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Reducing Accidental Injuries During Surgery Released: July 2005 Sponsored by Dannemiller Memorial Educational Foundation  Supported by an unrestricted educational grant from 
Faculty: Kant Y. Lin, M.D. Professor of Plastic Surgery Chief of Division of Craniofacial Surgery University of Virginia Health Systems Charlottesville, Virginia William B. Long III, M.D. President and Medical Director Legacy Verified Level I Shock Trauma Center for Children and Adults Portland, OR Richard F. Edlich, M.D., Ph.D. Distinguished Professor Emeritus of Plastic Surgery Biomedical Engineering, and Emergency Medicine Founder of the DeCamp Burn and Wound Healing Center University of Virginia Health Systems Director of Trauma,Prevention, Education and Research Trauma Specialists, LLP, Legacy Verified Level I Shock Trauma Center for Pediatrics and Adults Legacy Emanuel Hospital, Portland, OR Statement of Need: Continuing research into present and future techniques of reducing accidental injuries during surgery makes it important for surgeons and surgical specialists to stay informed about recent advances in the design of surgical needles, as well as surgical gloves that dramatically reduce accidental injuries during surgery. Surgeons must be able to restore the physical integrity and function of the injured or diseased tissue without being subjected to an accidental injury during surgery, which is an invitation to the spread of deadly blood-borne viral infections between the surgeon and the patient. Goal: The broad mission of this continuing education program is to teach the surgeon and surgical specialists the scientific basis for selecting innovative techniques that will reduce accidental injuries during surgery. Objectives: At the completion of the training, the participant will be able to:
To receive credit, participants should, in order, view the objectives, read the educational material, then go to the link at the end of this activity to complete the post-test, evaluation, and then print the CME certificate. This activity should take approximately 1 hour to complete. This activity is available through July 31, 2008. No credit will be awarded after this date. Target Audience: This educational program is intended for general surgeons as well as other surgical specialists or physicians involved in wound closure. Accreditation: The Dannemiller Memorial Educational Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Dannemiller Memorial Educational Foundation designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s),TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. The Dannemiller Memorial Educational Foundation is an approved provider of the California Board of Registered Nursing. Provider approved by the California Board of Registered Nursing, Provider Number 4229 for 1.2 contact hours. RNs outside California must verify with their licensing agency for approval of this course. Faculty Disclosure: In accordance with ACCME requirements, Dr. Lin has nothing to disclose. In accordance with ACCME requirements, Dr. Long has nothing to disclose. In accordance with ACCME requirements, Dr. Edlich has nothing to disclose. Sponsor's Disclosure: In accordance with the Accreditation Council for Continuing Medical Education (ACCME), the Dannemiller Memorial Educational Foundation requires that any person who is in a position to control the content of a CME activity must disclose all relevant financial relationships they have with a commercial interest. Accordingly: The Dannemiller Memorial Educational Foundation staff that was involved in the development of this activity has no financial relationships with any commercial interests that are relevant to this activity. Disclaimer: The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of the Dannemiller Memorial Educational Foundation or U.S. Surgical/Division of Tyco Healthcare. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity. I. INTRODUCTION All surgical healthcare professionals and their patients should be aware of exposure to blood from individuals infected with potentially transmissible disease. The danger to the patient was graphically illustrated by a report by Carl et al.1 in 1982. Between January 1979 and January 1980, hepatitis B developed in three women within 6 months of gynecological surgery at a community hospital in Mississippi. An investigation of these hospital-acquired infections uncovered one other case of hepatitis B following gynecological surgery. The gynecologist who performed all four procedures was later found to be a chronic carrier of hepatitis B. Hepatitis B surface antigen subtyping on serum from this gynecologist and one of the hepatitis B patients gave identical results. When the gynecologist was interviewed about his surgical technique, it was learned that he often held a surgical needle in his hand during suturing instead of using a needle holder. In addition, he remembered finding blood on his hands after removing his gloves at the end of surgical procedures several times during the year. The Mississippi State Health Department allowed the gynecologist "to resume his surgical practice after he agreed to use a needle