Updated CDC Recommendations for the Management of Hepatitis B

Recommendations and Reports / Vol. 61 / No. 3 July 6, 2012

Virus–Infected Health-Care Providers and Students

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

Morbidity and Mortality Weekly Report

Please note: An erratum has been published for this issue. To view the erratum, please click here.

Recommendations and Reports

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Suggested Citation: Centers for Disease Control and Prevention. [Title]. MMWR 2012;61(No. RR-3):[inclusive page numbers].

Centers for Disease Control and Prevention

Thomas R. Frieden, MD, MPH, Director

Harold W. Jaffe, MD, MA, Associate Director for Science

James W. Stephens, PhD, Director, Office of Science Quality

Stephen B. Thacker, MD, MSc, Deputy Director for Surveillance, Epidemiology, and Laboratory Services

Stephanie Zaza, MD, MPH, Director, Epidemiology and Analysis Program Office

MMWR Editorial and Production Staff

Ronald L. Moolenaar, MD, MPH, Editor, MMWR Series

Christine G. Casey, MD, Deputy Editor, MMWR Series

Teresa F. Rutledge, Managing Editor, MMWR Series

David C. Johnson, Lead Technical Writer-Editor

Jeffrey D. Sokolow, MA, Project Editor

Martha F. Boyd, Lead Visual Information Specialist

Maureen A. Leahy, Julia C. Martinroe,

Stephen R. Spriggs, Terraye M. Starr

Visual Information Specialists

Quang M. Doan, MBA, Phyllis H. King

Information Technology Specialists

MMWR Editorial Board

William L. Roper, MD, MPH, Chapel Hill, NC, Chairman

Matthew L. Boulton, MD, MPH, Ann Arbor, MI

Virginia A. Caine, MD, Indianapolis, IN

Jonathan E. Fielding, MD, MPH, MBA, Los Angeles, CA

David W. Fleming, MD, Seattle, WA

William E. Halperin, MD, DrPH, MPH, Newark, NJ

King K. Holmes, MD, PhD, Seattle, WA

Deborah Holtzman, PhD, Atlanta, GA

Timothy F. Jones, MD, Nashville, TN

Dennis G. Maki, MD, Madison, WI

Patricia Quinlisk, MD, MPH, Des Moines, IA

Patrick L. Remington, MD, MPH, Madison, WI

John V. Rullan, MD, MPH, San Juan, PR

William Schaffner, MD, Nashville, TN

Dixie E. Snider, MD, MPH, Atlanta, GA

John W. Ward, MD, Atlanta, GA

CONTENTS

Introduction ...........................................................................................................1

Methods

...................................................................................................................2

Major Trends in Regard to Providers with HBV Infection

....................... 2

Health-Care Provider-to-Patient Transmission of HBV

........................2

National Trends in Acute Hepatitis B Incidence and Prevalence

.....4

Treatments for Chronic Hepatitis B Infection

.........................................4

Consistency with Other Guidelines

............................................................4

Prevention Strategies

..........................................................................................5

Standard Precautions

......................................................................................5

Work Practice and Engineering Controls

.................................................6

Testing and Vaccination of Health-Care Providers

................................ 6

Actions Taken Against HBV-Infected Health-Care Providers and

Students

.............................................................................................................6

Technical and Ethical Issues in Developing Recommendations

.........6

Monitoring HBV DNA Level and Hepatitis B e Antigen (HBeAg)

.....6

Assessing a Safe Level of HBV DNA

............................................................7

Fluctuating HBV DNA Levels

......................................................................... 7

Specifying Exposure-Prone Procedures ....................................................7

Notification of Patients of HBV-Infected Health-Care Providers

...... 8

Ethical Considerations

....................................................................................8

Guidance for Expert Review Panels at Institutions

............................... 9

Recommendations for Chronically HBV-Infected Health-Care

Providers and Students ....................................................................................9

Practice Scope

....................................................................................................9

Hepatitis B Vaccination and Screening

.....................................................9

Expert Panel Oversight Not Needed

...................................................... 10

Expert Panel Oversight Recommended

................................................ 10

Institutional Policies and Procedures

..................................................... 10

CONTENTS (Continued)

Recommendations and Reports

MMWR / July 6, 2012 / Vol. 61 / No. 3 1

The material in this report originated in the National Center for

HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Kevin

Fenton, MD, PhD, Director, and the Division of Viral Hepatitis, John

W. Ward, MD, Director.

Corresponding preparer: Scott D. Holmberg, MD, Division of Viral

Hepatitis, 1600 Clifton Rd, NE, MS G-37, Atlanta, GA 30329.

