Special Article
Risk of Exposure of Surgical Personnel to Patients' Blood during Surgery at San Francisco General Hospital
N Engl J Med 1990; 322:1788-1793June 21, 1990
- Abstract
- Abstract
We undertook an observational study of 1307 consecutive surgical procedures at San Francisco General Hospital to record descriptions of intraoperative exposures to blood and other body fluids, determine the factors predictive of these exposures, and identify interventions that might reduce their frequency. During a two-month period, circulating nurses took note of parenteral and cutaneous exposures to blood and recorded information about all procedures. In a follow-up validation study, 50 additional procedures were observed by the study investigators to determine the accuracy of the data collected by the nurses. A total of 960 gloves used by surgical personnel during the validation study were examined to determine the perforation rate.
Accidental exposure to blood (parenteral or cutaneous) occurred during 84 procedures (6.4 percent; 95 percent confidence interval, 5.1 to 7.8 percent). Parenteral exposure occurred in 1.7 percent. The risk of exposure was highest when the procedures lasted more than three hours, when blood loss exceeded 300 ml, and when major vascular and intraabdominal gynecologic surgery was involved. Neither knowledge of diagnosed human immunodeficiency virus (HIV) infection nor awareness of a patient's high-risk status for such infection influenced the rate of exposure. Double gloving prevented perforations of the inner glove and cutaneous exposures of the hand.
We conclude that all surgical personnel are at risk for intraoperative exposure to blood. Our data support the practice of double gloving and the increased use of waterproof garments and face shields to prevent mucocutaneous exposures to blood. No evidence was found to suggest that preoperative testing for HIV infection would reduce the frequency of accidental exposures to blood. (N Engl J Med 1990; 322:1788–93.)
Media in This Article
Table 1
Parenteral and Cutaneous Exposures Observed during 1307 Surgical Procedures.Table 2
Exposure Rates According to Surgical Subspecialty.Article Activity
- Article
SURGICAL personnel who are exposed to blood risk infection with the hepatitis B virus (HBV) and the human immunodeficiency virus (HIV). The recommendations from the Centers for Disease Control for the prevention of infection with blood-borne pathogens during invasive procedures emphasize the prevention of needle sticks and the use of barriers to prevent mucocutaneous contact with blood.1 The relevance of these guidelines to the operating room and their effect on efforts to reduce the frequency of blood exposure have not been assessed.
Preoperative testing for HIV has also been advocated as an infection-control measure.2 3 4 The proponents of this approach believe that identifying infected patients will allow the selective implementation of special infection-control precautions or improve compliance with standard precautions and hence reduce the risk of exposure.4 , 5 The effect of preoperative identification of HIV infection on the frequency of intraoperative exposure to blood has also not been assessed.
We undertook a study of surgical procedures at San Francisco General Hospital to describe and quantify intraoperative exposures to blood and other potentially infectious body fluids, identify factors predictive of such exposures, estimate the effect of the perceived risk of HIV infection on the frequency of exposures, and identify interventions that might reduce the frequency of occupational exposures among surgical personnel.
San Francisco General Hospital is a large public teaching hospital affiliated with the University of California, San Francisco, which provides trauma care and medical and surgical services to a heterogeneous population of patients. Although the actual prevalence of HIV and HBV infection at the hospital is unknown, a high proportion of the surgical patients there are natives of countries where HBV is endemic, and many are intravenous drug users or homosexual men at risk for infection with HIV or HBV. The surgical procedures performed at San Francisco General Hospital therefore provide an ideal opportunity to evaluate intraoperative exposures to blood and other body fluids in an environment where HBV and HIV are prevalent.
