Publications
Books
These books are available for purchase on amazon.com.
1. Applied Biomedical Microbiology: A Biofilms Approach (Hardcover) , Edited by Daryl S. Paulson, Ph.D., CRC Press, 2010
2. Handbook of Regression and Modeling: Applications for the Clinical and Pharmaceutical Industries, Daryl S. Paulson, Ph.D., Chapman and Hall/CRC Biostatistics Series, 2007
3. Competitive Business, Caring Business , Daryl S. Paulson, Ph.D., Paraview Press, 2002
4. Applied Statistical Designs for the Researcher, Daryl S. Paulson, Ph.D., Marcel Dekker, 2003
5. Handbook of Topical Antimicrobials: Industrial Applications in Consumer Products and Pharmaceuticals (Manufacturing Engineering and Materials Processing), Daryl S. Paulson, Ph.D., Marcel Dekker, 2002
6. Topical Antimicrobial Testing and Evaluation, Daryl S. Paulson, Ph.D., Marcel Dekker, 1999
7.Handbook of Disinfectants and Antiseptics , Chapter Two: "A Broad-Based Approach to Evaluating Topical Antimicrobial Products", Daryl S. Paulson, Ph.D., Marcel Dekker, 1996
Journal Articles and Posters
Click on the corresponding link to download a copy of any of these publications.
1. Virucidal Efficacy of Topical Antiseptics Versus a Novel Strain of H1N1 Influenza Volha Dzyakanava, Ph.D. and Kelly Burningham, Poster for ICID, March 2010 View Abstract Request Document Virucidal Efficacy of Topical Antiseptics Versus a Novel Strain of H1N1 Influenza
ASTM E1052-96, Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension, was used to evaluate a non-medicated soap and three topical antiseptics: AvagardTM Surgical and Healthcare Personnel Hand Antiseptic (1% Chlorhexidine Gluconate, 61% Ethanol); AvagardTM Foam Instant Hand Antiseptic (62% Ethanol); and AvagardTM D Instant Hand Antiseptic (61% Ethanol). All products were tested at a 90% (v/v) concentration versus Influenza H1N1strain A/California/04/2009 with exposures of 30 seconds, 1 minute, and 2 minutes. Viral titers were alculated using the Spearman-Karber Method.
Significant reduction (>99.99%) in the population of A/California/04/2009 strain was achieved after 30-second exposures of the virus to the hand sanitizers. In a pandemic situation, the rapid virucidal activity provides a decided advantage in reducing Influenza transmission via hand contact. . Competitive Spirit Daryl S. Paulson, Ph.D., Lab Manager Magazine, May 2009 View Abstract Request Document Competitive Spirit
A competitive spirit within any organization -- business or research lab -- is fostered only when management is trusted and members of the organization feel that their unique talents and contributions are appreciated and nurtured. Create that atmosphere and winning will happen. But first one needs to understand some basic principles of human psychology, principles that reverse some of the top-down assumptions that, I would argue, have led to many of the current business failures.
Key to that understanding is recognizing each individual's subjectivity, which refers to one's perspective or opinion, particularly feelings, beliefs, and desires. We have cured illnesses, we have gone to the moon, and we have learned an incredible amount, but we continue to ignore our subjectivity. Since subjectivity is emotionally learned and thus lacks objective truth, many of us consider it unimportant (Habermas, 1987).
But in today's competitive environment, it is critical that managers acknowledge subjectivity within their staff members and work to understand each one's unique point of view, orientation, and psychology. If you are a manager of a lab and you need to rely on your staff to get jobs done, you first need to understand what motivates and inspires each person on your team. . Evaluation of Three Preoperative Preparation Products When Used in a Pre-operative Site Regimen Christopher M. Beausoleil, CCRP, Poster for ECCMID, May 2009 View Abstract Request Document Evaluation of Three Preoperative Preparation Products When Used in a Pre-operative Site Regimen
Objective:
Many patients undergoing orthopedic, cardiovascular, and general thoracic or abdominal surgeries experience post-surgical infections, prolonging their medical treatments, and imposing unnecessary medical risk and expense. The standard of practice for preoperative preparation (PreOp Prep) is to treat the intended surgical site with an effective topical antimicrobial immediately prior to a surgery, usually with prophylactic antibiotic therapy before and after the surgery. However, some medical practitioners currently prescribe for their presurgical patients, in addition, a preoperative site-wash (PreOp SW) regimen with the intention of reducing microbial populations residing on the skin prior to the routine site preparation at the time of the surgery. The logical rationale has been that such a combination procedure would reduce potentially contaminative microbial populations to levels far lower than could the PreOp Prep alone.
The purpose of this study was to evaluate effectiveness of a PreOp SW procedure by measuring reductions of normal and transient microorganisms produced at a specific site, the knee, by applications of a marketed PreOp Prep product over the course of 4 consecutive days. Three different commercially available products were tested -- TRISEPTIN Water-Aided, MaxiClens, and ChloraPrep.
Methods:
Two products were evaluated on each human subject to provide 10 data files per product (15 subjects, total). Technicians applied the products per use-instructions to the skin of subjects' knees once per day for 4 consecutive days. Microbial populations were sampled each day prior to and immediately following treatment. Performance of a product was evaluated in terms of its ability to reduce microbial populations progressively and in total over the 4-day period of testing.
Results:
All products tested produced significant reductions in the populations of microbial flora on the skin of the knee (see table).
