Glove Perforations in Ophthalmic Surgery Paul P r e n d i v i l l e , M.D., Peter J. M c D o n n e l l , M.D., and Paul P. Lee, M . D .
To determine the potential rate of intraoperative parenteral exposure of physicians and patients caused by glove perforation during ophthalmic surgery, gloves were analyzed after 125 procedures. Gloves were collected from all surgical team members (surgeon, assistants, scrub nurse, and circulating nurse). The rate of glove perforation was significantly lower for the surgeon, 0.3% (one of 303 gloves) than for the assistants, 5% (ten of 202 gloves [P = .001]), scrub nurses, 16% (52 of 326 gloves [P = .0001]), and circulating nurses, 15% (43 of 293 gloves [P = .0001]); similarly, assistants had a significantly lower rate than did scrub nurses (P = .0001) and circulating nurses (P = .001). There was no statistically significant difference in number of perforations on the basis of surgery duration or type of ophthalmic procedure. These findings suggest that the risk of parenteral exposure during ophthalmic surgery is low for the surgeon, and higher for other surgical personnel. We also analyzed additional safety precautions. Further study is warranted to determine the effectiveness of precautions and to guide policy formulation.
INCREASING PREVALENCE of the acquired immu nodeficiency syndrome (AIDS) has engendered serious concern among physicians and the pub lic about the risks of transmission during medi cal or dental procedures. 1 The wisdom, ethics, and necessity of widespread testing for the human immunodeficiency virus (HIV) have been extensively debated. 1,2 To date, only one focus (with five cases) of dentist-to-patient transmission has been documented, 1 whereas at least 15 cases of HIV infection in health care workers, contracted through occupational ex posure, have been documented. 8
Accepted for publication July 2, 1992. From the Doheny Eye Institute, and Department of Ophthalmology, University of Southern California School of Medicine, Los Angeles, California. Reprint requests to Paul P. Lee, M.D., Doheny Eye Institute, 1450 San Pablo St., Los Angeles, CA 90033.
To formulate a sound policy governing physi cian-to-patient disclosure, specific data should be acquired. The risk, as well as the mechanism, of intraoperative parenteral exposure to blood from the provider should be determined and precautions to decrease or eliminate such expo sure should be investigated. After such infor mation is known, and current knowledge of the rate of actual infection from a given number of exposures is considered, a more informed deci sion can be made. Exposure between physicians and patients is most likely during invasive procedures and dur ing trauma stabilization in the emergency room. Given the current use of protective barri er devices, most notably the use of gloves, exposure cannot occur without a breach in that barrier. Furthermore, for physician exposure, there must be a breach in the integrity of the physician's integument, and for patient expo sure, there must be an additional step of paren teral exposure to the physician's blood, either directly by seepage through the break in the barrier and then a break in the patient's skin, or indirectly through the instrument or object that breached the protective device and the physi cian's skin. Although HIV has been found in human tears, 4 no case of transmission by tears has ever been documented. Ophthalmic surgery involves little bleeding and no sharp objects except for surgical instru ments. Irrigating fluid is collected so that it does not run onto the floor or the surgical team. The use of waterproof gowns, masks, and boots, as well as the use of a microscope for most surgery, effectively isolates the surgeon (and thus the patient) from routes of exposure other than glove perforation. Recent studies have identified glove perfo ration rates of 17% to 57% in various surgi cal subspecialties, not including ophthalmol ogy. 511 In a 1984 study of ophthalmic surgery in Japan,12 a rate of 4% to 6% was identified, whereas a recently published abstract, limited to the gloves of ophthalmic surgeons, described a 15% perforation rate. 13 We studied ophthal mic surgical procedures at the Doheny Eye Institute to further describe and quantify intra-
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operative exposure to potentially infectious flu ids among members of the surgical team and, indirectly, the potential exposure of patients.
Methods Data collection—From 125 procedures, 1,124 gloves were collected for the study (303 from the surgeons, 202 from the assistants [not all cases had an assistant], 326 from the scrub nurses, and 293 from the circulating nurses). Before the initiation of this study, the circulat ing nurses were asked to change their usual routine and wear sterile gloves. At the conclu sion of the procedures, all gloves were collected by one of us (P.P.) and were evaluated for both gross and hidden perforations. The nursing staff was informed that all gloves should be saved for a study, but the purpose of the study was not disclosed to minimize the possibility that practices might be changed by the study. Because some personnel preferred the hypoallergenic (brown) gloves (Becton Dickinson, Franklin Lakes, New Jersey) over the tradition al (white) gloves (Baxter, Valencia, California), a control pair of each type of glove was ob tained each day. These 100 gloves were opened and immediately tested for perforations, with out previous use; no perforations were detect ed, which is below the accepted standard for quality assurance (1.5% perforation rate) as designated by the American Society for Testing and Materials. 14 Gloves that had been contaminated and changed intraoperatively were included in the study. There was no known instance of gloves being changed by the surgeon because of a suspected puncture wound; information on this possibility was not obtained for the assistant or nurses. In the few cases in which a team mem ber wore double gloves, both pairs were tested for perforations and were included in the data analysis. All cases were performed in the operating suites at the Doheny Eye Institute in Los Ange les, California. The study included both inpatient and outpatient modes of surgery, but did not include any procedures performed in an outpatient office. Testing for perforations—All gloves were ex amined initially for gross tears, which were defined as those occurring at the base of the glove and extending distally in a triangular or crescentic pattern. Such tears were assumed to
have occurred while putting on or taking off the gloves, and were considered too conspicuous to have gone unnoticed and introduced into the operative field. On this basis, gloves with gross tears (of which there were ten) were excluded from the analyses. After initial inspection, all gloves were distended by filling with a standard volume (500 ml) of water and firmly squeezing. All microperforations were then recorded by number per glove. Before the study, this method of identifying micropunctures was validated by puncturing three of six gloves with a single pass of a nee dle attached to a 10-0 nylon suture to ensure that leakage would be detected by a masked ob server. Statistical analysis—The data were evaluated by using both the number of glove perforations (glove perforation rate) and the number of pro cedures in which perforation occurred (case perforation rate). Each of these was examined separately. Differences between subspecialties, team members, locations of perforations, glove types, and duration of procedure were exam ined by chi-square analysis. Before analysis, procedures were categorized by duration of surgery as follows: group 1, 0 to 60 minutes (51 procedures); group 2, 61 to 120 minutes (48 procedures); and group 3, more than 120 min utes (26 procedures). The difference in punc ture rate between types of gloves was further investigated to control for differences between team members using the Cochran-Mantel Haenszel test. The significance level used for all tests was .05.
Results At least one glove was perforated by a mem ber of the surgical team during 64 of the 125 procedures, for a case perforation rate of 5 1 % . When analyzed by team members, however, the rates of perforation differed significantly be tween surgeons, 0.8% (one of 125 procedures) and assistants, 10% (nine of 91 procedures [P = .008]), scrub nurses, 3 1 % (39 of 125 procedures [P = .0001]), and circulating nurses, 22% (27 of 125 procedures [P = .0001]) (Table 1). The difference between assistants and scrub nurses (P = .0001) and circulating nurses (P = .006) was also significant. Case perforation rates among subspecialties were as follows: cornea, 42% (16 of 38 cases); glaucoma, 48% (13 of 27 cases); oculoplastics,
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399
TABLE 1 GLOVE PERFORATION RATE AND CASE PERFORATION RATE BY TEAM MEMBER
Surgeon Assistant Scrub nurse Circulating nurse Total
NO. OF PERFORA
NO. OF
GLOVE PERFORATION
TIONS
GLOVES
TOTAL NO. OF
RATE(%)
CASES OF PERFORATION*
CASES PER TEAM MEMBER
CASE PERFORATION RATE(%)
1 10 52
303 202 326
0.3 5.0 16.0
1 9 39
125 91 125
0.8 10.0 31.2
43
293
14.7
27
125
21.6
106
1124
9.4
64
125
9.4
*A given case can count only once toward the total number of cases.
