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Glove resistance to permeation by a 7.5% hydrogen peroxide sterilizing and disinfecting solution
BRIEF REPORTS Glove resistance to permeation by a 7.5% hydrogen peroxide sterilizing and disinfecting solution Michael V. Monticello, BS Donna J. Gaber, BA, MT Montvale, New Jersey
Background: This study evaluated 6 types of glove materials for resistance to permeation by a 7.5% hydrogen peroxide liquid chemical germicide. Methods: Based on American Society for Testing and Materials Method F739-96, a small piece of glove material was placed in the center of a dual chamber test cell. The challenge and collection chambers of the test cell were filled with the hydrogen peroxide test chemical and the collecting medium (deionized water), respectively. Chemical permeation was determined by measuring the concentration of hydrogen peroxide in the collection medium at various time intervals. Results: Both the polyvinylchloride and disposable latex examination gloves at 4.5 mil thickness provided less than 30 minutes of protection from hydrogen peroxide. The natural rubber latex glove at 16.5 mil lasted for 8 hours without any detectable penetration. Neoprene (15 mil) and nitrile butyl rubber (18 mil) both provided excellent protection throughout the 8-hour test period. Conclusion: Disposable latex examination gloves should be used for short-term exposure to hydrogen peroxide solutions. Thicker rubber latex gloves provided adequate protection and necessary dexterity for conducting intricate tasks. The level of protection depends largely on the thickness and quality of the glove material. (AJIC Am J Infect Control 1999;27:364-6)
Health care workers need to be well informed when making decisions about use of personal protective equipment. The use of appropriate gloves for safe handling of liquid chemical germicides is one of the most important steps in protecting workers against exposure to infectious agents and chemicals. Exposure to certain chemicals can cause acute effects, such as irritation, rash, or burns. Repeated contact also may cause skin sensitization. Chemical agents that are incompatible with certain glove materials can compromise the barrier properties of the glove, allowing permeation of infectious materials. 1,2 Workers need to understand what types of glove materials will provide the best barrier against permeation of the specific liquid chemical germicide being used. The process for choosing an appropriate glove should begin with an assessment of the hazards associated with the specific liquid chemical germicide in conjunction with the task being performed.2
For decades, glutaraldehyde has been the main choice among liquid chemical germicides for reprocessing flexible endoscopes and other heat sensitive medical instruments. Previous studies have been published showing the resistance of various glove materials to permeation by glutaraldehyde.3,4 Through years of experience, workers have learned which types of gloves provide the best barriers to chemical permeation of glutaraldehyde. Whereas these types of gloves have routinely worked best for glutaraldehyde, they may not be the right choice for the newer alternative liquid chemical germicides containing oxidizing agents, such as hydrogen peroxide. The purpose of this study was to evaluate the resistance of 6 different glove materials to permeation by a 7.5% hydrogen peroxide liquid chemical germicide. Although this study was not intended to establish safe exposure levels for hydrogen peroxide, it should be noted that if contact with skin occurs, the 7.5% hydrogen peroxide solution may cause temporary whitening accompanied by a tingling sensation.5
From Reckitt & Colman, Inc. Reprint requests: Michael V. Monticello, BS, Reckitt & Colman, Inc, Research and Development, One Philips Parkway, Montvale, NJ 07645. Copyright © 1999 by the Association for Professionals in Infection Control and Epidemiology, Inc. 0196-6553/99/$8.00 + 0
364
17/47/96645
MATERIALS The test solution used in this study was a 7.5% hydrogen peroxide disinfectant (Sporox Disinfectant and Sterilizing Solution, Reckitt & Colman, Montvale, NJ). The types of gloves evaluated in this study included latex (Latex Micro touch Exam Gloves, Johnson &
AJIC
Monticello and Gaber 365
Volume 27, Number 4
Table 1. Glove materials and thickness, permeation rate, and breakthrough detection time Steady state Glove material
Manufacturer
Latex
Johnson & Johnson Latex Micro Touch Exam Gloves Oak Technical, Inc Van Waters & Rogers Sol-Vex, Ansell Edmont Ansell Edmont Best Manufacturing Co
PVC Polyethylene Nitrile butyl rubber Neoprene Natural rubber latex
Breakthrough
mean permeation rate
Steady state
Thickness (mil)
detection time*
(P) (µg/cm2/min)
permeation time†
4.50
<30 min
1.00
>3 h
4.50 1.50 18.00 15.00 16.50
<30 min 1h >8 h >8 h >8 h
0.08 0 N/A N/A N/A
4h 8h N/A N/A N/A
NA, Not applicable. *Breakthrough Detection Time is the time at which permeation reached 0.25µg/cm2. †Steady state permeation time is the point at which the rate of permeation becomes constant. (Ci – Ci–1) V P= (Ti – Ti–1) A Where I is indexing number of each test interval, C is concentration of collection medium, T is time, A is area of test specimen, and V is volume.