holder during suturing and to wear two pairs of gloves during surgery. He also agreed to change gloves and surgical instruments if he pricked himself with a needle or other instrument or if he tore his glove." In addition, each of his subsequent patients were required to give written informed consent indicating that she knew her gynecologist had transmitted hepatitis B and that it was possible that he could do so again. No further transmission of hepatitis B was found after the gynecologist began wearing two pairs of gloves. The Mississippi State Health Department concluded that modifying the gynecologist's surgical technique by wearing double-gloves was a far better solution to the problem of transmitting further disease than his dismissal or cessation of his practice. Because operating room personnel are at highest risk among healthcare professionals for occupational hepatitis B and C infections because of their frequent exposure to blood,2 they are also at comparatively high risk for human immunodeficiency virus (HIV) infection. McKinney and Young3 describe a mathematical model for assessing the individual risk for HIV infection after multiple potential exposures after many years for surgeons and other operating room personnel. They considered the risk to surgeons in three large hospitals with high, intermediate, and low estimated seroprevalence of HIV infection. They estimated the cumulative risk for a surgeon during a 30-year career using seroprevalence data from the three patient populations. In addition, they calculated the cumulative risk of HIV infection to surgeons by the rate of skin/glove puncture per procedure. They demonstrated that the combination of high skin puncture rate and high patient seroprevalence over a long period of time places the surgeon at considerable risk of HIV infection. If the seroprevalence rate of the hospital was 1% and the surgeon performed procedures with an estimated 10% skin puncture rate, the surgeon's cumulative risk of developing HIV infection after performing a total of 10,000 cases was 4%. When the seroprevalence rate of the hospital was 10% and the skin puncture rate was 10%, the surgeon's cumulative risk of developing HIV infection was calculated to be a staggering 33%. While these investigators described several limitations in their mathematical model, the results of their studies should be taken very seriously by operating room personnel. In addition, these investigators suggested several options that would reduce the surgeon's susceptibility to HIV infection. First, surgeons could lower their risk by moving to a hospital or geographical region with a lower patient seroprevalence of HIV infection. Such a move would have serious personal and financial repercussions. Another suggested alternative was to reduce selectively the number of invasive procedures performed on patients with HIV infections. This latter consideration has obviously serious medicolegal consequences. The most attractive alternative presented was to make a determined effort to decrease the likelihood of percutaneous exposures to blood during each surgical procedure. II. SEARCH FOR THE CAUSES OF ACCIDENTAL INJURIES DURING SURGERY Until the last decade, the development of strategies to prevent exposure of blood to operating room personnel has been limited by a lack of knowledge about the specific mechanisms of exposure. In 1988, Hussain et al.4 reported a survey that was designed to determine the incidence of accidental injuries to surgeons during operations, the mechanism of injury, and the anatomic site on the surgeon's body. Other factors such as duration of operations, time of day, and experience of surgeons were also correlated to the frequency of injury. This survey included eight general surgeons, four orthopedic surgeons, two urologists, and four surgical residents in a hospital in Saudi Arabia. In their study of 2016 operations, the authors identified 112 accidental injuries (5.6%). Needlestick injuries accounted for the vast majority of injuries, 107 (95.5%). Only four (3.6%) were caused by cuts with surgical knives. One injury was caused by a burn from electrosurgery. The general surgeons and their residents in general surgery had the highest frequency of accidental injuries (7.0%), followed by the urologists (3%), and then the orthopedic surgeons (2.8%). The site that was most susceptible to injury was the left index finger of the surgeon's hand, which represented 42 injuries (37.5%). Most injuries occurred during wound closure (85 injuries, 75.9%). Most needlestick injuries were noted as the needle emerged from the tissue, puncturing the glove of the overlying finger that was not under direct vision of the surgeon. Longer operative procedures had a greater frequency of accidental injuries than did shorter operative procedures. It was surprising that most injuries were considered trivial and disregarded completely (84 injuries, 75%). The surgeons changed their gloves in only 28 incidences (25%), rescrubbed their hands in 14 cases (12.5%), and applied an antiseptic agent to the site of the injury in 13 incidences (11.6%). In another effort to classify the mechanisms of accidental injuries in the operating room, Wright