55% (18 of 29 cases); and retina, 56% (15 of 27 cases) (Table 2). There was no statistically sig nificant difference in case perforation rates among subspecialties (P = .66) or duration of procedure (P = .39) for the team as a whole or for surgeons alone among subspecialties (P = .36). Of the 1,124 gloves, 106 had a perforation, for an overall rate of 9.4%. There were seven gloves with more than one perforation. When analyzed by team members (Table 1), surgeons, 0.3% (one of 303 gloves) had a statis tically significant lower rate of glove perfora tions than did assistants, 5% (ten of 202 gloves [P = .001]), scrub nurses, 16% (52 of 326 gloves [P = .0001]), and circulating nurses, 15% (43 of 293 gloves [P = .0001]). Similarly, assistants had a significantly lower rate than did scrub nurses (P = .0001) and circulating nurses (P = .001). The 95% confidence interval for the rate of glove punctures in surgeons was 0% to 1.0%, whereas that of the assistants was 2.0% to 7.9%.
The differences in glove perforation rate be tween the subspecialty procedures of cornea (11% [32 of 297 gloves]), glaucoma (7% [16 of 237 gloves]), oculoplastics (11% [28 of 260 gloves]), and retina (9% [26 of 285 gloves]) were not statistically significant (P = .33). Duration of procedure was not associated significantly with glove puncture rate for any team member, although the relationship for scrub nurses ap proached significance (P = .07) (Table 3). There was no significant difference by subspecialty procedure when analyzed by specific team members. The difference between perforation rates in brown gloves (12.9% [34 of 263 gloves]) and white gloves (8.4% [72 of 861 gloves]) was significant (P = .03). Further investigation showed that the perforation rates for scrub nurses for brown and for white gloves were 17.7% (28 of 158 gloves) and 14.3% (24 of 168 gloves), respectively; and for the other team members the rates were 6.3% (seven of 111 gloves) and 6.9% (47 of 687 gloves), respective-
TABLE 2 GLOVE PERFORATION RATE AND CASE PERFORATION RATE BY SUBSPECIALTY NO. OF
Cornea Glaucoma Oculoplastics Retina Total
PERFORA
NO. OF
GLOVE PERFORATION RATE(%)
CASES OF PERFORATION*
TOTAL NO. OF CASES
CASE PERFORATION RATE*(%)
TIONS
GLOVES
32 16 28 26 106t
297 237 260 285 1,124+
10.8 6.8 10.8 9.1 9.4
16 13 16 15 64
38 27 29 27 125*
42.1 48.2 55.2 55.6 51.2
"Defined as cases in which there was at least one puncture in one glove of the surgeon, assistant, scrub nurse, or circulating nurse. f Four cases are included in the total number but are excluded from the subspecialty data because they were procedures involving two subspecialties.
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TABLE 3 GLOVE PERFORATION RATE AND CASE PERFORATION RATE BY SUBSPECIALTY AND BY TEAM MEMBER GLOVE
NO. OF TEAM MEMBER
PERFORA-
NO. OF
PERFORATION
ATIONS
GLOVES
RATE(%)
0 0 17 15
77 42 88 90
0 3 7 6
Cornea Surgeon Assistant Scrub nurse Circulating nurse Glaucoma Surgeon Assistant Scrub nurse Circulating nurse Oculoplastics Surgeon Assistant Scrub nurse Circulating nurse Retina Surgeon Assistant Scrub nurse Circulating nurse
CASE PERFORATION
CASES OF PERFORATION
TOTAL NO. OF CASES
0 0 19.3 16.7
0 0 3 8
38 20 8 38
0 0 37.5 21.1
62 50 67 58
0 6.0 10.5 10.3
0 3 6 5
27 23 27 27
0 13.0 22.2 18.5
1 4 9 14
67 49 81 63
1.5 8.2 11.1 22.22
1 3 9 7
29 22 29 29
3.5 13.6 31.0 24.1
0 3 17 6
81 54 76 74
0 5.6 22.4 8.1
0 2 9 6
27 22 27 27
0 9.1 33.3 22.2
ly. When this difference between scrub nurses and the other team members was considered, there was no significant difference in perfora tion rates between the two types of gloves (P = .58). In other words, the seeming disparity between white and brown gloves was caused by a relative preference for brown gloves among the group with the largest number of punc tures—scrub nurses (49% [52 of 106 total punc tures]) as opposed to a strong preference for white gloves among those with lower rates (surgeons and assistants, particularly).
Discussion The risk of exposure of ophthalmologists to blood-borne diseases while performing ocular surgery in an operating room appears to be low. There was a 0.33% rate (one of 303 gloves) of surgeon glove perforation (and a 0.80% case perforation rate [one of 125 cases] for surgeons) in this study. The rate of perforation was higher for assistants, scrub nurses, and circulating nurses.
