| Abstract|| |
Hepatitis B virus is the most transmissible virus and is very resistant to heat and chemicals, because of its unique structure. Blood has the maximum concentration of the virus among all the body fluids and the risk of transmission is related to the presence of HBeAg and the Hepatitis B virus DNA level in the blood. In India, about 1-10% of the healthcare workers are HBsAg positive. Healthcare workers, especially surgeons, and laboratory technicians are at a high risk of developing Hepatitis B infection. Transmission from Hepatitis B positive surgeons to patients has been well-documented. However, the risk of transmission from a patient to a surgeon is higher - about 30% - following a needle stick injury from an HBeAg positive individual. In India, there is low awareness among healthcare personnel about Hepatitis B vaccination and its related issues, and there is no health policy in this regard. In relation to the healthcare workers, there is an urgent need to formulate guidelines on HBsAg testing, hepatitis B vaccination, restriction of exposure-prone procedures that have to be performed, the extent to which their serological status can be revealed to patients, implementation of universal precautions, and post-exposure prophylaxis.
Keywords: Exposure prone procedure, HBsAg, healthcare worker, India, universal precautions, vaccination
|How to cite this article:|
Sable S, Nagral A. Hepatitis B and the surgeon. Hep B Annual 2011;8:17-31
| Introduction|| |
Occupationally acquired disease is a major emerging healthcare problem. Surgeons and healthcare workers (HCWs) are at particular risk of both acquiring and transmitting the Hepatitis B virus from and to their patients. A high degree of vigilance and a careful surgical technique is the only means available to prevent the transmission of the virus to the surgeon and the patient.
| Hepatitis B virus|| |
The human hepatitis B virus (HBV) is the prototype virus of the Hepadna virus family and is a DNA virus that is surrounded by a host cell-derived envelope. The HBV is remarkably stable to organic solvents. It is also heat- and pH-resistant. The glycoproteins on the virus surface contain antigenic determinants that are group- and type-specific. Using these determinants, epidemiologists identify eight subtypes of HBV. The infectivity of the person depends on the HBV DNA viral load. Individuals who are HBeAg positive, have a replicating virus and thus have a high viral load. Patients who are HBeAg negative are expected to have a non-replicating virus and a low HBV DNA. The exception to this are patients who have pre-core mutations leading to the non-secretion of HBeAg, thus making them HBeAg negative, but they have a replicating virus, as reflected in the high HBV DNA levels. Blood contains the highest HBV titers of all body fluids and is the most important vehicle for transmission in the healthcare setting. HBsAg is also found in several other body fluids, including breast milk, bile, cerebrospinal fluid, feces, nasopharyngeal washings, saliva, semen, sweat, and synovial fluid.  The concentration of HBsAg can be 100-1000 fold higher than the concentration of infectious HBV particles in the body fluids. Therefore, most body fluids are not efficient vehicles of transmission because they contain low quantities of infectious HBV despite the presence of HBsAg.
| Transmission from surgeons (healthcare workers) to patients|| |
The prevalence of HBsAg among the HCWs in Indian studies has ranged from 1 to 10%. ,,, In a study from US, 15.5% of the emergency physicians had evidence of HBV exposure,  as against Nigeria where 26% of the surgeons were HBsAg positive as compared to 15% in the control group (administrative staff).  The risk of transmission of HBV from a patient to a surgeon is much greater than the risk of transmission from an infected surgeon to a patient.  The risk of transmitting HBV from an e-antigen-positive surgeon to a patient during an invasive procedure varies with the procedure and the character of the exposure event (such as puncture or cut). The actual number of surgeons who have tested positive for the e-antigen is unknown. 