et al.5 had a nurse interview operating room personnel in a tertiary care teaching hospital immediately after glove tear or sharp injury. Potential exposures were categorized into the following three types: glove tears, sharp injuries, or gown leaks. A glove tear was considered to be any perforation of a glove that exposed bare skin. A sharp injury was judged to be an injury by a sharp instrument that caused pain to an injured person. A gown leak was judged to be any contact with body fluids at, or proximal to, the gown-glove margin. In the 2292 surgical operations within the scope of the study, most of the accidental operative exposures were glove tears (249, 75%). Sharp injuries accounted for 70 (21%). Gown leaks accounted for only 12 exposures. Almost all of the glove tears were located over the digits (208, 84%). It was surprising that the mechanism of glove tears could not be identified in the majority (168, 67%) of the 249 tears. More importantly, contact with the patient's blood was even more common when the mechanism of tear was not identified (128, 76%). It is important to note that the vast majority (92%) of the operating room personnel who experienced glove tears wore single gloves. It is also important to note that needles caused the vast majority of sharp injuries (47, 67%). Only seven (10%) of the sharp injuries were from scalpels. The remaining 16 (23%) sharp injuries were from other instruments, such as the tip of the electrosurgical device, wire, skin staple, bone cutter, capillary tube, or chisel. Bleeding was caused by the injury in 56 (80%) cases of sharp injuries. The anatomic locations of sharp injuries were remarkably similar to those of glove tears. Eleven of the 12 gown leaks were encountered during gynecologic or general surgical abdominal operations. In either case, the surgeon or assistant was reaching into the abdomen filled with blood or fluid. One gown leak was noted when blood soaked through the gown cuff of a plastic surgeon. The mechanism of exposure was recognized in 81 glove tears and 71 sharp injuries. In 34 exposures, the injured hand was being used as a retractor. The injured hand was suturing in 17 of these 34 exposures, and was usually passing the surgical needle through the tissue. In the 23 exposures identified as "hand holding an instrument," the injured hand was stationary over the wound holding an instrument, while sharp instruments were passed into or out of the held instrument. Six exposures were encountered during hand tying of sutures, in which the suture material cut through the glove. In three of these incidents, the suture cut through the skin of the operating room personnel. When suture tying cut through the glove, the personnel were wearing single gloves. On the basis of this comprehensive study, the investigators recommended preventive strategies to reduce the risk of exposure. First, the glove hand should never be used as a retractor. Injuries to the hand holding a retractor could be reduced by distancing the hand from the site of the injury by using longer forceps, by holding the forceps at a more acute angle with the skin, or by designing new forceps. Injuries from sharps not being used may be decreased by eliminating or shielding the sharp instrument. It was surprising to us that the investigators did not recommend double-gloves in all operative procedures. In 1992, Tokars et al.6 reported the results of a multi-center observational study to record detailed information on the frequency and circumstances of blood contacts during surgical procedures. Observers, nurses, or operating room technicians were present at 1382 surgical procedures to record information about the procedure, the personnel present, and the percutaneous injuries that evolved. The investigators defined percutaneous injury as penetration of a healthcare worker's skin by a needle, other sharp instrument, or object that has been contaminated with a patient's blood. They judged recontact to be (1) recontact of a sharp object with a patient's open wound after penetration of the healthcare worker's skin, or (2) injury of a worker by a bone fragment or surgical wire attached to the patient's body. During the 1382 procedures observed in this study, 99 percutaneous injuries were noted. One or more injuries were recorded during the 95 procedures. As expected, suture needles accounted for the majority (76, 77%). Electrosurgical devices, scalpels, or wire caused only three injuries. Suture threads produced two injuries. There were single reports of injuries caused by a bone fragment, a bone hook, an orthopedic pin, a cannula, a retractor, scissors, a staple gun, and a trocar. The objects causing four injuries were not known. Suture needles placed on the surgical field that were not being used by the surgeon produced two injuries. As expected, injuries were more common on the non-dominant than on the dominant hand (63% vs. 34%). The most commonly injured area was the palmer surface of the distal forefinger. We were alarmed by the operating room personnel's inappropriate responses to these percutaneous injuries. No glove changes were made after 15 injuries (15%). One individual (1%) placed a clean glove over the punctured