RATE(%)
The low rate of surgeon glove perforation is not unexpected, as there are no sharp instru ments in the operative field except those wield ed by the surgeon, and there are no sharp edges, such as broken bone, except in certain oculoplastic cases. The only uncertain element is the passing of instruments between the sur geon and the assistant or the scrub nurse. If surgical methods were modified slightly, glove perforations might occur less frequently. Possible modifications include the use of a no-touch rule,15,16 the use of deliberate wellchoreographed movements between team members, and the use of instrument-to-instru ment methods for passing needles. The notouch rule calls for an instrument never to be handled by more than one team member at a time. 16 When being passed between team mem bers, instruments are placed down in a neutral zone that consists of a tray or mat before being picked up by the next team member. This re duces the risk posed by unchoreographed movements between team members. If the area for placing instruments were magnetic, it might also prevent instruments from falling to the ground, and possibly prevent injuries from
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team members reflexively reaching out to grab falling sharp instruments. 16 Also, with increas ing use of laser and ultrasonic cutting devices, surgeons will have less frequent contact with blood and tissue. 16 The instrument-to-instru ment method entails the use of forceps and needle holders for loading and unloading nee dles and the use of forceps or a needle holder to advance needles through tissue. At no time is an ophthalmic needle handled directly by a gloved hand. Given the side-cutting nature of many needles, an instrument-to-instrument technique should minimize inadvertent perfo rations. It is hoped that such measures would decrease the frequency of glove perforations. We detected a lower rate of surgeon glove perforations than a recently published study, also limited to ophthalmology, which de scribed a rate of 15%. 13 This higher rate may be explained by the testing of each glove by more than one method, including some methods that were more rigorous than ours. Our method of study was similar to that in a 1984 Japanese study of ophthalmic surgery. 12 Although the control gloves in our study had no perforations, previous studies have found that 2% to 7% of sterile surgical gloves tested immediately after opening of the package had perforations. 5 · 13 Thus, the one incident of perfo ration of a surgeon glove in our study may not have resulted from an actual perforation, since this is below the defect rate set for the manufac ture of gloves. 13 Even if the perforation were real, the 95% confidence interval suggests that the rate of surgeon glove perforation is less than 1%. The high rate of perforations for the circulat ing nurses, 15% (43 of 293 gloves), may suggest that gloves can be torn or perforated by nonpuncture mechanisms. In particular, moving of equipment, twisting of lids, and opening of packages may lead to tearing of the glove. It may also mean that additional precautions need to be taken during disposal of sharp ob jects. Our circulating nurses do not directly handle unguarded sharp objects before or dur ing their use for patients. The rates of perforation for assistants, 5% (ten of 202 gloves), and for scrub nurses, 16% (52 of 326 gloves), however, were higher than that for the surgeon, but were consistent with levels described in a 1984 Japanese study. 12 In that study, the incidence of holes in the gloves of assistants ranged from 1.7% to 4.1%, where as that of nurses ranged from 10% to 1 1 % . It is
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not altogether surprising that assistants have a higher rate of perforation than do the actual surgeons, since they generally do not control the sharp objects and have their hands and fingers near the operative field, in a position to be stuck. A recent study (not limited to ophthal mic surgery) found that, among perforations with a known cause, a free gloved hand (that is, not holding a sharp instrument) in the opera tive field was the most likely to be perforat ed.17 Also, some assistants help the scrub nurse in various functions, such as loading needles onto forceps, which might further increase the risk of puncture or tearing of the glove. The high rate of perforation among scrub nurses, however, is more difficult to explain. Some scrub nurses act as assistants for certain procedures, thereby increasing the risk of being stuck by a sharp object near the operative field. The passing of sharp objects between the sur geon and nurse is of major concern, particularly since standard practice is to point the sharp object away from the surgeon—and thus toward the scrub nurse. Additionally, the scrub nurse is asked to perform functions that place shear ing stresses on the gloves, such as opening packages or twisting two halves of a sterile instrument together. These nonpuncture mech anisms may have been especially important in our study. Toward the end of a procedure, the scrub nurse begins to clean the tray and surgical area to minimize turnaround time for the next case, which can increase the chances of similar nonpuncture events. Thus, some of the record ed perforations may not be related to mecha nisms in the operative field at all. Finally, it is the nursing staff that is expected to dispose of sharp objects after a procedure; in operating suites today, where a quick turnover is expect ed, careful attention may not always be accord ed to precautions. When combined, these fac tors may account for the higher rate of perforations among scrub nurses. These findings have implications for sur geons, nurses, and patients. For the health care team, the findings show that the risk of parenteral exposure to viral disease is small for the surgeon, but higher for the nursing staff. Al though we did not examine inner and outer gloves separately when double gloves were worn, previous studies have demonstrated that perforation of inner gloves in other surgical specialties is significantly less when double gloves are worn. 6 7 1 8 Why this occurs is uncer tain. It could conceivably represent elimination
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of those cases in which glove perforation is caused by mechanisms other than direct pene tration by sharp objects. Beck19 found that, al though double-gloving is effective, requiring manufacturers to strengthen gloves might yield even more protection. Even if stronger gloves result in diminished tactile sensation, measures such as texturing the outside of gloves (like our own skin) could compensate for the difference. The use of a thimble or selective reinforcement of glove fingertips has also been advocate(J
9,10,19,20
The more daunting concern to patients is the risk of contracting HIV (or hepatitis B) from the surgeon or other members of the surgical team. From the mechanics of HIV transmission, it is clear that the protective barrier must first be breached and that the health care provider's blood be introduced parenterally into the pa tient. Thus, the risk of transmission from the provider to the patient in the surgical setting can be no higher than is the risk of a breach of the sterile barrier. When the additional steps needed to introduce the virus into the patient are added, the breach must be major (to reach the provider's blood), and unrecognized so that the glove is not changed or the instrument replaced. As such, the rate of patient exposure to the blood of a provider is bound to be less than the rate of perforation. Not all glove perfo rations may be caused by penetration with a sharp object. Furthermore, even after exposure, although the rate of actual infection is not known, it is estimated to be exceedingly low.21,22 One author estimates the risk of trans mission from a surgical team member to a patient to be one in 21 million per hour of surgery. 21 Conversely, the transmission from an HIV-positive patient to a health care worker is estimated to be higher, about 0.4% for each percutaneous exposure.23·24 The Centers for Disease Control and the American Medical Association do not support the concept of creating a list of exposure-prone services. Further commentary has suggested that even a risk of exposure lower than being struck by lightning may not be acceptable to the public as far as HIV is concerned. 25 Although many authorities support voluntary physician testing for HIV,26 issues surrounding this are unsettled. Much of the debate about current infection control procedures focuses on the respective roles of universal precautions 26 and HIV screen ing. As a single method, the use of universal precautions appears to have several advantages
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over HIV screening. Universal precautions pro tect both the patient and health care work ers,23,27 and the protection extends to infectious agents other than HIV.23·27 Also, universal pre cautions can be used in the emergency setting, where there is no time to wait for HIV test results, 23,27 and they avoid the socioeconomic pitfalls of dealing with HIV-positive labels. 27 Disadvantages of universal precautions are the additional cost of extra equipment and training, lack of compliance by health care workers, and the reality that universal precautions do not offer 100% protection, especially against inju ries from sharp objects.27 Human immunodeficiency virus screening does not offer 100% protection either. Because of the lag time between infection and seroconversion, HIV-negative results sometimes pro vide a false sense of security.16,23,27 Questions about who should be tested (patients only vs patients and health care workers), the frequen cy of testing, and the expense of testing and follow-up must all be considered. 23,27 Also, false-positive individuals would incur extra medical costs and, more importantly, face the current stigma of being HIV-positive. 27 Propo nents of HIV screening argue that knowledge of HIV-positive status would allow for special infection control procedures or more strict ad herence to standard procedures. However, there is evidence that knowledge of a patient's HIV-positive status does not improve precau tionary practices by health care workers. 5 ' 27 Also, such measures would already be in place if precautions were adhered to universally. Studies of preventable exposures to blood and body fluids estimate that as many as 74% of injuries would be prevented by adherence to universal precautions.5,20,28,29 Implicit in this fig ure is that 26% were essentially unavoidable despite the use of current universal precau tions. 28 The debate about whether limitations of universal precautions can be used to justify HIV screening or only the use of selective HIV testing will surely continue. The use of HIV testing in selected cases, as opposed to mass screening, seems to be justified in the hope that it will improve worker compliance with univer sal precautions. We know of two studies that have specifically examined the impact of universal precautions on health care worker behavior.28,30 One, a sur vey based on the behavior of health care work ers before and after universal precautions train ing, found a decrease of 5 1 % in blood exposures per year, and a similar decrease of
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annual exposures to all body fluids.28 The study concluded that compliance with universal pre cautions significantly reduced but did not elim inate the risk of exposure. Another study found low compliance among house officers caring for trauma victims in an emergency setting. 30 Strict universal precautions were adhered to in only 16% of cases, including a compliance rate of only 11% in cases when HIV was suspected. The study found a higher rate of compliance (62% of cases) after universal precautions packs (consisting of gloves, gowns, and the like) were placed in patient care areas. Certain ly, universal precautions can be cumbersome in certain situations, especially in emergency rooms, and compliance will sometimes be a problem. It is hoped that increased commit ment to universal precautions by hospital ad ministrators and health care workers will de crease parenteral virus exposures. Certainly, universal precautions should already be near optimal levels in operating suites. In our study, only one surgeon glove had an unrecognized perforation, the cause of which was unknown. Given the rate of perforation caused by manufacturing defects of 1.5% allowed by the American Society for Testing and Materials, 14 this perforation may not have occurred intraoperatively. Additional monitor ing may be helpful, but, in this study, the rate of surgeon glove perforation was less than 1%. The rate was higher for surgical assistants and nurses, but the routine use of doublegloving and greater attention to precautions and intraoperative techniques (such as instru ment-to-instrument methods of handling nee dles by nurses) may significantly lower perfora tion rates. Unfortunately, in our study, the rate of double-gloving was too small to be valid for statistical analysis. Further investigation is needed to determine the effectiveness of these interventions and to quantify the rate of unrec ognized perforation among nurses and assis tants. There are data to suggest that the rate of unrecognized perforations is high when com paring intraoperative reporting of perforations to actual postoperative testing of gloves for microperforations, 6 ' 6 and it may be useful if fu ture studies take this into account. We recommend the use of universal precau tions as the primary method for infection con trol. The use of double gloves, which appears to be increasing among our personnel, should be encouraged. We also recommend the use of selective HIV testing, as well as other tests (such as testing for hepatitis B), rather than the
403
use of mass HIV screening. The risk of transmission of HIV cannot be totally eliminated in any interaction between two individuals. One could postulate that HIVinfected individuals would wipe their faces, get saliva or tears on a hand, and introduce it (and HIV) into an open wound on an acquaintance's hand by shaking it. Although extremely unlike ly, this is not theoretically impossible. Thus, as a matter of policy, we cannot totally eliminate the risk of HIV transmission in our society unless we are to adopt certain measures unac ceptable to most individuals. 31 This study suggests that the rate of unsus pected glove perforations for surgeons during ophthalmic surgery is less than the expected rate of manufacturing defects for surgical gloves. As such, physicians and patients should be reassured that the risk is low, lower than our ability to detect a difference compared to manu facturing standards. The higher perforation rates for nurses and assistants suggest the need for additional investigation.
