing cleansing bar on their lower legs. Subjects washed twice a day and were asked to refrain from using moisturizing products and asked not to shave their legs within 72 hours of the test day. A NOVA DPM 9003 (NOVA Technology Corporation, Portsmouth, NH) was used to quantify skin hydration. Based upon a NOVA reading of less than 110, 12 of the subjects were selected for testing. Subjects were placed in a controlled environment ( RESULTS: The average percent changes in NOVA readings compared to baseline at t = 0, 1, 2, 3, and 4 hours, respectively, for each treatment were as follows: A (7.1, 12.0, 23.9, 20.1, 31.9); B (−0.3, 6.0, 3.8, 0.4, 2.2); C (4.2, 10.7, 11.7, 7.5, 9.8); D (−0.3, −1.2, 1.1, 1.6, 2.3); E (−0.8, −1.4, −1.2, −0.8, −1.3). The site with treatment A was found to have a statistically significant improvement in skin moisturization (p CONCLUSIONS: The NOVA DPM 9003 is an effective instrument for determining and comparing the skin moisturization of alcohol-based handwashes. The use of skin conditioning components in these handwashes can increase the moisturization level of dry skin.

A unique water optional health care personnel handwash provides antimicrobial persistence and residual effects while decreasing the need for additional products

BackgroundThe Centers for Disease Control and Prevention (CDC) has published guidelines for hand hygiene practices, recommending a handwash regimen that alternates between waterless alcohol products and antimicrobial or nonantimicrobial soap and water. The advent of an alcohol-based product that can be used with or without water (ie, water optional) to decontaminate the hands while providing immediacy of kill and antimicrobial persistence could reduce the confusion associated with handwash guidelines. Such a product has been developed, is alcohol-based (61%), and zinc pyrithione (ZPT) preserved (61% alcohol-ZPT) and has proven to be fully compliant with the Food and Drug Administration (FDA) and CDC guidelines.MethodsFDA-required testing of the 61% alcohol-ZPT product for the health care personnel handwash indication was performed as outlined in the Tentative Final Monograph (TFM) for Health-Care Antiseptic Drug Products, employing waterless and water-aided product applications. It was next assessed for antimicrobial persistence and residual effects by comparing it, in separate waterless and water-aided applications, with commonly available handwashes containing various antimicrobials in a 5-day study employing 49 subjects, in which samples were collected immediately and at 4 hours and 8 hours postapplication. The skin conditioning properties of this formulation were investigated via appropriate methods.ResultsThe 61% alcohol-ZPT product easily produced >3.0 log10 reduction in the indicator strain (Serratia marcescens) following the first wash, exceeding the 2.0 log10 FDA requirement. This level of performance was maintained through the tenth wash, surpassing the 3.0 log10 FDA requirement for the handwash indication. For the assessment of persistence and residual effect in the waterless mode, the water-optional, 61% alcohol-ZPT product consistently produced log10 reductions of nearly 3.5 or greater at every point over the entire study period. In the water-aided configuration, similar results were obtained as log10 reductions of 2.5 were observed. The formulation is nonirritating, actually contributing to hand skin condition.ConclusionsThe 61% alcohol-ZPT product exceeds all FDA criteria for the health care personnel handwash indication and is a significant advancement in the concept of skin antisepsis. It represents a single product suitable for use in all hand hygiene settings, demonstrating improved antimicrobial persistence and residual effects. The 61% alcohol-ZPT formulation contributes positively to overall hand conditioning, and a previously reported study has documented it to be virucidal for several DNA and RNA viruses.