Johnson Medical Inc, Arlington, Tex), polyvinylchloride (PVC; Oak Technical, Inc, Stow, Ohio), polyethylene (Van Waters & Rogers, West Chester, Pa), nitrile butyl rubber (Sol-Vex, Ansell Edmont, Coshoczon, Ohio), neoprene (Ansell Edmont), and natural rubber latex (Best Manufacturing Co, Menlo, Ga). Table 1 lists the thickness of each glove. METHODS The resistance to permeation of each glove material by continuous contact with the test chemical was determined by using American Society for Testing and Materials (ASTM) Method F739-96.6 The apparatus used in this method was an ASTM dual chamber test cell manufactured by Pesce Lab Sales (Kennett Square, Pa). A 2 × 2-in sample was cut from the palm area of each glove and measured for thickness. The test cell was then assembled with the glove sample placed in the center between each chamber. The sampling chamber was filled to the mark with the collecting medium (deionized water). The challenge chamber was then filled with the test chemical, 7.5% hydrogen peroxide disinfectant solution. Resistance to permeation by the test chemical was determined by measuring the breakthrough detection time. Breakthrough detection time is the elapsed time from the start of the test to the time the test chemical first breaks through the barrier material and can be measured in the collecting medium. The ASTM definition of breakthrough detection time is the time at which chemical permeation reaches a concentration of 0.25µg/cm2. The more time required to reach 0.25µg/cm2, the more resistant the barrier material is to the test chemical. Samples of the collecting medium were taken every 10 minutes for the first hour and then hourly until steady state permeation was reached, but
not longer than 8 hours. Each glove was tested in duplicate at ambient room temperature. Hydrogen peroxide was measured by using CHEMetrics ULR CHEMet test kit #K-5511 (CHEMetrics Inc, Calverton, Va). This analytical method was capable of measuring hydrogen peroxide concentrations as low as 0.04µg/cm2 and was well within the ASTM sensitivity requirements for this study. It should be noted that permeation of the inert ingredients in the test solution, such as surfactants and corrosion inhibitors, were not measured in this study because their concentrations in the collection medium (if present) would be too low to be meaningful. RESULTS The permeation rate and breakthrough detection time of each glove is summarized in Table I. The results of this study showed that the 4.5-mil disposable latex examination glove provided less than 30 minutes of resistance to permeation by the test solution. At 3 hours, the test was stopped because the permeation rate was accelerating at a rate too high to be meaningful. The natural rubber latex glove was 4 times thicker (16.5 mil) and lasted throughout the 8-hour period without any detectable penetration. PVC reached steady state permeation at 4 hours; however, similar to the disposable latex examination glove, it had a breakthrough detection time of less than 30 minutes. The polyethylene glove provided resistance to permeation of hydrogen peroxide for about 1 hour. This glove was the thinnest of all the gloves tested. The gloves that showed no detectable permeation of hydrogen peroxide (in addition to natural latex rubber) were nitrile butyl rubber and neoprene. DISCUSSION The disposable latex examination glove evaluated in this study was among the thinnest (4.0-5.0 mil) and pro-
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vided the least protection. A thicker brand most likely would have improved the barrier properties of this material. Gloves of this type should be used for short-term exposure to hydrogen peroxide (<30 minutes). Although this study did not include double gloving, it has been documented that use of 2 disposable latex examination gloves can significantly increase protection.3,7 For long-term use, the thicker, (16.5 mil) higher quality, natural rubber latex glove would be a more suitable choice. In addition to thickness, the composition and quality of the latex raw material used in manufacturing this glove also may have improved its barrier properties. Whereas gloves of higher quality and thickness are initially more expensive, they are reusable. For workers with latex allergy, the next best alternatives would be PVC and polyethylene. However, similar to the disposable latex examination glove, these materials are only suitable for short-term use. Neoprene and nitrile butyl rubber heavy-duty type gloves were completely impervious to 7.5% hydrogen peroxide during the 8-hour test period. It should be noted that the manufacturers of bulk hydrogen peroxide recommend both of these types of gloves on their material safety data sheet when handling concentrations of 35% and higher. However, these gloves would not be appropriate, because they would not provide the necessary dexterity required for handling endoscopes and performing intricate tasks. In summary, the ideal glove should be flexible, tear
resistant, and provide a barrier to chemical or liquid permeation for the duration of use. Some gloves provide the necessary dexterity and others may be more impervious to chemical permeation. Because results may vary with other brands and product characteristics, workers should check with individual glove manufacturers for specifications, such as thickness, tear resistance, and overall quality. We thank Tony Schatz, PhD, Product Safety Toxicologist, R & C, for his advice.