glove. One individual was not wearing gloves at the time of injury. Immediate glove change was encountered in 61 (62%) of the injured operating room personnel. In 11 (11%) injuries, glove change was delayed from 5 to 15 minutes. Worker injury rates were greatest for surgeons and their resident staff (88 injuries). There were a total of 28 injuries to surgeons in which the sharp object that caused the injury recontacted the patient. The risk of injury, adjusted by confounding variables by logistic regression, was greatest during vaginal hysterectomy and lower during certain orthopedic procedures than during the other observed operative procedures. III. REVOLUTIONARY ADVANCES IN PREVENTING ACCIDENTAL SURGICAL NEEDLESTICK INJURIES During the last two decades, there have been two revolutionary advances in preventing accidental needle stick injuries during surgery that include the development blunt tapering point needles as well as the double-glove hole indication systems. IIIA. Blunt Taper Point Needle In 1991, Montz et al.7 announced the development of a blunt tapering point needle, with a dolphin-shaped tip that allows tissue penetration with minimum force, but does not puncture gloves. These surgeons used these needles in fascia closure. While they found that these needles were easily passed through the fascia, they did not penetrate the glove, limiting penetrating cutaneous injury to the surgeon and operating staff. In 1993, Wright et al.8 expanded the evaluation of this new taper point needle. They compared the performance of the new blunt taper point needle with the traditional taper point needle in a prospective randomized trial of 69 patients who underwent total hip arthroplasty or hemi-arthroplasty. The surgeons wore two pairs of gloves. The outer pair was changed before the insertion of the prosthetic components and also before wound closure. The inner gloves were worn throughout the operation unless there was evidence of a glove puncture. After the operation, all gloves used by the surgeons were labeled and tested for perforations using water inflation as described by Brough et al.9 Each glove was inflated with water to a diameter of 10 cm above the palm and then squeezed to inflate each digit to a diameter of 4 cm, allowing the number and site of perforations to be identified. The blunt taper point needle was used in 38 operations, while the standard taper point needle was employed in 31. At least one glove perforation was noted in 46 of the 69 operations (67%). A total of 138 outer gloves were worn during wound closure. When 62 outer gloves were worn using the standard taper point needle, 31 perforations were identified in 16 gloves. In the 76 outer gloves worn while using the blunt taper point needle, there were 18 perforations in 10 gloves. This reduced level of outer glove perforations encountered with the blunt taper point needle was statistically significant (p = 0.049). It is important to point out that the frequency of perforation of the undergloves was not altered by needle configuration. Two undergloves were punctured by the blunt taper point needle at a site corresponding to the holes in the outer gloves. Similarly, two undergloves were punctured by standard taper point needles at sites corresponding to holes in the outer gloves. It was interesting that the undergloves were not changed during the operations. Moreover, it was uncertain at which stage the perforations had occurred. The surgeons rarely recognized glove damage, identifying it in only 11 cases (7%) of the perforations. The difficulty in detecting glove damage emphasizes the need for a glove hole puncture detection system that accurately identifies glove perforations. In 1994, Miller and Sabharwal10 reported that the new blunt taper point needles could be effectively used for subcuticular skin closure. In 108 skin incisions in 40 patients, it was reported that the new blunt taper point needle successfully penetrated the subcuticular layers, allowing the use of a subcuticular closure technique with a reduced risk of glove puncture. In 1994, Dauleh et al.11 evaluated the performance of blunt-tipped needles produced in their hospital workshops. The tips of taper point and reverse cutting edge needles were subjected to this blunting process. When the standard needles were used in 253 procedures, 48 (18.9%) glove hole punctures were detected. In 22 of these cases, the needle penetrated the surgeon's skin. When blunt-tipped needles were used in 78 operations, only 2 glove perforations were identified, with no skin injury. The surgeons concluded that their blunt-tipped needles were a practical option against the hazard of needlestick injury. In a report from the Centers for Disease Control and Prevention (CDC) published in 1995, Bell et al.12 recommended the use of instruments, such as the new blunt taper point needle, new surgical protective equipment, and techniques that would reduce the likelihood of intraoperative blood exposure without adversely affecting patient care. Lewis et al.13 wrote a collective review on techniques to minimize sharp injuries in gynecologic and obstetric operations in 1995. They concluded that gynecologic surgery appears to have one of