Double-glove Systems Research Articles

An Update on the Innovative Surgical Double-Glove Hole Puncture Indication Systems: Reliability and Performance.

During operative procedures, operating room personnel wear sterile surgical gloves designed to protect them and their patients against transmissible infections. The Food and Drug Administration (FDA) has set compliance policy guides for manufacturers of gloves. The FDA allows surgeons' gloves whose leakage defect rates do not exceed 1.5 acceptable quality level (AQL) to be used in operating rooms. The implications of this policy are potentially enormous to operating room personnel and patients. This unacceptable risk to the personnel and patient could be significantly reduced by the use of sterile double surgical gloves. Because double-gloves are also susceptible to needle puncture, a double-glove hole indication system is urgently needed to immediately detect surgical needle glove punctures. This warning would allow surgeons to remove the double-gloves, wash their hands, and then don a sterile set of double-gloves with an indication system. During the last decade, Regent Medical has devised non-latex and latex double-glove hole puncture indication systems. The purpose of this comprehensive study is to detect the accuracy of the non-latex and latex double-glove hole puncture indication systems using five commonly used sterile surgical needles: the taper point surgical needle, tapercut surgical needle, reverse cutting edge surgical needle, taper cardio point surgical needle, and spatula surgical needle. After subjecting both the non-latex and latex double-glove hole puncture indication systems to surgical needle puncture in each glove fingertip, these double-glove systems were immersed in a sterile basin of saline, after which the double-gloved hands manipulated surgical instruments. Within two minutes, both the non-latex and latex hole puncture indication systems accurately detected needle punctures in all of the surgical gloves, regardless of the dimensions of the surgical needles. In addition, the size of the color change visualized through the translucent outer glove did not correlate with needle diameter. On the basis of this extensive experimental evaluation, both the non-latex and latex double-glove hole puncture indication systems should be used in all operative procedures by all operating room personnel.

Reliability and performance of innovative surgical double-glove hole puncture indication systems.

During operative procedures, operating room personnel wear sterile surgical gloves designed to protect them and their patients against transmissible infections. The Food and Drug Administration (FDA) has set compliance policy guides for manufacturers of gloves. The FDA allows surgeons' gloves whose leakage defect rates do not exceed 1.5 acceptable quality level (AQL) to be used in operating rooms. The implications of this policy are potentially enormous to operating room personnel and patients. This unacceptable risk to the personnel and patient could be significantly reduced by the use of sterile double surgical gloves. Because double-gloves are also susceptible to needle puncture, a double-glove hole indication system is urgently needed to immediately detect surgical needle glove punctures. This warning would allow surgeons to remove the double-gloves, wash their hands, and then don a sterile set of double-gloves with an indication system. During the last decade, Regent Medical has devised non-latex and latex double-glove hole puncture indication systems. The purpose of this comprehensive study is to detect the accuracy of the non-latex and latex double-glove hole puncture indication systems using five commonly used sterile surgical needles: the taper point surgical needle, tapercut surgical needle, reverse cutting edge surgical needle, taper cardiopoint surgical needle, and spatula surgical needle. After subjecting both the non-latex and latex double-glove hole puncture indication systems to surgical needle puncture in each glove fingertip, these double-glove systems were immersed in a sterile basin of saline, after which the double-gloved hands manipulated surgical instruments. Within two minutes, both the non-latex and latex hole puncture indication systems accurately detected needle punctures in all of the surgical gloves, regardless of the dimensions of the surgical needles. In addition, the size of the color change visualized through the translucent outer glove did not correlate with needle diameter. On the basis of this extensive experimental evaluation, both the non-latex and latex double-glove hole puncture indication systems should be used in all operative procedures by all operating room personnel.

Reducing accidental injuries during surgery.

Extensive clinical investigations have demonstrated that double-gloves and blunt-tipped surgical needles dramatically reduced the risk of accidental injuries during surgery. During the last decade, double-glove hole puncture indication systems have been developed that reduce the clinical risk of accidental needlestick injuries as well as detect the presence of glove hole puncture in the presence of fluids. When the outer glove is punctured, the colored underglove becomes apparent through the translucent outer glove, necessitating glove removal, hand washing, and donning of another double-glove hole puncture Indicator system. This article presents the first biomechanical performance study that documents the puncture resistance of blunt surgical needles in latex and nonlatex single gloves and double-glove hole puncture indication systems. The technique for measuring glove puncture resistance simulates the standard test for material resistance to puncture outlined by the American Society for Testing and Materials. The maximum puncture resistance force was measured by the compression load cell and recorded in grams with a strip chart recorder. Ten puncture resistance measurements for the taper point needle, blunt taper point needle, and blunt needle were taken from five samples of the Biogel Indicator underglove, Biogel Super-Sensitive glove, Biogel glove, Biogel Skinsense N Universal underglove, and Biogel Skinsense Polyisoprene glove; and the Biogel, Biogel Super-Sensitive, and Biogel Skinsense Polyisoprene double-glove hole puncture indication systems. The magnitude of puncture resistance forces recorded was influenced by several factors: glove material, number of glove layers, and type of surgical needle. For each type of curved surgical needle,the resistance to needle penetration by the nonlatex gloves was significantly greater than those encountered by the latex glove materials. The resistance to needle puncture of all three double-glove systems was significantly greater than that of either the nonlatex or latex underglove or outer glove. The taper point needle encountered the lowest puncture resistance forces in the five single gloves and the three double-glove systems. Blunting the sharp end of the taper point needle markedly increased its resistance to glove puncture in the five single gloves and five double-glove systems. The blunt-point surgical needle elicited the greatest needle penetration force in all of the single and double-glove systems.

