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Postexposure Prophylaxis for Deadly Bloodborne Viral Infections
Released: September 2005
Sponsored by Dannemiller Memorial Educational Foundation

Supported by an unrestricted educational grant from

Faculty:
Kant Y. Lin. M.D.
Professor of Plastic Surgery
Chief of Division of Craniofacial Surgery
University of Virginia Health Systems
Charlottesville, VA
William B. Long III, M.D.
President and Medical Director
Legacy Verified Level I Shock Trauma Center for Children and Adults
Portland, OR
Richard F. Edlich, M.D., Ph.D.
Distinguished Professor Emeritus of Plastic Surgery
Biomedical Engineering, and Emergency Medicine
Founder of the DeCamp Burn and Wound Healing Center
University of Virginia Health Systems
Director of Trauma,Prevention, Education and Research
Trauma Specialists, LLP, Legacy Verified Level I Shock Trauma Center
for Pediatrics and Adults
Legacy Emanuel Hospital, Portland, OR
Statement of Need:
During any surgical procedure, operating room personnel are subjected to exposure to deadly bloodborne viral infections. In the event of exposure to these deadly bloodborne viral infections, operating room personnel must have a comprehensive postexposure prophylaxis plan to prevent the development of these deadly bloodborne viral infections.
Goal:
The broad mission of this course is to outline a comprehensive postexposure prophylaxis plan against deadly bloodborne viral infection that will reduce the frequency of these illnesses in both the operating room personnel as well as the patients.
Objectives:
At the completion of the training, the participant will be able to:
- Describe the treatment of the exposure site.
- Evaluate the type of exposure for its ability to produce a deadly bloodborne viral infection.
- Complete a postexposure report for the operating room personnel.
- Describe postexposure prophylaxis for the deadly bloodborne viruses.
Method of Participation:
To receive credit, participants should, in order, view the objectives, read the educational material, then click on the link at the end of the activity to complete the post-test, evaluation, and then print the CME certificate. This activity should take approximately one hour to complete. This activity is available through September 30, 2008. No credit will be awarded after this date.
Target Audience:
This educational program is intended for general surgeons as well as other surgical specialists or physicians involved in wound closure.
Accreditation:
The Dannemiller Memorial Educational Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The Dannemiller Memorial Educational Foundation designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s),TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
The Dannemiller Memorial Educational Foundation is an approved provider of the California Board of Registered Nursing. Provider approved by the California Board of Registered Nursing, Provider Number 4229 for 1.2 contact hours.
RNs outside California must verify with their licensing agency for approval of this course.
Disclosure Policy:
In accordance with the Accreditation Council for Continuing Medical Education (ACCME), the Dannemiller Memorial Educational Foundation requires that any person who is in a position to control the content of a CME activity must disclose all relevant financial relationships they have with a commercial interest. Accordingly:
Faculty Disclosure:
In accordance with ACCME requirements, Dr. Long has nothing to disclose.
In accordance with ACCME requirements, Dr. Lin has nothing to disclose.
In accordance with ACCME requirements, Dr. Edlich has nothing to disclose.
Dannemiller Memorial Educational Foundation Disclosure:
The Dannemiller Memorial Educational Foundation staff that was involved in the development of this activity has no financial relationships with any commercial interests that are relevant to this activity.
Disclaimer:
The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of the Dannemiller Memorial Educational Foundation or U.S. Surgical. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publication and materials on the subject matter before relying solely upon the information contained within this educational activity.
INTRODUCTION
Because surgical needles have a proven role in spreading deadly bloodborne viral infection, the surgeon must select surgical gloves that reduce the risk of accidental injuries during surgery.1 A unique double-glove hole indicator system has been developed that reduces the incidence of needle puncture as well as provides a unique glove hole detection system that facilitates an initiation of postexposure prophylaxis. Postexposure prophylaxis consists of the following components: (1) treatment of exposure site, (2) evaluation of the type of exposure, (3) evaluation of the exposure source, (4) completion of the exposure report, (5) postexposure prophylaxis and (6) occupational exposure management resources. By following these comprehensive recommendations, the reader should be able to institute this program in his/her hospital that will reduce the frequency of deadly bloodborne viral infections.
A. RELIABILITY OF SURGICAL DOUBLE-GLOVE HOLE INDICATION SYSTEMS
1. Double-glove hole puncture indication systems
Because surgical glove perforation provides exposure to viruses that can infect operating room personnel as well as the patient, Palmer and Rickett2 examined the mechanisms and risks of surgical glove perforation in a hospital. In their study, 275 pairs of surgeons' gloves were collected from 100 consecutive operations. In 42% of the operations where glove damage occurred, the surgeon was aware of the needle perforation. It was surprising that in only 28% of the operations did the surgeons change their gloves because the surgeon was aware of the surgical glove needle puncture. Surgical glove puncture was unnoticed in 58% of the instances where it occurred. On the basis of this clinical study, Palmer and Rickett2 indicated that a surgeon risks acquiring more than one hepatitis B infection per lifetime. In addition, they estimated that at least one in 1,500 surgeons is likely to be infected by the human immunodeficiency virus (HIV) infection during the next 35 years.
Because most surgical glove hole punctures go unnoticed for some time after perforation, Regent Medical (Norcross, GA) designed and manufactured a new double-glove hole puncture indication system called the Biogel® RevealTM Puncture Indication System. This glove hole indication system was first developed for latex gloves. It consisted of a double-glove puncture indication system with the inner glove uniformly colored green. Later, Regent Medical replaced the Biogel Reveal Puncture Indication System with the Biogel Indicator Underglove that can be combined with a variety of Biogel latex gloves as the outer glove. When the outer glove was punctured, the green inner glove immediately was exposed to the blood and other fluids in the operative procedure. After exposure to fluids, this double-glove puncture indication system developed the appearance of a darker green color around the outer glove puncture site, a warning to operating room personnel of the presence of glove puncture of the outer glove. This color change is an optical effect and does not involve release of dye or any other material. After noting this color change, the surgeon should remove all surgical gloves, wash hands and don a new double-glove puncture indication system.
The biomechanical research laboratory was the first to measure the puncture resistance of the double-glove hole puncture indication system manufactured by Regent Medical.3 Using a computerized needle penetration system, the computer plotted the vertical force exerted on the glove membrane by a wide diameter (0.45mm) taper point needle. The penetration force data typically showed an initial penetration force followed by a maximum force. The initial force peak represents the first point at which the needle actually penetrated the glove membrane. The maximum force peak, however, was reached as the wider needle body followed the taper point through the channel created in the membrane. Penetration force data were collected for the Biogel Indicator Underglove, the standard Biogel glove and a combination of the two into a Biogel double-glove hole puncture indication system. The initial and maximum penetration forces required for the needle to penetrate the Biogel double-glove hole puncture indication system were significantly greater than those required to penetrate either the single Biogel® outer glove or the single Biogel Indicator Underglove.