the highest rates of injury of the surgical specialties, and rates of injury vary by procedure within a given specialty. They also concluded that suture needles caused the majority of injuries. They reported that certain actions, such as holding tissue while suturing or cutting, were associated with a higher risk of injury. In 1996, Hartley et al.14 reported a randomized trial of the new blunt taper point needle during mass closure of abdominal wounds. A total of 85 patients were randomly assigned to the clinical trial. The new blunt taper point needle was used in 46 patients, while 39 patients were subjected to wound closure with the standard taper point needle. Glove perforation was encountered in only 3 of the 46 abdominal wound closures accomplished with the blunt taper point needle. In contrast, 14 of the 39 operations using the standard taper point resulted in glove puncture. The surgeon was aware of the glove punctured by the standard taper point needle in 8 of the 14 incidences. The surgeon recognized 1 of the 3 punctures caused by the blunt taper point needle. In this study, none of the glove punctures led to needlestick injuries to the surgeons. In 1996, Mingoli et al.15 evaluated the performance of another blunt taper point needle. The blunt needle and the standard tapered needle were subjected to a random number allocation in 200 patients. These needles were used for abdominal fascia closure in emergency general, vascular, and trauma procedures. The investigators reported that surgeons had 14 needlestick injuries and 76 perforations in 69 pair of gloves. They reported that the standard taper point needles were responsible for all injuries and 58 (76%) glove perforations. The investigators concluded that the risk of glove perforations was 17-fold greater if standard taper point needles were used. They agreed that blunt needles reduced sharp injuries and improved safety for surgeons. In 1997, the CDC reported their evaluation of blunt surgical needles in preventing percutaneous injuries among healthcare workers during gynecologic surgical procedures.16 The blunt point needles were evaluated as a potential replacement for conventional taper point needles in gynecologic surgery. From March 1993 through June 1994, trained nurse observers systematically recorded information about the nature and frequency of all percutaneous injuries and the number and type of suture needles used. They reported that 87 percutaneous injuries occurred during 84 (6%) of the 1464 procedures. Of the 61 injuries involving suture needles, none were encountered with the blunt taper point needle. The CDC concluded that the findings of this report support the use of blunt needles as an effective component of a percutaneous injury prevention program in gynecologic surgery and possibly for other surgical specialties. IIIB. Double-Glove Hole Indication Systems In 1998, Berridge et al.17 reported a randomized controlled trial of vascular surgical operations in which the value of double-gloving was evaluated. Wherever possible, the blunt taper point needles were used. The frequency of perforations in the single- and double-glove systems was determined by testing under high pressure of water. All episodes of obvious blood contamination of the hands or undergloves were determined. It was interesting to note that the frequency of perforation was greatest with double-gloves. However, the incidence of contamination was lowest with double-gloves. Contamination was judged to be present if there was macroscopic evidence of blood on the hand. For the 129 operating room personnel wearing single gloves, 18 had evidence of perforation. Beneath these 18 glove perforations, 8 had evidence of contamination. In contrast, 32 perforations were evident in the double-glove systems, but only 4 had evidence of contamination. During the innovative development of the blunt taperpoint needles, a glove manufacturer (Regent Medical, Division of SSL America, Norcross, Georgia) devised nonlatex and latex double-glove hole puncture indication systems. These double-glove systems accurately identify the site of glove hole puncture. In 2003, Edlich et al.18 performed a biomechanical performance study that quantified the resistance to glove puncture of these double-glove hole puncture indication systems to blunt-tipped and standard taper point needles. The manufacturer of these surgical needles was SynetureTM, a division of US Surgical/Tyco Healthcare (Norwalk, Connecticut). The Biogel® IndicatorTM latex surgical underglove, made by Regent Medical, is a sterile green underglove that is used in combination with any other Biogel®-brand latex surgical glove to form a double-glove hole puncture indication system. This underglove has a polymer coating on its inner surface that allows it to be donned on damp, wet, or dry hands. Its outer surface is specially treated so that a latex outer glove can be easily donned over the underglove. The thickness of the fingertips of the undergloves is 0.19 mm. This underglove has a curved finger design and a distinct green color that becomes apparent when the outer translucent latex glove is punctured in the presence of fluid. In this study, the sterile Biogel® or