ACKNOWLEDGMENT
Martha Lee, Ph.D., performed statistical analyses.
References 1. Centers for Disease Control: Update. Transmis sion of HIV infection during invasive dental proce dures—Florida. M.M.W.R. 40:377, 1991. 2. Brennan, T. A.: Transmission of the human im munodeficiency virus in the health care setting— time for action. N. Engl. J. Med. 324:1504, 1991. 3. Centers for Disease Control: Update. Acquired immunodeficiency syndrome and human immunode ficiency virus infection among health-care workers. M.M.W.R. 37:229, 1988. 4. Fujikawa, L. S., Salahuddin, S. Z., Ablashi, D., Palestine, A. G., Masur, H., Nussenblatt, R. B., and Gallo, R. C: HTLV-III in the tears of AIDS patients. Ophthalmology 93:1479, 1986. 5. Gerberding, J. L., Littell, C , Tarkington, A., Brown, A., and Schecter, W. P.: Risk of exposure of surgical personnel to patients' blood during surgery at San Francisco General Hospital. N. Engl. J. Med. 322:1788, 1990. 6. Eckersley, J. R. T., and Williamson, D. M.: Glove punctures in an orthopaedic trauma unit. Inju ry 21:177, 1990. 7. McCue, S. F., Berg, E. W., and Saunders, E. A.: Efficacy of double-gloving as a barrier to microbial
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contamination during total joint arthroplasty. J. Bone Joint Surg. 63:811, 1981. 8. McNicholas, T. A., Jones, D. J., and Sibley, G. N. A.: AIDS. The contamination risk in urological surgery. Br. J. Urol. 63:565, 1989. 9. Lowenfels, A. B., Wormser, G. P., and Jain, R.: Frequency of puncture injuries in surgeons and esti mated risk of HIV infection. Arch. Surg. 124:1284, 1989. 10. Hussain, S. A., Latif, A. B. A., and Choudhary, A. A. A. A.: Risk to surgeons. A survey of accidental injuries during operations. Br. J. Surg. 75:314, 1988. 11. Brough, S. J., Hunt, T. M., and Barrie, W. W.: Surgical glove perforations. Br. J. Surg. 75:317, 1988. 12. Nakazawa, M., Sato, K., and Mizuno, K.: Inci dence of perforations in rubber gloves during oph thalmic surgery. Ophthalmic Surg. 15:236, 1984. 13. Miller, K. M., and Apt, L.: Occult perforations in surgical gloves during ophthalmic surgical proce dures. ARVO abstracts. Supplement to Invest. Ophthalmol. Vis. Sci. Philadelphia, J. B. Lippincott, 1992, p. 254. 14. Beck, W. C , and Nora, P. F.: In brief. Bull. Am. Coll. Surg. 62:17, 1977. 15. Bessinger, C D . : Preventing transmission of human immunodeficiency virus during operations. Surg. Gynecol. Obstet. 167:287, 1988. 16. Sim, A. J. W., and Dudley, H. A. F.: Surgeons and HIV. Br. Med. J. 296:80, 1988. 17. Wright, J. G., McGeer, A. J., Chyatte, D., and Ransohoff, D. F.: Mechanisms of glove tears and sharp injuries among surgical personnel. J.A.M.A. 266:1668, 1991. 18. Matta, H., Thompson, A. M., and Rainey, J. B.: Does wearing two pairs of gloves protect operating theatre staff from skin contamination? Br. Med. J. 197:597, 1988. 19. Beck, W. C : The hole in the surgical glove. A change in attitude. Bull. Am. Coll. Surg. 74:15, 1989. 20. Panilio, A. L., Foy, D. R., Edwards, J. R., Bell, D. M., Welch, B. A., Parrish, C. M., Culver, D. H., Lowry, P. W., Jarvis, W. R., and Perlino, C. A.: Blood
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contacts during surgical procedures. J.A.M.A. 265:1533, 1991. 21. Lowenfels, A. B., and Wormser, G.: Risk of HIV transmission from surgeon to patient. N. Engl. J. Med. 325:888, 1991. 22. Chamberland, M. E.: HIV transmission from health care worker to patient. What is the risk? Ann. Intern. Med. 116:871, 2792. 23. Becker, C. E., Cone, J. E., and Gerberding, J. L.: Occupational infection with human immunode ficiency virus (HIV). Ann. Intern. Med. 110:653, 1989. 24. Bell, D. M.: Human immunodeficiency virus transmission in health care settings. Risks and risk reduction. Am. J. Med. 91(S3B):294S, 1991. 25. Daniels, N.: HIV-infected professionals, pa tient rights, and the "switching dilemma." J.A.M.A. 267:1368, 1992. 26. Centers for Disease Control: Recommenda tions for prevention of HIV transmission in health care settings. M.M.W.R. 36(suppl.):3S, 1987. 27. Gerberding, J. L., and Henderson, D. K.: De sign of rational infection control policies for human immunodeficiency virus infection. J. Infect. Dis. 156:861, 1987. 28. Hammond, J. S., Eckes, J. M„ Gomez, G. A., and Cunningham, D. N.: HIV, trauma, and ignored infection control. Universal precautions are univer sally ignored. J. Trauma 30:555, 1990. 29. McCray, E., and The Cooperative Needlestick Surveillance Group: Occupational risk of the ac quired immunodeficiency syndrome among health care workers. N. Engl. J. Med. 314:1127, 1986. 30. Fahey, B. J., Koziol, D. E., Banks, S. M., and Henderson, D. K.: Frequency of nonparenteral occu pational exposures to blood and body fluids before and after universal precaution training. Am. J. Med. 90:145, 1991. 31. Lo, B., and Steinbrook, R.: Health care workers infected with the human immunodeficiency virus. J.A.M.A. 267:1100, 1992.