The exact mechanism of transmission from surgeon to patient is unknown, but has been thought to be from contact with the surgeon's blood. Blood exposure from the surgeon to the patient may occur when the surgeon sustains an intraoperative injury (such as needle stick or cut), which allows the surgeon's blood to directly come into contact with the patient's open tissues. Existing evidence demonstrates that prolonged knot tying or other shear injury may allow the surgeons virus to be transmitted to the patient. Thus, surgeon-to-patient transmission of HBV can occur even without obvious blood contact. The two major risks of transmission identified are, the presence of HBeAg and / or high levels of HBV-DNA in the HCW and the degree of invasiveness of the procedure performed. Other minor factors include glove failure, skin lesions, long duration of the operation, and the use of blood products. Although in the majority of cases there may be no identifiable causes for surgical outbreaks, the most likely explanations are thought to be related to needle sticks incurred while suturing (which remains under-reported) and inadvertent cuts through gloves, while securing knots.
Surgical techniques believed to decrease the risk of transmission include the use of double latex gloves, changed hourly, enclosed hood and face-masks and operative isolator with umbilical-cord aspirator, knee length impermeable gowns, a combination of shoe covers with coverage to the knee and disposable drapes. Current information about mechanisms of transmission is insufficient to know whether modifying surgical technique might prevent surgeon-to-patient transmission
In an outbreak in a US hospital, an infected thoracic surgeon transmitted HBV to at least 19 patients during surgery. These patients were retrospectively studied by Harpaz et al., who traced the virus subtypes from the surgeon to the patients he had operated upon. The presence of HBsAg subtype adw2 in the surgeon and in 13 of the patients in whom the subtype of the antigen could be determined. The DNA sequences of the HBV core region from the surgeon and from nine case patients who could be evaluated were identical. In this group of patients, in spite of all universal measures being taken, the infection could not be prevented and the investigators could not identify any specific event that led to the transmission
Recommendations for a Hepatitis B-positive surgeon (Healthcare Worker)
In India, there is no formal testing of HCWs, including surgeons, as a pre-employment measure. Each public or private hospital may have its own policy, but there are no uniform guidelines.
Certain countries have specific guidelines on policies with regard to HCWs who are HBsAg positive. The Canadian Medical Association recommends that 'physicians who test positive for HBsAg cease activities of their practice that could expose patients to their body fluids until their practice has been reviewed by an expert committee. The HCWs have an obligation to be tested following a significant exposure to the patient. If the HCWs test positive for HBV, HCV, or HIV, the patient has the right to know to which pathogen he / she was exposed, in order to access the appropriate post-exposure protocol'., It also includes notifying the prospective patients of the HCWs seropositivity before they undergo exposure-prone invasive procedures. The transmission of HBV by HBeAg-negative surgeons  has directed the focus of the Public Health Policy in the UK and the Netherlands from the HBeAg status to the serum HBV DNA level. Viral load and the volume of blood transmitted determine the transmission risk of HBV. To prevent both loss of expertise and nosocomial infection, highly viremic HCWs can be offered antiviral therapy from the wide armamentarium available.  The suppression of viral load in HBV-infected HCWs could minimize the risk of doctor-to-patient transmission to such an extent that job modifications will no longer be indicated. To limit the risk of drug resistance, the use of combination therapy is advocated.
A UK study in HBV-positive surgeons who were HBeAg negative (and had therefore been previously cleared to conduct EPPs, but had transmitted the virus) suggested that in those with a viral load of more than 4 x 10  copies / ml, transmission of hepatitis B during conduct of EPPs could not be excluded.  In a study among the German HCWs, in last 15 years, highly viremic HBV carriers with HBeAg, transmitted the virus to 4% of their patients, on an average, when performing operations with high risk of injuries. HBeAg-negative surgeons with a HBV DNA of 10  to 10  copies / ml transmitted HBV to 1.5% of the patients.  A study of an HBeAg-positive general surgeon from Netherlands, demonstrated that although the risk of HBV infection during high-risk procedures was seven times higher than that during low-risk procedures, at least 29% of the 28 patients were infected during low-risk procedures. 