Several clinical studies have been subsequently reported that confirm the value of the double-glove hole puncture indication system. In 1996, Brown4 reported on the use of this double-glove puncture indication system during trauma surgery. These double-glove puncture indication systems were used in 40 consecutive operative procedures for lower limb fracture fixation. Glove perforations were noted in 48% of the operative procedures. Perforations of the outer gloves were evident in 26 occasions; glove punctures of the under gloves were noted in two occasions. This clinical study indicated that there were no false positive color changes. However, no indication of perforation was visible on one occasion. The study concluded that the rapidity and accuracy of color change allowed identification of glove punctures intraoperatively.
In the next year, Nicolai et al.5 described their experience with this glove system in major joint replacement surgery. They performed a prospective, randomized trial comparing the incidence of glove perforation using this new double-glove puncture Biogel Indicator system and standard double-gloves in total hip and knee replacement surgery. One or more perforations were detected in 14.6% of all double-glove systems. The investigators concluded that the new double-glove puncture indication system increased significantly the awareness of perforations. It was also observed that the dexterity of surgeons using the double-glove puncture Biogel Indicator system was similar to that of the standard double-gloves.
In 1999, Avery et al.6 evaluated this new double-glove puncture IndicatorTM system in maxillofacial trauma surgery. Surgeons wearing the double-glove puncture indication systems detected more perforations (79%) than surgeons wearing the standard double-gloves (19%.) They noted that the accuracy of the double-glove puncture indication system was most noticeable in wet operating fields.
It is important to emphasize that fluid must be present in the operative environment because ingress of fluid through the puncture hole is necessary to cause a color change in the double-glove hole puncture indication system. Consequently, this system is not reliable for surgeries that are performed in relatively dry clinical settings. The need for a wet surgical environment for this double-glove puncture indication system was clearly demonstrated in the evaluation of 50 consecutive patients in the emergency department.7 During wound closure, there was no color change in the double-glove puncture indication system indicating glove puncture. When the same gloves were then analyzed for holes by water filling and distention as described by Brough et al.8, 14 of the 50 double-glove puncture indication systems failed. All 14 outer gloves were punctured, and three inner gloves had holes without demonstrable injury to the skin. The results of this clinical study have caused one to alter the wound closure procedures in the emergency department. A sterile basin has been added to our sterile wound closure tray. When the tray is opened aseptically, sterile 0.9% sodium chloride is added to the sterile basin. The emergency physician then immerses his/her hands in the sterile fluid before beginning surgical wound treatment and periodically during longer surgeries. This glove exposure to fluid now allows the accurate detection of glove hole puncture using this double-glove puncture indication system.
When the Biogel Reveal system was first developed, two pairs of gloves were packaged in the same heat-sealed paper overwrap. The inner glove, the green Biogel Indicator Underglove, was a half size larger than the outer Biogel glove. This difference in the sizes of the underglove and the outer glove was based on the results of clinical trials reported by Webb and Pentlow.9 In their clinical studies involving 17 surgeons of all specialties, they reported that wearing the smaller glove on the outside of the larger glove was considered more comfortable than wearing a similarly sized underglove and outer glove. In addition, they found that double-gloving did not alter two-point discrimination or ability to tie surgical knots in their clinical study.
Clinical studies are continuing to be reported in the surgical literature demonstrating the merit of this unique latex double-glove puncture indication system. Aarnio and Laine10 confirmed the value of this double-glove puncture indication system in vascular surgery. The gloves used in this study were either double-gloves with the hole puncture indication system or the standard single glove used in the hospital. In 73 operations, 200 gloves were tested; half of them were double-gloves and half of them were single systems. Perforation was experienced in three double-glove systems. The perforation was detected in two of the three double-glove systems. Glove hole puncture was encountered in 12 of the single gloves. These investigators expanded their clinical evaluation of this double-glove hole puncture indication system to 885 operations.11 According to their study, the early detection of glove hole perforations occurred in 86% of the perforations involving this double-glove hole puncture indication system.
Naver and Gottrup12 investigated the incidence of glove perforations using this double-glove IndicatorTM system during various types of gastrointestinal surgery. The surgeons, assistants and scrub nurses were assigned to wear either single gloves or the Biogel Indicator double-glove indication system; 566 pairs of gloves were tested. The perforation rate in single gloves was 17%; perforations were identified in both the outer Biogel and the inner green Biogel Indicator gloves in only 2% of the double-gloves. In addition, they observed that double-gloving reduced the rate of blood contamination of the hands among surgeons from 13% using single gloves to 2% using double-gloves. The investigators concluded that the Biogel Indicator double-gloving system was recommended in gastrointestinal surgery because of the appreciable protection against blood contamination that it offers.
During operative procedures, the operating room personnel wear sterile surgical gloves that are designed to protect them and their patients against transmissible infections. The Food and Drug Administration (FDA) has set compliance policy guides for manufacturers of gloves. The FDA allows surgeons' gloves whose leakage defect rates do not exceed 2.5% Acceptable Quality Level (AQL) to be used in operating rooms. The implications of this policy are potentially enormous to operating room personnel and the patient. For a surgeon with a transmissible infection using surgical gloves with this rate of leakage, it could be estimated that one in 40 of his/her patients could potentially become infected due to exposure via failure of his/her surgical gloves. This unacceptable risk to the patient could be significantly reduced by the use of sterile double surgical gloves.
2. Latex allergy among operating room personnel
Operating room personnel have a high frequency of exposure to latex gloves which has led to the development of a greater than average incidence of latex allergies.13-14 In addition, they care for certain patient groups that are considered to be at risk for latex allergies. Staff allergic to latex and those caring for patients allergic to latex must wear latex-free gloves to protect themselves and their patients. In response to this latex allergy epidemic, Regent Medical has just developed a new non-latex double-glove hole puncture indication system.15
Because Regent Medical has devised non-latex double-glove hole puncture indication and latex double-glove Biogel® Indicator Puncture Indication Systems, the accuracy of the blue non-latex double-glove hole puncture indication and the green latex double-glove Biogel® IndicatorTM systems has been evaluated in detecting holes made by five commonly used sterile SynetureTM surgical needles: taper point surgical needle, tapercut surgical needle, reverse cutting edge surgical needle, taper cardiopoint surgical needle and spatula surgical needle.13 After subjecting both the non-latex double-glove puncture indication system and the latex double-glove Biogel Indicator system to surgical needle puncture in each glove fingertip, these double-glove systems were immersed in a sterile basin of saline after which the double-gloved hands manipulated surgical instruments. Within two minutes, both the non-latex double-glove hole puncture indication system and the latex double-glove Biogel Indicator system accurately detected needle punctures in all of the surgical gloves, regardless of the dimensions of the surgical needles. In addition, the size of the color change visualized through the translucent outer glove did not correlate with needle diameter. On the basis of this extensive experimental evaluation, both the non-latex double-glove hole puncture indication system and the latex double-glove Biogel Indicator system should be used in all operative procedures by all operating room personnel.
