Prevention of occupational transmission of bloodborne pathogens (BBP) including the human immunodeficiency virus (HIV), hepatitis B virus (HBV) and more recently hepatitis C virus (HCV), has received significant attention. Although HCWs are the primary occupational group at risk of acquisition of infection, any worker who is exposed to blood or other potentially infectious body fluids during the performance of job duties is at risk. Populations at risk for occupational exposure to BBP include workers in health care delivery, public safety and emergency response workers and others such as laboratory researchers and morticians. The potential for occupational transmission of bloodborne pathogens including HIV will continue to increase as the number of persons who have HIV and other bloodborne infections and require medical care increases.
In the US, the Centers for Disease Control and Prevention (CDC) recommended in 1982 and 1983 that patients with the acquired immunodeficiency syndrome (AIDS) be treated according to the (now obsolete) category of “blood and body fluid precautions” (CDC 1982; CDC 1983). Documentation that HIV, the causative agent of AIDS, had been transmitted to HCWs by percutaneous and mucocutaneous exposures to HIV-infected blood, as well as the realization that the HIV infection status of most patients or blood specimens encountered by HCWs would be unknown at the time of the encounter, led CDC to recommend that blood and body fluid precautions be applied to all patients, a concept known as “universal precautions” (CDC 1987a, 1987b). The use of universal precautions eliminates the need to identify patients with bloodborne infections, but is not intended to replace general infection control practices. Universal precautions include the use of handwashing, protective barriers (e.g., goggles, gloves, gowns and face protection) when blood contact is anticipated and care in the use and disposal of needles and other sharp instruments in all health care settings. Also, instruments and other reusable equipment used in performing invasive procedures should be appropriately disinfected or sterilized (CDC 1988a, 1988b). Subsequent CDC recommendations have addressed prevention of transmission of HIV and HBV to public safety and emergency responders (CDC 1988b), management of occupational exposure to HIV, including the recommendations for the use of zidovudine (CDC 1990), immunization against HBV and management of HBV exposure (CDC 1991a), infection control in dentistry (CDC 1993) and the prevention of HIV transmission from HCWs to patients during invasive procedures (CDC 1991b).
In the US, CDC recommendations do not have the force of law, but have often served as the foundation for government regulations and voluntary actions by industry. The Occupational Health and Safety Administration (OSHA), a federal regulatory agency, promulgated a standard in 1991 on Occupational Exposure to Bloodborne Pathogens (OSHA 1991). OSHA concluded that a combination of engineering and work practice controls, personal protective clothing and equipment, training, medical surveillance, signs and labels and other provisions can help to minimize or eliminate exposure to bloodborne pathogens. The standard also mandated that employers make available hepatitis B vaccination to their employees.
The World Health Organization (WHO) has also published guidelines and recommendations pertaining to AIDS and the workplace (WHO 1990, 1991). In 1990, the European Economic Council (EEC) issued a council directive (90/679/EEC) on protection of workers from risks related to exposure to biological agents at work. The directive requires employers to conduct an assessment of the risks to the health and safety of the worker. A distinction is drawn between activities where there is a deliberate intention to work with or use biological agents (e.g., laboratories) and activities where exposure is incidental (e.g., patient care). Control of risk is based on a hierarchical system of procedures. Special containment measures, according to the classification of the agents, are set out for certain types of health facilities and laboratories (McCloy 1994). In the US, CDC and the National Institutes of Health also have specific recommendations for laboratories (CDC 1993b).
Since the identification of HIV as a BBP, knowledge about HBV transmission has been helpful as a model for understanding modes of transmission of HIV. Both viruses are transmitted via sexual, perinatal and bloodborne routes. HBV is present in the blood of individuals positive for hepatitis B e antigen (HBeAg, a marker for high infectivity) at a concentration of approximately 108 to 109 viral particles per millilitre (ml) of blood (CDC 1988b). HIV is present in blood at much lower concentrations: 103 to 104 viral particles/ml for a person with AIDS and 10 to 100/ml for a person with asymptomatic HIV infection (Ho, Moudgil and Alam 1989). The risk of HBV transmission to a HCW after percutaneous exposure to HBeAg-positive blood is approximately 100-fold higher than the risk of HIV transmission after percutaneous exposure to HIV-infected blood (i.e., 30% versus 0.3%) (CDC 1989).
