Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures

This document has been developed by the Centers for Disease Control (CDC) to update recommendations for prevention of transmission of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) in the health-care setting. Current data suggest that the risk for such transmission from a health-care worker (HCW) to a patient during an invasive procedure is small; a precise assessment of the risk is not yet available. This document contains recommendations to provide guidance for prevention of HIV and HBV transmission during those invasive procedures that are considered exposure-prone. INTRODUCTION

Recommendations have been made by the Centers for Disease Control (CDC) for the prevention of transmission of the human immunodeficiency virus (HIV) and the hepatitis B virus (HBV) in health-care settings (1-6). These recommendations emphasize adherence to universal precautions that require that blood and other specified body fluids of all patients be handled as if they contain blood-borne pathogens (1,2).

Previous guidelines contained precautions to be used during invasive procedures (defined in Appendix) and recommendations for the management of HIV- and HBV-infected health-care workers (HCWs) (1). These guidelines did not include specific recommendations on testing HCWs for HIV or HBV infection, and they did not provide guidance on which invasive procedures may represent increased risk to the patient.

The recommendations outlined in this document are based on the following considerations:

• Infected HCWs who adhere to universal precautions and who

do not perform invasive procedures pose no risk for transmitting HIV or HBV to patients.

• Infected HCWs who adhere to universal precautions and who

perform certain exposure-prone procedures (see page 4) pose a small risk for transmitting HBV to patients.

• HIV is transmitted much less readily than HBV. In the interim, until further data are available, additional

precautions are prudent to prevent HIV and HBV transmission during procedures that have been linked to HCW-to-patient HBV transmission or that are considered exposure-prone. BACKGROUND Infection-Control Practices

Previous recommendations have specified that infection-control programs should incorporate principles of universal precautions (i.e., appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments) and should maintain these precautions rigorously in all health-care settings (1,2,5). Proper application of these principles will assist in minimizing the risk of transmission of HIV or HBV from patient to HCW, HCW to patient, or patient to patient.

As part of standard infection-control practice, instruments and other reusable equipment used in performing invasive procedures should be appropriately disinfected and sterilized as follows (7):

• Equipment and devices that enter the patient's vascular

system or other normally sterile areas of the body should be sterilized before being used for each patient.

• Equipment and devices that touch intact mucous membranes

but do not penetrate the patient's body surfaces should be sterilized when possible or undergo high-level disinfection if they cannot be sterilized before being used for each patient.

• Equipment and devices that do not touch the patient or

that only touch intact skin of the patient need only be cleaned with a detergent or as indicated by the manufacturer.

Compliance with universal precautions and recommendations for disinfection and sterilization of medical devices should be scrupulously monitored in all health-care settings (1, 7, 8). Training of HCWs in proper infection-control technique should begin in professional and vocational schools and continue as an ongoing process. Institutions should provide all HCWs with appropriate inservice education regarding infection control and safety and should establish procedures for monitoring compliance with infection-control policies.

All HCWs who might be exposed to blood in an occupational setting should receive hepatitis B vaccine, preferably during their period of professional training and before any occupational exposures could occur (8, 9).

Transmission of HBV During Invasive Procedures

Since the introduction of serologic testing for HBV infection in the early 1970s, there have been published reports of 20 clusters in which a total of over 300 patients were infected with HBV in association with treatment by an HBV-infected HCW. In 12 of these clusters, the implicated HCW did not routinely wear gloves; several HCWs also had skin lesions that may have facilitated HBV transmission (10-22). These 12 clusters included nine linked to dentists or oral surgeons and one cluster each linked to a general practitioner, an inhalation therapist, and a cardiopulmonary-bypass-pump technician. The clusters associated with the inhalation therapist and the cardiopulmonary-bypass-pump technician--and some of the other 10 clusters--could possibly have been prevented if current recommendations on universal precautions, including glove use, had been in effect. In the remaining eight clusters, transmission occurred despite glove use by the HCWs; five clusters were linked to obstetricians or gynecologists, and three were linked to cardiovascular surgeons (6, 22-28). In addition, recent unpublished reports strongly suggest HBV transmission from three surgeons to patients in 1989 and 1990 during colorectal (CDC, unpublished data), abdominal, and cardiothoracic surgery (29).

Seven of the HCWs 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) (6,11- 13,15,16, 24). For five HCWs, no further transmission to patients was observed. In two instances involving an obstetrician/gynecologist and an oral surgeon, HBV was transmitted to patients after techniques were modified (6, 12).