The Italian Association for the study of the liver recommends that all HCWs must undergo hepatitis B vaccination and adopt the standard measures for infection control in hospitals. Furthermore, HCWs who directly perform invasive procedures must undergo serological testing and the evaluation of markers of viral infection. Those found to be positive for: (1) HBsAg and HBeAg, (2) HBsAg and hepatitis B virus DNA, or (3) anti-hepatitis C virus and hepatitis C virus RNA, must abstain from directly performing invasive procedures; no other limitations in their activities are necessary. Infected HCWs are urged to inform their patients of their infectious status, although this is left to the discretion of the HCWs; whose privacy is guaranteed by law. 
It therefore seems that a balance should be struck between patients' wishes to know of risks to which they have been exposed, however small they may be, and the professional view that when risks are negligible, patients need not be informed. 
Transmission from HBV-positive patients to surgeons (healthcare workers)
The human hepatitis B virus infection is a well-recognized occupational risk for HCWs. The risk of HBV infection is primarily related to the degree of contact with blood in the workplace and also to the HBeAg and HBV DNA status of the source person. In studies of HCWs, who sustained injuries from needles contaminated with blood containing HBV, the risks encountered have been shown in [Table 1]. 
|Table 1: Risk of Hepatits B virus infection in a healthcare worker exposed to a needle stick17 |
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Although percutaneous injuries are among the most likely modes of HBV transmission, these exposures probably account for only a minority of HBV infections among HCWs. In several investigations of nosocomial hepatitis B outbreaks, the most infected HCWs could not recall an overt percutaneous injury, although in some studies, up to one-third of the infected HCWs recalled caring for a patient who was HBsAg-positive.  In a US study of high-risk individuals like transplant surgeons, the HBV vaccination schedule was incomplete in 22.5%, and of the 311 transplant surgeons interviewed, two-thirds had never reported exposures to the healthcare authorities.  In addition, HBV has been demonstrated to survive in dried blood at room temperature on environmental surfaces for at least a week.  Thus, HBV infections that occur in HCWs with no history of non-occupational exposure or occupational percutaneous injury might have resulted from direct or indirect blood or body fluid exposures that probably inoculated HBV into cutaneous scratches, abrasions, burns, other lesions, or on mucosal surfaces. The potential for HBV transmission through contact with environmental surfaces has been demonstrated in investigations of HBV outbreaks among patients and staff of Hemodialysis Units.  In the serologic studies conducted in the United States during the 1970s, HCWs had a prevalence of HBV infection approximately 10 times higher than in the general population. 
Centers for Disease Control and Prevention guidelines for the management of healthcare workers - potentially exposed to the human hepatitis B virus 
Hepatitis B Vaccination
Any person who performs tasks involving contact with blood, blood-contaminated body fluids, other body fluids, sharps, or exposure-prone procedures should be vaccinated against hepatitis B. Pre-vaccination serologic screening for previous infection is not indicated for persons being vaccinated because of occupational risk, unless the hospital or healthcare organization considers the screening to be cost-effective.
Hepatitis B vaccine should always be administered via the intramuscular route, in the deltoid muscle, with a 1-1.5 inch long needle. Hepatitis B vaccine can be administered at the same time as other vaccines, with no interference of antibody response from the other vaccines. If the vaccination series is interrupted after the first dose, the second dose should be administered as soon as possible. The second and third doses should be separated by an interval of at least two months. If only the third dose is delayed, it should be administered when convenient. HCWs who have contact with patients or blood and are at an ongoing risk for percutaneous injuries should be tested one to two months after completion of the three-dose vaccination series for anti-HBs. Persons who do not respond to the primary vaccine series (i.e., anti-HBs < 10 mIU / mL) should complete a second three-dose vaccine series or be evaluated to determine if they are HBsAg-positive. Revaccinated persons should be retested at the completion of the second vaccine series. Persons who do not respond to an initial three-dose vaccine series have a 30-50% chance of responding to a second three-dose series. Persons who prove to be HBsAg-positive should be counseled on how to prevent HBV transmission to others and on the need for medical evaluation. Non-responders to vaccination, who are HBsAg-negative, should be considered susceptible to HBV infection and should be counseled on the precautions to prevent HBV infection and the need to obtain Hepatitis B Immune globulin (HBIG) prophylaxis for any known or probable parenteral exposure to HBsAg-positive blood.