Hepatitis
Hepatitis, or inflammation of the liver, can be caused by a variety of agents, including toxins, drugs, autoimmune disease and infectious agents. Viruses are the most common cause of hepatitis (Benenson 1990). Three types of bloodborne viral hepatitis have been recognized: hepatitis B, formerly called serum hepatitis, the major risk to HCWs; hepatitis C, the major cause of parenterally transmitted non-A, non-B hepatitis; and hepatitis D, or delta hepatitis.
Hepatitis B. The major infectious bloodborne occupational hazard to HCWs is HBV. Among US HCWs with frequent exposure to blood, the prevalence of serological evidence of HBV infection ranges between approximately 15 and 30%. In contrast, the prevalence in the general populations averages 5%. The cost-effectiveness of serological screening to detect susceptible individuals among HCWs depends on the prevalence of infection, the cost of testing and the vaccine costs. Vaccination of persons who already have antibodies to HBV has not been shown to cause adverse effects. Hepatitis B vaccine provides protection against hepatitis B for at least 12 years after vaccination; booster doses currently are not recommended. The CDC estimated that in 1991 there were approximately 5,100 occupationally acquired HBV infections in HCWs in the United States, causing 1,275 to 2,550 cases of clinical acute hepatitis, 250 hospitalizations and about 100 deaths (unpublished CDC data). In 1991, approximately 500 HCWs became HBV carriers. These individuals are at risk of long-term sequelae, including disabling chronic liver disease, cirrhosis and liver cancer.
The HBV vaccine is recommended for use in HCWs and public safety workers who may be exposed to blood in the workplace (CDC 1991b). Following a percutaneous exposure to blood, the decision to provide prophylaxis must include considerations of several factors: whether the source of the blood is available, the HBsAg status of the source and the hepatitis B vaccination and vaccine-response status of the exposed person. For any exposure of a person not previously vaccinated, hepatitis B vaccination is recommended. When indicated, hepatitis B immune globulin (HBIG) should be administered as soon as possible after exposure since its value beyond 7 days after exposure is unclear. Specific CDC recommendations are indicated in table 1 (CDC 1991b).
Table 1. Recommendation for post-exposure prophylaxis for percutaneous or permucosal exposure to hepatitis B virus, United States
|
Exposed person |
When source is |
||
|
HBsAg1 positive |
HBsAg negative |
Source not tested or |
|
|
Unvaccinated |
HBIG2´1 and initiate |
Initiate HB vaccine |
Initiate HB vaccine |
|
Previously Known |
No treatment |
No treatment |
No treatment |
|
Known non- |
HBIG´2 or HBIG´1 and |
No treatment |
If known high-risk source |
|
Response |
Test exposed for anti-HBs4 |
No treatment |
Test exposed for anti-HBs |
1 HBsAg = Hepatitis B surface antigen. 2 HBIG = Hepatitis B immune globulin; dose 0.06 mL/kg IM. 3 HB vaccine = hepatitis B vaccine. 4 Anti-HBs = antibody to hepatitis B surface antigen. 5 Adequate anti-HBs is ≥10 mIU/mL.