To determine the potential rate of intraoperative parenteral exposure of physicians and patients caused by glove perforation during ophthalmic surgery, gloves were analyzed after 125 procedures. Gloves were collected from all surgical team members (surgeon, assistants, scrub nurse, and circulating nurse). The rate of glove perforation was significantly lower for the surgeon, 0.3% (one of 303 gloves) than for the assistants, 5% (ten of 202 gloves [P = .001]), scrub nurses, 16% (52 of 326 gloves [P = .0001]), and circulating nurses, 15% (43 of 293 gloves [P = .0001]); similarly, assistants had a significantly lower rate than did scrub nurses (P = .0001) and circulating nurses (P = .001). There was no statistically significant difference in number of perforations on the basis of surgery duration or type of ophthalmic procedure. These findings suggest that the risk of parenteral exposure during ophthalmic surgery is low for the surgeon, and higher for other surgical personnel. We also analyzed additional safety precautions. Further study is warranted to determine the effectiveness of precautions and to guide policy formulation.
INCREASING PREVALENCE of the acquired immu nodeficiency syndrome (AIDS) has engendered serious concern among physicians and the pub lic about the risks of transmission during medi cal or dental procedures. 1 The wisdom, ethics, and necessity of widespread testing for the human immunodeficiency virus (HIV) have been extensively debated. 1,2 To date, only one focus (with five cases) of dentist-to-patient transmission has been documented, 1 whereas at least 15 cases of HIV infection in health care workers, contracted through occupational ex posure, have been documented. 8
Accepted for publication July 2, 1992. From the Doheny Eye Institute, and Department of Ophthalmology, University of Southern California School of Medicine, Los Angeles, California. Reprint requests to Paul P. Lee, M.D., Doheny Eye Institute, 1450 San Pablo St., Los Angeles, CA 90033.
To formulate a sound policy governing physi cian-to-patient disclosure, specific data should be acquired. The risk, as well as the mechanism, of intraoperative parenteral exposure to blood from the provider should be determined and precautions to decrease or eliminate such expo sure should be investigated. After such infor mation is known, and current knowledge of the rate of actual infection from a given number of exposures is considered, a more informed deci sion can be made. Exposure between physicians and patients is most likely during invasive procedures and dur ing trauma stabilization in the emergency room. Given the current use of protective barri er devices, most notably the use of gloves, exposure cannot occur without a breach in that barrier. Furthermore, for physician exposure, there must be a breach in the integrity of the physician's integument, and for patient expo sure, there must be an additional step of paren teral exposure to the physician's blood, either directly by seepage through the break in the barrier and then a break in the patient's skin, or indirectly through the instrument or object that breached the protective device and the physi cian's skin. Although HIV has been found in human tears, 4 no case of transmission by tears has ever been documented. Ophthalmic surgery involves little bleeding and no sharp objects except for surgical instru ments. Irrigating fluid is collected so that it does not run onto the floor or the surgical team. The use of waterproof gowns, masks, and boots, as well as the use of a microscope for most surgery, effectively isolates the surgeon (and thus the patient) from routes of exposure other than glove perforation. Recent studies have identified glove perfo ration rates of 17% to 57% in various surgi cal subspecialties, not including ophthalmol ogy. 511 In a 1984 study of ophthalmic surgery in Japan,12 a rate of 4% to 6% was identified, whereas a recently published abstract, limited to the gloves of ophthalmic surgeons, described a 15% perforation rate. 13 We studied ophthal mic surgical procedures at the Doheny Eye Institute to further describe and quantify intra-
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operative exposure to potentially infectious flu ids among members of the surgical team and, indirectly, the potential exposure of patients.
Methods Data collection—From 125 procedures, 1,124 gloves were collected for the study (303 from the surgeons, 202 from the assistants [not all cases had an assistant], 326 from the scrub nurses, and 293 from the circulating nurses). Before the initiation of this study, the circulat ing nurses were asked to change their usual routine and wear sterile gloves. At the conclu sion of the procedures, all gloves were collected by one of us (P.P.) and were evaluated for both gross and hidden perforations. The nursing staff was informed that all gloves should be saved for a study, but the purpose of the study was not disclosed to minimize the possibility that practices might be changed by the study. Because some personnel preferred the hypoallergenic (brown) gloves (Becton Dickinson, Franklin Lakes, New Jersey) over the tradition al (white) gloves (Baxter, Valencia, California), a control pair of each type of glove was ob tained each day. These 100 gloves were opened and immediately tested for perforations, with out previous use; no perforations were detect ed, which is below the accepted standard for quality assurance (1.5% perforation rate) as designated by the American Society for Testing and Materials. 14 Gloves that had been contaminated and changed intraoperatively were included in the study. There was no known instance of gloves being changed by the surgeon because of a suspected puncture wound; information on this possibility was not obtained for the assistant or nurses. In the few cases in which a team mem ber wore double gloves, both pairs were tested for perforations and were included in the data analysis. All cases were performed in the operating suites at the Doheny Eye Institute in Los Ange les, California. The study included both inpatient and outpatient modes of surgery, but did not include any procedures performed in an outpatient office. Testing for perforations—All gloves were ex amined initially for gross tears, which were defined as those occurring at the base of the glove and extending distally in a triangular or crescentic pattern. Such tears were assumed to
have occurred while putting on or taking off the gloves, and were considered too conspicuous to have gone unnoticed and introduced into the operative field. On this basis, gloves with gross tears (of which there were ten) were excluded from the analyses. After initial inspection, all gloves were distended by filling with a standard volume (500 ml) of water and firmly squeezing. All microperforations were then recorded by number per glove. Before the study, this method of identifying micropunctures was validated by puncturing three of six gloves with a single pass of a nee dle attached to a 10-0 nylon suture to ensure that leakage would be detected by a masked ob server. Statistical analysis—The data were evaluated by using both the number of glove perforations (glove perforation rate) and the number of pro cedures in which perforation occurred (case perforation rate). Each of these was examined separately. Differences between subspecialties, team members, locations of perforations, glove types, and duration of procedure were exam ined by chi-square analysis. Before analysis, procedures were categorized by duration of surgery as follows: group 1, 0 to 60 minutes (51 procedures); group 2, 61 to 120 minutes (48 procedures); and group 3, more than 120 min utes (26 procedures). The difference in punc ture rate between types of gloves was further investigated to control for differences between team members using the Cochran-Mantel Haenszel test. The significance level used for all tests was .05.
Results At least one glove was perforated by a mem ber of the surgical team during 64 of the 125 procedures, for a case perforation rate of 5 1 % . When analyzed by team members, however, the rates of perforation differed significantly be tween surgeons, 0.8% (one of 125 procedures) and assistants, 10% (nine of 91 procedures [P = .008]), scrub nurses, 3 1 % (39 of 125 procedures [P = .0001]), and circulating nurses, 22% (27 of 125 procedures [P = .0001]) (Table 1). The difference between assistants and scrub nurses (P = .0001) and circulating nurses (P = .006) was also significant. Case perforation rates among subspecialties were as follows: cornea, 42% (16 of 38 cases); glaucoma, 48% (13 of 27 cases); oculoplastics,
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399
TABLE 1 GLOVE PERFORATION RATE AND CASE PERFORATION RATE BY TEAM MEMBER
Surgeon Assistant Scrub nurse Circulating nurse Total
NO. OF PERFORA
NO. OF
GLOVE PERFORATION
TIONS
GLOVES
TOTAL NO. OF
RATE(%)
CASES OF PERFORATION*
CASES PER TEAM MEMBER
CASE PERFORATION RATE(%)
1 10 52
303 202 326
0.3 5.0 16.0
1 9 39
125 91 125
0.8 10.0 31.2
43
293
14.7
27
125
21.6
106
1124
9.4
64
125
9.4
*A given case can count only once toward the total number of cases.