Antimicrobial Persistence and Residual Effect in Healthcare Personnel Handwashes

BACKGROUND: Alcohol-based hand sanitizers can reduce nosocomial infections by >30.0%. The Food and Drug Administration (FDA) via the Tentative Final Monograph assesses efficacy immediately post wash. Antimicrobial persistence and residual effect are not evaluated. Recently a novel water-optional, alcohol-based formulation preserved with zinc pyrithione has been developed that provides antimicrobial persistence and residual activity, while surpassing the FDA criteria as a healthcare personnel handwash in both the waterless and water-aided modes. METHODS: This formulation was compared to common handwashes containing various antimicrobials (0.5% triclosan, 61.0% ethanol, 2.0% chlorhexidine gluconate [CHG], and 4.0% CHG) in waterless and/or water-aided modes to assess immediacy of kill, persistence, and residual effects in a 5-day study employing >60 subjects. Following collection of baseline data, the participants were instructed to wash with each product four times within 1 hour per label instructions and then glove. Representative samples were taken by the glove juice method at selected post-wash intervals that included immediate, 4-hour (except 4.0% CHG), and 8-hour. Post-wash samples were compared to baseline and log10 reductions were calculated. RESULTS: When tested waterless, the water-optional product consistently produced log10 reductions of nearly 3.5 or greater at every point over the entire study period, demonstrating vastly superior efficacy over the CHG and other alcohol-based products. In the water-aided configuration, similar results were obtained, as log10 reductions of 2.5 were observed, thus demonstrating vastly superior efficacy over triclosan. CONCLUSIONS: The new formulation exceeds FDA criteria for classification as a healthcare personnel handwash and demonstrates exceptional persistence and residual effects.

Antimicrobial Efficacy of Activated Triclosan in Surfactant-Based Formulation versus Pseudomonas putida

BACKGROUND: There is a need in healthcare settings for efficacious broad-spectrum antimicrobial handwash products. Experts agree on the importance of hand hygiene for the reduction or prevention of infection from bacteria. The antimicrobial activity of triclosan in surfactant-based formulations against Pseudomonas species has been questioned in the literature. Published articles have claimed that triclosan's activity is limited and not effective against gram-negative organisms, particularly Pseudomonas species. OBJECTIVE: We examined the efficacy of an “activated” 0.45% triclosan formula, compared to a formula containing 4% chlorhexidine gluconate (CHG). In vivo antimicrobial efficacy was assessed using the ASTM E-1174 (Healthcare Personnel Handwash) method, using Pseudomonas putida as the test organism. Efficacy was measured following a single as well as multiple (ten) 30-second handwashes. RESULTS: The activated triclosan formula achieved a 3.16 log10 reduction after a single wash and 3.30 log10 following ten consecutive washes. This compared to 2.53 log10 and 4.03 log10 reductions for the 4% CHG formula. The triclosan formula was significantly more effective following the single wash (p <0.001) while the 4% CHG was more effective after the tenth wash. CONCLUSIONS: This study demonstrates that a properly formulated triclosan containing product is effective at reducing gram-negative organisms such as Pseudomonas putida. In the 1994 Monograph for Healthcare Antiseptic Drug Products, FDA requires a 2 log10 reduction after a single wash and a 3 log10 reduction following ten washes. Both formulas met these criteria. The triclosan formula achieved the higher log reduction immediately, while the 4% CHG required ten washes.

Development of a Water-Optional Healthcare Personnel Handwash May Allow for Increased Compliance

Development of a Water-Optional Healthcare Personnel Handwash May Allow for Increased Compliance

Development of a Water-Optional Healthcare Personnel Handwash May Allow for Increased Compliance

BACKGROUND: Recently the Centers for Disease Control and Prevention has codified guidelines for hand hygiene practices, recommending a handwash regimen that alternates between waterless alcohol products and antimicrobial or non-antimicrobial soap and water. The advent of an alcohol-based product that can be used with or without water to decontaminate the hands while providing immediacy of kill with antimicrobial persistence could allow for increased compliance with handwash guidelines. Such a product has been developed and has proven to be fully compliant with the Food and Drug Administration (FDA). METHODS: FDA-required testing was performed as outlined in the Tentative Final Monograph for Health-Care Antiseptic Drug Products. The virucidal capacity and the skin-conditioning properties of this formulation were assessed. RESULTS: The in vitro results documented the antimicrobial prowess of this formulation as bacterial strains were reduced by not less that 4 log10 and frequently 6 log10 in 15 seconds or less. Data generated in vivo confirmed the in vitro findings, as this product easily produced a >3.0 log10 reduction in the indicator strain (S. marcescens) following the first wash, exceeding the 2.0 log10 FDA requirement. This level of performance was maintained through the tenth wash, surpassing the 3.0 log10 FDA requirement. The formulation is virucidal for several DNA and RNA viruses. The product is not a dermal irritant and contributes positively to overall skin conditioning. CONCLUSION: This product exceeds all FDA criteria and is a significant advancement in concept of handwashing. It represents a single product suitable for use in all hand hygiene settings.