the Biogel® Super-SensitiveTM gloves have been used as the outer gloves. These outer gloves have polymer coatings on the inner surfaces of the gloves. They are translucent, permitting visualization of color changes in the underglove when the outer glove is punctured in the presence of fluid. The Biogel® glove is a relatively thick glove with a microroughened surface. The thickness of its fingertip is 0.25 mm. In contrast, the Biogel® Super-SensitiveTM glove is approximately 20% thinner than the standard Biogel® glove, with a fingertip thickness of 0.19 mm. Regent Medical has recently designed the first nonlatex double-glove hole puncture indication system. The underglove, Biogel® SkinsenseTM N Universal, has a polymer coating on its inner surface and a special treatment of its outer surface that allows it to be used as part of a double-glove hole puncture indication system. The thickness of this nonlatex glove, made of NeopreneTM, is remarkably similar to that of the latex IndicatorTM underglove, measuring 0.20 mm. It has a distinct dark blue color that becomes apparent when the translucent outer glove is punctured in the presence of fluid. The nonlatex outer glove, Biogel® SkinsenseTM Polyisoprene, has a polymer coating on its inner surface. This nonlatex glove, made of polyisoprene, has the same thickness (0.20 mm) as the nonlatex underglove. It can be donned with damp, wet, or dry hands or can serve as the outer glove of the nonlatex double-glove hole puncture indication system. After outer glove puncture, its translucent light blue color allows visualization of the dark blue underglove in the presence of fluid. This technique for measuring glove puncture resistance simulates the standard test for material resistance to puncture outlined by the American Society for Testing and Materials (West Conshohocken, Pennsylvania, USA).19 Measurement of puncture resistance was accomplished using a stationary support assembly affixed to the lower arm of a tension testing machine. Three curved needles, produced by SynetureTM, were used in this evaluation: taper point needle, blunt taper point needle, and blunt point needle. The taper point needle tapers to a sharp point. In contrast, the blunt taper point needle has a remarkably similar geometry to the taper point needle, except that its point has a blunt ending at the tip of the needle. The geometry of the blunt-point needle differs from those of the taper point and blunt taper point needles. Instead of tapering to either a sharp or dull tip, it has no taper at all. The full needle diameter extends to the tip of the needle, which has a blunt configuration. Each surgical needle was firmly mounted into a suitable fixture and attached to a penetrometer stand. The order in which the needles were tested was randomly assigned. The whole assembly was attached to the compression load cell of an Instron model 1222 (Instron Corp., Canton, Massachusetts). The glove membrane was supported between two flat metal plates. The glove membrane or membranes were affixed to the top plate, which was shaped like a ring and served to secure the edges of the sample. The top plate, with the attached glove membrane or membranes, was then placed over another plate containing 24 holes whose size was 0.6 cm diameter, located 1.9 cm from the plate edge, through which one of the curved surgical needles would pass. Four screws were placed through the plates to firmly secure the glove membrane or membranes. The support plates were then set on top of the load cell, which was then calibrated in grams. Glove samples were taken from the tubular area of the glove near the cuff and secured between the support plates, allowing a uniform strain to be placed upon the glove membrane or membranes by the pulling clamp. The curved surgical needle was positioned above one of the puncture holes and then moved downward at a rate of 10 mm/minute. After glove membrane puncture, the needle movement was stopped and returned to the starting position. The plate was then rotated to align another puncture hole, and the process was repeated. The force applied to the load cell was graphed throughout the process by a strip chart recorder. 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 each needle were taken from five samples of the Biogel® IndicatorTM underglove, Biogel® Super-SensitiveTM glove, Biogel® glove, Biogel® SkinsenseTM N Universal underglove, Biogel® SkinsenseTM Polyisoprene glove, Biogel® SkinsenseTM Polyisoprene double-glove hole puncture indication system, Biogel® Super-SensitiveTM double-glove hole puncture indication system, and the Biogel® double-glove hole puncture indication system. The computer system calculated the means and standard deviations of the puncture forces of each of the three curved surgical needles for the different glove samples. The statistical significance of the data was determined by the Student's test. The magnitude of the puncture resistance forces encountered was influenced by three factors: (1) the glove material, (2) the number of glove layers, and (3) the type of surgical needle. For each type of curved surgical needle, the resistance to needle penetration by the nonlatex gloves was significantly greater