55% (18 of 29 cases); and retina, 56% (15 of 27 cases) (Table 2). There was no statistically sig nificant difference in case perforation rates among subspecialties (P = .66) or duration of procedure (P = .39) for the team as a whole or for surgeons alone among subspecialties (P = .36). Of the 1,124 gloves, 106 had a perforation, for an overall rate of 9.4%. There were seven gloves with more than one perforation. When analyzed by team members (Table 1), surgeons, 0.3% (one of 303 gloves) had a statis tically significant lower rate of glove perfora tions than did assistants, 5% (ten of 202 gloves [P = .001]), scrub nurses, 16% (52 of 326 gloves [P = .0001]), and circulating nurses, 15% (43 of 293 gloves [P = .0001]). Similarly, assistants had a significantly lower rate than did scrub nurses (P = .0001) and circulating nurses (P = .001). The 95% confidence interval for the rate of glove punctures in surgeons was 0% to 1.0%, whereas that of the assistants was 2.0% to 7.9%.
The differences in glove perforation rate be tween the subspecialty procedures of cornea (11% [32 of 297 gloves]), glaucoma (7% [16 of 237 gloves]), oculoplastics (11% [28 of 260 gloves]), and retina (9% [26 of 285 gloves]) were not statistically significant (P = .33). Duration of procedure was not associated significantly with glove puncture rate for any team member, although the relationship for scrub nurses ap proached significance (P = .07) (Table 3). There was no significant difference by subspecialty procedure when analyzed by specific team members. The difference between perforation rates in brown gloves (12.9% [34 of 263 gloves]) and white gloves (8.4% [72 of 861 gloves]) was significant (P = .03). Further investigation showed that the perforation rates for scrub nurses for brown and for white gloves were 17.7% (28 of 158 gloves) and 14.3% (24 of 168 gloves), respectively; and for the other team members the rates were 6.3% (seven of 111 gloves) and 6.9% (47 of 687 gloves), respective-
TABLE 2 GLOVE PERFORATION RATE AND CASE PERFORATION RATE BY SUBSPECIALTY NO. OF
Cornea Glaucoma Oculoplastics Retina Total
PERFORA
NO. OF
GLOVE PERFORATION RATE(%)
CASES OF PERFORATION*
TOTAL NO. OF CASES
CASE PERFORATION RATE*(%)
TIONS
GLOVES
32 16 28 26 106t
297 237 260 285 1,124+
10.8 6.8 10.8 9.1 9.4
16 13 16 15 64
38 27 29 27 125*
42.1 48.2 55.2 55.6 51.2
"Defined as cases in which there was at least one puncture in one glove of the surgeon, assistant, scrub nurse, or circulating nurse. f Four cases are included in the total number but are excluded from the subspecialty data because they were procedures involving two subspecialties.
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TABLE 3 GLOVE PERFORATION RATE AND CASE PERFORATION RATE BY SUBSPECIALTY AND BY TEAM MEMBER GLOVE
NO. OF TEAM MEMBER
PERFORA-
NO. OF
PERFORATION
ATIONS
GLOVES
RATE(%)
0 0 17 15
77 42 88 90
0 3 7 6
Cornea Surgeon Assistant Scrub nurse Circulating nurse Glaucoma Surgeon Assistant Scrub nurse Circulating nurse Oculoplastics Surgeon Assistant Scrub nurse Circulating nurse Retina Surgeon Assistant Scrub nurse Circulating nurse
CASE PERFORATION
CASES OF PERFORATION
TOTAL NO. OF CASES
0 0 19.3 16.7
0 0 3 8
38 20 8 38
0 0 37.5 21.1
62 50 67 58
0 6.0 10.5 10.3
0 3 6 5
27 23 27 27
0 13.0 22.2 18.5
1 4 9 14
67 49 81 63
1.5 8.2 11.1 22.22
1 3 9 7
29 22 29 29
3.5 13.6 31.0 24.1
0 3 17 6
81 54 76 74
0 5.6 22.4 8.1
0 2 9 6
27 22 27 27
0 9.1 33.3 22.2
ly. When this difference between scrub nurses and the other team members was considered, there was no significant difference in perfora tion rates between the two types of gloves (P = .58). In other words, the seeming disparity between white and brown gloves was caused by a relative preference for brown gloves among the group with the largest number of punc tures—scrub nurses (49% [52 of 106 total punc tures]) as opposed to a strong preference for white gloves among those with lower rates (surgeons and assistants, particularly).
Discussion The risk of exposure of ophthalmologists to blood-borne diseases while performing ocular surgery in an operating room appears to be low. There was a 0.33% rate (one of 303 gloves) of surgeon glove perforation (and a 0.80% case perforation rate [one of 125 cases] for surgeons) in this study. The rate of perforation was higher for assistants, scrub nurses, and circulating nurses.
RATE(%)
The low rate of surgeon glove perforation is not unexpected, as there are no sharp instru ments in the operative field except those wield ed by the surgeon, and there are no sharp edges, such as broken bone, except in certain oculoplastic cases. The only uncertain element is the passing of instruments between the sur geon and the assistant or the scrub nurse. If surgical methods were modified slightly, glove perforations might occur less frequently. Possible modifications include the use of a no-touch rule,15,16 the use of deliberate wellchoreographed movements between team members, and the use of instrument-to-instru ment methods for passing needles. The notouch rule calls for an instrument never to be handled by more than one team member at a time. 16 When being passed between team mem bers, instruments are placed down in a neutral zone that consists of a tray or mat before being picked up by the next team member. This re duces the risk posed by unchoreographed movements between team members. If the area for placing instruments were magnetic, it might also prevent instruments from falling to the ground, and possibly prevent injuries from
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team members reflexively reaching out to grab falling sharp instruments. 16 Also, with increas ing use of laser and ultrasonic cutting devices, surgeons will have less frequent contact with blood and tissue. 16 The instrument-to-instru ment method entails the use of forceps and needle holders for loading and unloading nee dles and the use of forceps or a needle holder to advance needles through tissue. At no time is an ophthalmic needle handled directly by a gloved hand. Given the side-cutting nature of many needles, an instrument-to-instrument technique should minimize inadvertent perfo rations. It is hoped that such measures would decrease the frequency of glove perforations. We detected a lower rate of surgeon glove perforations than a recently published study, also limited to ophthalmology, which de scribed a rate of 15%. 13 This higher rate may be explained by the testing of each glove by more than one method, including some methods that were more rigorous than ours. Our method of study was similar to that in a 1984 Japanese study of ophthalmic surgery. 12 Although the control gloves in our study had no perforations, previous studies have found that 2% to 7% of sterile surgical gloves tested immediately after opening of the package had perforations. 5 · 13 Thus, the one incident of perfo ration of a surgeon glove in our study may not have resulted from an actual perforation, since this is below the defect rate set for the manufac ture of gloves. 13 Even if the perforation were real, the 95% confidence interval suggests that the rate of surgeon glove perforation is less than 1%. The high rate of perforations for the circulat ing nurses, 15% (43 of 293 gloves), may suggest that gloves can be torn or perforated by nonpuncture mechanisms. In particular, moving of equipment, twisting of lids, and opening of packages may lead to tearing of the glove. It may also mean that additional precautions need to be taken during disposal of sharp ob jects. Our circulating nurses do not directly handle unguarded sharp objects before or dur ing their use for patients. The rates of perforation for assistants, 5% (ten of 202 gloves), and for scrub nurses, 16% (52 of 326 gloves), however, were higher than that for the surgeon, but were consistent with levels described in a 1984 Japanese study. 12 In that study, the incidence of holes in the gloves of assistants ranged from 1.7% to 4.1%, where as that of nurses ranged from 10% to 1 1 % . It is
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not altogether surprising that assistants have a higher rate of perforation than do the actual surgeons, since they generally do not control the sharp objects and have their hands and fingers near the operative field, in a position to be stuck. A recent study (not limited to ophthal mic surgery) found that, among perforations with a known cause, a free gloved hand (that is, not holding a sharp instrument) in the opera tive field was the most likely to be perforat ed.17 Also, some assistants help the scrub nurse in various functions, such as loading needles onto forceps, which might further increase the risk of puncture or tearing of the glove. The high rate of perforation among scrub nurses, however, is more difficult to explain. Some scrub nurses act as assistants for certain procedures, thereby increasing the risk of being stuck by a sharp object near the operative field. The passing of sharp objects between the sur geon and nurse is of major concern, particularly since standard practice is to point the sharp object away from the surgeon—and thus toward the scrub nurse. Additionally, the scrub nurse is asked to perform functions that place shear ing stresses on the gloves, such as opening packages or twisting two halves of a sterile instrument together. These nonpuncture mech anisms may have been especially important in our study. Toward the end of a procedure, the scrub nurse begins to clean the tray and surgical area to minimize turnaround time for the next case, which can increase the chances of similar nonpuncture events. Thus, some of the record ed perforations may not be related to mecha nisms in the operative field at all. Finally, it is the nursing staff that is expected to dispose of sharp objects after a procedure; in operating suites today, where a quick turnover is expect ed, careful attention may not always be accord ed to precautions. When combined, these fac tors may account for the higher rate of perforations among scrub nurses. These findings have implications for sur geons, nurses, and patients. For the health care team, the findings show that the risk of parenteral exposure to viral disease is small for the surgeon, but higher for the nursing staff. Al though we did not examine inner and outer gloves separately when double gloves were worn, previous studies have demonstrated that perforation of inner gloves in other surgical specialties is significantly less when double gloves are worn. 6 7 1 8 Why this occurs is uncer tain. It could conceivably represent elimination