Telephone: 404-718-8550; Fax: 404-718-8585; E-mail: [email protected].

Introduction

In 1991, CDC published recommendations to prevent

transmission of bloodborne viruses from infected health-care

providers to patients while conducting exposure-prone invasive

procedures (1). These recommendations did not prohibit the

continued practice of invasive surgical techniques by HBV-

infected surgeons, dentists, and others, provided that the nature

of their illnesses and their practices are reviewed and overseen

by expert review panels. Essential elements of the 1991 CDC

recommendations relevant to HBV included that 1) there be

no restriction of activities for any health-care provider who does

not perform invasive (exposure-prone) procedures; 2) exposure-

prone procedures should be defined by the medical/surgical/

dental organizations and institutions at which the procedures

are performed; 3) providers who perform exposure-prone

procedures and who do not have serologic evidence of immunity

to HBV from vaccination should know their HBsAg status and,

if that is positive, also should know their hepatitis B e-antigen

(HBeAg) status; and 4) providers who are infected with HBV

(and are HBeAg-positive) should seek counsel from and perform

procedures under the guidance of an expert review panel (1).

The 1991 recommendations also recommended that an

HBV-infected health-care provider who performed exposure-

prone procedures, broadly defined, should notify patients

Updated CDC Recommendations for the Management of Hepatitis B

Virus–Infected Health-Care Providers and Students

Prepared by

Scott D. Holmberg, MD

Anil Suryaprasad, MD

John W. Ward, MD

Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Summary

This report updates the 1991 CDC recommendations for the management of hepatitis B virus (HBV)–infected health-care

providers and students to reduce risk for transmitting HBV to patients during the conduct of exposure-prone invasive procedures

(CDC. Recommendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during

exposure-prone invasive procedures. MMWR 1991;40[No. RR-8]). This update reflects changes in the epidemiology of HBV

infection in the United States and advances in the medical management of chronic HBV infection and policy directives issued by

health authorities since 1991.

The primary goal of this report is to promote patient safety while providing risk management and practice guidance to HBV-

infected health-care providers and students, particularly those performing exposure-prone procedures such as certain types of surgery.

Because percutaneous injuries sustained by health-care personnel during certain surgical, obstetrical, and dental procedures provide

a potential route of HBV transmission to patients as well as providers, this report emphasizes prevention of operator injuries and

blood exposures during exposure-prone surgical, obstetrical, and dental procedures.

These updated recommendations reaffirm the 1991 CDC recommendation that HBV infection alone should not disqualify

infected persons from the practice or study of surgery, dentistry, medicine, or allied health fields. The previous recommendations have

been updated to include the following changes: no prenotification of patients of a health-care provider’s or student’s HBV status; use

of HBV DNA serum levels rather than hepatitis B e-antigen status to monitor infectivity; and, for those health-care professionals

requiring oversight, specific suggestions for composition of expert review panels and threshold value of serum HBV DNA considered

“safe” for practice (<1,000 IU/ml). These recommendations also explicitly address the issue of medical and dental students who

are discovered to have chronic HBV infection. For most chronically HBV-infected providers and students who conform to current

standards for infection control, HBV infection status alone does not require any curtailing of their practices or supervised learning

experiences. These updated recommendations outline the criteria for safe clinical practice of HBV-infected providers and students

that can be used by the appropriate occupational or student health authorities to develop their own institutional policies. These

recommendations also can be used by an institutional expert panel that monitors providers who perform exposure-prone procedures.

Recommendations and Reports

2 MMWR / July 6, 2012 / Vol. 61 / No. 3

in advance regarding the provider’s seropositivity. However,

scientific data and clinical experience accumulated since 1991

demonstrate that the risk for HBV and other bloodborne virus

transmission from providers in health-care settings is extremely

low. In addition, improvements in infection control practices

put into effect since 1991 have enhanced both health-care

provider and patient protection from exposure to blood and

bloodborne viruses in health-care settings.