Table 2. Provisional US Public Health Service recommendations for chemoprophylaxis after occupational exposure to HIV, by type of exposure and source of material, 1996
|
Type of exposure |
Source material1 |
Antiretroviral |
Antiretroviral regimen3 |
|
Percutaneous |
Blood |
|
|
|
Mucous membrane |
Blood |
Offer |
ZDV plus 3TC, ± IDV5 |
|
Skin, increased risk7 |
Blood |
Offer |
ZDV plus 3TC, ± IDV5 |
1 Any exposure to concentrated HIV (e.g., in a research laboratory or production facility) is treated as percutaneous exposure to blood with highest risk. 2 Recommend—Postexposure prophylaxis (PEP) should be recommended to the exposed worker with counselling. Offer—PEP should be offered to the exposed worker with counselling. Not offer—PEP should not be offered because these are not occupational exposures to HIV. 3 Regimens: zidovudine (ZDV), 200 mg three times a day; lamivudine (3TC), 150 mg two times a day; indinavir (IDV), 800 mg three times a day (if IDV is not available, saquinavir may be used, 600 mg three times a day). Prophylaxis is given for 4 weeks. For full prescribing information, see package inserts. 4 Risk definitions for percutaneous blood exposure: Highest risk—BOTH larger volume of blood (e.g., deep injury with large diameter hollow needle previously in source patient’s vein or artery, especially involving an injection of source-patient’s blood) AND blood containing a high titre of HIV (e.g., source with acute retroviral illness or end-stage AIDS; viral load measurement may be considered, but its use in relation to PEP has not been evaluated). Increased risk—EITHER exposure to larger volume of blood OR blood with a high titre of HIV. No increased risk—NEITHER exposure to larger volume of blood NOR blood with a high titre of HIV (e.g., solid suture needle injury from source patient with asymptomatic HIV infection). 5 Possible toxicity of additional drug may not be warranted. 6 Includes semen; vaginal secretions; cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids. 7 For skin, risk is increased for exposures involving a high titre of HIV, prolonged contact, an extensive area, or an area in which skin integrity is visibly compromised. For skin exposures without increased risk, the risk for drug toxicity outweighs the benefit of PEP.
Article 14(3) of EEC Directive 89/391/EEC on vaccination required only that effective vaccines, where they exist, be made available for exposed workers who are not already immune. There was an amending Directive 93/88/EEC which contained a recommended code of practice requiring that workers at risk be offered vaccination free of charge, informed of the benefits and disadvantages of vaccination and non-vaccination, and be provided a certificate of vaccination (WHO 1990).
The use of hepatitis B vaccine and appropriate environmental controls will prevent almost all occupational HBV infections. Reducing blood exposure and minimizing puncture injuries in the health care setting will reduce also the risk of transmission of other bloodborne viruses.
Hepatitis C. Transmission of HCV is similar to that of HBV, but infection persists in most patients indefinitely and more frequently progresses to long-term sequelae (Alter et al. 1992). The prevalence of anti-HCV among US hospital-based health care workers averages 1 to 2% (Alter 1993). HCWs who sustain accidental injuries from needlesticks contaminated with anti-HCV-positive blood have a 5 to 10% risk of acquiring HCV infection (Lampher et al. 1994; Mitsui et al. 1992). There has been one report of HCV transmission after a blood splash to the conjunctiva (Sartori et al. 1993). Prevention measures again consist of adherence to universal precautions and percutaneous injury prevention, since no vaccine is available and immune globulin does not appear to be effective.
Hepatitis D. Hepatitis D virus requires the presence of hepatitis B virus for replication; thus, HDV can infect persons only as a coinfection with acute HBV or as a superinfection of chronic HBV infection. HDV infection can increase the severity of liver disease; one case of occupationally acquired HDV infection hepatitis has been reported (Lettau et al. 1986). Hepatitis B vaccination of HBV-susceptible persons will also prevent HDV infection; however, there is no vaccine to prevent HDV superinfection of an HBV carrier. Other prevention measures consist of adherence to universal precautions and percutaneous injury prevention.
HIV
The first cases of AIDS were recognized in June of 1981. Initially, over 92% of the cases reported in the United States were in homosexual or bisexual men. However, by the end of 1982, AIDS cases were identified among injection drug users, blood transfusion recipients, haemophilia patients treated with clotting factor concentrates, children and Haitians. AIDS is the result of infection with HIV, which was isolated in 1985. HIV has spread rapidly. In the United States, for example, the first 100,000 AIDS cases occurred between 1981 and 1989; the second 100,000 cases occurred between 1989 and 1991. As of June 1994, 401,749 cases of AIDS had been reported in the United States (CDC 1994b).
Globally, HIV has affected many countries including those in Africa, Asia and Europe. As of 31 December 1994, 1,025,073 cumulative cases of AIDS in adults and children had been reported to the WHO. This represented a 20% increase from the 851,628 cases reported through December 1993. It was estimated that 18 million adults and about 1.5 million children have been infected with HIV since the beginning of the pandemic (late 1970s to early 1980s) (WHO 1995).