Review of the 20 published studies indicates that a combination of risk factors accounted for transmission of HBV from HCWs to patients. Of the HCWs whose hepatitis B e antigen (HBeAg) status was determined (17 of 20), all were HBeAg positive. The presence of HBeAg in serum is associated with higher levels of circulating virus and therefore with greater infectivity of hepatitis-B-surface-antigen (HBsAg)-positive individuals; the risk of HBV transmission to an HCW after a percutaneous exposure to HBeAg-positive blood is approximately 30% (30-32). In addition, each report indicated that the potential existed for contamination of surgical wounds or traumatized tissue, either from a major break in standard infection-control practices (e.g., not wearing gloves during invasive procedures) or from unintentional injury to the infected HCW during invasive procedures (e.g., needle sticks incurred while manipulating needles without being able to see them during suturing).

Most reported clusters in the United States occurred before awareness increased of the risks of transmission of blood-borne pathogens in health-care settings and before emphasis was placed on the use of universal precautions and hepatitis B vaccine among HCWs. The limited number of reports of HBV transmission from HCWs to patients in recent years may reflect the adoption of universal precautions and increased use of HBV vaccine. However, the limited number of recent reports does not preclude the occurrence of undetected or unreported small clusters or individual instances of transmission; routine use of gloves does not prevent most injuries caused by sharp instruments and does not eliminate the potential for exposure of a patient to an HCW's blood and transmission of HBV (6, 22-29).

Transmission of HIV During Invasive Procedures

The risk of HIV transmission to an HCW after percutaneous exposure to HIV-infected blood is considerably lower than the risk of HBV transmission after percutaneous exposure to HBeAg-positive blood (0.3% versus approximately 30%) (33-35). Thus, the risk of transmission of HIV from an infected HCW to a patient during an invasive procedure is likely to be proportionately lower than the risk of HBV transmission from an HBeAg-positive HCW to a patient during the same procedure. As with HBV, the relative infectivity of HIV probably varies among individuals and over time for a single individual. Unlike HBV infection, however, there is currently no readily available laboratory test for increased HIV infectivity.

Investigation of a cluster of HIV infections among patients in the practice of one dentist with acquired immunodeficiency syndrome (AIDS) strongly suggested that HIV was transmitted to five of the approximately 850 patients evaluated through June 1991 (36-38). The investigation indicates that HIV transmission occurred during dental care, although the precise mechanisms of transmission have not been determined. In two other studies, when patients cared for by a general surgeon and a surgical resident who had AIDS were tested, all patients tested, 75 and 62, respectively, were negative for HIV infection (39, 40). In a fourth study, 143 patients who had been treated by a dental student with HIV infection and were later tested were all negative for HIV infection (41). In another investigation, HIV antibody testing was offered to all patients whose surgical procedures had been performed by a general surgeon within 7 years before the surgeon's diagnosis of AIDS; the date at which the surgeon became infected with HIV is unknown (42). Of 1,340 surgical patients contacted, 616 (46%) were tested for HIV. One patient, a known intravenous drug user, was HIV positive when tested but may already have been infected at the time of surgery. HIV test results for the 615 other surgical patients were negative (95% confidence interval for risk of transmission per operation=0.0%-0.5%).

The limited number of participants and the differences in procedures associated with these five investigations limit the ability to generalize from them and to define precisely the risk of HIV transmission from HIV-infected HCWs to patients. A precise estimate of the risk of HIV transmission from infected HCWs to patients can be determined only after careful evaluation of a substantially larger number of patients whose exposure-prone procedures have been performed by HIV-infected HCWs.

Exposure-Prone Procedures

Despite adherence to the principles of universal precautions, certain invasive surgical and dental procedures have been implicated in the transmission of HBV from infected HCWs to patients, and should be considered exposure-prone. Reported examples include certain oral, cardiothoracic, colorectal (CDC, unpublished data), and obstetric/gynecologic procedures (6, 12, 22-29).