References 1. Lavbanchy C. Selection and use of disposable gloves in health care facilities. J Healthcare Safety Compliance Infect Control. 1998;June/July:223-9. 2. Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens; final rule. Federal Register 1991;56(235):64117. 3. Jordan SL, Stowers MF, Trawick EG, Theis AB. Glutaraldehyde permeation: choosing the proper glove. AJIC Am J Infect Control 1996;24:67-9. 4. Lehman PA, Franz TJ, Guin JD. Penetration of glutaraldehyde through glove material: tactylon versus natural rubber latex. Contact Dermatitis 1994;30:176-7. 5. Hydrogen peroxide. Meditext Med Manage 1997;July 31:33. 6. American Society for Testing and Materials. ASTM Method F739. In: 1996 annual book of ASTM standards. Philadelphia: Atmospheric Analysis; Occupational Health and Safety; Protective Clothing. American Society for Testing and Materials; 1993. p. 695704. 7. Rabussay DP, Korniewicz DM. Improving glove barrier effectiveness. AORN J 1997;66:1043-60.
Availability of Journal back issues As a service to our subscribers, copies of back issues of AJIC: American Journal of Infection Control for the preceding 5 years are maintained and are available for purchase from the publisher, Mosby, at a cost of $15.00 per issue until inventory is depleted. The following quantity discounts are available: 25% off on quantities of 12 to 23, and one third off on quantities of 24 or more. Please write to Mosby, Inc, Subscription Services, 11830 Westline Industrial Dr, St Louis, MO 63146-3318, or call 800-453-4351 or 314-453-4351 for information on availability of particular issues. If unavailable from the publisher, photocopies of complete issues may be purchased from Bell & Howell Information and Learning, 300 N Zeeb Rd, Ann Arbor, MI 48106-1346, 734-761-4700.
Background: This study evaluated 6 types of glove materials for resistance to permeation by a 7.5% hydrogen peroxide liquid chemical germicide. Methods: Based on American Society for Testing and Materials Method F739-96, a small piece of glove material was placed in the center of a dual chamber test cell. The challenge and collection chambers of the test cell were filled with the hydrogen peroxide test chemical and the collecting medium (deionized water), respectively. Chemical permeation was determined by measuring the concentration of hydrogen peroxide in the collection medium at various time intervals. Results: Both the polyvinylchloride and disposable latex examination gloves at 4.5 mil thickness provided less than 30 minutes of protection from hydrogen peroxide. The natural rubber latex glove at 16.5 mil lasted for 8 hours without any detectable penetration. Neoprene (15 mil) and nitrile butyl rubber (18 mil) both provided excellent protection throughout the 8-hour test period. Conclusion: Disposable latex examination gloves should be used for short-term exposure to hydrogen peroxide solutions. Thicker rubber latex gloves provided adequate protection and necessary dexterity for conducting intricate tasks. The level of protection depends largely on the thickness and quality of the glove material. (AJIC Am J Infect Control 1999;27:364-6)
Health care workers need to be well informed when making decisions about use of personal protective equipment. The use of appropriate gloves for safe handling of liquid chemical germicides is one of the most important steps in protecting workers against exposure to infectious agents and chemicals. Exposure to certain chemicals can cause acute effects, such as irritation, rash, or burns. Repeated contact also may cause skin sensitization. Chemical agents that are incompatible with certain glove materials can compromise the barrier properties of the glove, allowing permeation of infectious materials. 1,2 Workers need to understand what types of glove materials will provide the best barrier against permeation of the specific liquid chemical germicide being used. The process for choosing an appropriate glove should begin with an assessment of the hazards associated with the specific liquid chemical germicide in conjunction with the task being performed.2
For decades, glutaraldehyde has been the main choice among liquid chemical germicides for reprocessing flexible endoscopes and other heat sensitive medical instruments. Previous studies have been published showing the resistance of various glove materials to permeation by glutaraldehyde.3,4 Through years of experience, workers have learned which types of gloves provide the best barriers to chemical permeation of glutaraldehyde. Whereas these types of gloves have routinely worked best for glutaraldehyde, they may not be the right choice for the newer alternative liquid chemical germicides containing oxidizing agents, such as hydrogen peroxide. The purpose of this study was to evaluate the resistance of 6 different glove materials to permeation by a 7.5% hydrogen peroxide liquid chemical germicide. Although this study was not intended to establish safe exposure levels for hydrogen peroxide, it should be noted that if contact with skin occurs, the 7.5% hydrogen peroxide solution may cause temporary whitening accompanied by a tingling sensation.5