Conclusion:
A PreOp SW regimen using any of the products tested -- TRISEPTIN Water-Aided, MaxiClens, or ChloraPrep -- plainly would present a much reduced population of microbial flora in challenge to the site PreOp Prep procedure to be performed immediately prior to surgery. The data indicate that the PreOp SW process should be initiated at least 2 days prior to the scheduled surgery, and that 3 or 4 days prior would be better yet. . A Sub-Draize Evaluation of Various Eyelash Mascara Products Jessica McDonnell and Sabrina Bakich, Poster for SOT, March 2009 View Abstract Request Document A Sub-Draize Evaluation of Various Eyelash Mascara Products
Through collaboration and development of alternative to animal test methods, BSLI has completed the testing of a protocol to categorize a level of irritation much lower than standard models can produce. Applicable to personal care products that want to claim "ultra-mild"; the sub-draize protocol was designed to determine if there is a noticeable difference among "mild" cosmetic products. . Evaluation of Two Methods of Determining the Efficacies of Two Alcohol-Based Hand Rubs for Surgical Hand Antisepsis Gunter Kampf, Christiane Ostermeyer, Peter Heeg, and Daryl S. Paulson, Ph.D., Applied and Environmental Microbiology, June 2006 View Abstract Request Document Evaluation of Two Methods of Determining the Efficacies of Two Alcohol-Based Hand Rubs for Surgical Hand Antisepsis
The antimicrobial efficacies of preparations for surgical hand antisepsis can be determined according to a European standard (prEN l279l [ENl) 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 reduce 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-l-ol, and 0.2% mecetronium etilsufate and applied for 1.5 min. The ethanol-based hand rub was equally effective as the 3-min reference disinfection of prEN 12791. Some formulations have beeen 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. . Letter to the Editor on Comparative Efficacy of Hand Hygiene Agents Daryl S. Paulson, Ph.D., American Journal of Infection Control, July 2005 View Abstract Request Document Letter to the Editor on Comparative Efficacy of Hand Hygiene Agents
To the Editor:
I have some concerns regarding a recent major article ("Comparative efficacy of hand hygiene agents in the reduction of bacteria and viruses," Sickbert-Bennett et al 2005;33:67-77), published in the American Journal of Infection Control. This article purports to evaluate the antimicrobial efficacies of 14 different handcleansing agents, including tap water, using the ASTM Standard Method E-1174-94, which is similar in its procedures to those specified by the Food and Drug Administration's (FDA) Tentative Final Monograph for evaluation of health care personnel handwashes. My criticisms and concerns will focus specifically on the portion of the paper related to use of Serratia marcescens as the hand contaminant, although many of my comments hold for the testing versus the MS2 bacteriophage, as well. . Transmission of Surrogate Norwalk Virus Daryl S. Paulson, Ph.D.,Food Protection Trends, June 2005 View Abstract Request Document Transmission of Surrogate Norwalk Virus
The United States Food Code requires that workers wear gloves while working wiht ready-to-eat foods. However, it has been observed that those wearing gloves do not always adher to good hygienic practices. There has been little focus on the transfer of viruses to gloved hands. The objective this research was to determin the amount of viurs transferred from contaminated surfaces to gloved hands. Results from this exploratory work showed that a significant viral load (4 to 5 logs) was transferable. . Efficacy of Preoperative Antimicrobial Skin Preparation Solutions on Biofilm Bacteria Daryl S. Paulson, Ph.D., AORN Journal, March 2005 View Abstract Request Document Efficacy of Preoperative Antimicrobial Skin Preparation Solutions on Biofilm Bacteria
RESEARCH ON THE MEDICAL EFFICACY of topical antimicrobials and antibiotics against infections has focused largely on the effect on free-floating planktonic bacteria.
IN THE PRESENCE OF nonbiological surfaces (e.g., catheters, prosthetic devices, biomaterials), however, bacteria form highly complex BioFilm systems that resist traditional medical treatment.
BACTERIAL PATHOGENS commonly found in chronic infections in both the planktonic and
BioFilm state were challenged with a variety of commonly used topical antimicrobial formulations.
BIOFILM BACTERIA were shown to be more resistant to killing than planktonic bacteria. Antimicrobial skin preparation times were adequate to significantly reduce bacterial populations protected in biofilms.
. Hand Scrub Products-Performance Requirements Daryl S. Paulson, Ph.D., AORN Journal, August 2004 View Abstract Request Document Hand Scrub Products-Performance Requirements
The US Food and Drug Administration regulates antimicrobial label claims for surgical hand scrub products. Surgical scrub products must meet preset performance criteria for immediate, persistent, and residual antimicrobial properties.
Although the test currently used to validate surgical hand scrub producis is rigorous in research methodology, it lacks pracfical clinical relevance. . Simulated Use Evaluation of a Strategy for Preventing Biofilm Formation in Dental Unit Waterlines James W. McDowell, Daryl S. Paulson, Ph.D., John A. Mitchell, Ph.D., Journal of the American Dental Association, June 2004 View Abstract Request Document Simulated Use Evaluation of a Strategy for Preventing Biofilm Formation in Dental Unit Waterlines
Background: Prevention of BioFilm formation is important in the maintenance of dental unit waterline systems. Without effective control measures, the waterlines will become contaminated with rouinte use.
Methods: The authors used a simulated use dental unit waterline system to evaluate the ability of a test product, A-dec ICX, to prevent biofilm formation. They evaluate buffered distilled water and a hard water model versus mixed-challenge suspensions of Staphylococcus aureus, Klebsiella pneumoniae and Pseudomonas aeruginosa.