The purpose of this study was to examine the reliability of these unique non-latex and latex double-glove hole puncture indication systems. These double-glove puncture indication systems were subjected to surgical needle puncture by a wide variety of surgical needles produced by one of the leading surgical needle manufacturers. The time of appearance of the color changes in the double-glove puncture indication system was carefully monitored. In addition, the intensity and configuration of the color changes following puncture by the different surgical needles were evaluated.
3. Surgical double-glove hole puncture indication systems
a. Surgical glove packaging
Regent Medical has designed an enhanced glove packaging system that offers features conducive to the medical industry's fast-paced environment, with improved accessibility through an easy-to-open film pack. This modified design offers easy access into a rectangular heat-sealed plastic overwrap. One side of the overwrap has product information printed on its surface; the other side is devoid of information, indicating that it is the back of the overwrap. One end of the overwrap has two unsealed edges that extend to its heat-sealed border. One unsealed edge from the front of the overwrap has the directions "pull down to open." With the unsealed edges grasped between the thumb and index fingertip of each hand, the glove package is opened to expose the paper wallet containing two surgical gloves.
b. Surgical gloves
The Biogel Indicator Underglove is a green latex glove that is used in combination with any other Biogel® latex surgical glove to create a double-glove puncture indication system. This underglove has a methacrylate polymer lining that is bonded to its inner surface that enables it to be donned on damp, wet or dry hands. The outer surface is specially treated so that the underglove can be easily donned by a latex outer glove. This methacrylate polymer lining allows donning without the presence of cornstarch powders, eliminating glove-powder complications. Its thickness at the fingertip is 0.19mm. The glove has a curved finger design. The glove is manufactured to contain 50 mg or less of water extractable latex protein per gm. This underglove has a distinct green color that is not apparent when the underglove is covered by the translucent surface of the outer glove. When the outer glove is punctured, leakage of fluids through the puncture hole allows the green underglove to be visualized through the translucent outer glove.
In this study, the standard Biogel or the Biogel® Super-Sensitive gloves were used as the outer gloves. These outer gloves have Biogel coatings on only the inner surfaces of the gloves. These outer gloves are translucent, permitting visualization of color changes in the underglove in the event that these outer gloves are punctured. The standard Biogel glove is a relatively thick glove with a microroughened surface. The thickness of its fingertip is 0.25mm. It also contains 50 mg or less of water extractable latex protein per gram. In contrast, the Biogel Super-Sensitive glove is approximately 20% thinner than the standard Biogel glove, and its thickness at the fingertip is 0.19mm.
In addition, Regent Medical has designed the first non-latex double-glove hole puncture indication system. The blue underglove, Biogel® SkinsenseTM N Universal has a polymer coating on its inner surface and a special treatment of its outer surface that allows it to be used either as a single glove or as part of a double-glove puncture indication system. Its thickness is remarkably similar to the green latex Biogel Indicator glove, measuring 0.20mm. It has a distinct dark blue color that becomes apparent following glove puncture of the translucent light blue outer glove.
The non-latex outer glove, Biogel® SkinsenseTM PI, has a polymer coating on its inner surface. This non-latex glove, made of polyisoprene, has the same thickness (0.20mm) as the non-latex underglove. This can either be donned over damp, wet or dry hands or can serve as the outer glove of the non-latex double-glove hole puncture indicator system. Its translucent light blue color allows visualization of the dark blue underglove after puncture of this outer glove.
B. POSTEXPOSURE PROPHYLAXIS OF OPERATING ROOM PERSONEL
For all operating room personnel, the potential exists for blood and body fluid exposure. This exposure places the operating room personnel at risk for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and human T-cell lymphotropic virus type-I infection (HTLV-I).16-19 This exposure occurs either as a percutaneous injury (e.g., a needlestick or cut with a sharp object) or contact of mucous membrane, or nonintact skin (e.g., exposed skin that is chapped, abraded, or afflicted with dermatitis) with blood, tissue, or other body fluids that are potentially infectious.16,17 The risk of infection from these viruses is extremely low even when operating room personnel come in contact with feces, nasal secretions, saliva, sputum, sweat, tears, urine and vomitus, unless they contain blood. The purpose of this part of the continuing education program is to provide recommendations for operating room personnel and patients exposed to these bloodborne diseases. These recommendations include the following: (1) treatment of the exposure site, (2) evaluation of the type of exposure, (3) evaluation of the exposure source, (4) preparation of exposure report, and (5) postexposure prophylaxis for HBV, HCV, HIV and HTLV-I.
1. Treatment of the exposure site
During the last decade, there have been numerous technologic advances in wound care that have allowed the open wound to heal without infection. These technologic innovations have emerged from comprehensive, well-designed, experimental and clinical studies in microbiology, molecular biology, and mechanical engineering. These technologic advances in wound repair have gradually transformed the decision-making process in emergency wound care. The exposure site must be examined using aseptic technique with mask and gloves. The surgeon should examine and repair the wound using the sterile powder-free double-gloves. Powdered surgical gloves should be avoided because the powder on surgical gloves causes damage to all tissues and is the vector for the latex allergy epidemic.20 Ideally, the examiner should wear a sterile double-glove puncture indication system that has been developed for the accurate detection of a hole in the outer glove.21 It consists of a colored underglove within the translucent outer glove. When a hole in the outer glove occurs in the presence of fluids, the underglove develops a color change around the needle puncture hole, which is a visible indicator for immediate glove change. If hair removal around the wound is necessary to visualize accurately the exposure site, surgical clippers, rather than a razor, should be employed for atraumatic removal of the hair.22 The exposure site should be washed with a sterile fine pore-cell size sponge soaked in poloxamer 188 (ShurClensTM, ConvaTec Inc., Skillman, NJ).23 Poloxamer 188 has been used to cleanse wounds in more than 10,000,000 patients without an adverse effect.
The commercially available surgical scrub solutions that contain iodophors or chlorhexidines are not safe for use in wounds.24 These solutions contain toxic antiseptic agents and detergents that damage tissue defenses and potentate the development of infection. The cleansed exposure site should then be covered by a sterile dressing.
2. Evaluation of the type of exposure
The type of exposure should be evaluated for its potential to transmit HBV, HCV, HIV and HTLV-I based on the type of body substance involved and the route and severity of exposure.25 In most cases, there is evidence of compromised skin integrity which includes dermatitis, abrasion or open wound. Blood, fluid, fluid containing visible blood, or other potentially infectious fluid, including semen, vaginal secretions, cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids, or tissue, can be also infectious for transmission of bloodborne viruses. The routes for exposure to these fluids or tissue that pose a risk for bloodborne virus transmission is usually a percutaneous injury (i.e., needle stick or other penetrating sharps-related event) or through contact with a mucous membrane. For HCV and HIV, exposure to a blood-filled hollow needle or visibly bloody instrument carries a higher risk than exposure to a needle that was used for giving an injection. Furthermore, any direct contact with a concentrated virus in a research laboratory or production facility is considered an exposure that requires clinical evaluation.
