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A laboratory-based study to assess the performance of surgical gloves
Denis M. KorniewiczSince the nineteenth century, health care workers have worn gloves during surgical procedures to protect their hands and to protect patients from the potential risk of infection. (1) The fear of contracting occupational hepatitis and the emergence of the AIDS epidemic during the 1980s, however, added a new dimension to the necessity of using surgical gloves. Today, health care workers use surgical gloves to protect themselves and their patients from potentially fatal bloodborne infections. (2) A variety of surgical latex gloves ranging from powdered to powder-free, thin to thick, general-use to task-specific, and textured to smooth are available. (3) Health care workers continue to use latex gloves because of their tear resistance, flexibility, comfort, fit, and elasticity. As the use of latex gloves has increased, however, there has been a consequential increase in the rate of latex sensitivity among perioperative personnel. (4) One researcher found that the prevalence of latex sensitization was 12.1% among hospital personnel in general; the same article says latex sensitization was 7% to 10% among perioperative staff members. (5) Responses to the increased prevalence of latex allergy have included strategies such as changing the work environment, changing gloving practices, and using nonlatex surgical gloves. (6)
Few published studies address the barrier qualities of nonlatex surgical gloves, and even fewer address how nonlatex surgical gloves perform during routine use. Current glove standards set by ASTM (formerly American Society for Testing Materials) permit a failure rate of 1.5% for lots of sterile surgical latex gloves and a failure rate of 2.5% for nonsterile latex medical gloves. (7) The US Food and Drug Administration (FDA) has recommended that nonlatex surgical gloves meet the same failure rates as latex surgical groves. (8) In one randomized study investigating the differences in barrier quality of surgical gloves, researchers found that failure rates of latex and nonlatex surgical gloves were not significantly different. (9) Only one nonlatex glove material was examined by this group, however, and they did not test the effect of glove manufacturer or glove powder on failure rates. A more extensive laboratory analysis performed on medical examination gloves found that when adjusted for the confounding effects of glove durability and quality of manufacture, some nonlatex gloves were inferior in barrier effectiveness to latex gloves. (10)
The adverse effects of glove powder on patients has been noted in a number of studies. Glove powder-induced adhesions, (11) delayed wound healing, (12) and misdiagnosis of cancer (13) are a few reported examples of glove powder complications. One group of researchers found, however, that powder had no effect on glove durability. (14)
Overall, there is a shortage of data about how nonlatex surgical gloves perform during routine use and whether the proposed recommendations by ASTM or the FDA are adequate. To determine the barrier effectiveness of nonlatex surgical gloves under stress, researchers in the current study devised a laboratory-based stress protocol intended to mimic many of the stresses that surgical gloves undergo during use. They compared the barrier effectiveness of latex and nonlatex surgical gloves during simulated use and examined differences in performance associated with glove material, stress, manufacturer, and the presence or absence of glove powder. The study was designed to examine the hypothesis that there is no difference in defect rates between latex and nonlatex surgical gloves after adjusting for glove manufacturer, stress level, and the use of powder.
METHOD
A laboratory-based experimental design was used to compare durability of latex and nonlatex surgical gloves as measured by defect rates. A convenience sample of 4,006 surgical gloves (ie, 962 latex; 2,046 neoprene; 500 nitrile; 498 isoprene) representing eight brands was divided into two groups (ie, stressed and unstressed). This sample size was large enough to provide 80% power, assuming a defect rate of 1% among unstressed gloves compared to a conservative 2% defect rate among stressed gloves when the ratio of stressed to unstressed gloves in the sample was 1:1. Gloves were examined for barrier effectiveness by five research assistants who were graduate nursing students. The research assistants wore no jewelry, cut their fingernails short, wore gloves of appropriate size, and rotated using the eight brands to minimize bias. All research assistants who participated in the study were trained in the glove testing protocol, which has been replicated and validated in several previously published studies. (15) Each glove was examined once by one research assistant. Research assistants could not be blinded to the brand of gloves because gloves were opened from sterile packages. The study was laboratory based and exempt from full institutional review board review because it did not involve human participants.
Study protocol. Unstressed gloves were tested according to the flowchart in Figure 1. Gloves were taken directly out of the package and visually inspected for defects. If a visible defect was observed, the glove failed the test. If no visible defect was observed, the research assistant tested the glove using the FDA water leak protocol. Gloves were filled with 1,000 mL of water, suspended for two minutes, and observed for the presence of leaks. (16) If a glove did not leak water, the glove was determined to have passed the test.