From Reckitt & Colman, Inc. Reprint requests: Michael V. Monticello, BS, Reckitt & Colman, Inc, Research and Development, One Philips Parkway, Montvale, NJ 07645. Copyright © 1999 by the Association for Professionals in Infection Control and Epidemiology, Inc. 0196-6553/99/$8.00 + 0
364
17/47/96645
MATERIALS The test solution used in this study was a 7.5% hydrogen peroxide disinfectant (Sporox Disinfectant and Sterilizing Solution, Reckitt & Colman, Montvale, NJ). The types of gloves evaluated in this study included latex (Latex Micro touch Exam Gloves, Johnson &
AJIC
Monticello and Gaber 365
Volume 27, Number 4
Table 1. Glove materials and thickness, permeation rate, and breakthrough detection time Steady state Glove material
Manufacturer
Latex
Johnson & Johnson Latex Micro Touch Exam Gloves Oak Technical, Inc Van Waters & Rogers Sol-Vex, Ansell Edmont Ansell Edmont Best Manufacturing Co
PVC Polyethylene Nitrile butyl rubber Neoprene Natural rubber latex
Breakthrough
mean permeation rate
Steady state
Thickness (mil)
detection time*
(P) (µg/cm2/min)
permeation time†
4.50
<30 min
1.00
>3 h
4.50 1.50 18.00 15.00 16.50
<30 min 1h >8 h >8 h >8 h
0.08 0 N/A N/A N/A
4h 8h N/A N/A N/A
NA, Not applicable. *Breakthrough Detection Time is the time at which permeation reached 0.25µg/cm2. †Steady state permeation time is the point at which the rate of permeation becomes constant. (Ci – Ci–1) V P= (Ti – Ti–1) A Where I is indexing number of each test interval, C is concentration of collection medium, T is time, A is area of test specimen, and V is volume.
Johnson Medical Inc, Arlington, Tex), polyvinylchloride (PVC; Oak Technical, Inc, Stow, Ohio), polyethylene (Van Waters & Rogers, West Chester, Pa), nitrile butyl rubber (Sol-Vex, Ansell Edmont, Coshoczon, Ohio), neoprene (Ansell Edmont), and natural rubber latex (Best Manufacturing Co, Menlo, Ga). Table 1 lists the thickness of each glove. METHODS The resistance to permeation of each glove material by continuous contact with the test chemical was determined by using American Society for Testing and Materials (ASTM) Method F739-96.6 The apparatus used in this method was an ASTM dual chamber test cell manufactured by Pesce Lab Sales (Kennett Square, Pa). A 2 × 2-in sample was cut from the palm area of each glove and measured for thickness. The test cell was then assembled with the glove sample placed in the center between each chamber. The sampling chamber was filled to the mark with the collecting medium (deionized water). The challenge chamber was then filled with the test chemical, 7.5% hydrogen peroxide disinfectant solution. Resistance to permeation by the test chemical was determined by measuring the breakthrough detection time. Breakthrough detection time is the elapsed time from the start of the test to the time the test chemical first breaks through the barrier material and can be measured in the collecting medium. The ASTM definition of breakthrough detection time is the time at which chemical permeation reaches a concentration of 0.25µg/cm2. The more time required to reach 0.25µg/cm2, the more resistant the barrier material is to the test chemical. Samples of the collecting medium were taken every 10 minutes for the first hour and then hourly until steady state permeation was reached, but
not longer than 8 hours. Each glove was tested in duplicate at ambient room temperature. Hydrogen peroxide was measured by using CHEMetrics ULR CHEMet test kit #K-5511 (CHEMetrics Inc, Calverton, Va). This analytical method was capable of measuring hydrogen peroxide concentrations as low as 0.04µg/cm2 and was well within the ASTM sensitivity requirements for this study. It should be noted that permeation of the inert ingredients in the test solution, such as surfactants and corrosion inhibitors, were not measured in this study because their concentrations in the collection medium (if present) would be too low to be meaningful. RESULTS The permeation rate and breakthrough detection time of each glove is summarized in Table I. The results of this study showed that the 4.5-mil disposable latex examination glove provided less than 30 minutes of resistance to permeation by