3. Evaluation of the exposure source
The person whose blood or body fluid is the source of operating room personnel's exposure should be evaluated for HBV, HCV, HIV and HTLV-I infection. Information available in the patient's medical record at the time of exposure or from the source person might confirm or exclude bloodborne virus infection. The laboratory test results, admitting diagnosis, as well as previous medical history, must be reviewed carefully in the patient's hospital record. There are specific segments of the population that have increased risk for these bloodborne infections and consequently a higher prevalence of infection. These segments of the population have several important risk factors. Life style risk factors include male homosexuality and injection drug use. Geographic risk factors involve infection acquired in economically disadvantaged parts of the world where the prevalence of bloodborne infections is higher. Occupational risk factors, such as healthcare workers exposed frequently to blood, are other important considerations.
If the HBV, HCV, HIV, and HTLV-I infection status of the source is unknown, the source person should be informed of the incident and tested for serologic evidence of bloodborne virus infection. When testing the source person, one must obtain informed consent in accordance with state and local laws. When the source person is found to be infected with these bloodborne viruses, he/she should be referred for appropriate counseling and treatment. Strict confidentiality of the source person must be maintained.
Testing for these bloodborne infections in the exposure source must be performed as soon as possible. Hospitals, clinics and other sites that manage operating room personnel exposed to bloodborne infections should consult their laboratories regarding the most appropriate test that will expedite obtaining the laboratory results. An FDA-approved rapid HIV antibody test kit is valuable in making the diagnosis, especially if testing by standard enzyme immunoassay (EIA) cannot be tested within 24-48 hours. A new rapid test, Determine (Abbott, Abbott Park, IL), detects HIV-1 and HIV-2 antibodies within 15 minutes by using 50 mL of serum or plasma.26 It is important to point out that this rapid test detects HIV infection in serum from patients with CD4+ T-cell counts as low as 5 cells/mm3. Rapid testing is efficient for laboratories that have small volumes of fluid for testing, that require rapid results, and do not have technically advanced equipment, such as the EIA plate readers. Repeatedly reactive results by EIA or rapid HIV-antibody test are highly suggestive of infection, whereas a negative result is an excellent indicator of the absence of HIV antibody. Confirmation of a reactive result by Western Blot or immunofluorescent antibody is not necessary to initiate postexposure management, but should be done to complete the testing process and before informing the source person. Repeatedly reactive results by EIA for anti-HCV should be confirmed by an additional test (i.e., recombinant immunoblot assay (RIBATM) or HCV polymerase chain reaction (PCR)). Direct virus assays (e.g., HIV p24 antigen EIA or test for HIV RNA or HCV RNA) for routine testing of HIV or HCV screening of source persons should not be instituted.
If the exposure is unknown or cannot be tested, information about where and under what circumstances the exposure occurred in the operating room should be assessed epidemiologically for the potential of transmission of HBV, HCV, HIV or HTLV-I. An important consideration in this decision is the prevalence of HBV, HCV, HIV or HTLV-I in the population group from which the contamination source is derived. For example, an exposure that occurs in a geographic area where injection-drug use is frequent would be considered epidemiologically to have a higher risk of transmission than an exposure that occurs in a nursing home for the elderly. Testing of needles or other sharp instruments implicated in an exposure is not recommended. Healthcare providers should be aware of the state and local laws governing the collection and release of serostatus information on the source person following an occupational exposure.
If the source person is known to have an HIV infection, the following information should be gathered, including the person's stage of infection (i.e., asymptomatic, symptomatic, or AIDS), CD4+ T-cell count, results of viral load testing, current and previous anti-retroviral therapy and results of any genotypic or phenotypic viral resistance testing, so that an appropriate postexposure prevention program can be instituted. If this information is not available, initiation of postexposure prophylaxis should not be delayed. Changes in the regimen can be made later. Revaluation of the postexposure regimen should be done within 72 hours after postexposure.
If the source person is HIV seronegative and has no clinical evidence of AIDS or symptoms of HIV infection, no further testing of the source person for HIV infection is indicated. The likelihood of the source person being in the "window period" of HIV infection in the absence of symptoms is rare.
4. Completion of exposure report
When an operating room exposure occurs, an occupational exposure report must be completed. This report should list the day and time of exposure. It should provide details of the procedure being performed, including where and how the exposure occurred. If the exposure was due to a sharp device, the type and brand of the device should be identified. In addition, the circumstances involved in the course of handling the device when the exposure occurred should be documented. Furthermore, the type and amount of fluid or material should be identified. In addition, the severity of the exposure should be carefully noted. For a percutaneous exposure, depth of injury and whether fluid was injected are important considerations. For a skin or mucous membrane exposure, the estimated volume of material and the condition of the skin (e.g., chapped, abraided, intact) should be listed. Moreover, the details of the exposure source should be carefully listed including whether the source material contained HBV, HCV, HIV or HTLV-I. If the source is HIV-infected, the stage of disease, history of antiretroviral therapy viral load, and antiretroviral drug resistance must be identified. Pertinent information about the exposed person to include hepatitis B vaccination and vaccine-response status must be reported. This report should be completed with information about counseling, postexposure management and follow-up.
5. Postexposure prophylaxis
The postexposure prophylaxis for HBV, HCV, HIV and HTLV-I differs considerably and will be discussed separately.
a. Postexposure prophylaxis for HBV
HBV infection is a well-recognized risk for operating room personnel(Table 1).25 The risk of HBV infection to operating room personnel is primarily related to the degree of contact with blood in the operating room and also to hepatitis B e antigen (HBeAg) status of the patient. In studies of healthcare personnel who sustained injuries from needles contaminated with blood containing HBV, the risk of developing clinical hepatitis was 22-31% if the blood was both hepatitis B surface antigen (HBsAg) and HBeAg-positive. In these patients, the risk of developing serologic evidence of HBV infection was considerably greater, 37%-62%. In contrast, the risk of developing clinical hepatitis from a needle contaminated with HBsAg-positive, HBeAg-negative blood was only 1%-6%. In these circumstances, the risk of developing serologic evidence of HBV infection was 23%-37%.25
All operating room personnel should be vaccinated against hepatitis B27,28 (Table 1). Prevaccination serologic screening for previous infection is not recommended for persons being vaccinated because of occupational risk. Hepatitis B vaccine contains purified recombinant HBsAg and causes anti-HBs production to hepatitis B. Hepatitis B vaccines are licensed for preexposure and postexposure prophylaxis. Two recombinant DNA hepatitis B vaccines are available, one prepared by Merck Sharp and Dohme (Recombivax HB®) and the other by SmithKline Beecham (ENGERIX-B®). A genetically engineered yeast strain results in both vaccines. Recombivax® is available in 10 mg/mL of purified hepatitis B surface antigen, while Engerix-B® contains 20 mg/mL of the same antigen. A more concentrated solution of Recombivax® contains 40 mg/mL for use in patients who receive hemodialysis. Twinrex® (SmithKline Beecham) is a bivalent vaccine that produces protective antibodies against hepatitis A and hepatitis B.