Certain other invasive procedures should also be considered exposure-prone. In a prospective study CDC conducted in four hospitals, one or more percutaneous injuries occurred among surgical personnel during 96 (6.9%) of 1,382 operative procedures on the general surgery, gynecology, orthopedic, cardiac, and trauma services (43). Percutaneous exposure of the patient to the HCW's blood may have occurred when the sharp object causing the injury recontacted the patient's open wound in 28 (32%) of the 88 observed injuries to surgeons (range among surgical specialties=8%-57%; range among hospitals=24%-42%). Characteristics of exposure-prone procedures include digital palpation of a needle tip in a body cavity or the simultaneous presence of the HCW's fingers and a needle or other sharp instrument or object in a poorly visualized or highly confined anatomic site. Performance of exposure-prone procedures presents a recognized risk of percutaneous injury to the HCW, and--if such an injury occurs--the HCW's blood is likely to contact the patient's body cavity, subcutaneous tissues, and/or mucous membranes.

Experience with HBV indicates that invasive procedures that do not have the above characteristics would be expected to pose substantially lower risk, if any, of transmission of HIV and other blood-borne pathogens from an infected HCW to patients. RECOMMENDATIONS

Investigations of HIV and HBV transmission from HCWs to patients indicate that, when HCWs adhere to recommended infection-control procedures, the risk of transmitting HBV from an infected HCW to a patient is small, and the risk of transmitting HIV is likely to be even smaller. However, the likelihood of exposure of the patient to an HCW's blood is greater for certain procedures designated as exposure-prone. To minimize the risk of HIV or HBV transmission, the following measures are recommended:

--All HCWs 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. HCWs 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. HCWs should also comply with current guidelines for disinfection and sterilization of reusable devices used in invasive procedures.

--Currently available data provide no basis for recommendations to restrict the practice of HCWs infected with HIV or HBV who perform invasive procedures not identified as exposure-prone, provided the infected HCWs practice recommended surgical or dental technique and comply with universal precautions and current recommendations for sterilization/disinfection.

--Exposure-prone procedures should be identified by medical/surgical/dental organizations and institutions at which the procedures are performed.

--HCWs who perform exposure-prone procedures should know their HIV antibody status. HCWs who perform exposure-prone procedures and who 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.

--HCWs who are infected with HIV or HBV (and are HBeAg positive) should not perform exposure-prone procedures unless they have sought counsel from an expert review panel and been advised under what circumstances, if any, they may continue to perform these procedures.* Such circumstances would include notifying prospective patients of the HCW's seropositivity before they undergo exposure-prone invasive procedures.

--Mandatory testing of HCWs for HIV antibody, HBsAg, or HBeAg is not recommended. The current assessment of the risk that infected HCWs will transmit HIV or HBV to patients during exposure-prone procedures does not support the diversion of resources that would be required to implement mandatory testing programs. Compliance by HCWs with recommendations can be increased through education, training, and appropriate confidentiality safeguards.

*The review panel should include experts who represent a balanced perspective. Such experts might include all of the following: a) the HCW's personal physician(s), b) an infectious disease specialist with expertise in the epidemiology of HIV and HBV transmission, c) a health professional with expertise in the procedures performed by the HCW, and d) state or local public health official(s). If the HCW's practice is institutionally based, the expert review panel might also include a member of the infection-control committee, preferably a hospital epidemiologist. HCWs who perform exposure-prone procedures outside the hospital/institutional setting should seek advice from appropriate state and local public health officials regarding the review process. Panels must recognize the importance of confidentiality and the privacy rights of infected HCWs. HCWS WHOSE PRACTICES ARE MODIFIED BECAUSE OF HIV OR HBV STATUS

HCWs whose practices are modified because of their HIV or HBV infection status should, whenever possible, be provided opportunities to continue appropriate patient-care activities. Career counseling and job retraining should be encouraged to promote the continued use of the HCW's talents, knowledge, and skills. HCWs whose practices are modified because of HBV infection should be reevaluated periodically to determine whether their HBeAg status changes due to resolution of infection or as a result of treatment (44). NOTIFICATION OF PATIENTS AND FOLLOW-UP STUDIES

The public health benefit of notification of patients who have had exposure-prone procedures performed by HCWs infected with HIV or positive for HBeAg should be considered on a case-by-case basis, taking into consideration an assessment of specific risks, confidentiality issues, and available resources. Carefully designed and implemented follow-up studies are necessary to determine more precisely the risk of transmission during such procedures. Decisions regarding notification and follow-up studies should be made in consultation with state and local public health officials. ADDITIONAL NEEDS

• Clearer definition of the nature, frequency, and circumstances of blood contact between patients and HCWs during invasive procedures.

• Development and evaluation of new devices, protective barriers, and techniques that may prevent such blood contact without adversely affecting the quality of patient care.