[FIGURE 1 OMITTED]
To mimic the stresses that surgical gloves undergo during clinical situations, gloves were stressed according to the flowchart shown in Figure 2. After removal from the package and after each step of the stress protocol, each glove was inspected visually. If a visible defect was observed, the glove failed the test. If no visible defects were observed after completion of steps one through eight, the glove wearer removed the glove and performed the FDA water leak test. If no water leak was observed, the glove was determined to have passed the test.
[FIGURE 2 OMITTED]
DATA ANALYSIS
All data analysis procedures were performed using SPSS--Statistical Package for the Social Sciences, version 10. (17) For the purpose of the analysis, data from the eight brands of gloves were recoded to reflect the four independent variables of interest:
* stress protocol,
* material,
* manufacturer, and
* presence or absence of glove powder.
The outcome variable was pass or fail determined either by the visual or water leak tests. General frequencies were performed to provide basic descriptive analysis of the study findings. Chi-square analysis was used to test the differences between the frequencies of failure across each of the study variables and to examine for possible confounding effects between pairs of these variables. Crude odds ratios were calculated to assess the effect of study variables on glove failure rates. Multivariate logistic regression analysis was used to calculate the adjusted odds ratio of failure rates. An [alpha] of 0.05 was established for statistical significance.
RESULTS
Table 1 presents basic descriptive statistics of glove failure rates according to material, brand, presence of glove powder, manufacturer, and stress. Nitrile gloves exhibited the lowest failure rate (1%), followed by latex (2.9%) and neoprene (3.1%). Isoprene gloves had the highest failure rate (16.3%). Failure rates among the four glove materials were found to be significantly different ([X.sup.2] = 191.15, P < .001); however, failure rates of latex gloves were significantly lower than those of the nonlatex gloves combined ([X.sup.2] = 7.005, P = .005). The analysis in Table 2 indicates that subjecting gloves to stress significantly increased their failure rates when compared to unstressed gloves (6.8% and 1.9% respectively, [X.sup.2] = 59.94, P < .001). Powdered gloves had significantly higher failure rates than nonpowdered gloves (6.7% and 3.1% respectively, [X.sup.2] = 28.74, P < .001). Failure rates were found to be significantly different among the six glove manufacturers included in the study ([X.sup.2] = 128.35, P < .001), with manufacturer (M) 5 having the lowest failure rate (0.4%) and M3 having the highest failure rate (7.5%).
In assessing for possible confounding effects among the study variables, powder was significantly associated with stress ([X.sup.2] = 9.52, P = .001), material ([X.sup.2] = 1,320; P < .001), and manufacturer ([X.sup.2] = 1,902; P < .001). Stress had a significant association with manufacturer ([X.sup.2] = 20.94, P = .001) but not with material ([X.sup.2] = 6.17, P = .104). The association between material and manufacturer also was found to be significant ([X.sup.2] = 7,515; P < .001). These associations suggested confounding effects among the study variables; therefore, a statistical adjustment was completed by multivariate logistic regression analysis. It is worthy to note that the data in the initial multivariate model did not converge due to M1 and M6 having similar manufacturing qualities and M4 and M5 having similar manufacturing qualities after adjusting for glove material. Therefore, M1 and M6 were grouped in one category (M1/M6) and M4 and M5 were grouped in another category (M4/M5).
After statistically adjusting for glove stress, material, and manufacturer, defect rates between powdered and nonpowdered gloves were not significantly different (odds ratio [OR] = 1.48, 95% confidence interval [C[I.sup.95]] = 0.69-3.16) even though the defect rate in powdered gloves was 1.48 times that of nonpowdered gloves (Table 3). When statistically adjusted for powder, material, and manufacturer, the stressed gloves had higher defect rates than the unstressed gloves (OR = 4.26, C[I.sup.95] = 2.92-6.21). When controlling for type of material, powder, stress, and manufacturer, isoprene gloves had higher defect rates than latex (OR = 8.91, C[I.sup.95] = 4.85-16.35), and neoprene did not differ from latex (OR = 0.95, C[I.sup.95] = 0.47-1.93). Defect rates of nitrile gloves were not significantly different than those of latex gloves despite an odds ratio of 2.36. Defect rates of M4/M5 were lower than those of the remaining three manufacturer categories.
DISCUSSION
The findings demonstrate that glove material, manufacturer, and stress during use were important factors in determining the barrier quality of surgical gloves. Stress was not a confounding factor; when gloves were stressed, the likelihood for failure increased approximately 4.26 times regardless of the glove material, manufacturer, or effect of powder.