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of those cases in which glove perforation is caused by mechanisms other than direct pene tration by sharp objects. Beck19 found that, al though double-gloving is effective, requiring manufacturers to strengthen gloves might yield even more protection. Even if stronger gloves result in diminished tactile sensation, measures such as texturing the outside of gloves (like our own skin) could compensate for the difference. The use of a thimble or selective reinforcement of glove fingertips has also been advocate(J
9,10,19,20
The more daunting concern to patients is the risk of contracting HIV (or hepatitis B) from the surgeon or other members of the surgical team. From the mechanics of HIV transmission, it is clear that the protective barrier must first be breached and that the health care provider's blood be introduced parenterally into the pa tient. Thus, the risk of transmission from the provider to the patient in the surgical setting can be no higher than is the risk of a breach of the sterile barrier. When the additional steps needed to introduce the virus into the patient are added, the breach must be major (to reach the provider's blood), and unrecognized so that the glove is not changed or the instrument replaced. As such, the rate of patient exposure to the blood of a provider is bound to be less than the rate of perforation. Not all glove perfo rations may be caused by penetration with a sharp object. Furthermore, even after exposure, although the rate of actual infection is not known, it is estimated to be exceedingly low.21,22 One author estimates the risk of trans mission from a surgical team member to a patient to be one in 21 million per hour of surgery. 21 Conversely, the transmission from an HIV-positive patient to a health care worker is estimated to be higher, about 0.4% for each percutaneous exposure.23·24 The Centers for Disease Control and the American Medical Association do not support the concept of creating a list of exposure-prone services. Further commentary has suggested that even a risk of exposure lower than being struck by lightning may not be acceptable to the public as far as HIV is concerned. 25 Although many authorities support voluntary physician testing for HIV,26 issues surrounding this are unsettled. Much of the debate about current infection control procedures focuses on the respective roles of universal precautions 26 and HIV screen ing. As a single method, the use of universal precautions appears to have several advantages
October, 1992
over HIV screening. Universal precautions pro tect both the patient and health care work ers,23,27 and the protection extends to infectious agents other than HIV.23·27 Also, universal pre cautions can be used in the emergency setting, where there is no time to wait for HIV test results, 23,27 and they avoid the socioeconomic pitfalls of dealing with HIV-positive labels. 27 Disadvantages of universal precautions are the additional cost of extra equipment and training, lack of compliance by health care workers, and the reality that universal precautions do not offer 100% protection, especially against inju ries from sharp objects.27 Human immunodeficiency virus screening does not offer 100% protection either. Because of the lag time between infection and seroconversion, HIV-negative results sometimes pro vide a false sense of security.16,23,27 Questions about who should be tested (patients only vs patients and health care workers), the frequen cy of testing, and the expense of testing and follow-up must all be considered. 23,27 Also, false-positive individuals would incur extra medical costs and, more importantly, face the current stigma of being HIV-positive. 27 Propo nents of HIV screening argue that knowledge of HIV-positive status would allow for special infection control procedures or more strict ad herence to standard procedures. However, there is evidence that knowledge of a patient's HIV-positive status does not improve precau tionary practices by health care workers. 5 ' 27 Also, such measures would already be in place if precautions were adhered to universally. Studies of preventable exposures to blood and body fluids estimate that as many as 74% of injuries would be prevented by adherence to universal precautions.5,20,28,29 Implicit in this fig ure is that 26% were essentially unavoidable despite the use of current universal precau tions. 28 The debate about whether limitations of universal precautions can be used to justify HIV screening or only the use of selective HIV testing will surely continue. The use of HIV testing in selected cases, as opposed to mass screening, seems to be justified in the hope that it will improve worker compliance with univer sal precautions. We know of two studies that have specifically examined the impact of universal precautions on health care worker behavior.28,30 One, a sur vey based on the behavior of health care work ers before and after universal precautions train ing, found a decrease of 5 1 % in blood exposures per year, and a similar decrease of
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annual exposures to all body fluids.28 The study concluded that compliance with universal pre cautions significantly reduced but did not elim inate the risk of exposure. Another study found low compliance among house officers caring for trauma victims in an emergency setting. 30 Strict universal precautions were adhered to in only 16% of cases, including a compliance rate of only 11% in cases when HIV was suspected. The study found a higher rate of compliance (62% of cases) after universal precautions packs (consisting of gloves, gowns, and the like) were placed in patient care areas. Certain ly, universal precautions can be cumbersome in certain situations, especially in emergency rooms, and compliance will sometimes be a problem. It is hoped that increased commit ment to universal precautions by hospital ad ministrators and health care workers will de crease parenteral virus exposures. Certainly, universal precautions should already be near optimal levels in operating suites. In our study, only one surgeon glove had an unrecognized perforation, the cause of which was unknown. Given the rate of perforation caused by manufacturing defects of 1.5% allowed by the American Society for Testing and Materials, 14 this perforation may not have occurred intraoperatively. Additional monitor ing may be helpful, but, in this study, the rate of surgeon glove perforation was less than 1%. The rate was higher for surgical assistants and nurses, but the routine use of doublegloving and greater attention to precautions and intraoperative techniques (such as instru ment-to-instrument methods of handling nee dles by nurses) may significantly lower perfora tion rates. Unfortunately, in our study, the rate of double-gloving was too small to be valid for statistical analysis. Further investigation is needed to determine the effectiveness of these interventions and to quantify the rate of unrec ognized perforation among nurses and assis tants. There are data to suggest that the rate of unrecognized perforations is high when com paring intraoperative reporting of perforations to actual postoperative testing of gloves for microperforations, 6 ' 6 and it may be useful if fu ture studies take this into account. We recommend the use of universal precau tions as the primary method for infection con trol. The use of double gloves, which appears to be increasing among our personnel, should be encouraged. We also recommend the use of selective HIV testing, as well as other tests (such as testing for hepatitis B), rather than the
403
use of mass HIV screening. The risk of transmission of HIV cannot be totally eliminated in any interaction between two individuals. One could postulate that HIVinfected individuals would wipe their faces, get saliva or tears on a hand, and introduce it (and HIV) into an open wound on an acquaintance's hand by shaking it. Although extremely unlike ly, this is not theoretically impossible. Thus, as a matter of policy, we cannot totally eliminate the risk of HIV transmission in our society unless we are to adopt certain measures unac ceptable to most individuals. 31 This study suggests that the rate of unsus pected glove perforations for surgeons during ophthalmic surgery is less than the expected rate of manufacturing defects for surgical gloves. As such, physicians and patients should be reassured that the risk is low, lower than our ability to detect a difference compared to manu facturing standards. The higher perforation rates for nurses and assistants suggest the need for additional investigation.