As required under the National Childhood Vaccine Injury Act, all healthcare providers in the United States who administer any vaccine shall, prior to administration of the vaccine, provide a copy of the Vaccine Information Statements (VIS) (Figure 1) produced by the CDC to the parent or legal representative of any child to whom the provider intends to administer such vaccine, or to any adult to whom the provider intends to administer such a vaccine. The VIS must be supplemented with visual presentation or oral explanations, as appropriate. If there is not a single VIS for a combination vaccine (e.g., HAV/HBV), use the VIS for both HAV and HBV component vaccines. Copies of the VIS are available at cdc.gov/nip/publications/VIS. Copies are available in English as well as many other languages.
The adverse reactions to the HBV vaccines are outlined to the patient or guardian in clear, understandable language. The VIS also emphasizes that in the rare event that you or your child has a serious reaction to a vaccine, a federal program (the National Vaccine Injury Compensation Program) has been created to help the individual pay for care resulting from the adverse reaction. For details about the National Vaccine Injury Compensation Program, call 800-338-2382 or visit hrsa.gov/bhpr/vicp.
Figure 1. Hepatitis B Vaccine Information Statement
Surveillance for vaccine-associated adverse events is an integral part of patient care in spite of the current record of safety of the HBV vaccine. Any adverse events suspected to be associated with HBV vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS) (800-822-7967). VAERS is a cooperative program for vaccine safety of the CDC and FDA. VAERS is a post marketing safety surveillance program that collects information about adverse events that occur after the administration of vaccines licensed in the United States. Its website, vaers.org, provides a nationwide mechanism by which adverse events following immunization may be reported, analyzed, and published. Its website provides a valuable vehicle for disseminating vaccine safety-related information to parents/guardians, healthcare providers, vaccine manufacturers, state vaccine programs, and other institutions and facilities.
The recommended schedule for hepatitis B vaccine is three doses administered at 0, 1 and 6 months. There is some evidence indicating the closer the last dose is given to 12 months after the first, the greater and longer lasting the antibody response will be. Interruption of the immunization schedule does not require that any dose be repeated, as long as the minimum intervals between doses are initiated. Vaccines produced by the different manufacturers can be used interchangeably despite the different doses. The dose used should be that recommended by the manufacturer. Hepatitis B vaccine must always be administered by the intramuscular route in the deltoid muscle with a needle 1-1.5 inches long.
Operating room personnel who have contacts with patients or blood and are at ongoing risk for percutaneous injuries should be evaluated 1-2 months after completion of the three-dose vaccination series for anti-HBs.25 Operating room personnel who do not respond to the primary vaccine series (i.e., anti-HBs <10m IU/mL) should complete a second three-dose vaccine series or be evaluated to determine if they are HBsAg-positive. Revaccinated operating room personnel should be retested at the end of the second vaccine series. Persons who do not respond to the first three-dose vaccine series have a 30-50% chance of responding to a second three-dose series.29
Operating room personnel who are found to be HBsAg-positive should be counseled on how to prevent HBV transmission to others and referred for further medical evaluation. Operating room personnel who do not respond to vaccination, and who are HBsAg-negative, should be susceptible to HBV infection and should be counseled regarding precautions to prevent HBV infection. It should be emphasized that these non-responders to vaccination need 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 recommended for these non-responders.
There are no reported risks to developing fetuses when hepatitis B vaccine is administered to pregnant women. While the vaccine contains non-infectious HBsAg particles, they should pose no risk to the fetus. Because HBV infection may result in severe disease for the mother and chronic infection for the newborn, neither pregnancy nor lactation should be considered a contraindication to vaccination of women. HBIG is also not contraindicated for pregnant or lactating women.25
HBIG is prepared from pooled human plasma from selected donors with a high level of antibody to HBsAg (anti-HBs). The plasma from which HBIG is prepared is screened carefully for HBsAg and antibodies to HCV and HIV. During the process of preparation of HBIG, HIV is inactivated and eliminated from the final product. Since 1996, the final product is free of HCV RNA as recorded by PCR. All products since 1999 have been available in the United States using a manufacturing process that inactivates HCV and other viruses. There is no evidence that the commercially available HBIG has ever transmitted HBV, HCV, or HIV in the United States.30
Serious adverse reactions from HBIG when administered as recommended have been rare. Local pain and tenderness at the injection site, urticaria, and angioedema might occur. Although rare, anaphylactic reactions have been reported following the injection of human immune globulin preparations.31 Consequently, persons with a history of anaphylactic reaction to immune globulin should not receive HBIG. There are many indications for administration of HBIG, including the following: percutaneous or mucosal exposure to blood containing hepatitis B virus, birth of an infant to a mother with acute hepatitis B infection, and sexual contact with an acute case of hepatitis B. If the exposure source is known to be positive, HBIG should be administered as soon as possible after exposure, preferably within 24 hours. The injection of HBIG should be at a site separate from the vaccine.
The efficacy of HBIG and/or hepatitis B vaccine has been examined in several perspective studies in various postexposure settings. For perinatal exposure to an HBsAg- , HBeAg-positive mother, a combination of HBIG and initiation of hepatitis B vaccine series at birth is 85-95% effective in preventing HBV infection.32,33 Regimens involving either multiple doses of HBIG alone or the hepatitis B vaccine series alone were 70-75% effective in preventing HBV infection.34 Multiple doses of HBIG initiated within one week following percutaneous exposure to HbsAg-positive blood in the occupational setting provided an estimated 75% protection from HBV infection.35-38 The increased postexposure efficacy of the combination of HBIG and hepatitis B vaccine series in the perinatal setting, compared with HBIG alone, would suggest that this combination therapy would prove superior in the occupational setting as well.