This report is intended to guide the practices of chronically

HBV-infected providers and students and the institutions that

employ, oversee, or train them; it does not address those with

acute HBV infection. This report is limited to the provider-

to-patient transmission of HBV; it does not address infection

control measures to prevent bloodborne transmission of HBV

to patients through receipt of human blood products, organs,

or tissues because these measures have been described elsewhere

(2). Nor does this report provide comprehensive guidance

about prevention of patient-to-health-care provider bloodborne

pathogen transmission because this guidance also has been

published previously (3,4). On the basis of a through literature

review, reports of providers who experienced curtailed scope of

practice, and expert consultation, CDC considered the following

issues when developing these recommendations:1) very rare or, for

most types of clinical practice, no detected transmission of HBV

from providers to patients; 2) nationally decreasing trends in the

incidence of acute HBV infection in both the general population

and health-care providers; 3) successful implementation and

efficacy of policies promoting hepatitis B vaccination; 4) evolving

and improving therapies for HBV infection; 5) guidelines in

the United States and other developed countries that propose

expert-based approaches to the risk management of infected

health-care providers; 6) the adoption of Standard Precautions

(formerly known as universal precautions) as a primary prevention

intervention for the protection of patients and providers from

infectious agent transmission; 7) the implementation of improved

work practice and engineering controls, including safety devices; 8)

the testing and vaccination of providers; 9) increasing availability

of HBV viral load testing; and 10) instances of restrictions or

prohibitions for HBV-infected providers and students that are

not consistent with CDC and other previous recommendations.

Methods

To update recommendations for the risk management of HBV-

infected health-care providers and students, CDC considered

data that have become available since the 1991 recommendations

were published. Information reviewed was obtained through

literature searches both by standard search engines (PubMed)

and of other literature reviews used in guidelines developed by

other professional organizations since 1991. Search terms used

included “hepatitis B,” “hepatitis B virus,” or “HBV” with

“healthcare,” “health-care,” “healthcare workers” or “providers”

or “personnel”; “nosocomial” or “healthcare transmission”; and

“healthcare worker-to-patient.” However, these searches did not

identify additional cases beyond the few already known to CDC

and the experts consulted. To gather data on HBV transmission,

CDC reviewed all hepatitis B outbreak investigations conducted

by CDC and state officials since 1991. CDC national hepatitis

surveillance data were examined for reports of acute HBV

infection in persons with information about recent health

care, as well as reports received regarding dismissal of HBV-

infected health-care providers (i.e., surgeons) or prohibition

from matriculation of medical, dental, and osteopathic students

identified as HBV-infected after acceptance (see Actions Taken

Against HBV-Infected Health Care Providers and Students).

Medical, dental, infection control, public health, infectious

disease, and hepatology experts, officials, and representatives

from government, academia, the public, organizations

representing medical, dental and osteopathic colleges, and

professional medical organizations were consulted.* Some

were consulted at an initial meeting on June 4, 2011. All

experts and organizations were provided draft copies of these

recommendations as they were developed, and they provided

insights, information, suggestions, and edits. In finalizing these

recommendations, CDC considered all available information,

including expert opinion, results of the literature review,

findings of outbreak investigations, surveillance data, and

reports of adverse actions taken against HBV-infected surgeons

and students.

Major Trends in Regard to Providers

with HBV Infection

Health-Care Provider-to-Patient

Transmission of HBV

Since publication of the 1991 CDC recommendations (1),

CDC has accrued substantial information about HBV-infected

health-care providers and students. Many interventions,

including the adoption of Standard Precautions (formerly known

as universal precautions) and double-gloving during invasive

surgical procedures, have eliminated almost completely the very

low risk for transmission of HBV (as well as hepatitis C virus

[HCV] and human immunodeficiency virus) during exposure-

prone procedures. In developing these recommendations, CDC

weighed the risk for HBV transmission based on the following:

* A list of the persons consulted appears on page 10.