Methods
Observation
Circulating nurses at San Francisco General Hospital were asked to elicit and record descriptions of exposures to blood and other body fluids or tissues that occurred during 1307 consecutive operating-room procedures performed over a two-month observation period, from August 16 through October 18, 1988. Circulating nurses were defined as nurses present during each surgical procedure with responsibility for the nonsterile perioperative care of the patient. Data on the patients (age and sex), the procedures (type, surgical specialty involved, elective or emergency status, starting time, duration, and estimated blood loss), and the exposures (type, mechanism, site, source, magnitude, number of personnel exposed, and type of infection-control precautions used, if any) were recorded on standardized report forms during each procedure. Biopsies, laceration repairs, laparoscopies, endoscopies, abscess drainages, cystoscopies, changes of dressings, and the like were considered minor surgical procedures; all others were considered major. In addition, the procedures were grouped into 20 broad categories according to the body cavity involved or the site and type of procedure — such as abdominal laparotomies, vascular repairs, open reductions and internal fixations, craniotomies, or cesarean sections.
A parenteral exposure was defined as (1) a puncture or laceration with a needle, another instrument, or a bone contaminated with blood or another body fluid; (2) contamination of a skin wound or other nonintact skin with blood or another body fluid; or (3) contact of a mucous membrane with blood or another body fluid. A cutaneous exposure was defined as contact of the skin with blood or another body fluid.
Validation Study
To estimate the reliability of the data, 50 surgical procedures selected at random after the end of the observation period were observed by one of the study investigators, using a data-collection instrument identical to that used by the nurses. All gloves worn by surgical personnel during these procedures (a total of 960 gloves) were collected. The gloves were labeled as "single" when only one glove was worn on each hand; as "double-outer" or "double-inner" when two gloves were worn; and as "triple-outer," "triple-middle," or "triple-inner" when three gloves were worn. The gloves were examined for visible blood contamination of the outer and inner surfaces and visible punctures or tears. They were then filled with water to a standard volume (500 ml) and gently squeezed to identify occult perforations.6 To estimate the proportion of perforations occurring during the surgical procedures, three pairs of unused gloves were selected at random from the supply provided for each procedure and examined for visible and occult punctures and tears.
Risk Assessment for HIV and HBV Infection
Circulating nurses recorded the perceived risk of HIV and HBV infection in each patient. This assessment was based on information obtained from the surgical team at the beginning of the procedure or recorded in the preoperative surgical notes. Procedures with a high HIV risk were those in which the surgical team knew that the patient had had a positive HIV antibody test or had the acquired immunodeficiency syndrome (AIDS) or AIDS-related conditions and those in which the team believed the patient to be at high risk for HIV infection (a homosexual or bisexual man or an intravenous drug user). Procedures in which the patients were known to be HIV-seronegative or perceived to be at low risk for infection were coded as having a low HIV risk. A similar assessment was made to determine the high or low risk status of the procedures with respect to HBV. To estimate the accuracy of these assessments, a random sample of medical records (up to the date of the index procedure) from 50 patients at high risk for HIV and 150 patients at low risk for HIV was carefully reviewed. Clinical or laboratory confirmation of HIV infection and the documentation in the surgical team's preoperative record of a history of high-risk behavior for acquiring such infection (male homosexual activity or intravenous drug use) were used as criteria to validate HIV risk status.
Statistical Analysis
The "case exposure rate" was defined as the number of procedures in which exposures occurred divided by the total number of procedures. The "exposure rate" was defined as the number of exposures per 1000 hours of surgery. The distribution of the variables potentially predictive of exposure among the procedures in which an exposure occurred and those in which no exposure occurred was assessed by chi-square analysis or, when appropriate, Fisher's exact test. The duration of each procedure was divided into quartiles for this assessment. Variables associated at a significance level of P≤0.25 with procedures in which exposures occurred were then entered into a stepwise logistic-regression analysis to evaluate their independent predictive effect.7 The distributions of factors found to be predictive of exposure were compared in the procedures that presented a high risk of HIV or HBV and in those that presented a low risk, with use of chi-square analysis.
This study was approved by the Committee on Human Research of the University of California, San Francisco.