than that encountered by the latex glove material (p < .001). This enhanced resistance to glove puncture of the nonlatex gloves was noted with both the nonlatex underglove and the latex underglove. Blunting the sharp end of the taper point needle nonlatex outer glove (p < .001) markedly increased its resistance to glove puncture in the latex and nonlatex outerglove. Using the same surgical needle type, the Biogel® SkinsenseTM Polyisoprene outer glove provided the greatest resistance to surgical needle puncture followed by the Biogel® SkinsenseTM N Universal underglove (p<0.001) The resistance to needle puncture of all three double-glove hole puncture indication systems was significantly greater than that of either the non-latex or latex undergloves or outer gloves. The taper point needle encounters the lowest puncture resistance forces in the five single gloves and three double-gloves hole puncture indication systems (p<0.001). Blunting the sharp end of the taper point needle markedly increased its resistance to glove puncture of the five single gloves as well as the three double-glove hole puncture indication systems (p<0.001). The blunt point surgical needle elicited the greatest needle penetration force of all of the single- and double-glove hole puncture indication systems (p<0.001). Mast et al.20 developed both an in vitro and an ex vivo model of percutaneous needle stick injury and compared blood volumes transferred while varying exposure parameters. They also evaluated the efficacy of latex and vinyl surgical gloves for blood transfer in both models. Needle size and depth of needle penetration had statistically significant correlation with the amount of blood volume transferred by hollow needles when surgical needles were tested. Only the depth of penetration had significant influence on the volume of blood transferred. The use of glove material of any type was associated with a reduction in blood volume transferred by both hollow-bore and suture needles. The observation that glove material may decrease the exposure volume by < 50% during simulated needle sticks indicates that the risk of infection could be decreased when a needle passes through a glove before contacting skin. Even though the glove materials do not prevent all needlestick injuries, they may reduce infection risk even though there is skin penetration. In 1994, Bennett and Howard21 further evaluated the quantity of blood inoculated in a needlestick injury from suture and hypodermic needles using an in vitro model. Their study quantified the amount of blood inoculums present on several commonly used surgical and phlebotomy needles. In addition, they determined the effect of single- or double-gloving, depth of needle penetration, and needle size on inoculums volume. Nineteen gauge, 22 gauge, and 25 gauge phlebotomy needles, taper point surgical needles attached to 0, 3-0, and 5-0 sutures, as well as a cutting edge needle with a 4-0 suture were evaluated. The needles were positioned into blood labeled with epidermal growth factor and then embedded 2 or 5 mm into an agarose gel. The volume of blood inoculum varied from 133 to 683 nanoliters for the phlebotomy needles and from 35 to 366 nanoliters for surgical needles. These different needles were then passed through two, one, or no layers of surgical glove material before embedding the needles 5 mm into agarose gel. They reported that the use of one layer of surgical glove resulted in a significant (p < 0.001) decrease in inoculum from taper point needles, but not from cutting edge needles. They noted that double-gloves were even more efficient (p < 0.001) than one glove in removing blood from all suture needles, including the cutting-edge surgical needle. In contrast, surgical glove material did not significantly reduce the volume of blood inoculum transferred by phlebotomy needles. Like the above in vitro investigations, a wide variety of surgical specialists have provided convincing evidence that double-gloving protects the operating room staff from skin contamination during accidental surgical needle puncture. In 1997, Marin-Bertolin et al.22 evaluated the effectiveness of double-gloving in maintaining an intact barrier between the patient and the hands of the surgical staff during plastic surgical operations. For 2 months, the surgical staff of a plastic surgery unit randomly wore single or double-gloves during all elective surgical procedures. All operating room personnel wore latex double-gloves, except one of the surgeons with chronic eczema of the hands who wore vinyl undergloves. One pair of unused latex gloves was selected at random in one of four of all the operative procedures and tested for perforations. The perforation rate of the control as well as the operative gloves was determined using the water leak method. It was gratifying to find that the 54 control gloves had no perforations. During the 107 operations, the parenteral exposure rate was 9.3% (10 of 107). All exposures were a result of surgical needle puncture. The perforation rate for the single glove (7.3%) was similar to that for the outer glove of the double-glove system (9.8%). They reported that the perforation rate for the underglove of the