When failure rates of different glove materials were compared using univariate analysis, latex had a lower defect rate than isoprene, comparable defect rate to neoprene, and higher defect rate than nitrile. Powder, manufacturer, and stress were important variables to review, however, because they showed that latex was not a poor choice but was comparable to nitrile. The findings suggest that when nitrile and latex are viewed in isolation, one would assume the defect rate of nitrile gloves was three times lower than the defect rate of latex gloves. Readers also should note that all nitrile gloves tested were made by M4. In this study, M4/M5 was found to have the lowest defect rate. Latex gloves all were made by M1 and M6. The defect rate for M1/M6 was eight times higher than that of M4/M5. After adjusting for glove manufacturer, therefore, durability of latex and nitrile gloves was comparable. These findings explain the importance of statistical adjustment for glove manufacturer when determining the durability of different glove materials. This was supported by researchers (18) who found that there were differences in the quality and durability of surgical gloves among manufacturers when gloves were tested after use. (19)
There has been documentation concerning complications from the use of powdered gloves; (20) therefore, the researchers examined the effect of glove powder on barrier quality. When glove material, stress, and manufacturer were accounted for by multivariate analysis, powder was found not to affect the durability of the glove or its barrier properties. Use of powder primarily is intended to facilitate glove donning. (21) Several studies have suggested, however, that powder is a predisposing factor for latex sensitivity (22) and surgical complications; (23) thus, if the choice to use powder is based on the assumption that powder will enhance glove donning and, therefore, contribute to glove performance, that assumption is not supported by the results of this study.
CONCLUSION
This study was a laboratory simulation; therefore, it was limited by the number of gloves tested and the 30-minute stress protocol. The average time for surgical glove use ranges from 20 minutes to 30 minutes not including preparation time or the use of gloves before surgery. (24) It is evident, however, that gaining a clearer picture of the effectiveness of glove barrier quality requires consideration of glove material, manufacturer, and the use of a stress protocol or actual use in surgery. Although the researchers compared glove defects between latex and nonlatex gloves by manufacturer, it should be mentioned that the study did not include gloves from all available manufacturers. This study was limited to gloves from six manufacturers that were available at the institution in which the study was performed. Researchers found that nitrile and neoprene surgical gloves were comparable to latex gloves in a simulated surgical stress protocol. They recommend that specific standards for testing the barrier effectiveness of surgical gloves include a stress protocol consistent with the type of material used.
Table 1
GLOVE FAILURE RATES ANALYZED BY MATERIAL, BRAND, POWDER,
MANUFACTURER, AND STRESS
Brand Manufacturer Stressed Unstressed
Material code Powder code Pass Fall Pass Fail
Latex A No M1 208 12 247 3
B Yes M6 299 11 180 2
Neoprene C Yes M2 270 8 250 0
D No M3 211 35 246 2
E No M6 263 11 242 6
F No M5 250 2 250 0
Nitrile G No M4 245 5 250 0
Isoprene H Yes M1 189 57 228 24
Brand failure Material failure
Material Rate % Rate %
Latex 15/470 3.2 28/962 2.9
13/492 2.6
Neoprene 8/528 1.5 64/2046 3.1
37/494 7.5
17/522 3.3
2/502 0.4
Nitrile 5/500 1.0 5/500 1.0
Isoprene 81/498 16.3 81/498 16.3
Table 2
FAILURE RATES OF GLOVES: STRESSED
UNSTRESSED, POWDER, MATERIAL, AND MANUFACTURER
Failure rote
Variable Yes No % Fishers [chi square] P value
Stress 59.942 < .001
Stressed 141 1,935 6.8
Unstressed 37 1,893 1.9
Powder 28.741 < .001
Powdered 102 1,416 6.7
Powder free 76 2,412 3.1
Material 191.153 < .001
Latex 28 934 2.9
Neoprene 64 1,982 3.1
Nitrile 5 495 1.0
Isoprene 81 417 16.3
Manufacturer 128.348 < .001
M1 96 872 9.9
M2 8 520 1.5
M3 37 457 7.5
M4 5 495 1.0
M5 2 500 0.4
M6 30 984 3.0
Table 3
CRUDE VERSUS ADJUSTED ODDS RATIO (OR) OF
GLOVE FAILURE RATES, 95% CONFIDENCE INTERVAL (C[I.sup.95])
Variable Crude OR (C[I.sup.95]) Adjusted OR (C[I.sup.95])
Powder
Powdered 0.437 (0.32-0.59) * 1.48 (0.69-3.16)
Powder free 1.0 (Reference) 1.0 (Reference)
Stress
Stressed 3.722 (2.58-5.37) * 4.26 (2.92-6.21) *
Unstressed 1.0 (Reference) 1.0 (Reference)
Material
Nitrile 0.34 (0.13-0.88) * 2.36 (0.40-14.00)
Isoprene 6.48 (4.15-10.11) * 8.91 (4.85-16.35) *
Neoprene 1.08 (0.67-1.70) 0.95 (0.47-1.93)
Latex 1.0 (Reference) 1.0 (Reference)
Manufacturer
M1/M6 9.63 (4.49-20.69) * 8.09 (1.88-34.77) *
M2 2.18 (0.79-6.05) 5.42 (0.97-30.23)
M3 11.49 (5.09-25.95) * 20.48 (4.97-84.40) *
M4/M5 1.0 (Reference) 1.0 (Reference)
* Indicates P value < 0.05
Editor's Note: This study was funded in port by a grant from Safeskin Corp, a subsidiary of Kimberly-Clark Corp, Roswell, Ga.
