A laboratory-based study to assess the performance of surgical gloves

AORN Journal,  April, 2003  by Denis M. Korniewicz,  Maher M. El-Masri,  John M. Broyles,  Christopher D. Martin,  Kevin P. O'Connell

• E-mail
• Print
• Link

Since 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.