Results: The authors documented development of significant biofilm in untreated test units, while treated test units showed no indication of biofilm formation throughout the 16-week study. Student t test and 95 percent confidence intervals performed on the plate count data confirmed that untreated test units had significant greater bacterial population than did treated test units (P<0.05). Qualitative images by scanning electron microscopy verified these findings.
Conclusion: In this simulated clinical-use study, the test product effectively reduced bacterial counts in incoming water and produced water quality exceeding stated recommendations of the American Dental Association.
Clinical Implications: The test product provides and approach to the dental unit waterline maintenance that is simple to use and that, by continuously preventing biofilm formation, reduces concerns about bacterial contamination in dental unit water.
. Taking Care of Patients and Caring for Patients Are Not the Same Daryl S. Paulson, Ph.D., AORN Journal, February 2004 View Abstract Request Document Taking Care of Patients and Caring for Patients Are Not the Same
THERE IS A SIGNIFICANT difference between taking care of patients and caring for patients.
TAKING CARE OF PATIENTS emphasizes objective, professional care, such as the medical and psychological aspects of nursing.
CARING FOR PATIENTS, on the other hand, is a humanistic way of interacting with patients that demonstrates sincere care and concern for patients simply because they are human beings.
. What Does BioScience Do For You Daryl S. Paulson, Ph.D., Big Sky Publishing, August 2002 View Abstract Request Document What Does BioScience Do For You
At BioScience Laboratories, Inc., we evaluate how effectively Products kill disease-causing germs. This is important when you have surgery because you want to know that the antimicrobial Product applied to your skin before the incision is made not only kills the germs right away, but will continue killing throughout the entire surgery. At BioScience Laboratories, Inc., we assure that the antimicrobial product used does this. . New Ideas for Successful Product Development for Topical Antimicrobial Manufacturers Daryl S. Paulson, Ph.D., Soaps & Cosmetics, December 2001 View Abstract Request Document New Ideas for Successful Product Development for Topical Antimicrobial Manufacturers
I cannot keep count of the number of topical antimicrobial products I have witnessed being developed that never became successful, in terms of business; and words cannot describe the anguish I have had seeing friends terminated because the products they developed were marketing disasters.
Why is it that some of our brightest individuals are behind the development of marketing flops? Chance plays a role. But, more importantly is failure to develop a functional strategy for targeting a market, educating that market as to the benefits of the product, and preparing for a rapid response from competitors. Most topical antimicrobial products are developed by chemists and transferred to marketing for a launch. If the launch is successful, great; if not, it's time for reevaluation.
One of the main reasons (or marketing flops is compartmentalization. Microbiologists tend to engage the market in terms of microbiology that is, the antimicrobial efficacy of the product; and they perceive little else. Chemists view the product in terms of compound stability, correct surfactant mix, content uniformity, and little else. Business people tend to view the product in terms of market share and mover advantage, as well as return on investment. Marketing people hope the product will perform some kind of magic and sell. Few, however, perceive it in terms of the end-user, and this is where the problem so often lies.
. A New, Water-Resistant, Film-Forming, 30-Second, One-Step Application Iodophor Preoperative Skin Preparation David K. Jeng, ScD, American Journal of Infection Control, December 2001 View Abstract Request Document A New, Water-Resistant, Film-Forming, 30-Second, One-Step Application Iodophor Preoperative Skin Preparation
Background: A 1-step, film-forming iodophor preoperative skin preparation, Prevail-Fx, was developed. It forms a water-resistant film once dried on skin. To evaluate the partially water-soluble formulation, the testing method was validated with spore-challenge techniques and the efficacy was studied microbiologically and chemically. The importance of method validation and the presence of free iodine as criteria for product evaluation of partially water-soluble or water-insoluble skin preparations are discussed.
Methods: The test methods outlined in the Federal Register, 21 CFR Parts 333 and 369 (Monograph), were used. Twenty-five American Type Culture Collection (Rockville, Md) species of organisms and 25 correspondent clinical isolates were tested in vitro. FDA In the clinical studies, the skin normal flora of the inguinal and abdominal sites were evaluated in a 30-second, single-step application. Betadine (Purdue Frederick Co, Norwalk, Conn) on scrub (7.5%) and Betadine solution (10%) were tested as controls in a 5-minute, 2-step application.
Results: Prevail-Fx solution showed a broad spectrum in a minimum inhibitory concentration test. It delivered rapid bactericidal activity in a timekill test, reducing 5 to 6 log of allenging organism in 3 minutes, as required by the Federal Drug Administration (FDA). In an in vivo clinical test with a single-step, 30-second application, Prevail-Fx effectively reduced greater than 4 log or greater than 3 log of normal skin flora in inguinal and abdominal testing sites, respectively. The bacterial levels remained significantly less than the baseline for 6 to 24 hours. These results meet and exceed the Federal Drug Administration's requirements. The efficacy of Prevail-Fx in a 30-second, single application is as effective as Betadine scrub and Betadine solution applied in a traditional 5-minute, 2-step scrubbing and painting.