Resistance of double-glove hole puncture indication systems to surgical needle puncture.

Double-gloving has been shown to reduce conclusively the risk of operating room personnel's exposure to blood. Limiting risk of exposure to blood by double-gloving provides protection against the transmission of bloodborne diseases. Realizing the importance of double-gloving, a double-glove hole puncture indication system exists that accurately detects the presence of glove hole puncture in the presence of fluid. Once a glove puncture is recognized by this double-glove hole puncture indication system, it provides a warning to the surgeon to remove the punctured gloves, wash hands, and don a new, sterile double-glove hole puncture indication system. While accurately identifying the presence of glove hole puncture in the presence of fluid, this double-glove hole puncture indication system also has resistance to needle puncture superior to that of single gloves. It is the purpose of this study to document the resistance to needle puncture of latex and non-latex double-glove hole puncture indication systems using a reproducible experimental model. The resistance to needle puncture of the double-glove systems was significantly greater than that of the undergloves or outer gloves alone. The resistance to glove puncture of the non-latex and latex single and double-glove systems was significantly greater than those encountered by the latex single and double-glove systems, respectively. On the basis of their accuracy in detecting glove hole puncture, combined with their demonstrated superior resistance to surgical needle puncture as compared to single gloves, these latex and non-latex double-glove hole puncture indication systems are recommended for all surgical procedures.

How often does glove perforation occur in surgery? comparison between single gloves and a double-gloving system

Background: In surgery, intact gloves protect the surgeon from bloodborne pathogens and the surgical wound from microorganisms on the skin of the surgeon. However, glove perforation is very common, and puncture rates as high as 61% are published in the literature. One objective of this study was to compare puncture rates between a unique double-gloving puncture indication system and single-use gloves, and another was to determine the extent to which glove perforations remain undetected during surgery. Methods: The study material comprised all gloves used in surgical operations at our hospital for a period of 2 months. The analysis was made by the glove type in a prospective and randomized manner. Gloves were tested immediately after the surgical procedure using the approved standardized water-leak method for 2 minutes to detect any holes. The gloves used in this study were either a double-gloving puncture indication system or the standard glove used at our hospital. Results: In 885 operations altogether, 2,462 gloves were tested; 1,020 single gloves, 1,148 double-glove systems, and 294 combination gloves were studied. The overall perforation rate was 192 out of 2,462 gloves (7.80%), and 162 out of 885 operations (18.3%). The detection of perforation during surgery was 28 out of 76 (36.84%) with single gloves, 77 out of 89 with the double-gloving system (86.52%), and 9 out of 27 with combination gloves (33.33%; P <0.001). The inner glove of the double-gloving system was punctured in 6 out of 88 outer glove perforations (6.82%). Conclusions: In view of the critical importance of safety at work by having a sterile barrier between surgeon and patient, it is very important to use a double-gloving puncture indication system, at least in operations where there is a high risk of glove perforation.

Biomechanical performance of orthopedic gloves.

The purpose of this study was to compare the biomechanical performance of commercially available orthopedic gloves to that of a single surgical glove, as well as a double glove system. The orthopedic gloves were found to be thicker than the single surgical glove. This increased thickness of the orthopedic glove was associated with a greater resistance to glove puncture. The thickest orthopedic gloves also had reduced tactile sensitivity when compared to the single surgical glove. In addition, the glove donning forces and glove hydration rates varied considerably. These latter biomechanical performance parameters were not significantly related to glove thickness. The double glove systems tested in this study had similar performance characteristics in regard to many of the orthopedic gloves. The glove donning forces for the double glove systems were the lowest of the gloves tested. In addition, the double glove systems displayed the greatest resistance to glove hydration of the gloves tested. Their performance in the glove hydration tests and the force required to don the double glove systems were much more desirable than any of the orthopedic gloves. The results of this study indicate that the double glove systems may provide a desirable alternative to the use of the single orthopedic gloves.

Biomechanical performance of latex and non-latex double-glove systems.

The purpose of this study was to evaluate ten commercially available latex, powder-free surgical gloves and four commercially available non-latex, powder-free surgical gloves using standardized, reproducible biomechanical parameters that included glove thickness, puncture resistance, and glove donning force. For all gloves tested, with one exception (Neolontrade mark PF), puncture resistance increased for double-gloves as compared to single-gloves. In addition, single-glove thickness was not a reliable determinant of puncture resistance for either latex or non-latex gloves. For the latex gloves, the Ultrafree double and single-gloves exhibited the highest puncture resistance. The glove donning forces for the Biogeltrade mark M and Biogel Sensortrade mark single-gloves were the lowest. In contrast, the Biogel Revealtrade mark and Encoretrade mark Ultra-Thick exhibited the lowest double-glove donning forces. On the basis of these performance tests of latex gloves, the surgeon should consider the Biogel Reveal as well as the Ultrafree gloves for their latex double-glove system. For the non-latex gloves, the Pure Advantage Nitriletrade mark glove had the highest puncture resistance for one layer and two layers of glove material. The thin Pure Advantage Nitrile glove was the most resistant to glove puncture. The Pure Advantage Nitrile glove had low glove donning forces for both single-glove donning configurations and double-glove donning configurations. Consequently, we recommend the Pure Advantage Nitrile glove as the powder-free, non-latex, double-glove system.