Booster doses of hepatitis B vaccine are not necessary and periodic serological testing to monitor antibody concentrations after completion of the vaccine series is not recommended. This is because, during the first exposure to the vaccine, responders produce an anamnestic response to the antigen, which is presented to the immune system, that is, the T-cell (memory cell).
Any blood or body fluid exposure sustained by an unvaccinated, susceptible person should lead to the initiation of the hepatitis B vaccine series.
Management of exposure to a potentially infective patient
Treatment of an Exposure Site
Wounds and skin sites that have been in contact with blood or body fluids should be washed with soap and water; mucous membranes should be flushed with water. No evidence exists that using antiseptics for wound care or expressing fluid by squeezing the wound further reduces the risk of blood-borne pathogen transmission; however, the use of antiseptics is not contraindicated. The application of caustic agents (e.g., bleach) or the injection of antiseptics or disinfectants into the wound is not recommended.
If an occupational exposure occurs, the circumstances and post-exposure management should be recorded in the exposed person's confidential medical record.
Recommendations for the contents of the occupational exposure report:
Management of Exposures to HBV
- Date and time of exposure
- Details of the procedure being performed, including where and how the exposure occurred; if related to a sharp device, the type and brand of device, and how and when in the course of handling the device the exposure occurred
- Details of the exposure, including the type and amount of fluid or material and the severity of the exposure, for example, for a percutaneous exposure, the depth of injury and whether fluid was injected; for skin or mucous membrane exposure, the estimated volume of material and the condition of the skin, for example, chapped, abraded or intact
- Details about the exposure source, for example, whether the source material contained HBV, HCV, or HIV. Testing to determine the HBV infection status of an exposure source should be performed as soon as possible. Hospitals, clinics, and other sites that manage exposed HCWs should consult their laboratories regarding the most appropriate test to use, to expedite obtaining these results. Testing of needles or other sharp instruments implicated in an exposure, regardless of whether the source is known or unknown, is not recommended. The reliability and interpretation of findings in such circumstances are unknown, and testing might be hazardous to persons handling the sharp instrument
- Details about the exposed person (e.g., hepatitis B vaccination and vaccine-response status)
- Details about counseling, post-exposure management, and follow-up.
A summary of prophylaxis recommendations for percutaneous or mucosal exposure to blood according to the HBsAg status of the exposure source and the vaccination and vaccine-response status of the exposed person is included in this report [Table 2].
|Table 2: CDC guidelines for post-exposure prophylaxis for hepatitis B virus23 |
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When Hepatitis B Immune Globulin (HBIG) is indicated, it should be administered as soon as possible after exposure (preferably within 24 hours). The effectiveness of HBIG when administered more than seven days after exposure is unknown. When the hepatitis B vaccine is indicated, it should also be administered as soon as possible (preferably within 24 hours) and can be administered simultaneously with HBIG, at a separate site (the vaccine should always be administered in the deltoid muscle).
The effectiveness of HBIG and / or hepatitis B vaccine in various post-exposure settings has been evaluated by prospective studies. In the occupational setting, multiple doses of HBIG, initiated within one week following percutaneous exposure to HBsAg-positive blood, provides an estimated 75% protection from HBV infection. Although the post-exposure efficacy of the combination of HBIG and the hepatitis B vaccine series has not been evaluated in the occupational setting, the increased efficacy of this regimen observed in the perinatal setting, compared to HBIG alone, is presumed to apply to the occupational setting as well. In addition, persons requiring post-exposure prophylaxis in the occupational setting are generally at continued risk for HBV exposure, they should receive the hepatitis B vaccine series. 
Hepatitis B vaccines have been found to be safe when administered to infants, children, or adults. The most common side effects from hepatitis B vaccination are pain at the injection site and mild-to-moderate fever. Studies indicate that these side effects are reported no more frequently among persons vaccinated than among those receiving placebo. HBIG is prepared from human plasma, and is known to contain a high titer of antibody to HBsAg (anti-HBs). The plasma from which HBIG is prepared is screened for HBsAg and antibodies to HIV and HCV. Serious adverse effects from HBIG, when administered as recommended, have been rare. Local pain and tenderness at the injection site, urticaria, and angioedema might occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin (IG) and HBIG  preparations. Persons with a history of anaphylactic reaction to immune globulins should not receive HBIG.