The effects of test variables on the efficacy of hand hygiene agents

Background Hand hygiene is essential to interrupting disease transmission in health care facilities. Multiple hand hygiene agents are currently available for use in the health care setting. To evaluate the utility of these agents, both the user acceptability and the efficacy need to be evaluated. Different hand hygiene test methodologies have been used to measure the efficacy of these agents, but efficacy results vary depending on variations to key parameters in these methodologies. The purpose of this study was to evaluate the effect of test variables on the efficacy of hand hygiene agents. Methods Both a comprehensive literature review and original hand hygiene efficacy studies were undertaken. The literature review was conducted using a Medline search, and hand hygiene efficacy studies were conducted under the American Society for Testing and Materials (ASTM). E 1174 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulation. Results The literature review and our original data showed that the following variables affected the hand hygiene efficacy measurements: hand jewelry, experimental contamination versus normal flora, method of application of test organism, hand hygiene agent, concentration of active ingredient, volume of hand hygiene agent, duration of application of hand hygiene agent, method of application of hand hygiene agent, and study method (human challenge trial versus in vitro suspension test). Conclusions Although many methodological variables affect efficacy results, infection control professionals in their analysis of product information should always assess the results in light of the following key variables: concentration and type of active ingredient, duration of exposure to hand hygiene agent, volume of hand hygiene agent applied, test organism, and study method (ie, human challenge vs. in vitro suspension test).

Methods for evaluating changes in skin condition due to the effects of antimicrobial hand cleansers: Two studies comparing a new waterless chlorhexidine gluconate/ethanol-emollient antiseptic preparation with a conventional water-applied product

Background: Hand-cleansing products that are milder to the skin of health care personnel are being developed, but the available methodologies to appropriately evaluate these products and quantify differences are not generally being applied in well-controlled studies. Methods: Two randomized, blinded, bilateral comparison studies evaluated skin condition during use of 2 antiseptic hand preparation products: a new 1% chlorhexidine gluconate (CHG)/61% wt/wt ethanol antiseptic hand preparation in a unique emollient system for waterless/brushless application and a conventional 4% CHG antimicrobial product that is applied with water and a scrub brush. Trained technicians applied treatments 6 times (for a surgical scrub study) or 24 times (for a personnel handwash study) daily to the hands of healthy volunteers during 5 days of controlled washing. An expert grader evaluated skin for dryness, erythema, and roughness. Subjects completed a self-assessment questionnaire on skin condition. Transepidermal water loss was measured by an evaporimeter, and the skin surface hydration level was measured by an electrical conductance meter. Results: Fifty-eight subjects were enrolled in the 2 studies and received both treatments. In general, skin treated with the waterless CHG/ethanol product scored significantly (P < .004) better on evaluations of visual dryness and erythema and showed greater improvement in the level of hydration (P < .003). In the health care personnel handwash study, transepidermal water loss was less than that for skin treated with the conventional CHG product (P < .002). Subject assessments showed similar results (total score, P < .007). Conclusions: All 3 approaches of expert grader evaluation, subject assessment, and instrumentation were in concordance, demonstrating that the waterless CHG/ethanol product was gentler to skin than the conventional CHG product. (Am J Infect Control 2001;29:361-9.)

A close look at alcohol gel as an antimicrobial sanitizing agent

Background: Hand transmission of microbes by health care workers is a primary cause of nosocomial infections in both long-term and acute care facilities. Compliance with effective handwashing and hand sanitization regimens can break this cycle. Methods: We investigated the antimicrobial efficacy and irritation potential of 5 handwash product regimens: a nonantimicrobial lotion soap, an antimicrobial lotion soap, an alcohol gel sanitizer, a nonantimicrobial lotion soap with an alcohol gel sanitizer, and an antimicrobial lotion soap with an alcohol gel sanitizer. The regimens were evaluated by using a Healthcare Personnel Handwash procedure, and irritation was assessed by using expert hand evaluation after 25 consecutive washes. Results: The Healthcare Personnel Handwash data showed that the mean log reductions from baseline were greatest for the lotion soaps with alcohol gel sanitizer, less for the alcohol and the antimicrobial soap alone, and least for the bland soap. All of the product regimens showed a low potential for skin irritation. Conclusion: In terms of both microorganism reduction and skin irritation, the most effective product regimens were the use of alcohol gel sanitizer in combination with either an antimicrobial or a plain lotion soap. (AJIC Am J Infect Control 1999;27:332-8)