double-glove system (3%) was significantly lower than those of the single gloves or outer gloves of the double-glove systems (p < 0.05). The investigators concluded that double-gloving reduced the risk of skin contamination in plastic surgical procedures. In 1999, Hollaus et al.23 examined the glove perforation rate of the latex double-glove hole puncture indication system during 100 thoracotomies. The outer gloves were the Biogel® Super-SensitiveTM glove. The underglove was the green IndicatorTM glove. Perforation of the outer gloves allowed inflow of fluid between the two pairs of gloves. The wet area of the underglove then appeared as a green spot through the translucent outer glove once the outer glove has a perforation. Because Brown24 demonstrated a 100% accuracy of this double-glove hole puncture indication system, Hollaus et al.24 used this modality rather than the water leak test as evidence of glove hole puncture. The investigators reported 150 outer glove perforations (8.9%) and only 19 underglove perforations (1.1%). On the basis of these results, they concluded that cutaneous blood exposure was prevented in 78% of all operations. They indicated that double-gloving should become a routine for thoracic surgeons, to prevent transmission of bloodborne infections. Despite the dangers of transmission of bloodborne pathogens,1 many surgeons are reluctant to use double-gloves for a variety of reasons. Some do not see the need and ignore the overwhelming evidence of bloodborne transmission of infections during surgery.2 Others complain of symptoms of hand tingling, numbness, or pain while wearing double-gloves. Others note decreased hand sensitivity, which interferes with manipulation of instruments. Consequently, Novak et al.2 assessed the hand sensitivity of surgeons without surgical gloves, with single gloves, and with double-gloves. They performed a sensory evaluation that included cutaneous pressure threshold, moving two-point discrimination, and static two-point discrimination. The cutaneous pressure thresholds varied from 1.65 to 3.22 with no gloves, 2.44 to 3.61 with single gloves, and 3.22 to 4.17 with double-gloves. It was interesting that the moving two-point discrimination was 2 mm in the majority (22 of 25) of surgeons. They reported that the lowest cutaneous pressure thresholds were noted when measured with no gloves and increased with single- and double-gloves. Statistically significant differences in cutaneous pressure thresholds were found for gloves versus no gloves and single versus double-gloves. In addition, statistically significant differences in moving two-point discriminations were identified in single versus double-gloves. The investigators concluded that double-gloves do indeed impair hand sensation. They did, however, point out that the surgeon will be able to find the correct and comfortable fit for double-gloves after a trial period that takes approximately 1 to 120 days. They suggest that the perception of decreased sensation experienced by the surgeon when first using double-gloves will likely be minimized and overcome with sensory cortex remapping. The Food and Drug Administration mandates that the glove hole leakage rate of manufactured sterile surgical gloves must not exceed 2.5%. It is surprising to the authors of this continuing education program that the potential glove leakage rate is not listed on every sterile glove package, which would remind operating room personnel that a significant number of sterile surgical gloves have holes, an invitation to the spread of deadly bloodborne viral infections between the patient and the surgeon. Moreover, it is very disappointing that the Food and Drug Administration has still not banned the use of powder on sterile surgical gloves that potentiates tissue toxicity and infection, as well as adhesions, and remains as a vector for the latex allergy epidemic.27 It is important to emphasize that the hospital setting in which double glove hole systems are used has an important influence on the accuracy of the system to detect holes in the outer glove. Fisher et al 28 documented the performance of the double glove hole indication system in the emergency department. In their study, the frequency of holes in both gloves of the double glove hole indication system was determined using a water tight test method. Second, the frequency of glove puncture was determined first by searching for the optical color change that occurs when the ingress of fluid in the double glove hole detection systems. In 50 consecutive patients, there was no color change in the inner glove indicating glove puncture. When the same gloves were then tested with the watertight test method, 14 of 50 double glove hole indication systems had indication of glove puncture. The failure of the physicians to detect visual changes at the site of glove hole puncture was due to the absence of a wet surface over the outer glove. Because it is difficult to wet the outer surface of the glove with sterile saline in the emergency department, the double glove hole indication system has no value in detecting glove puncture in the emergency department. REFERENCES
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