NOTES
(1.) M O Osman, S L Jensen, "Surgical gloves: Current problems," World Journal of Surgery 23 (July 1999) 630-637.
(2.) L W Hunt et al, "An epidemic of occupational allergy to latex involving health care workers," Journal of Occupational and Environmental Medicine 37 (October 1995) 1204-1209; "Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings," Morbidity and Mortality Weekly Report 37 (June 24, 1988) 377-382, 387-388; "Occupational exposure to bloodborne pathogens; Final rule," Federal Register 56 (Dec 6, 1991) 64004-64182; M F Goldsmith, "OSHA bloodborne pathogens standard aims to limit occupational transmission," JAMA 267 (June 3, 1992) 2853-2854.
(3.) A Rego, L Roley, "In-use barrier integrity of gloves: Latex and nitrile superior to vinyl," American Journal of Infection Control 27 (October 1999) 405-410.
(4.) D R Roy, "Latex glove allergy--Dilemma for health care workers. An overview," AAOHN Journal 48 (June 2000) 267-277; D H Garabrant et al, "Latex sensitization in health care workers and in the US general population" American Journal of Epidemiology 153 (March 15, 2001) 515-522; A J Shoup, "Guidelines for the management of latex allergies and safe use of latex in perioperative practice settings," AORN Journal 66 (October 1997) 726-731; D M Korniewicz, K J Kelly, "Barrier protection and latex allergy associated with surgical gloves," AORN Journal 61 (June 1995) 1037-1044.
(5.) G L Sussman et al, "Incidence of latex sensitization among latex glove users," Journal of Allergy and Clinical Immunology 101 (February 1998) 171-178.
(6.) Ibid; C J Palenik, C H Miller, "Moving towards a latex-free environment: Advice from experiences in US dentistry," Dental Update 26 (December 1999) 427-430; M D Fisher et al, "Biomechanical performance of latex and non-latex double-glove systems," Journal of Biomedical Materials Research 48 no 6 (1999) 797-806.
(7.) "D5151-5192: Test method for detection of holes in medical gloves," in 1992 Annual Book of ASTM Standards (Philadelphia: American Society for Testing and Materials, 1992); "D-3577-5199: Standard specification for rubber surgical gloves," in 1991 Annual Book of ASTM Standards (Philadelphia: American Society for Testing and Materials, 1991); "D-5250-5299: Specification for polyvinyl chloride gloves for medical application," in 1992 Annual Book of ASTM Standards (Philadelphia: American Society for Testing and Materials, 1992).
(8.) "Medical devices; patient examination and surgeons' gloves; adulteration--FDA. Final rule," Federal Register 55 (Dec 12, 1990) 51254-51258.
(9.) S W Newsom, M O Smith, P Shaw, "A randomised trial of the durability of non-allergenic latex-free surgical gloves versus latex gloves" Annals of the Royal College of Surgeons of England 80 (July 1998) 288-292.
(10.) D M Korniewicz et al, "Performance of latex and nonlatex medical examination gloves during simulated use," American Journal of Infection Control 30 (April 2002) 133-138.
(11.) Osman, Jensen, "Surgical gloves: Current problems," 630-637; M P van den Tel et al, "Glove powder promotes adhesion formation and facilitates tumour cell adhesion and growth," British Journal of Surgery 88 (September 2001) 1258-1263; W J Kamffer et al, "Surgical glove powder and intraperitoneal adhesion formation. An appeal for the use of powder-free surgical gloves," South African Medical Journal 81 (Feb 1, 1992) 158-159; H Myllamiemi, M Frilander, "Adhesion and granuloma inducing capacity of glove powders in the abdominal cavity," Journal of the International College of Surgeons 44 (December 1965) 677-681.