Hepatitis B vaccines are reported to be safe when administered to infants, children or adults.39,40 Approximately 100 million persons have received hepatitis B vaccine in the United States. The most common side effects from hepatitis B vaccination are mild to moderate fever as well as pain at the injection site. These side effects are reported no more frequently than among those receiving placebo.41 Surveillance of adverse events following hepatitis B vaccination in the United States has demonstrated no association between hepatitis B vaccine and the occurrence of serious adverse events, including Guillain-Barré syndrome, transverse myelitis, multiple sclerosis, optic neuritis, and seizures.41 While there have been several case reports that have claimed an association between hepatitis B vaccination and the demyelinating diseases, reviews by international panels of experts have concluded that available data do not demonstrate a causal relationship between hepatitis B vaccination and demyelinating diseases, including multiple sclerosis.42
b. Postexposure prophylaxis for HCV
HCV is not transmitted efficiently through occupational exposures to blood. The average incidence of anti-HCV seroconversion after accidental percutaneous exposure from an HCV-positive source was 1.8%, varying from 0%-7%.25 One study noted that transmission occurred only from hollow-bore needles compared with other sharps.43 No transmission in healthcare personnel has been reported from intact or non-intact skin exposures to blood. The high risk for HCV transmission in hemodialysis units has been contributed to poor infection-control practices as well as environmental conditions of this hospital setting.44,45
In several studies, investigators have attempted to assess the effectiveness of immune globulin following hospital exposure to hepatitis C. These studies have been difficult to interpret because they lack uniformity in diagnostic criteria and study design.26 In one experimental study, the investigators found no therapeutic merit in the use of high anti-HCV titer immune globulin administered to chimpanzees one hour after exposure to HCV-positive blood.46 In 1994, the Advisory Committee on Immunization Practices (ACIP) concluded that using immune globulin for postexposure prophylaxis for hepatitis C was not indicated.47
No clinical trials have been conducted to evaluate postexposure using antiviral agents (e.g., interferon with or without ribavirin) to prevent HCV infections. Consequently, antiviral agents are not approved by the FDA for this indication. Clinical studies suggest that an established infection must be present before interferon can be an effective treatment. Kinetic studies indicate that the effect of interferon on chronic HCB infection occurs in two phases. During the first phase, interferon interrupts the production or release of virus from infected cells. In the second phase, virus is eliminated from infected cells.48
In the absence of postexposure prophylaxis for HCV, recommendations for postexposure management are designed to achieve early identification of chronic disease and, if evident, referral for evaluation of treatment options. However, there is a theoretical argument that intervention with antivirals when HCV RNA first become detectable might indeed prevent the development of chronic infection. Data from studies initiated in the United States indicated that a short course of interferon started early in the course of acute hepatitis C was associated with a higher rate of resolved infection than that achieved when therapy has begun after chronic hepatitis C had become well established.49-51 It is important to emphasize that no studies have been initiated that have evaluated the treatment of acute infection with no evidence of liver disease.
Hospitals must establish policies and procedures for testing operating room personnel for HCV after percutaneous or mucosal exposures to blood and insure that all personnel are familiar with these policies. The patient first must be tested for anti-HCV. For operating room personnel exposed to a HCV-positive patient, immediate baseline testing for anti-HCV and alanine aminotransferase(ALT) activity must be performed. If early diagnosis of HCV infection in the hospital personnel is desired, testing for HCV RNA must be initiated at 4-6 weeks. In any event, follow-up testing at 4-6 months for anti-HCV and ALT activity is mandatory. All anti-HCV results that are positive must be confirmed by enzyme immunoassay using supplemental anti-HCV testing (e.g., recombinant immunoblot assay) RIBATM.18
c. Counseling operating room personnel exposed to viral hepatitis
Operating room personnel exposed to HBV- or HCV-infected blood do not need to take any special precautions to prevent transmission to other patients during the 4-6-month follow-up period.25 However, they must refrain from donating blood, plasma, organs, tissue or semen. In addition, the exposed person does not need to modify sexual practices or refrain from becoming pregnant. The exposed person can continue breastfeeding.
No modifications in the operating room personnel's patient-care responsibilities are necessary to prevent transmission to their patients based solely on their exposure to HBV- or HCV-positive blood. However, if the exposed operating room personnel become acutely infected, the person should be evaluated. In 1991, the Centers for Disease Control made recommendations for preventing transmission of hepatitis B virus as well as HIV during exposure-prone invasive procedures.52 It has been reported that the risk of HIV transmission to a healthcare worker after percutaneous exposure to HIV-infected blood was considerably lower than the risk of HBV transmission after percutaneous exposure to HBeAg-positive blood (0.3 versus approximately 30%).53-55 On this basis, it can be assumed that the risk of transmission of HIV from an infected healthcare worker to a patient during an invasive procedure will be proportionately lower than the risk of HBV transmission from a HBeAg-positive healthcare worker to a patient during the same procedure.
Since the introduction of serologic testing for HBV infection in the early 1970's, there have been published reports of more than 20 clusters in which a total of more than 300 patients were infected in association with treatment by a HBV-infected healthcare worker.52 Five clusters were linked to obstetricians or gynecologists, and three were linked to cardiovascular surgeons. In addition, recent reports strongly suggest HBV transmissions from three surgeons to patients in 1989 and 1990 during colorectal, abdominal and cardiothoracic surgery.56
Seven of the healthcare workers who were linked to published clusters in the United States were allowed to perform invasive procedures following modification of invasive techniques (e.g., double-gloving and restriction of certain high-risk procedures).56-63 For five healthcare workers, there was no further transmission. In two instances involving an obstetrician/gynecologist and an oral surgeon, HBV was transmitted to patients after techniques were modified.57,59
Despite adherence to principles of universal precautions, certain invasive surgical and dental procedures have been implicated in the transmission of HBV from infected healthcare workers to patients. These procedures should be considered exposure-prone and include certain oral, cardiothoracic, colorectal, and obstetric/gynecologic procedures. Experience with HBV indicates that other invasive procedures would pose substantially lower risk, if any, of transmission of HIV and other bloodborne pathogens from an infected healthcare worker to patients.
The Centers for Disease Control has made the following recommendations for healthcare workers with either HIV, HBV or HCV infections25:
1. All healthcare workers should adhere to universal precautions including
the appropriate use of hand washing, protective barriers, and care in the
use and disposal of needles and other sharp instruments.
2. Healthcare workers who have exudative lesions or weeping dermatitis
should refrain from all direct patient care and from handling patient care
equipment and devices used in performing invasive procedures until the
condition resolves.
3. Currently available data provide no basis for recommendations to restrict the practice of healthcare workers infected with HIV or HBV who perform invasive procedures not identified as exposure-prone.
4. Exposure-prone procedures should be identified by medical/surgical/dental organizations and institutions at which the procedures are performed.
5. Healthcare workers who perform exposure-prone procedures should know their HIV antibody status. Healthcare workers who perform exposure-prone procedures and do not have serologic evidence of immunity to HBV from vaccination or from previous infection should know their HBsAg status, and if that is positive, should also know their HBeAg status.
6. Healthcare workers who are infected with HIV or HBV should not perform exposure-prone procedures unless they have sought counsel from an expert review panel and advised under what circumstances, if any, they may continue to perform these procedures. Such circumstances would include notifying prospective patients of the healthcare worker's seropositivity before the patient undergoes exposure-prone invasive procedures.