Although HIV has been isolated from human blood, breast milk, vaginal secretions, semen, saliva, tears, urine, cerebrospinal fluid and amniotic fluid, epidemiological evidence has implicated only blood, semen, vaginal secretions and breast milk in the transmission of the virus. The CDC has also reported on the transmission of HIV as the result of contact with blood or other body secretions or excretions from an HIV-infected person in the household (CDC 1994c). Documented modes of occupational HIV transmission include having percutaneous or mucocutaneous contact with HIV-infected blood. Exposure by the percutaneous route is more likely to result in infection transmission than is mucocutaneous contact.
There are a number of factors which may influence the likelihood of occupational bloodborne pathogen transmission, including: the volume of fluid in the exposure, the virus titre, the length of time of the exposure and the immune status of the worker. Additional data are needed to determine precisely the importance of these factors. Preliminary data from a CDC case-control study indicate that for percutaneous exposures to HIV-infected blood, HIV transmission is more likely if the source patient has advanced HIV disease and if the exposure involves a larger inoculum of blood (e.g., injury due to a large-bore hollow needle) (Cardo et al. 1995). Virus titre can vary between individuals and over time within a single individual. Also, blood from persons with AIDS, particularly in the terminal stages, may be more infectious than blood from persons in earlier stages of HIV infection, except possibly during the illness associated with acute infection (Cardo et al. 1995).
Occupational exposure and HIV infection
As of December 1996, CDC reported 52 HCWs in the United States who have seroconverted to HIV following a documented occupational exposure to HIV, including 19 laboratory workers, 21 nurses, six physicians and six in other occupations. Forty-five of the 52 HCWs sustained percutaneous exposures, five had mucocutaneous exposures, one had both a percutaneous and a mucocutaneous exposure and one had an unknown route of exposure. In addition, 111 possible cases of occupationally acquired infection have been reported. These possible cases have been investigated and are without identifiable non-occupational or transfusion risks; each reported percutaneous or mucocutaneous occupational exposures to blood or body fluids, or laboratory solutions containing HIV, but HIV seroconversion specifically resulting from an occupational exposure was not documented (CDC 1996a).
In 1993, the AIDS Centre at the Communicable Disease Surveillance Centre (UK) summarized reports of cases of occupational HIV transmission including 37 in the United States, four in the UK and 23 from other countries (France, Italy, Spain, Australia, South Africa, Germany and Belgium) for a total of 64 documented seroconversions after a specific occupational exposure. In the possible or presumed category there were 78 in the United States, six in the UK and 35 from other countries (France, Italy, Spain, Australia, South Africa, Germany, Mexico, Denmark, Netherlands, Canada and Belgium) for a total of 118 (Heptonstall, Porter and Gill 1993). The number of reported occupationally acquired HIV infections is likely to represent only a portion of the actual number due to under-reporting and other factors.
HIV post-exposure management
Employers should make available to workers a system for promptly initiating evaluation, counselling and follow-up after a reported occupational exposure that may place a worker at risk of acquiring HIV infection. Workers should be educated and encouraged to report exposures immediately after they occur so that appropriate interventions can be implemented (CDC 1990).
If an exposure occurs, the circumstances should be recorded in the worker’s confidential medical record. Relevant information includes the following: date and time of exposure; job duty or task being performed at the time of exposure; details of exposure; description of source of exposure, including, if known, whether the source material contained HIV or HBV; and details about counselling, post-exposure management and follow-up. The source individual should be informed of the incident and, if consent is obtained, tested for serological evidence of HIV infection. If consent cannot be obtained, policies should be developed for testing source individuals in compliance with applicable regulations. Confidentiality of the source individual should be maintained at all times.
If the source individual has AIDS, is known to be HIV seropositive, refuses testing or the HIV status is unknown, the worker should be evaluated clinically and serologically for evidence of HIV infection as soon as possible after the exposure (baseline) and, if seronegative, should be retested periodically for a minimum of 6 months after exposure (e.g., six weeks, 12 weeks and six months after exposure) to determine whether HIV infection has occurred. The worker should be advised to report and seek medical evaluation for any acute illness that occurs during the follow-up period. During the follow-up period, especially the first six to 12 weeks after the exposure, exposed workers should be advised to refrain from blood, semen or organ donation and to abstain from, or use measures to prevent HIV transmission, during sexual intercourse.