Conclusion: The Prevail-Fx film-forming formulation delivered rapid antimicrobial activity against a broad spectrum of micro-organisms in vitro and a rapid, persistent bactericidal activity in vivo in a 30-second, 1-step application against normal skin flora. This study also found that the spore-challenge validation of the testing methods and the evidence of free iodine are 2 indispensable criteria for the efficacy evaluation of the film-forming iodophor skin preparations. . Handwashing, Gloving, and Disease Transmission by the Food Preparer Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, November 2000 View Abstract Request Document Handwashing, Gloving, and Disease Transmission by the Food Preparer
Issues of foodborne diesease transmission continue to be of frontline importance to the restaraunt industry. A well-designed, vigorously maintained program incorporating poper handwashing and/or gloving practices wiht control of the work environment can provide consisten assurance that patrons are served safe-to-eat food. . Efficacy Evaluation of Four Hand Cleansing Regimens for Food Handlers Daryl S. Paulson, Ph.D., Carol Riccardi, and Christopher Beausoleil, Dairy, Food and Environmental Sanitation, October 1999 View Abstract Request Document Efficacy Evaluation of Four Hand Cleansing Regimens for Food Handlers
Effective handwashing by foodhandlers is an important control measure for preventing transmission of foodborne diseases in food-handling environments, including food-service establishments. Effective handwashing requires both effective methods and effective handwash formulations. Test methods for determining the effectiveness of antimicrobial formulations for healthcare workers can be modified and used to determine the effectiveness of hand-washing regimens recommended for use by foodhandlers. To date, the relative antimicrobial effectiveness of various hand-cleaning formulations and practices have not been established forfoodhandlers. This study examined the ability of four handwashing regimens to reduce ffansient microorganisms on the skin of hands. The efficacy of. these handwashing regimens was determined using a modified Health Care personnel Handwash procedure and Escherichia colias the transient marker organism. The regimens consisted of a nonantimicrobial hand cleanser, an alcohol gel hand sanitizer, an antibacterial soap, and an antibacterial soap plus application of an alcohol gel hand sanitizer. All four regimens significantly reduced E. coli populations from baseline values. The most effective regimen for antimicrobial control was clearly the combination of the antibacterial soap handwash followed by the alcohol gel application. This regimen demonstrated a high immediate reduction of the transient microorganism, with the potential for further reductions with multiple applications of the antimicrobial hand soap over a period of days.
. Suggested Method for Evaluating Foodhandler-Process Handwash Formulations Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, August 1999 View Abstract Request Document Suggested Method for Evaluating Foodhandler-Process Handwash Formulations
The regulatory function for assuring that antimicrobial handwash products are effective has been transferred to the FDA from the USDA. BioScience Laboratories, Inc. has designed a protocol for testing food-handler handwash products for antibacterial efficacy. It is based on the current healthcare personnel handwash evaluation in which a marker microorganism is used to contaminate subjects' hands, and the Glove Juice Sampling Procedure is used to establish the baseline population. Subjects' hands are then recontaminated ten successive times, and each contamination is followed by a hand-wash procedure with product. Glove juice samples are collected after inoculation/handwash procedures l, 3, 7, and 10. The healthcare personnel handwash has been modified to simulate more closely the conditions of hand contamination that may be associated with food preparation: Escherichia coli is substituted for Senatia marcescens and, instead of the hands being directly inoculated with bacteria, hamburger is inoculated with E. coli, and the subjects knead the hamburger so as to contaminate the hands with bacteria as well as with a significant organic load. Also discussed in this article is the importance of assessing a test product's potential for causing skin irritation with repeated use.
. Successfully Marketing Skin Moisturizing Products Daryl S. Paulson, Ph.D., Soaps & Cosmetics, August 1999 View Abstract Request Document Successfully Marketing Skin Moisturizing Products
There is tremendous opportunity for marketing effective and desired skin-moisturizing products, but vision is needed. For example, markets wide open to moisturizers include food service/processing antimicrobial handwash formulations and consumer and medical topical antimicrobial products. The key is to stay close to targeted customers and listen, listen, listen. . Handwashing and Glove for Food Protection Part I- Examination of the Evidence Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, December 1998 View Abstract Request Document Handwashing and Glove for Food Protection Part I- Examination of the Evidence
The potential for foodhandlers to be a factor in transmitting foodborne disease continues to be a significant issue. In a number of situations, foodhandlers have been implicated as a primary vector in contributing to foodborne illness. The most effective method to break the contamination vector between foodhandlers and consumers is intensely debated. One view holds that food servers must eliminate bare hand contact with ready-to-eat food (by use of gloving) to insure protection, while the other position is that a well managed hand washing and hand sanitizing program is sufficient to insure protection. This paper explores the evidence for these widely differing opinions via a literature review.
. Handwashing and Glove for Food Protection Part II - Effectiveness Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, December 1998 View Abstract Request Document Handwashing and Glove for Food Protection Part II - Effectiveness
Currently, there are insufficient scientific data to define and substantiate effective hand cleaning hygiene regimens for food protection and minimized risk of health hazards. No direct scientific evidence has been published to support the premise that use of a physical barrier (gloves) on the hands of food handling personnel prevents transfer of pathogens to food and, consequently, to support a requirement for no hand contact with ready-to-eat food. This study was carried out to obtain data under simulated food service conditions to define and support the most effective hand hygiene regimens for food protection and minimized risk of health hazards for the customer. . Topical Antimicrobials and Skin Irritation: The Next Step Daryl S. Paulson, Ph.D., Soaps/Cosmetics/Chemical Specialties, November 1998 View Abstract Request Document Topical Antimicrobials and Skin Irritation: The Next Step
ln the end, topical antimicrobial products should be evaluated for intrinsic irritation potential and for their relative irritation potentials compared to competitors, products. There are several effective ways of doing this. One is to recruit a set number of human volunteers who meet protocol and Institutional Review Board (lRB) requirements for participating in the study. The subjects would be placed on a restricted ,,conditioning,, products regimen for one to two weeks. This has the effect of bringing all subjects' skin conditions to a common state and eliminating the biasing influences of extraneous products upon the tested product(s). The subjects, hands would be "baseline" graded for dryness, swelling, chaffing, rash, redness, cracking, fissures, etc., depending upon the study requirements. The ubiects would then use the product(s) in a standardized manner for 10 to 50 washes per day over the course of one to several days. Every wash, every fifth wash or some other predetermined standard time wash interval would be used to evaluate the product. The hands would be graded visually and/or measured for Tran epidermal water loss. Generally, nonparametric statistics are used to make skin irritation comparisons Nonparametric statistics do not utilize parameters (mean, standard deviation and variance) in evaluating data and are often used when the sample size is small. When using small sample sizes, the variable data distribution cannot be assured to be "normal," a requisite for using parametric statistics. A normal bell curve distribution is not a requirement of nonparametric models. Hence, they are preferred in this area over parametric models, Common nonparametric models include Mann-Whitney Statistics. This test is the nonparametric analog to the student's t-test. lt is used to compare two product groups to one another. Unlike the parametric student’s t-test that assumes a normal "bell-shaped,, distribution, the Mann_ Whitney statistic requires only that the sample data collected be randomly selected. Another common nonparametric model is the Kruskal-Wallis Model. This is the non_ parametric analog to a one-factor ANOVA model. lt is used to compare multiple groups in terms of one factor. For example, if one wants to evaluate the irritation effects of five different hand soaps, the Kruskal-Wallis model should be employed for this evaluation.