• More information on the potential for HIV and HBV transmission through contaminated instruments.

• Improvements in sterilization and disinfection techniques for certain reusable equipment and devices.

• Identification of factors that may influence the likelihood of HIV or HBV transmission after exposure to HIV- or HBV-infected blood.

References

1. CDC. Recommendations for prevention of HIV transmission in

health-care settings. MMWR 1987;36(suppl. no. 2S):1-18S.

2. CDC. Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. MMWR 1988;37:377-82,387-8.

3. CDC. Hepatitis Surveillance Report No. 48. Atlanta: U.S. Department of Health and Human Services, Public Health Service, 1982:2-3.

4. CDC. CDC Guideline for Infection Control in Hospital Personnel, Atlanta, Georgia: Public Health Service, 1983. 24 pages. (GPO# 6AR031488305).

5. CDC. Guidelines for prevention of transmission of human immunodeficiency virus and hepatitis B virus to health-care and public-safety workers. MMWR 1989;38;(suppl. no. S-6):1-37.

6. Lettau LA, Smith JD, Williams D, et al. Transmission of hepatitis B with resultant restriction of surgical practice. JAMA 1986;255:934-7.

7. CDC. Guidelines for the prevention and control of nosocomial infections: guideline for handwashing and hospital environmental control. Atlanta, Georgia: Public Health Service, 1985. 20 pages. (GPO# 544-436/24441).

8. Department of Labor, Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens: proposed rule and notice of hearing. Federal Register 1989;54:23042-139.