the test solution. At 3 hours, the test was stopped because the permeation rate was accelerating at a rate too high to be meaningful. The natural rubber latex glove was 4 times thicker (16.5 mil) and lasted throughout the 8-hour period without any detectable penetration. PVC reached steady state permeation at 4 hours; however, similar to the disposable latex examination glove, it had a breakthrough detection time of less than 30 minutes. The polyethylene glove provided resistance to permeation of hydrogen peroxide for about 1 hour. This glove was the thinnest of all the gloves tested. The gloves that showed no detectable permeation of hydrogen peroxide (in addition to natural latex rubber) were nitrile butyl rubber and neoprene. DISCUSSION The disposable latex examination glove evaluated in this study was among the thinnest (4.0-5.0 mil) and pro-
AJIC
366 Monticello and Gaber
August 1999
vided the least protection. A thicker brand most likely would have improved the barrier properties of this material. Gloves of this type should be used for short-term exposure to hydrogen peroxide (<30 minutes). Although this study did not include double gloving, it has been documented that use of 2 disposable latex examination gloves can significantly increase protection.3,7 For long-term use, the thicker, (16.5 mil) higher quality, natural rubber latex glove would be a more suitable choice. In addition to thickness, the composition and quality of the latex raw material used in manufacturing this glove also may have improved its barrier properties. Whereas gloves of higher quality and thickness are initially more expensive, they are reusable. For workers with latex allergy, the next best alternatives would be PVC and polyethylene. However, similar to the disposable latex examination glove, these materials are only suitable for short-term use. Neoprene and nitrile butyl rubber heavy-duty type gloves were completely impervious to 7.5% hydrogen peroxide during the 8-hour test period. It should be noted that the manufacturers of bulk hydrogen peroxide recommend both of these types of gloves on their material safety data sheet when handling concentrations of 35% and higher. However, these gloves would not be appropriate, because they would not provide the necessary dexterity required for handling endoscopes and performing intricate tasks. In summary, the ideal glove should be flexible, tear
resistant, and provide a barrier to chemical or liquid permeation for the duration of use. Some gloves provide the necessary dexterity and others may be more impervious to chemical permeation. Because results may vary with other brands and product characteristics, workers should check with individual glove manufacturers for specifications, such as thickness, tear resistance, and overall quality. We thank Tony Schatz, PhD, Product Safety Toxicologist, R & C, for his advice.
References 1. Lavbanchy C. Selection and use of disposable gloves in health care facilities. J Healthcare Safety Compliance Infect Control. 1998;June/July:223-9. 2. Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens; final rule. Federal Register 1991;56(235):64117. 3. Jordan SL, Stowers MF, Trawick EG, Theis AB. Glutaraldehyde permeation: choosing the proper glove. AJIC Am J Infect Control 1996;24:67-9. 4. Lehman PA, Franz TJ, Guin JD. Penetration of glutaraldehyde through glove material: tactylon versus natural rubber latex. Contact Dermatitis 1994;30:176-7. 5. Hydrogen peroxide. Meditext Med Manage 1997;July 31:33. 6. American Society for Testing and Materials. ASTM Method F739. In: 1996 annual book of ASTM standards. Philadelphia: Atmospheric Analysis; Occupational Health and Safety; Protective Clothing. American Society for Testing and Materials; 1993. p. 695704. 7. Rabussay DP, Korniewicz DM. Improving glove barrier effectiveness. AORN J 1997;66:1043-60.
Availability of Journal back issues As a service to our subscribers, copies of back issues of AJIC: American Journal of Infection Control for the preceding 5 years are maintained and are available for purchase from the publisher, Mosby, at a cost of $15.00 per issue until inventory is depleted. The following quantity discounts are available: 25% off on quantities of 12 to 23, and one third off on quantities of 24 or more. Please write to Mosby, Inc, Subscription Services, 11830 Westline Industrial Dr, St Louis, MO 63146-3318, or call 800-453-4351 or 314-453-4351 for information on availability of particular issues. If unavailable from the publisher, photocopies of complete issues may be purchased from Bell & Howell Information and Learning, 300 N Zeeb Rd, Ann Arbor, MI 48106-1346, 734-761-4700.