Results
Exposures
Circulating nurses observed 1307 consecutive procedures; all were included in the study sample. A total of 117 exposures (22 parenteral and 95 cutaneous) were observed during 84 of these procedures (6.4 percent; 95 percent confidence interval, 5.1 to 7.8 percent) (Table 1Table 1
Parenteral and Cutaneous Exposures Observed during 1307 Surgical Procedures.). Parenteral exposures occurred in 1.7 percent of the procedures (22 of 1307; 95 percent confidence interval, 1.1 to 2.6 percent). Blood was the principal body fluid involved in 90 percent of the exposures; other body fluids and irrigating solutions contaminated with blood were involved in the remainder.The total exposure rates (the number of exposures of any type per 1000 hours of surgery) and the parenteral-exposure rates (the number of parenteral exposures per 1000 hours of surgery) did not differ significantly among the surgical specialties, but the rates were highest for trauma surgery, plastic surgery, obstetrical and gynecologic surgery, and orthopedic surgery (Table 2Table 2
Exposure Rates According to Surgical Subspecialty.).The parenteral exposures consisted of 10 needle sticks with a suture needle, 1 needle stick with a hollow needle, 6 hand lacerations (1 with a scalpel, 1 with bone, and 4 with other sharp instruments), 4 exposures of the mucous membranes (splashes in the eye), and 1 contamination of an open skin wound (Table 1). None of the needle-stick injuries involved the actual injection of blood, and all needle sticks and all but one laceration were judged to be superficial.
Twenty-six of 32 cutaneous exposures of the hand were due to glove tears; single gloves were torn during 18 of these exposures, and double or triple gloves in 8. Three hand exposures involved personnel not wearing gloves. Protective eyewear (goggles or glasses) and masks were worn during 23 of 25 cutaneous facial exposures, but no facial exposures involved personnel wearing face shields. Thirty-three cutaneous exposures at other sites were attributed to the saturation of clothing; waterproof gowns were worn during only 18 percent of the procedures during which these exposures took place. Five cutaneous foot exposures were recorded that involved personnel wearing standard surgical (nonwaterproof) boots.
All categories of surgical personnel (attending physicians, residents, students, anesthesiologists, and nurses) had parenteral and cutaneous exposures. Surgical residents had the largest proportion of both the parenteral (12 of 22) and the cutaneous (41 of 95) exposures. Nurses had few parenteral exposures but frequently sustained cutaneous hand exposures (n = 12).
Factors Predictive of Exposure
A univariate analysis of the variables potentially predictive of an intraoperative exposure demonstrated that several variables were associated with an increased risk (P≤0.25): a loss of more than 300 ml of blood, a procedure lasting more than three hours, emergency procedures, major surgical procedures, procedures required for trauma or fractures, laparotomies, intraabdominal gynecologic procedures, vascular procedures, otolaryngologic procedures, and cutaneous abscess drainages. Logistic-regression analysis using these variables demonstrated that only blood loss of more than 300 ml (odds ratio, 1.60; 95 percent confidence interval, 1.24 to 2.06), surgery lasting more than three hours (odds ratio, 1.63; 95 percent confidence interval, 1.27 to 2.11), vascular procedures (odds ratio, 3.19; 95 percent confidence interval, 1.95 to 5.21), and intraabdominal gynecologic procedures (odds ratio, 1.82; 95 percent confidence interval, 1.18 to 2.80) were independently associated with the risk of an exposure. When the logistic analysis was restricted so that only parenteral exposure was considered as the dependent variable, major surgical procedures and vascular procedures were the only independent predictive factors.
HIV Risk Status as a Predictor of Exposure
High HIV risk status was perceived in 375 procedures (29 percent of the total); in 351 of these, a high HBV risk was also recorded. High HBV risk status was assigned to an additional 41 procedures involving patients not at risk for HIV. High HIV risk status was not associated with a lower exposure rate than low HIV risk status; exposures occurred during 7.2 percent (27 of 375) of the procedures involving patients at high HIV risk and during 6.1 percent (57 of 932) of those involving patients at low HIV risk. The exposure rate was also the same in these two groups (41 vs. 37 exposures per 1000 hours, respectively). Similarly, no differences in the proportion of procedures in which an exposure occurred or in the exposure rate were found for the procedures presenting a high or a low HBV risk. The type of procedures performed, the extent of blood loss, the duration of surgery, and the proportion of cases involving trauma or fractures did not differ with respect to the risk of either HIV or HBV infection. The only factor predictive of exposure that differed among the risk groups was the frequency of intraabdominal gynecologic procedures, which was higher among the patients at low risk for HIV and HBV (P≤0.005). The absence of an association between the perceived HIV or HBV risk group and the exposure rate was evident even when the analysis was restricted to include only parenteral exposures as the dependent variable.