(12.) M Spicer, M Richardson, "Risky business: Pre-powdered gloves or powder-free gloves in the operating suite?" International Journal of Health Care Quality Assurance Incorporating Leadership in Health Services 11 no 6/7 (1998) 204-210; N Chegini, H Rong, "Post-operative exposure to glove powders modulates production of peritoneal eicosanoids during peritoneal wound healing," European Journal of Surgery 165 (July 1999) 698-704.
(13.) K E Giercksky, "Misdiagnosis of cancer due to multiple glove powder granulomas," European Journal of Surgery Supplement no 579 (1997) 11-14.
(14.) D M Korniewicz, et al, "Nonlatex surgical glove failure rates," Journal of Occupational and Environmental Medicine, in review.
(15.) Rego, Roley, "In-use barrier integrity of gloves: Latex and nitrile superior to vinyl," 405-410; Korniewicz et al, "Performance of latex and nonlatex medical examination gloves during simulated use," 133-138.
(16.) "Medical devices; patient examination and surgeons' gloves; adulteration--FDA. Final rule," 51254-51258; "Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule," Federal Register 58 (Aug 3, 1993) 41348-41354.
(17.) SPSS--Statistical Package for the Social Sciences, version 10 (Chicago: SPSS, Inc).
(18.) "Synthetic surgical gloves" Health Devices 29 (February/March 2000) 37-66.
(19.) Korniewicz, et al, "Nonlatex surgical glove failure rates."
(20.) Spicer, Richardson, "Risky business: Pre-powdered gloves or powder-free gloves in the operating suite?" 204-210; M Shymko, "Glove powder complications," Radiologic Technology 70 (July/August 1999) 576-578; E A Field, "The use of powdered gloves in dental practice: A cause for concern?" Journal of Dentistry 25 (May-July 1997) 209-214; H Ellis, "Pathological changes produced by surgical dusting powders," Annals of the Royal College of Surgeons of England 76 (January 1994) 5-8; G Malinger et al, "Starch peritonitis outbreak after introduction of a new brand of starch powdered latex gloves," Acta Obstetricia Gynecologica Scandinavica 79 (July 2000) 610-611.
(21.) M D Fisher et al, "Ease of donning commercially available powder-free surgical gloves" Journal of Biomedical Materials Research 33 (Winter 1996) 291-295; L J Pavlovich et al, "Ease of donning surgical gloves: An important consideration in glove selection," Journal of Emergency Medicine 13 (May/June 1995) 353-355.
(22.) Garabrant et al, "Latex sensitization in health care workers and in the US general population," 515-522; E L Petsonk, "Couriers of asthma: Antigenic proteins in natural rubber latex," Occupational Medicine 15 (April-June 2000) 421-430; H Allmers et al, "Reduction of latex aeroallergens and latex-specific IgE antibodies in sensitized workers after removal of powdered natural rubber latex gloves in a hospital," Journal of Allergy and Clinical Immunology 102 (November 1998) 841-846; M Lundberg, K Wrangsjo, S G Johansson, "Latex allergy from glove powder--An unintended risk with the switch from talc to cornstarch?" Allergy 52 (December 1997) 1222-1228.
(23.) Chegini, Rong, "Postoperative exposure to glove powders modulates production of peritoneal eicosanoids during peritoneal wound healing," 698-704; Malinger et al, "Starch peritonitis outbreak after introduction of a new brand of starch powdered latex gloves," 610-611; P W Sellar, R A Sparrow, "Are ophthalmic surgeons aware that starch powdered surgical gloves are a risk factor in ocular surgery?" International Ophthalmology 22 no 4 (1998/1999) 247-251; L Holmdahl, B Risberg, "Adhesions: prevention and complications in general surgery," European Journal of Surgery 163 (March 1997) 169-174; T K Hunt, J P Slavin, W H Goodson, "Starch powder contamination of surgical wounds," Archives of Surgery 129 (August 1994) 825-828.
(24.) D Korniewicz, L Garzon, S Plitcha, "Risk factors for non-latex and latex gloves during surgery," American Industrial Hygiene Association Journal, in press.
Denise M. Korniewicz, RN, DNSc, FAAN, is a professor, University of Maryland School of Nursing and Medicine, Baltimore.
Maher M. El-Masri, RN, PhD, is an assistant professor, University of Windsor, Ontario.
John M. Broyles, RN, MS, PNP, is a pediatric nurse clinician, University of Pittsburgh.
Christopher D. Martin, RN, MS, is a doctoral student, University of Maryland, Catonsville.
Kevin P. O'Connell, PhD, is a research microbiologist, University of Maryland School of Nursing and Medicine, Baltimore.
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