The Indian scenario
Although Hepatitis B is the most transmissible infection among the HCWs, it is the only one that is preventable by vaccination. However, hepatitis B vaccination coverage among healthcare workers is very low for various reasons, including awareness, risk assessment, and low priority given by the HCWs and managements of both public and private hospitals. Most of the hospitals lack post-exposure management strategies, including the coordination among various departments for reporting, testing, and vaccination. HBsAg prevalence of 4% of the general population, places India in an intermediate HBV endemicity zone.  The prevalence of HBsAg in HCWs and other hospital staff was reported to be 10% in 1992, in a study by Elavia et al., from Mumbai.  A study from Shimla showed a HBsAg positivity of 5%, the highest subgroup being laboratory technicians, 40% of whom were positive.  In another study from PGI Chandigarh, 1.7% of the 3556 HCWs tested were found to be HBsAg positive.  A New Delhi study  revealed that of the 2162 HCWs screened, 55% had been vaccinated, 28% HCWs had never been vaccinated, and 17% were unaware of their vaccination status. Protective (> 10 IU / mL) anti-hepatitis B surface (anti-HBs) antibody titers were seen in only 62%. One percent of HCWs were HBsAg-positive and 25% had evidence of past HBV exposure. The authors recommended that the use of HBIG be made mandatory in needle-pricked HCWs, in India, if they were unvaccinated or vaccinated more than five years back. Also, the study demonstrated that anti-HBs titers declined over a period of time in a fair proportion, thereby, justifying giving a booster dose of vaccine 10 years after the primary vaccination to HCWs in India. The authors suggested that until standard guidelines were universally implemented, as there could be non-responsiveness to the vaccine, this practice could be justified. The recommendations of this study could be debated (especially as the cost of HBIG was prohibitive) as they were in contradiction to the CDC guidelines.  In a recent study from a private hospital in Mumbai, 7 / 342 (2.4%) of the needle stick injuries were due to suturing, and a policy of HBIG with hepatitis B vaccine to those who were anti-HBs negative and a Hepatitis B vaccine booster to the others resulted in no HCW developing Hepatitis B.  In developing countries, 40-65% of HBV infections in healthcare workers were attributable to percutaneous occupational exposure. By contrast, in developed countries, the attributable fraction for HBV was less than 10%, largely because of immunization and post-exposure prophylaxis. 
The strict adherence to universal precautions would reduce the risk of exposure of HCWs to Hepatitis B. However in India, universal precautions are often followed in infected patients only, thereby defeating the entire purpose of the 'universality' of the precautions Most private hospitals follow a policy of mandatory testing for HBsAg and anti HCV as a pre-operative requirement. Although this may have its advantages, it is not a replacement for universal precautions. Also it is not practical to test for the viruses for select exposure-prone procedures. It also is not feasible in emergency situations. There is also a tendency to have a casual attitude toward vaccination, besides ignorance, among HCWs, which needs to change. Therefore, there is an urgent need to lay down guidelines and increase awareness among the HCWs about Hepatitis B infection, available vaccines, post-vaccine immune status, and post-exposure prophylaxis. A uniform health policy cutting across the states of the country and type of hospitals is urgently warranted.
| Conclusion|| |
Although our understanding of the HBV and the various therapeutic and preventive measures to protect against the virus have improved significantly in recent years, transmission of the virus from patients to surgeons and vice versa remains a potential problem. This is especially true in India where no clear cut guidelines have been established for screening HCWs who perform exposure-prone procedures on the one hand and need to adhere to strict implementation of universal precautions on the other hand.
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Department of Gastroenterology, Jaslok Hospital and Research Center, G. Deshmukh Marg, Mumbai - 400 026
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2]