Accuracy of HIV Risk Assessment
The review of medical records documented the presence of HIV infection or risk factors for HIV in 70 percent of the preoperative patients (35 of 50) in the sample who were perceived by the surgical team to be at high risk for HIV. In 5 percent (8 of 150) of the patients thought to have a low risk for HIV whose records were reviewed, the presence of risky behavior or evidence of HIV infection was clearly documented in the chart before surgery. When we extrapolated from these data, 23.6 percent of the 1307 surgical patients were estimated to be infected or at high risk for HIV infection.
Validation Study
The surgical subspecialty, type of procedure, and urgency of the procedures included in the validation sample were similar to those in the larger observation sample, except that patients with a low risk of HIV were intentionally overrepresented (to assess the degree to which underreporting may have biased the exposure rate for the procedures these patients underwent). Accidental exposures (one needle stick, two cutaneous) were reported in 6 percent of the procedures observed by the study investigators (3 of 50; 95 percent confidence interval, 5.2 to 14.5 percent). The exposure rate determined in the validation study (25 per 1000 surgical hours) was similar to that obtained by the circulating nurses (38 per 1000 surgical hours). The exposure rate for the 44 procedures with a low HIV risk that were observed by the study investigators was compared with that in the corresponding procedures observed by the circulating nurses, and no differences suggestive of underreporting were apparent in the case exposure rate (6.8 vs. 6.1 percent, respectively) or the exposure rate (25 vs. 39 exposures per 1000 surgical hours).
Gloves
Double gloving appears to be a routine practice among most surgical personnel at San Francisco General Hospital. Ninety-four percent of the scrub nurses, 90 percent of the house officers, and 76 percent of the attending surgeons observed during the validation study were double-gloved (or triple-gloved) for the entire procedure, although the circulating nurses were rarely gloved at any time. The double-gloved personnel often changed their outer gloves without changing the inner gloves. To estimate the effect of double gloving on the prevention of tears or punctures, perforation rates (number of perforations per 100 gloves) were compared for 80 gloves worn singly, 448 "double-outer" gloves, and 384 "double-inner" gloves. (Too few triple gloves were obtained to yield meaningful data.) The perforation rates for the single and "double-outer" gloves were identical (17.5 and 17.4 percent, respectively) and were three times higher than the rate (5.5 percent) for the "double-inner" gloves (Table 3Table 3
Perforation Rates in 960 Surgical Gloves.*). The inner glove was likely to have prevented cutaneous blood exposure in at least 20 percent of these perforations, since its outer surface was grossly contaminated with blood in 18 of 78 cases. The perforations were distributed equally between the right-hand and left-hand gloves, and no one site of perforation was conspicuously more common. Two percent of the sterile surgical gloves (3 of 150) had perforations when they were examined immediately after removal from the package.The "double-inner" and "double-outer" gloves were examined in sets to estimate the frequency of unreported or unrecognized needle-stick exposures. We assumed that a needle-stick puncture would produce matched defects in a "double-outer" glove and its "double-inner" counterpart, that needle-stick exposures accounted for all unexplained matched defects, and that double gloving was unlikely to prevent needle sticks. Single gloves were not included in this assessment, because the proportion of perforations due to needle sticks as compared with routine wear and tear could not be determined and because the vast majority of surgical personnel wore double gloves. Only three matched pairs of puncture defects were detected; one of these was reported as a glove tear and not a needle stick, and one had already been reported as a needle-stick exposure during the validation study. On the basis of this evidence, we estimate the case exposure rate of unreported needle sticks to be 2 percent (1 needle stick per 50 cases; 95 percent confidence interval, 1.8 to 10.8 percent).