7. Mandatory testing of healthcare workers for HIV antibody, HBsAg or HBeAg was not recommended.
8. No recommendations exist regarding restricting the professional activities of healthcare workers with HCV infection.18
d. Postexposure prophylaxis for HIV
In prospective studies of healthcare personnel, the average risk of HIV transmission after a percutaneous exposure to HIV-infected blood has been estimated to be approximately 0.3%.52 After a mucous membrane exposure, the average risk of HIV infection is even lower, 0.09%. Although episodes of HIV transmission after nonintact skin exposure have been documented, the average risk for transmission by this route has not been precisely quantified.64 As of June 2000, the Centers for Disease Control has received reports of 56 U.S. healthcare personnel with documented HIV seroconversion associated with an occupational HIV exposure.65 An additional 138 episodes of HIV infection in healthcare personnel are considered possible occupational HIV transmissions. In these latter cases, HIV conversion after a specific exposure was not documented.
Epidemiologic and laboratory studies indicate that several factors may influence the risk of HIV transmission after an occupational exposure. In a retrospective case-control study of healthcare personnel who had percutaneous exposure to HIV, the risk for HIV infection was reported to be increased with exposure to a larger quantity of blood from the source person as indicated by (1) a device visibly contaminated with the patient's blood, (2) a procedure that involved a needle being placed in a vein or artery, or (3) a deep injury.66 The risk also was enhanced by exposure to blood from source persons with terminal illness, possibly reflecting either the higher titer of HIV in blood late in the course of AIDS or other important factors (e.g., the presence of syncytia-inducing strains of HIV). A laboratory study that demonstrated that more blood is transferred by deeper injuries and hollow-bore needles lends credence to the observed variation in risk related to blood quantity.67
The use of the source person viral load of HIV as a measure of viral titer for assessing transmission risk remains to be established. Plasma viral load (e.g., HIV RNA) reflects only the level of cell-free virus in the peripheral blood; latently infected cells may transmit infection in the absence of viremia. Although a lower viral load (e.g., <1,500 RNA copies/mL) or one that is below the limits of detection probably suggests a lower titer exposure, it does not eliminate the possibility of transmission.25
Operating room personnel exposed to HIV should be evaluated within hours (rather than days) after exposure and should be tested for HIV at baseline to establish the infection status at the time of exposure. If the source person is seronegative for HIV, baseline testing or further follow-up of the exposed operating room personnel is not necessary. Serologic testing must be made available to all operating room personnel who are concerned that they might have been occupationally infected with HIV. When considering HIV postexposure prophylaxis, the evaluation should include information about medications the operating room personnel might be taking and any current or overlying medical conditions or circumstances that might influence drug selection to include pregnancy, breastfeeding, or renal or hepatic disease.
Recommendations have been developed for the operating room personnel that have been exposed to a source person with HIV infection or when information suggest the likelihood that the source person is HIV-infected (Table 2 and Table 3). These recommendations are based on the risk of HIV infection after different types of exposure as well as on limited data regarding efficacy and toxicity of postexposure prophylaxis. Because most occupational HIV exposures fortunately do not result in the transmission of HIV, potential drug toxicity must be considered carefully when prescribing postexposure prophylaxis. To assist with the initial management of an HIV exposure, hospitals should have drugs for an initial postexposure prophylaxis regimen selected and available for use. Ideally, these recommendations should be implemented in consultation with physicians who have expertise in antiretroviral therapy and HIV transmission.
1. Timing and duration of postexposure prophylaxis
Postexposure prophylaxis should be started as soon as possible. Animal studies have revealed the importance of starting postexposure prophylaxis for HIV soon after an exposure.68-70 When questions exist about which antiretroviral drugs to use or whether to use a basic or expanded regimen, begin the basic regimen immediately rather than delaying postexposure prophylaxis administration. Although animal studies indicate that postexposure prophylaxis is substantially less beneficial when started more than 24-36 hours postexposure, the interval after which no benefit is gained from postexposure prophylaxis for humans is not known. Consequently, postexposure prophylaxis should be initiated even when the interval since exposure exceeds 36 hours. Initiating therapy after a longer interval, one week, might be considered for exposures that present an increased risk for transmission. Today, the optimal duration of postexposure prophylaxis for HIV is still not known. Because four weeks of zidovudine (ZDV) was reported to be protective in occupational and animal studies, postexposure prophylaxis should be administered for four weeks, if tolerated.66,71
2. Use of postexposure prophylaxis when status of source person is unknown
If the source person's HIV infection status is not known at the time of exposure, use of postexposure prophylaxis should be made on a case-by-case basis, after considering the type of exposure and the clinical and/or epidemiologic likelihood of HIV infection in the source.25 If these considerations suggest a possibility for HIV transmission, and HIV testing of the source is pending, initiate a two-drug postexposure prophylaxis regimen until laboratory results have been obtained, after which the therapy can be modified or discontinued.
In any event, postexposure prophylaxis for HIV should be started as soon as possible after exposure. The exposed person must be re-evaluated 72 hours postexposure, especially as additional information about the exposure or source person becomes available. Postexposure prophylaxis should continue for four weeks, if tolerated.
3. Postexposure prophylaxis for pregnant operating room personnel
If the exposed person is pregnant, the evaluation of risk of infection and the need for postexposure prophylaxis should be approached as with any other operating room personnel who has had an HIV exposure. However, the decision to use any antiretroviral drugs during pregnancy should involve discussions between the woman and her primary care physician regarding the potential benefits and risk to her and her fetus. Certain drugs must be avoided in pregnant women because of their teratogenic effects. Because teratogenic effects were observed in primate studies, efavirenz (EFV) is not recommended during pregnancy. Moreover, reports of fatal lactic acidosis in pregnant women treated with a combination of stavudine (d4T) and didanosine (ddl) have prompted warnings about these drugs during pregnancy. Because the risk of hyperbilirubinemia in newborns, indinavir (IDV) should be avoided in pregnant women shortly before delivery.25
4. Recommendations for the selection of drugs for HIV post -exposure prophylaxis
The selection of a drug regimen for HIV postexposure prophylaxis will be determined by the potential risk for infection as well as the potential toxicity of the drug. Because the drugs used in postexposure prophylaxis for HIV are potentially toxic, their use is not justified for exposures that pose a negligible risk for transmission. In addition, there is insufficient evidence to support recommendations for a three-drug regimen for all HIV exposures. Consequently, two regimens are suggested: a basic two-drug regimen that should be appropriate for most HIV exposures and an expanded three-dose regimen that should be used for exposures that present an increased risk for transmission. These regimens should be implemented in consultation with physicians who have expertise in antiretroviral treatment and HIV transmission. Most HIV exposures will require a two-drug regimen using two nucleoside analogues (e.g., ZDV and lamivudine (3TC); or 3TC and d4T; or d4T and ddl). The addition of a third drug should be considered for exposures that present an increased risk for transmission. Selection of a postexposure prophylaxis regimen for HIV should consider the comparative risk represented by the exposure as well as information about the exposure source including history of and response to antiretroviral therapy based on clinical response to include CD4+ T-cell counts, viral load measurements, and current disease stage. When the source person's virus is known or suspected to be resistant to one or more of the drugs considered for the postexposure prophylaxis regimen for HIV, the selection of drugs to which the source person's virus is unlikely to be resistant is recommended. Expert consultation is obviously needed. If this information is not immediately available, initiation of the postexposure prophylaxis regimen, if indicated, should not be delayed. Changes in the regimen can be made after postexposure prophylaxis has been initiated. Re-evaluation of the exposed person must be undertaken within 72 hours after exposure.