9. CDC. Protection against viral hepatitis: recommendations of the immunization practices advisory committee (ACIP). MMWR 1990;39:(no. RR-2). 10. Levin ML, Maddrey WC, Wands JR, Mendeloff AI. Hepatitis B transmission by dentists. JAMA 1974; 228:1139-40. 11. Rimland D, Parkin WE, Miller GB, Schrack WD. Hepatitis B outbreak traced to an oral surgeon. N Engl J Med 1977;296:953-8. 12. Goodwin D, Fannin SL, McCracken BB. An oral-surgeon related hepatitis-B outbreak. California Morbidity 1976;14. 13. Hadler SC, Sorley DL, Acree KH, et al. An outbreak of hepatitis B in a dental practice. Ann Intern Med 1981;95:133-8. 14. Reingold AL, Kane MA, Murphy BL, Checko P, Francis DP, Maynard JE. Transmission of hepatitis B by an oral surgeon. J Infect Dis 1982;145:262-8. 15. Goodman RA, Ahtone JL, Finton RJ. Hepatitis B transmission from dental personnel to patients: unfinished business (Editorial). Ann Intern Med 1982;96:119. 16. Ahtone J, Goodman RA. Hepatitis B and dental personnel: transmission to patients and prevention issues. J Am Dent Assoc 1983;106:219-22. 17. Shaw FE, Jr, Barrett CL, Hamm R, et al. Lethal outbreak of hepatitis B in a dental practice. JAMA 1986;255:3260-4. 18. CDC. Outbreak of hepatitis B associated with an oral surgeon, New Hampshire. MMWR 1987;36:132-3. 19. Grob PJ, Moeschlin P. Risk to contacts of a medical practitioner carrying HBsAg. (Letter). N Engl J Med 1975;293:197. 20. Grob PJ, Bischof B, Naeff F. Cluster of hepatitis B transmitted by a physician. Lancet 1981;2:1218-20. 21. Snydman DR, Hindman SH, Wineland MD, Bryan JA, Maynard JE. Nosocomial viral hepatitis B. A cluster among staff with subsequent transmission to patients. Ann Intern Med 1976;85:573-7. 22. Coutinho RA, Albrecht-van Lent P, Stoutjesdijk L, et al. Hepatitis B from doctors (Letter). Lancet 1982;1:345-6. 23. Anonymous. Acute hepatitis B associated with gynaecological surgery. Lancet 1980;1:1-6. 24. Carl M, Blakey DL, Francis DP, Maynard JE. Interruption of hepatitis B transmission by modification of a gynaecologist's surgical technique. Lancet 1982;1:731-3. 25. Anonymous. Acute hepatitis B following gynaecological surgery. J Hosp Infect 1987;9:34-8. 26. Welch J, Webster M, Tilzey AJ, Noah ND, Banatvala JE. Hepatitis B infections after gynaecological surgery. Lancet 1989;1:205-7. 27. Haeram JW, Siebke JC, Ulstrup J, Geiram D, Helle I. HBsAg transmission from a cardiac surgeon incubating hepatitis B resulting in chronic antigenemia in four patients. Acta Med Scand 1981;210:389-92. 28. Flower AJE, Prentice M, Morgan G, et al. Hepatitis B infection following cardiothoracic surgery (Abstract). 1990 International Symposium on Viral Hepatitis and Liver Diseases, Houston. 1990;94. 29. Heptonstall J. Outbreaks of hepatitis B virus infection associated with infected surgical staff in the United Kingdom. Communicable Disease Reports 1991 (in press). 30. Alter HJ, Seef LB, Kaplan PM, et al. Type B hepatitis: the infectivity of blood positive for e antigen and DNA polymerase after accidental needlestick exposure. N Engl J Med 1976;295:909-13. 31. Seeff LB, Wright EC, Zimmerman HJ, et al. Type B hepatitis after needlestick exposure: prevention with hepatitis B immunoglobulin: final report of the Veterans Administration Cooperative Study. Ann Intern Med 1978;88:285-93. 32. Grady GF, Lee VA, Prince AM, et al. Hepatitis B immune globulin for accidental exposures among medical personnel: final report of a multicenter controlled trial. J Infect Dis 1978;138:625-38. 33. Henderson DK, Fahey BJ, Willy M, et al. Risk for occupational transmission of human immunodeficiency virus type 1 (HIV-1) associated with clinical exposures: a prospective evaluation. Ann Intern Med 1990;113:740-6. 34. Marcus R, CDC Cooperative Needlestick Study Group. Surveillance of health-care workers exposed to blood from patients infected with the human immunodeficiency virus. N Engl J Med 1988;319:1118-23. 35. Gerberding JL, Bryant-LeBlanc CE, Nelson K, et al. Risk of transmitting the human immunodeficiency virus, cytomegalovirus, and hepatitis B virus to health-care workers exposed to patients with AIDS and AIDS-related conditions. J Infect Dis 1987;156:1-8. 36. CDC. Possible transmission of human immunodeficiency virus to a patient during an invasive dental procedure. MMWR 1990;39:489-93. 37. CDC. Update: transmission of HIV infection during an invasive dental procedure - Florida. MMWR 1991;40:21-27,33. 38. CDC. Update: transmission of HIV infection during invasive dental procedures - Florida. MMWR 1991;40:377-81. 39. Porter JD, Cruikshank JG, Gentle PH, Robinson RG, Gill ON. Management of patients treated by a surgeon with HIV infection. (Letter) Lancet 1990;335:113-4. 40. Armstrong FP, Miner JC, Wolfe WH. Investigation of a health-care worker with symptomatic human immunodeficiency virus infection: an epidemiologic approach. Milit Med 1987;152:414-8. 41. Comer RW, Myers DR, Steadman CD, Carter MJ, Rissing JP, Tedesco FJ. Management considerations for an HIV positive dental student. J Dent Educ 1991;55:187-91. 42. Mishu B, Schaffner W, Horan JM, Wood LH, Hutcheson R, McNabb P. A surgeon with AIDS: lack of evidence of transmission to patients. JAMA 1990;264:467-70. 43. Tokars J, Bell D, Marcus R, et al. Percutaneous injuries during surgical procedures (Abstract). VII International Conference on AIDS. Vol 2. Florence, Italy, June 16-21, 1991:83.

44. Perrillo RP, Schiff ER, Davis GL, et al. A randomized, controlled trial of interferon alfa-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. N Engl J Med 1990;323:295-301. APPENDIX Definition of Invasive Procedure

An invasive procedure is defined as ``surgical entry into tissues, cavities, or organs or repair of major traumatic injuries'' associated with any of the following: ``1) an operating or delivery room, emergency department, or outpatient setting, including both physicians' and dentists' offices; 2) cardiac catheterization and angiographic procedures; 3) a vaginal or cesarean delivery or other invasive obstetric procedure during which bleeding may occur; or 4) the manipulation, cutting, or removal of any oral or perioral tissues, including tooth structure, during which bleeding occurs or the potential for bleeding exists.'' Reprinted from: Centers for Disease Control. Recommendation for prevention of HIV transmission in health-care settings. MMWR 1987;36 (suppl. no. 2S):6S-7S.

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