It is important in developing topical antimicrobiai products that skin irritation potential be addressed from a multi-perspective approach. This will help assure that the product is low in irritation. In this way, the product is more likely to have a long, useful and profitable life. . Povidone Iodine Gel -- A 30-Second One Time Application Preoperative Skin Preparation David K. Jeng, ScD and Jane E. Severin, American Journal of Infection Control, October 1998 View Abstract Request Document Povidone Iodine Gel -- A 30-Second One Time Application Preoperative Skin Preparation
Background: Simplifying and shortening the skin-preparation application procedure is desirable for many reasons, which include labor-cost savings and improved suite utilization. A new formulation, PVP-I Gel Alcohol (PGA) that contains 5% PVP-I and 62% ethanol in gel form, was developed to achieve a shorter preparation time with a rapid and persistent efficacy on a broad spectrum of microorganisms and to minimize the potential for iodine
irritation.
Method: The test methods outlined in the Federal Register, 21 CFR Parts 333 and 369, "Tentative Final Monograph for Health-Care Antiseptic Drug Products;" Proposed Rule, 1994 (Monograph), were adapted in this study. Efficacy of PGA was evaluated, both in vitro and in vivo. The in vitro timekill and minimum inhibition concentration tests were conducted by using 33 strains of aerobic and anaerobic gram-positive bacteria, gram-negative bacteria, yeasts, and antibiotic-resistant bacteria. In the clinical test, the inguinal and abdominal skin sites of human subjects were exposed to PGA for 30 seconds to assess the antimicrobial efficacy on normal skin flora. Betadine PVP-I scrub was tested in a 5-minute application as a control.
Results: The time-kill test showed that PGA delivered a rapid antimicrobial activity—reducing greater than 3 to 8 log microorganisms in 15 seconds in all of the 33 species of microorganisms tested. Within 30 seconds, all challenge organisms were reduced below detection level. Results of the minimum inhibition concentration test showed that PGA demonstrated an equivalent activity to Betadine control under the testing conditions. In the clinical test, PGA was effective in the reduction of greater than 3 log and 2 log of normal skin flora, respectively, in inguinal and abdominal sites in a single-
step 30-second application. Bacteria levels remained significantly below the baseline for 6 hours in the primary study and for 24 hours in a secondary study. These results show that the current PGA formulation with a 30-second application delivers an efficacy equivalent to Betadine scrub in a 5-minute application and that the PGA formulation has a long-lasting effect—up to 24 hours.
Conclusion: The PGA formulation delivered rapid and persistent antimicrobial activity against a broad spectrum of bacteria both in vitro and in vivo. PGA is an effective skin-preparation formulation for use in a single-step 30-second application. . Developing Effective Topical Antimicrobials Daryl S. Paulson, Ph.D.,Soaps/Cosmetics/Chemical Specialties, December 1997 View Abstract Request Document Developing Effective Topical Antimicrobials
It is important that, in developing topical antimicrobial products, a multidimensional approach be taken. This will help ensure that the product that results is designed for the specific needs of the market, and that those needs are met. In this way, the product is more likely to have a long, useful and profitable life. . Role of Quality Assurance in Effective Topical Antimicrobial Development Daryl S. Paulson, Ph.D., Pharmaceutical & Cosmetic Quality, December 1997 View Abstract Request Document Role of Quality Assurance in Effective Topical Antimicrobial Development
It is important that in developing topical antimicrobial products, a multidimensional approach be taken to assure their quality. This will help ensure that the developed product is designed for the specific needs and requirements of the market, and that those needs are met. In this way, the product is more likely to have a long, useful and quality life. . Foodborne Disease: Controlling the Problem Daryl S. Paulson, Ph.D., Environmental Health, May 1997 View Abstract Request Document Foodborne Disease: Controlling the Problem
The danger of foodborne disease continues to pose signifcant problems for the food industry. The main cause of foodborne illness is a transmission of pathogentic microorganisms from the hands of food service persnnel to the patrons via food served to them. There is an ongoing debate as to whether wearing protective barrier gloves or effective handwashing alone will best prevent food service personnel from contaminating the food served. It is suggested that relying solely on barrier gloes or handwashing is not prudent. Thoroguh training of personnel, routine retraining, consistent emphasis in the workplace on the need for safe food-handling practices, and a vigoruous internal program for assurance of compliance are the elements crucial to a program for the prevention of foodboarne illnes, whetheer glovers are worn or not. . Designing a Handwash Efficacy Program Daryl S. Paulson, Ph.D., Pharmaceutical & Cosmetic Quality, February 1997 View Abstract Request Document Designing a Handwash Efficacy Program
It is important that antimicrobial products be evaluated for efficacy. There are a number of ways to perform these evaluations using quantitative research designs, it is also vital that investigators be familiar with a selection of quantitative designs. This will prevent the researcher who has only one tool-a hammer-from viewing everything as a nail. . Assuring Label Claims with Shelf-Life Studies Daryl S. Paulson, Ph.D., Pharmaceutical Engineering, August 1996 View Abstract Request Document Assuring Label Claims with Shelf-Life Studies