Discussion
With the data obtained from this study, we calculated a theoretical risk of HIV infection in surgical personnel at San Francisco General Hospital of 0.125 infections per year, or 1 infection every eight years. This estimate assumes that the infection rate equals the rate of infection per single parenteral exposure (or 0.004, on the basis of published data, on the assumption that suture needle sticks, lacerations, and mucosal splashes confer the same risk as hollow-needle punctures) times the proportion of parenteral exposures derived from HIV-infected source patients (or 0.236, as estimated from reviews of patients' charts, given the assumption that all patients considered to be at high risk for HIV are infected) times the number of parenteral exposures (22 events per 2 months × 12 months per year = 132 per year).8 Although this risk of infection may not seem high when viewed in the context of the surgical care provided during the same period to an estimated 15,000 patients at high risk of HIV, it represents a major life-threatening occupational hazard for surgical personnel practicing at San Francisco General Hospital and similar locales with a high prevalence of HIV. On the other hand, the theoretical risk estimate would be reduced to 1 infection every 80 years in places where the prevalence of infection is less than 3 percent, as would typically be the case in many areas in the United States.
The parenteral-exposure rate we found (5.6 exposures per 1000 hours) is qualitatively similar to that observed in a retrospective survey of surgical personnel in New York City.9 Our parenteral case exposure rate (1.7 percent), however, is lower than that reported in the only published prospective survey of parenteral exposures among surgeons (5.6 percent),10 and it is considerably lower than the rate perceived by some surgeons.10 , 11 Several methodologic factors could have contributed to an underestimate of the exposure rate in our study. The majority of the surgical personnel were likely to have been aware that a study of exposures was being conducted. Awareness of the presence of an observer (the circulating nurse or the validation-study investigator) could have improved compliance with infection-control precautions so that fewer exposures occurred during the observation period (the Hawthorne effect). No trend was evident that suggested an increased exposure rate over time, as the subjects adjusted to the presence of an observer, but the two-month study interval may not have been long enough to detect such a trend. Variation in the extent to which the circulating nurses elicited descriptions of the exposure events and preoccupation on their part with other responsibilities could also have contributed to an underestimate of the true exposure rate, although the similarity between the exposure rates obtained by the circulating nurses and those obtained by the validation-study investigators suggests that such underreporting was not frequent. Finally, some inconspicuous cutaneous exposures may not have been recognized, because neither the circulating nurses nor the validation-study investigators were present in the locker room when the surgical personnel changed clothing after the procedures.
We believe that surgical personnel at San Francisco General Hospital have a lower risk of intraoperative exposure, because they recognize the high prevalence of blood-borne pathogens in surgical patients and practice a high standard of infection control. The surgical infection-control policy that was implemented at the hospital early in 1988 advocates the safer handling of needles and other sharp instruments, double gloving, and use of protective equipment and waterproof clothing during all surgical procedures. The high frequency of double gloving observed in the validation study suggests that most personnel comply with this policy. That 30 percent of the surgical patients included in this study were perceived to be at high risk for infection and that our chart review documented the presence of a risk of HIV in almost 25 percent of the patients lend further credibility to this hypothesis.
Our estimate of the risk of intraoperative exposure may not be generalizable to institutions at which surgical personnel who perceive a lower prevalence of HIV or HBV infection are less motivated to comply with recommendations for infection control or at which universal infection-control precautions have not been implemented. Furthermore, our study did not assess the risk of exposure during cardiac and transplantation surgery, because these procedures are not performed at San Francisco General Hospital. Since the major independent predictors of intraoperative exposure observed in our study (duration >3 hours, blood loss >300 ml, and major vascular procedures) are common during cardiac and transplantation surgery, the exposure rates we found may not accurately reflect the risk in centers at which such procedures are frequently performed.