5. Follow-up of operating room personnel exposed to HIV
HIV testing with EIA should be used to monitor for seroconversion. The routine use of direct virus assays (e.g., HIV p24 antigen EIA or test for HIV RNA) to detect infection in the exposed operating room personnel is not recommended.72 The high rate of false-positive test results using these tests in this study could lead to unnecessary patient anxiety and treatment changes. Despite the ability of direct virus assays to detect HIV infection a few days earlier than EIA, the infrequency of occupational seroconversion and increased cost of these tests has prompted the Centers for Disease Control not to recommend their routine use in this setting. In addition, the Centers for Disease Control recommends HIV-antibody testing for at least six months postexposure. Moreover, HIV testing should be performed on any exposed person who has an illness compatible with an acute retroviral syndrome. The monitoring and management of postexposure prophylaxis toxicity for HIV treatment should be done by a specialist skilled in the management of HIV.
It is important to emphasize that there is considerable emotional turmoil of the exposed operating room personnel to HIV.73-75 The operating room personnel are given seemingly conflicting information on the postexposure prophylaxis. First, they are told that a low risk exists for HIV transmission and a four-week regimen of postexposure prophylaxis might be recommended. They are then asked to commit to significant behavioral measures to prevent sexual transmission, all of which influence their lives for several weeks to months. These behavioral measures include abstinence or use of condoms to prevent sexual transmission and to avoid pregnancy as well as to refrain from donating blood, plasma, organs, tissue, or semen. If an exposed woman is breastfeeding, discontinuation of breastfeeding is recommended, especially in high-risk exposures.
The patient care responsibilities of an exposed person do not need to be modified, based solely on an HIV exposure. If HIV seroconversion is detected, the person should be evaluated according to published recommendations for infected healthcare personnel.76
e. Postexposure prophylaxis for HTLV-I/II
The year 2004 marks the 24th anniversary of the discovery of the first human retrovirus, human T-cell lymphotropic virus-I (HTLV-I).77 Its discovery has had several notable implications. First, this retrovirus provided clear proof of a relationship between viruses and cancer. Second, the obvious association of HTLV-I with a neurologic disease similar to multiple sclerosis created an opportunity to study the mechanisms that lead to chronic demyelinating diseases. Finally, its identification clearly facilitated the discovery and isolation of HIV, which has caused a global epidemic of a rapidly progressing fatal illness, AIDS. While the AIDS epidemic justifiably captured the attention of the most gifted scientists in the world, scientific attention to HTLV-I was dramatically diminished, permitting the development of a global epidemic of HTLV-I that causes fatal chronic diseases.
Another retrovirus, HTLV-II, has a biologic similarity to that of HTLV-I. Because of the absence of distinguishing serologic assays, HTLV-I and HTLV-II were often first grouped together in seroepidemiologic studies. When serologic assays were developed to distinguish these two retroviral viruses, it was realized that HTLV-II played a different role in the development of certain neurologic, hematologic, and dermatologic diseases.
The major modes of HTLV-I and HTLV-II transmission are perinatally (predominantly through breastfeeding), parenterally (through blood transfusions or exposure to needles and syringes contaminated with blood) and sexually. Promising public health initiatives to prevent HTLV-I and HTLV-II infection include routine screening of blood transfusion, protected sex, and avoidance of breastfeeding. Transmission by blood transfusions has been diminished by screening blood donors as is practiced in Japan, United States, France and certain islands of the West Indies.19 Despite the severe consequences of these bloodborne diseases, they have been ignored by the U.S. healthcare profession. When asymptomatic carriers of HTLV-I or HTLV-II are identified by blood banks, this information will be kept confidential and not become part of the patient's medical record. The blood bank will not report the patient's condition to the blood donor's primary physician, the Health Department or the Centers for Disease Control.
The Centers for Disease Control wrote a position paper for counseling persons infected with HTLV-I and HTLV-II.78 Its recommendations for counseling include the following: (1) share the information with their physician, (2) refrain from donating blood, semen, body organs or other tissues, (3) refrain from sharing needles or syringes with anyone, (4) refrain from breastfeeding infants, and (5) consider the use of latex condoms to prevent sexual transmission. Because this bloodborne disease is not reported to the state health departments, the Centers for Disease Control has no information regarding the incidence of these bloodborne infections in the United States. It has set no guidelines for postexposure prophylaxis of operating room personnel exposed to these bloodborne diseases. If the Centers for Disease Control does not mandate that it is a reportable infection, it will continue to be ignored by hospitals in the United States.
6. Occupational exposure management resources
Operating room personnel who sustain an occupational injury that may expose them to a bloodborne disease may be either unfamiliar with the postexposure prophylaxis that they are receiving or dissatisfied with the clinical expertise of the physicians providing postexposure prophylaxis. In these cases, there are superb 24-hour resources staffed by personnel trained in postexposure prophylaxis. The National Clinicians' Postexposure Prophylaxis Hotline (PEPline) is a unique resource for operating room personnel who have questions about postexposure prophylaxis. Its staff can be contacted by telephone, (888) 448-4911. This program is conducted by the University of California-San Francisco/San Francisco General Hospital staff. This program receives support from the Health Resources and Services Administration Ryan White CARE Act, HIV/AIDS Bureau, AIDS Education and Training Centers, and Centers for Disease Control. It has a valuable internet website that contains updated information (www.ucsf.edu/hivcntr). This service has been expanded to include a hepatitis hotline. Its telephone number is (888) 443-7232. It has a valuable website (http://www.cdc.gov/hepatitis). A website has also been developed to help clinicians manage and document occupational blood and body fluid exposures. It is developed and maintained by the University of California, Los Angeles (UCLA), Emergency Medicine Center, UCLA School of Medicine, and is funded in part by the Centers for Disease Control and the Agency for Healthcare Research and Quality. The success of these informational systems is serving as a model for dissemination of expert information regarding other emergencies, like malignant hyperthermia. This information service is managed by the Malignant Hyperthermia Association of the United States ((607) 674-7901, www.mhaus.org).
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