In 1990, CDC published a statement on the management of exposure to HIV including considerations regarding zidovudine (ZDV) post-exposure use. After a careful review of the available data, CDC stated that the efficacy of zidovudine could not be assessed due to insufficient data, including available animal and human data (CDC 1990).
In 1996, information suggesting that ZDV post-exposure prophylaxis (PEP) may reduce the risk for HIV transmission after occupational exposure to HIV-infected blood (CDC 1996a) prompted a US Public Health Service (PHS) to update a previous PHS statement on management of occupational exposure to HIV with the following findings and recommendations on PEP (CDC 1996b). Although failures of ZDV PEP have occurred (Tokars et al. 1993), ZDV PEP was associated with a decrease of approximately 79% in the risk for HIV seroconversion after percutaneous exposure to HIV-infected blood in a case-control study among HCWs (CDC 1995).
Although information about the potency and toxicity of antiretroviral drugs is available from studies of HIV-infected patients, it is uncertain to what extent this information can be applied to uninfected persons receiving PEP. In HIV-infected patients, combination therapy with the nucleosides ZDV and lamivudine (3TC) has greater antiretroviral activity than ZDV alone and is active against many ZDV-resistant HIV strains without significantly increased toxicity (Anon. 1996). Adding a protease inhibitor provides even greater increases in antiretroviral activity; among protease inhibitors, indinavir (IDV) is more potent than saquinavir at currently recommended doses and appears to have fewer drug interactions and short-term adverse effects than ritonavir (Niu, Stein and Schnittmann 1993). Few data exist to assess possible long-term (i.e., delayed) toxicity resulting from use of these drugs in persons not infected with HIV.
The following PHS recommendations are provisional because they are based on limited data regarding efficacy and toxicity of PEP and risk for HIV infection after different types of exposure. Because most occupational exposures to HIV do not result in infection transmission, potential toxicity must be carefully considered when prescribing PEP. Changes in drug regimens may be appropriate, based on factors such as the probable antiretroviral drug resistance profile of HIV from the source patient, local availability of drugs and medical conditions, concurrent drug therapy and drug toxicity in the exposed worker. If PEP is used, drug-toxicity monitoring should include a complete blood count and renal and hepatic chemical function tests at baseline and two weeks after starting PEP. If subjective or objective toxicity is noted, drug reduction or drug substitution should be considered, and further diagnostic studies may be indicated.
Chemoprophylaxis should be recommended to exposed workers after occupational exposures associated with the highest risk for HIV transmission. For exposures with a lower, but non-negligible risk, PEP should be offered, balancing the lower risk against the use of drugs having uncertain efficacy and toxicity. For exposures with negligible risk, PEP is not justified (see table 2 ). Exposed workers should be informed that knowledge about the efficacy and toxicity of PEP is limited, that for agents other than ZDV, data are limited regarding toxicity in persons without HIV infection or who are pregnant and that any or all drugs for PEP may be declined by the exposed worker.
PEP should be initiated promptly, preferably with 1 to 2 hours post-exposure. Although animal studies suggest that PEP probably is not effective when started later than 24 to 36 hours post-exposure (Niu, Stein and Schnittmann 1993; Gerberding 1995), the interval after which there is no benefit from PEP for humans is undefined. Initiating therapy after a longer interval (e.g., 1 to 2 weeks) may be considered for the highest risk exposures; even if infection is not prevented, early treatment of acute HIV infection may be beneficial (Kinloch-de-los et al. 1995).
If the source patient or the patient’s HIV status is unknown, initiating PEP should be decided on a case-by-case basis, based on the exposure risk and likelihood of infection in known or possible source patients.
Other Bloodborne Pathogens
Syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob disease, human T-lymphotropic virus type 1 and viral haemorrhagic fever have also been transmitted by the bloodborne route (CDC 1988a; Benenson 1990). Occupational transmission of these agents has only rarely been recorded, if ever.
Prevention of Transmission of Bloodborne Pathogens
There are several basic strategies which relate to the prevention of occupational transmission of bloodborne pathogens. Exposure prevention, the mainstay of occupational health, can be accomplished by substitution (e.g., replacing an unsafe device with a safer one), engineering controls (i.e., controls that isolate or remove the hazard), administrative controls (e.g., prohibiting recapping of needles by a two-handed technique) and use of personal protective equipment. The first choice is to “engineer out the problem”.