Recommendations and Reports

MMWR / July 6, 2012 / Vol. 61 / No. 3 3

1) documented cases of confirmed transmission of HBV from

health-care providers to patients are rare (up to eight cases from

one surgeon in the United States since 1994), 2) it has not

been possible to conduct case-control or cohort studies that

estimate the rate of such rare events, and 3) data are insufficient

to quantify the strength-of-evidence or enable the grading of a

recommendation (5).

Nonetheless, CDC and state authorities have been able to

detect instances of patient-to-patient transfer of HBV (and

HCV) from unsafe injection and dialysis practices, sharing of

blood-glucose monitoring equipment, and other unsanitary

practices and techniques (6). One report from an oral surgery

practice documented patient-to-patient HBV transmission,

although a retrospective assessment did not identify

inappropriate procedures (7). However, despite detecting

patient-to-patient transmission, there is only one published

report of health-care provider-to-patient transmission of HBV

during exposure-prone procedures in the United States since

1994 (8). In that case, an orthopedic surgeon who was unaware

of his HBV status and who had a very high level of HBV DNA

(viral load >17 million IU/ml) (9) transmitted HBV to between

two and eight patients during August 2008–May 2009 (10).

An international review of HBV health-care provider-to-

patient transmissions in other countries in which the HBV

DNA levels (viral load) of the providers were measured has

determined that 4 x 10

genome equivalents per ml (GE/ml)

(roughly comparable to 8,000 international units (IU)/ml)

was the lowest level of HBV DNA in any of several surgeons

implicated in transmission of HBV to patients between 1992

and 2008 (9–15; Table 1). This lowest measurement was

taken >3 months after the suspected transmission event, so

the relevance of the HBV DNA viral load to transmissibility

TABLE 1. Cases of surgeon-to-patient transmission of hepatitis B virus (HBV) in which the surgeon’s HBV DNA was quantified

Location of reported case (yr) Profession

HBV DNA

(GE/ml)*

HBV

e-antigen Quantification technique

Time sample taken

after transmission

United States (1992)

†

Thoracic surgery resident 1.0 X 10

Positive Semi-quantitative PCR dot-blot

hybridization, with comparison

serum containing 108

chimpanzee- infectious particles

4 mos

United Kingdom

(1990–1997)

Cardiothoracic surgeon 10

Positive Semi-quantification by end-point

dilution

6 mos

General surgeon 10

Positive >8 wks

General surgeon 10

Positive Unknown

General surgeon 10

Positive Unknown

Cardiothoracic surgeon 10

Positive Unknown

United Kingdom

(1988, 1993–1995)

General surgeon 1.0 X 10

Negative Liquid hybridization and enzyme-

linked oligonucleotide assay

12 wks

Gynecologist 4.4 X 10

Negative Unknown

Gynecologist 5.5 X 10

Negative Unknown

General surgeon 2.5 X 10

Negative 12 wks

United Kingdom (1999)** Surgeon 1.03 X 10

Negative Lightcycler PCR Unknown

Netherlands (1998–1999)

††

Surgeon 5.0 X 10

Positive Limited dilution PCR 1 yr

United Kingdom

(1988–1997)

§§

Surgeon 1.12 X 10

Negative Chiron Quantiplex Branched DNA

assay and Roche Amplicor HBV

DNA monitor assay

At least 3

mos after

transmission in

all surgeons

Surgeon 2.55 X 10

Surgeon 6.72 X 10

Surgeon 6.35 X 10

Surgeon 4.20 X 10

8¶¶

Surgeon 9.47 X 10

United States (2008)*** Orthopedic surgeon 1.79 X 10

Positive Versant 3.0 third generation

branched DNA assay

14 wks

* GE/ml, genome equivalents/ml; generally, approximately five times comparable measurement of international units (IU)/ml.

†

Source: Harpaz R, von Seidlin L, Averhoff AM, et al. Transmission of hepatitis B virus to multiple patients from a surgeon without evidence of inadequate infection

control. N Engl J Med 1996;334:549–54.

Source: Ngui SL, Watkins RPF, Heptonstall J, Teo CG. Selective transmission of hepatitis B after percutaneous exposure. J Infect Dis 2000;181:838–43.