ACKNOWLEDGMENT
Martha Lee, Ph.D., performed statistical analyses.
References 1. Centers for Disease Control: Update. Transmis sion of HIV infection during invasive dental proce dures—Florida. M.M.W.R. 40:377, 1991. 2. Brennan, T. A.: Transmission of the human im munodeficiency virus in the health care setting— time for action. N. Engl. J. Med. 324:1504, 1991. 3. Centers for Disease Control: Update. Acquired immunodeficiency syndrome and human immunode ficiency virus infection among health-care workers. M.M.W.R. 37:229, 1988. 4. Fujikawa, L. S., Salahuddin, S. Z., Ablashi, D., Palestine, A. G., Masur, H., Nussenblatt, R. B., and Gallo, R. C: HTLV-III in the tears of AIDS patients. Ophthalmology 93:1479, 1986. 5. Gerberding, J. L., Littell, C , Tarkington, A., Brown, A., and Schecter, W. P.: Risk of exposure of surgical personnel to patients' blood during surgery at San Francisco General Hospital. N. Engl. J. Med. 322:1788, 1990. 6. Eckersley, J. R. T., and Williamson, D. M.: Glove punctures in an orthopaedic trauma unit. Inju ry 21:177, 1990. 7. McCue, S. F., Berg, E. W., and Saunders, E. A.: Efficacy of double-gloving as a barrier to microbial
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contamination during total joint arthroplasty. J. Bone Joint Surg. 63:811, 1981. 8. McNicholas, T. A., Jones, D. J., and Sibley, G. N. A.: AIDS. The contamination risk in urological surgery. Br. J. Urol. 63:565, 1989. 9. Lowenfels, A. B., Wormser, G. P., and Jain, R.: Frequency of puncture injuries in surgeons and esti mated risk of HIV infection. Arch. Surg. 124:1284, 1989. 10. Hussain, S. A., Latif, A. B. A., and Choudhary, A. A. A. A.: Risk to surgeons. A survey of accidental injuries during operations. Br. J. Surg. 75:314, 1988. 11. Brough, S. J., Hunt, T. M., and Barrie, W. W.: Surgical glove perforations. Br. J. Surg. 75:317, 1988. 12. Nakazawa, M., Sato, K., and Mizuno, K.: Inci dence of perforations in rubber gloves during oph thalmic surgery. Ophthalmic Surg. 15:236, 1984. 13. Miller, K. M., and Apt, L.: Occult perforations in surgical gloves during ophthalmic surgical proce dures. ARVO abstracts. Supplement to Invest. Ophthalmol. Vis. Sci. Philadelphia, J. B. Lippincott, 1992, p. 254. 14. Beck, W. C , and Nora, P. F.: In brief. Bull. Am. Coll. Surg. 62:17, 1977. 15. Bessinger, C D . : Preventing transmission of human immunodeficiency virus during operations. Surg. Gynecol. Obstet. 167:287, 1988. 16. Sim, A. J. W., and Dudley, H. A. F.: Surgeons and HIV. Br. Med. J. 296:80, 1988. 17. Wright, J. G., McGeer, A. J., Chyatte, D., and Ransohoff, D. F.: Mechanisms of glove tears and sharp injuries among surgical personnel. J.A.M.A. 266:1668, 1991. 18. Matta, H., Thompson, A. M., and Rainey, J. B.: Does wearing two pairs of gloves protect operating theatre staff from skin contamination? Br. Med. J. 197:597, 1988. 19. Beck, W. C : The hole in the surgical glove. A change in attitude. Bull. Am. Coll. Surg. 74:15, 1989. 20. Panilio, A. L., Foy, D. R., Edwards, J. R., Bell, D. M., Welch, B. A., Parrish, C. M., Culver, D. H., Lowry, P. W., Jarvis, W. R., and Perlino, C. A.: Blood
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contacts during surgical procedures. J.A.M.A. 265:1533, 1991. 21. Lowenfels, A. B., and Wormser, G.: Risk of HIV transmission from surgeon to patient. N. Engl. J. Med. 325:888, 1991. 22. Chamberland, M. E.: HIV transmission from health care worker to patient. What is the risk? Ann. Intern. Med. 116:871, 2792. 23. Becker, C. E., Cone, J. E., and Gerberding, J. L.: Occupational infection with human immunode ficiency virus (HIV). Ann. Intern. Med. 110:653, 1989. 24. Bell, D. M.: Human immunodeficiency virus transmission in health care settings. Risks and risk reduction. Am. J. Med. 91(S3B):294S, 1991. 25. Daniels, N.: HIV-infected professionals, pa tient rights, and the "switching dilemma." J.A.M.A. 267:1368, 1992. 26. Centers for Disease Control: Recommenda tions for prevention of HIV transmission in health care settings. M.M.W.R. 36(suppl.):3S, 1987. 27. Gerberding, J. L., and Henderson, D. K.: De sign of rational infection control policies for human immunodeficiency virus infection. J. Infect. Dis. 156:861, 1987. 28. Hammond, J. S., Eckes, J. M„ Gomez, G. A., and Cunningham, D. N.: HIV, trauma, and ignored infection control. Universal precautions are univer sally ignored. J. Trauma 30:555, 1990. 29. McCray, E., and The Cooperative Needlestick Surveillance Group: Occupational risk of the ac quired immunodeficiency syndrome among health care workers. N. Engl. J. Med. 314:1127, 1986. 30. Fahey, B. J., Koziol, D. E., Banks, S. M., and Henderson, D. K.: Frequency of nonparenteral occu pational exposures to blood and body fluids before and after universal precaution training. Am. J. Med. 90:145, 1991. 31. Lo, B., and Steinbrook, R.: Health care workers infected with the human immunodeficiency virus. J.A.M.A. 267:1100, 1992.