There are a number of considerations to address when performing stability studies. Pilot studies need to be conducted to ascertain ifthe product is stable. Package selection and testing need to be performed prior to choosing the package configuration. Additionaily, the product must be assured to be stable over the intended use range. Finally, the statistical model used to calculate the degradation rate mustbe assured to accurately represent the data. . To Glove or To Wash Daryl S. Paulson, Ph.D., Food Quality, July 1996 View Abstract Request Document To Glove or To Wash
What has been presented is but a skeletal outline for a hand sanitation program. It is the responsibility of managers, quality control personnel, and other investigators to "flesh out" this program with specific technical requirements appropriate to their particular work environments to ensure that customers are served safe-to-eat food. . A Proposed Evaluation Method for Antimicrobial Hand Soaps Daryl S. Paulson, Ph.D.,Soaps/Cosmetics/Chemical Specialties, June 1996 View Abstract Request Document A Proposed Evaluation Method for Antimicrobial Hand Soaps
This design enables the measurement of the immediate degerming effects (first wash) as well as the effects after five consecutive inoculation/wash cycles to assure that there is no cumulative build-up of microorganisms after wash sample 5. Additional inoculation/wash cycles and samples will add no predictive value to the evaluation.
A minimum of 15 subjects per group is recommended, as well as the use of a control product. So if one test product is used, a minimum of 30 subjects should be employed (15 for the test product and I 5 for the control product). This is a statistically adequate number, in most cases, to detect true differences between the test and control products after washes 1 and 5, as well as the microbial reduction counts from baseline after washes 1 and 5. But this is true only if the baseline standard deviation value is less than 0.5 logs. If the standard deviation is greater, it will be difficult to detect a true difference between the test and control products after washes I and 5. It will also be more difficult to detect true microbial reductions from the baseline values after wash samples 1 and 5. Hence, using a larger sample size is in the best interest of the product manufacturers.
The required log reduction values of the antimicrobial soap are hotly debated. It is this author's opinion that the reduction values should be at least 1 log10 from the baseline value after wash 1 and 1.5 logs after wash 5.
It is necessary that antimicrobial soap product manufacturers take an active role in accurately and precisely measuring the antimicrobial effects of their antimicrobial hand soaps. And it is necessary that they be evaluated under simulated wash conditions employing human subjects.
Finally, it is important that other concerned parties are not only welcome to present their evaluative concerns, but that they do.
. Statistical Approach to Evaluating the Effectiveness of Hand-Cleansing Products Used in the Food Processing Industry Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, June 1996 View Abstract Request Document Statistical Approach to Evaluating the Effectiveness of Hand-Cleansing Products Used in the Food Processing Industry
It is important that each evaluation be designed to address the purpose of the evaluation. Additionally, it is important that investigator be familiar with a large selection of quantitative designs. This will prevent the investigator from trying to evaluate hand-washing products from a limited perspective with limited statistical ability, providing limited quality results. . Get a Handle on Hand Contamination Daryl S. Paulson, Ph.D., Food Quality, April 1996 View Abstract Request Document Get a Handle on Hand Contamination
Throughout the food industry, the importance of hand washing has been known for many years. The potential for food handlers to be a primary source of food transmitted disease continues to be significant
It is important that antimicrobial products be evaluated for efficacy. To do this properly, accurate and reliable determinations of the microbial populations residing on the hands must be used in evaluating the effectiveness of both handwash products and methods. Only when one is sure of reliable hand sampling methods can one attempt to assess the benefits of the handwash procedure in terms of microbial reductions.
Proper research design is also crucial to gathering accurate information. There are a number of ways to perform these evaluations using quantitative research designs and it is vital that investigators be familiar with the selection of designs at their disposal. . Research Designs for the Soap and Costmetics Industries - A Basic Approach Daryl S. Paulson, Ph.D., November 1995 View Abstract Request Document Research Designs for the Soap and Costmetics Industries - A Basic Approach
lt is important that soaps, cosmetics and toiletry products be evaluated for merit as well as efficacy. There are a number of ways to perform these evaluations, using either quantitative or qualitative research designs. It is also vital that investigators be familiar with a selection of quantitative and qualitative designs. This will prevent the researcher, who has only one tool - a hammer - from viewing everything as a nail. . Calculating D-Values for Steam Sterilization Processes Daryl S. Paulson, Ph.D., Medical Device & Diagnostic Industry, May 1995 View Abstract Request Document Calculating D-Values for Steam Sterilization Processes
If device manufacturers are to successfully estimate sterilization parameters using D-values, it is important that they understand the basic differences between the log10 linear regression and fraction negative calculation techniques. It is also critical that they ascertain that the microbial inactivation rate is linear before employing either type of D-value method.