The results of this study do not support the use of preoperative HIV testing to enhance awareness of the risk of HIV as an effective infection-control intervention at San Francisco General Hospital. Perception of the risk of HIV infection was not associated with a decreased risk of occupational exposure. The similarity in exposure rates for the procedures involving patients at high risk of HIV and those involving patients at low risk cannot be attributed to confounding by such variables as differences between patients or reporting bias. In fact, intraabdominal gynecologic procedures, the only predictor of exposure that differed between these groups, were more common in the group at low risk of HIV — a fact that, if anything, should have increased the exposure rate for these procedures. The sample in the validation study was not large enough to exclude the possibility of underreporting. However, selective underreporting of exposures involving patients at low risk of HIV is unlikely, since the exposure rate obtained by the circulating nurses for the procedures involving these patients was actually slightly higher than that found by the study investigators. Although the circulating nurses' records of HIV risk status may not have reflected the opinion of the entire surgical team in the case of some patients, the high degree of correlation between the risk assessments in the surgeons' preoperative notes and the assignments of risk status suggest that such differences were uncommon.
The failure of perceived HIV risk status to influence the probability of intraoperative exposure at San Francisco General Hospital has important implications for HIV testing and infection-control policies. If, as we believe, surgical personnel at the hospital maintain a high standard of infection control for all patients, regardless of perceived HIV risk status, no benefit with respect to infection control would be expected from preoperative HIV testing. Raising the standard of infection control requires motivation, effort, and expense, but in the long run it may be a more effective strategy for protecting surgical personnel from exposure to blood-borne pathogens than using special techniques to treat patients with diagnosed or suspected infections.4 , 12
The factors associated with an increased risk of exposure to blood are not readily amenable to intervention. Surgical personnel should be advised of the increased risk during procedures when these factors are present, so that appropriate protective equipment and safer procedures can be used. New devices, safer suturing techniques, and alternative procedures to prevent parenteral exposures should be considered for such cases when the risk of exposure is increased. Basing infection-control recommendations on the anticipated risk of exposure during the surgical procedure rather than the presence of diagnosed infection in the patient is a new concept that should be evaluated in other surgical settings, particularly those in which HIV is not highly prevalent.
Double gloving during surgical procedures should be routine. Our data from the validation study indicate that double gloving not only reduced the perforation rate for the inner glove by more than 60 percent but also prevented cutaneous hand exposure to blood. Furthermore, we estimate that at least half the cutaneous hand exposures that were caused by glove tears in the health care workers wearing single gloves would have been prevented by double gloving. These data are remarkably similar to those obtained in previous studies of glove perforation, in which double gloving resulted in an 80 percent reduction in inner-glove perforation.13
To prevent cutaneous exposures to blood and other body fluids, waterproof barriers are essential. HBV, other blood-borne viruses, and in rare cases HIV can be transmitted through minute breaks in the integument that may not be recognized by the health care provider. The opportunity for prolonged cutaneous contact during long surgical procedures could also increase the opportunity for transmission. Among our surgical personnel, the use of face shields, waterproof gowns, and waterproof boots could have prevented more than half the observed episodes of cutaneous exposure involving sites other than the hand.
Supported by an award (R88SF153) from the State of California Universitywide AIDS Research Program and by the AIDS Clinical Research Center of the University of California, San Francisco.
Presented in abstract form at the Fifth International Conference on AIDS, Montreal, June 4–9, 1989; and at the 29th Interscience Congress on Antimicrobials and Chemotherapy, Houston, September 17–20, 1989.
We are indebted to Dr. Nicholas Smedira for his input into the data-collection instrument; to Mr. Gunnard Modin, Dr. Peter Bacchetti, and Mr. Kjeld Molvig for statistical and technical support; to Dr. Andrew Moss, Dr. John Mills, Dr. Henry F. Chambers, and Dr. Merle A. Sande for helpful reviews and encouragement; and most important, to Nayda Ramiro and the circulating nurses and surgical staff at San Francisco General Hospital who generously contributed their time and effort to make the study possible.
Source Information
From the Departments of Medicine (J.L.G., C.L., A.B.) and Surgery (A.T., W.P.S.), University of California, San Francisco; and San Francisco General Hospital. Address reprint requests to Dr. Gerberding at the Medical Service, 5H-22, San Francisco General Hospital, 1001 Potrero Ave., San Francisco, CA 94110.
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