In order to reduce exposures to bloodborne pathogens, adherence to general infection control principles, as well as strict compliance with universal precaution guidelines, is required. Important components of universal precautions include the use of appropriate personal protective equipment, such as gloves, gowns and eye protection, when exposure to potentially infectious body fluids is anticipated. Gloves are one of the most important barriers between the worker and the infectious material. While they do not prevent needlesticks, protection for the skin is provided. Gloves should be worn when contact with blood or body fluids is anticipated. Washing of gloves in not recommended. Recommendations also advise workers to take precautions to prevent injuries by needles, scalpels and other sharp instruments or devices during procedures; when cleaning used instruments; during disposal of used needles; and when handling sharp instruments after procedures.
Percutaneous exposures to blood
Since the major risk of infection results from parenteral exposure from sharp instruments such as syringe needles, engineering controls such as resheathing needles, needleless IV systems, blunt suture needles and appropriate selection and use of sharps disposal containers to minimize exposures to percutaneous injuries are critical components of universal precautions.
The most common type of percutaneous inoculation occurs through inadvertent needlestick injury, many of which are associated with recapping of needles. The following reasons have been indicated by workers as reasons for recapping: inability to properly dispose of needles immediately, sharps disposal containers too far away, lack of time, dexterity problems and patient interaction.
Needles and other sharp devices can be redesigned to prevent a significant proportion of percutaneous exposures. A fixed barrier should be provided between hands and the needle after use. Worker’s hands should remain behind the needle. Any safety feature should be an integral part of the device. The design should be simple and little or no training should be required (Jagger et al. 1988).
Implementing safer needle devices must be accompanied by evaluation. In 1992, the American Hospital Association (AHA) published a briefing to assist hospitals with the selection, evaluation and adoption of safer needle devices (AHA 1992). The briefing stated that “because safer needle devices, unlike drugs and other therapies, do not undergo clinical testing for safety and efficacy before they are marketed, hospitals are essentially ‘on their own’ when it comes to selecting appropriate products for their specific institutional needs”. Included in the AHA document are guidance for the evaluation and adoption of safer needle devices, case studies of the use of safety devices, evaluation forms and listing of some, but not all, products on the US market.
Prior to implementation of a new device, health care institutions must ensure that there is an appropriate needlestick surveillance system in place. In order to accurately assess the efficacy of new devices, the number of reported exposures should be expressed as an incidence rate.
Possible denominators for reporting the number of needlestick injuries include patient days, hours worked, number of devices purchased, number of devices used and number of procedures performed. The collection of specific information on device-related injuries is an important component of the evaluation of the effectiveness of a new device. Factors to be considered in collecting information on needlestick injuries include: new product distribution, stocking and tracking; identification of users; removal of other devices; compatibility with other devices (especially IV equipment); ease of use; and mechanical failure. Factors which may contribute to bias include compliance, subject selection, procedures, recall, contamination, reporting and follow-up. Possible outcome measures include rates of needlestick injuries, HCW compliance, patient care complications and cost.
Finally, training and feedback from workers are important components of any successful needlestick prevention programme. User acceptance is a critical factor, but one that seldom receives enough attention.
Elimination or reduction of percutaneous injuries should result if adequate engineering controls are available. If HCWs, product evaluation committees, administrators and purchasing departments all work together to identify where and what safer devices are needed, safety and cost effectiveness can be combined. Occupational transmission of bloodborne pathogens is costly, both in terms of money and the impact on the employee. Every needlestick injury causes undue stress on the employee and may affect job performance. Referral to mental health professionals for supportive counselling may be required.
In summary, a comprehensive approach to prevention is essential to maintaining a safe and healthy environment in which to provide health care services. Prevention strategies include the use of vaccines, post-exposure prophylaxis and prevention or reduction of needlestick injuries. Prevention of needlestick injuries can be accomplished by improvement in the safety of needle-bearing devices, development of procedures for safer use and disposal and adherence to infection control recommendations.
Acknowledgements: The authors thank Mariam Alter, Lawrence Reed and Barbara Gooch for their manuscript review.