The log10 linear regression model is often more valuable than the fraction negative method because it is performed using specific data collected after five or more different exposure cycles, which generally provide enough data to verify that the microbial inactivation rate is linear. Because linearity cannot be readily verified using the fraction negative methods, these methods should probably be employed only after a log10 linear regression model has verified the inactivation rate to be linear. Therefore, the log10 linear regression method is recommended as the model of choice for sterilization cycle development when no previous D-value work has been completed and linearity must be verified. It is also most appropriate for revalidation after changes have been made to the sterilization process or after there has been a change in the supplier of the BIs or spore suspensions used for sterilization monitoring.
. Author's Response on Comparative Evaluation of Five Surgical Hand Scrub Preparations Daryl S. Paulson, Ph.D., AORN Journal, December 1994 View Abstract Request Document Author's Response on Comparative Evaluation of Five Surgical Hand Scrub Preparations
A three-log reduction after the first hand scrub using 4% chlorhexidine gluconate is common. I agree that when an antimicrobial product is not properly neutralized it appears to be more antimicrobially efficacious than it really is; hence, before initiating this type of study, it is crucial to perform a product neutralization study to ensure adequacy of the neutralizer. . Marketing Opportunities for Topical Anti-Infective Products Daryl S. Paulson, Ph.D.,Soaps/Cosmetics/Chemical Specialties, October 1994 View Abstract Request Document Marketing Opportunities for Topical Anti-Infective Products
The topical antimicrobial market, composed mainly of the medical and food processing sectors, can be very profitable for soap manufacturers. New products appear on the market nearly every month. Unfortunately, many of those are unsuccessful, failing to remain on the market more than a year. One of the main reasons for market failure is that the product was not designed for any specific market niche.
In order to understand what products are needed and how to market them, the medical and food processing sectors must first be explored in greater detail.
. A Comparative Evalution of Different Hand Cleansers Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, September 1994 View Abstract Request Document A Comparative Evalution of Different Hand Cleansers
The most effective product regimens, from an overall microorganism reduction profile as well as a skin irritation standpoint, were the combinations of alcohol gel with antimicrobial or plain lotion soap. Both of these configurations showed tremendous immediate transient organism reduction due to mechanical degerming by the soap hand wash coupled with the alcohol's tremendous immediate antimicrobial properties. Both regimens also demonstrated persistent antimicrobial properties.
Effective hand washing is a cornerstone in preventing foodhandler-borne illness. A second key issue is selection of effective hand cleansing product. The interaction of the product regimen selected and a well-managed hand washing/sanitizing program, which includes compliance measurement, provides the key to assuring the safety of the American food supply.
. Comparative Evaluation of Five Surgical Hand Scrub Preparations Daryl S. Paulson, Ph.D., AORN Journal, August 1994 View Abstract Request Document Comparative Evaluation of Five Surgical Hand Scrub Preparations
Surgical hand scrubs should remove microorganisms from health care professionals’ hands and forearms and maintain the lowest possible microbial counts during surgical procedures. This study evaluated the immediate, persistent, and residual efficacy of five surgical hand scrub products. The two chlorhexidine gluconate (CHG) products achieved significant immediate reduction in the croorganism count and demonstrated persistent and residual efficacy.
The iodophor product exhibited effective immediate and persistent antimicrobial properties but failed to show significant residual effects. The parachlorometaxylenol products emonstrated low levels of immediate and persistent effects and no residual antimicrobial effects. The alcohol product demonstrated low immediate, persistent, and residual effects. The investigator concludes that CHG products are the most favorable surgical hand scrub preparations. . Evaluation of Three Microorganism Recovery Procedures Used to Determine Handwash Efficacy Daryl S. Paulson, PhD., Dairy, Food & Environmental Sanitation, September 1993 View Abstract Request Document Evaluation of Three Microorganism Recovery Procedures Used to Determine Handwash Efficacy
Accurate and reliable determinations of the microbial populations residing on the hands are critical in evaluating the effectiveness of handwash products and methods (Block, 1991; Paulson, 1993). Only when one is sure of reliable hand sampling methods can one attempt to assess the benefits of the handwash procedure in terms of microbial reduction.
In trying to establish the efficacy of various handwash products and handwash methods, a number of food processing plants conduct experiments with their workers to evaluate antimicrobial efficacy. The two hand sampling methods most commonly used in these experiments in measuring the levels of microorganisms remaining on the hands are the "swab" and the "finger press" techniques.
In brief, the swab technique consists of swabbing the palmer surfaces of the hands as well as between the digits with a pre-moistened swab and culturing it on an agar plate. The finger press method is conduced by having test subjects press their palmer surface and/or finger pads lightly onto an agar plate.
There is also a third method which is not widely used in the food industry but is the standard hand sampling method for the evaluation of medical hand disinfection products. It is the "glove juice" method. This method consists of placing surgical gloves over the hands, instilling a surfactant to strip the hands of bacteria, and the plating of aliquots taken from the "glove juice" contained in the gloves (ASTM, 1987).
A study was designed in our laboratory to compare these three methods for their accuracy in estimating known microbial populations on the hands. Four different contamination levels were used to evaluate how the sampling methods responded in terms of accurate population estimates to varying population levels.
The focus of this study was with contaminating microorganisms, not with the normal microrgrnisms residing on the hands. We artificially seeded human volunteers' hands with known levels of the marker bacteria Serratia marcescens. The use of Serratia marcescens was valuable to this study in three ways. First, it is as resistant to mechanical removal from the hands as such pathogens as E coli, Salmonella sp., and Shiegella sp. Second it develops red bacterial colonies on tryptic soy agar which distinguishes it from any other microrganism residing on the hands. This prevents mistaking the artificially contaminated microorganisms with normal or other transient microorganisms, thereby preventing biasing the recovery estimate of the wash procedure. Third, since it is seeded onto the hands in known, equal population levels, the precision and accuracy of the three hand sampling procedures can be compared directly.
. Efficacy Evaluation of a 4 percent Chlorhexidine Gluconate as a Full-Body Shower Wash Daryl S. Paulson, Ph.D., American Journal of Infection Control, August 1993 View Abstract Request Document Efficacy Evaluation of a 4 percent Chlorhexidine Gluconate as a Full-Body Shower Wash
A 4% Chlorhexidine gluconate (Xttrium laboratories, Chicago, Ill.) was used in a shower bath application to evaluate its merits in reducing resident skin microorganisms. Five volunteers completed a 14-day microbial stabilization period, a 7-day baseline period, and e 5-day test period. Subjects followed a standard protocol, performed five shower washes and were sampled at both the abdominal and inguinal regions immediately after the shower wash as well as at 3 and 6 hours later on days 1, 2, and 5. Chlorhexidine gluconate provided significant microbial reductions from baseline, with greater reductions noted as the study progressed. Use of Chlorhexidine gluconate ln a shower wash application in conjunction with a preoperative skin-preparation procedure may reduce the probability of surgical associated infections. . Variability Evaluation of Two Handwash Modalities Employed in the Food Processing Industry Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, June 1993 View Abstract Request Document Variability Evaluation of Two Handwash Modalities Employed in the Food Processing Industry
Throughout the food industry, the importance of hand washing has been known for many years. The potential for food handlers to be a primary source of food transmitted disease continues to be significant. Usually, microorganisms which normally reside on the hand surfaces do not pose a threat of disease epidemics transmitted from food handlers to consumers. Instead, disease outbreaks occur when food handlers come into hand contact with transient pathogenic microorganisms. Often the transient contaminating microorganisms are encountered when food handlers come into hand contact with their own infected feces. the infected feces of others or with the feces of the animals being processed. Once the food handlers' hands are contaminated with disease-producing microorganisms, they can easily contaminate the food which they are processing. When that contaminated food is eaten by the consumer, they, in turn, may become infected.
The main purpose of any handwash regimen is to break the transmission vector between food handlers, the food they process, and the consumer. [f the disease-producing microorganism can be removed via an effective hand wash regimen, the disease transmission vector is broken and no disease will ensue. The effectiveness in breaking this cycle hinges upon the antimicrobial effectiveness of the handwash procedure, including the antimicrobial properties of the soap used.
In any successful handwash program, two main parameters must be considered. They are the immediate and the persistent antimicrobial effects. The immediate antimicrobial effects depend upon two attributes: the mechanical removal of contaminating microorganisms and the topical antimicrobial compound's ability to kill microorganisms upon contact.
The persistent antimicrobial effects, or the ability of the handwash to keep the microbial populations at a low level after washing, are mainly dependent upon the type of antimicrobial product used.
From this perspective, we were interested in evaluating two handwash regimens in terms of their consistent, reproducible microbial reduction results. We compared a manual handwash regimen to an automated handwash regimen in terms of consistent degerming results.
. Evaluation of Three Handwash Modalities Commonly Employed in the Food Processing Industry Daryl S. Paulson, Ph.D., Dairy, Food & Environmental Sanitation, September 1992 View Abstract Request Document Evaluation of Three Handwash Modalities Commonly Employed in the Food Processing Industry
Clearly, based on the results of this study, the use of either the manual or automated machine wash procedures is equivalent in antimicrobial efficacy. Both of these methods are more effective than using an iodine dip to prevent transient microorganism contamination. While an iodine dip is effective, the manual or machine wash is more so.
This is probably due to the mechanical degerming action to the skin surfaces used in both the manual and machine modes of washing but absent in the dip procedure.
Since there were only three subjects used per wash method, detecting a difference between the groups is much more difficult than when using a larger sample size. That is because committing a Type I error (alpha error) in statistics is considered more serious than committing a Type II (beta error). Recall that a Type I error is committed when one states a significant difference exists but in fact there is no difference between the groups. A Type II error exists when one concludes that no difference exists when one really does. Hence it is felt that the results presented are reliable. That is, the iodine dip method is less effective in antimicrobial efficacy than either the manual or machine method.
. The Anti-Infective Market - Where is it Going Daryl S. Paulson, Ph. D., Soaps/Cosmetics/Chemical Specialties, March 1990 View Abstract Request Document The Anti-Infective Market - Where is it Going
Although there is some market activity in developing and introducing new anti-infective formulations for the health care personnel handwash, surgical scrub and preoperative skin prepping products, most of the efforts will be focused on using the common antimicrobials (e.g., iodophors and chlorhexidine gluconates) as the active ingredients, but applied with new and novel delivery systems.
Health care personnel formulations
will increasingly be developed as health care personnel products, not relabeled surgical scrubs. Surgical
scrub formulations introduced in the early 1990s will, again, tend to be modifications of existing products. The preoperative skin prepping solution area will experience the most activity, rvith new product delivery systems. Additionally, several new "long acting" preoperative prepping products that keep the microorganism counts exceptionally low for up to 96 hours post prep will probably be introduced.
Also of note. a number of new applications will be developed and
introduced for existing products.
One will be a "full body shower wash" to,be used in conjunction with preoperative prepping solution
regimens. (3) The full body shower
wash will be given to reduce the microbial baseline counts on the patient's body prior to being prepped
for surgery. The preoperative skin
prep formulation will not have as
large a microorganism population
to reduce, making it more effective
in its intended use.
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