Source: The Incident Investigation Teams and Others. Transmission of hepatitis to patients from four infected surgeons without hepatitis B e antigen. N Engl J Med

1997;336:178–84.

** Source: Molyneaux P, Reid TM, Collacott I, Mcintyre PG, Dillon JF, Laing RB. Acute hepatitis B in two patients transmitted from an e antigen negative cardiothoracic

surgeon. Commun Dis Publ Health 2000;3:250–2.

††

Source: Spijkerman IJ, van Doorn LJ, Janssen MH, et al. Transmission of hepatitis B virus from a surgeon to his patients during high risk and low risk surgical

procedures during 4 years. Infect Contr Hosp Epidemiol 2002;23:306–12.

§§

Source: Corden S, Ballard AJ, Ijaz S, et al. HBV DNA levels and transmission of hepatitis B by health care workers. J Clin Virol 2003;27:52–8.

¶¶

Lowest value in any transmitting surgeon; average of testing at two laboratories using the same (Roche) assay.

*** Source: Enfield KB, Sharapov U, Hall K, et al. Transmission of hepatitis B virus to patients from an orthopedic surgeon [Abstract no. 420]. Presented at the 5th

Decennial International Conference on Healthcare-Associated Infections, Atlanta, Georgia; March 18–20, 2010. Available at http://shea.confex.com/shea/2010/

webprogram/Paper2428.html.

Recommendations and Reports

4 MMWR / July 6, 2012 / Vol. 61 / No. 3

is unclear. In general, those surgeons who transmitted HBV to

patients appear to have had HBV DNA viral loads well above

GE/ml (or above 20,000 IU/ml) at the earliest time that

viral load was tested after transmission (Table 1). However, the

few studies conducted in nonhuman primates have reported

different results regarding the correlation between HBV DNA

levels in blood and infectivity. One study found a correlation

(16), but another did not (17).

In addition to the rarity of surgery-related transmission of

HBV since 1994 (one reported instance), the most recent

case of HBV transmission from a U.S. dental health-care

provider to patients was reported in 1987 (18,19). Since this

event, certain infection control measures are thought to have

contributed to the absence of detected transmissions; such

measures include widespread vaccination of dental health-care

professionals, universal glove use, and adherence to the tenets

of the 1991 Occupational Safety and Health Administration

(OSHA) Bloodborne Pathogens Standard (20). Since 1991, no

transmission of HBV has been reported in the United States

or other developed countries from primary care providers,

clinicians, medical or dental students, residents, nurses, other

health-care providers, or any others who would not normally

perform exposure-prone procedures (21).

National Trends in Acute Hepatitis B

Incidence and Prevalence

Symptomatic acute HBV infections in the United States,

as reported through health departments to CDC, have

declined approximately 85% from the early 1990s to 2009

(22), following the adoption of universal infant vaccination

and catch-up vaccinations for children and adolescents (23).

If declining trends continue, an ever-increasing proportion

of patients receiving health care and their providers will be

protected by receipt of hepatitis B vaccination.

Patient-to-health-care provider transmission of HBV also has

declined markedly. Reflecting this finding, the reported number

of acute HBV infections among providers in the United States,

not all of which reflect occupational exposure, decreased from

approximately 10,000 in 1983 to approximately 400 in 2002

(24) and to approximately 100 by 2009 (22).

Treatments for Chronic

Hepatitis B Infection

Medications for hepatitis B have been improving continually

and are usually effective at reducing viral loads markedly or even to

undetectable levels. Currently, seven therapeutic agents are approved

by the Food and Drug Administration for the treatment of chronic

hepatitis B, including two formulations of interferon (interferon

alpha and pegylated interferon) and five nucleoside or nucleotide

analogs (lamuvidine, telbivudine, abacavir, entecavir, and tenofovir).

Among the approved analogs, both entecavir and tenofovir have

potent antiviral activity as well as very low rates of drug resistance.

Treatment with these agents reduces HBV DNA levels to undetectable

or nearly undetectable levels in most treated persons (25–27).

Virtually all treated patients, even those few still receiving older agents

(e.g., lamuvidine), can expect to achieve a reduction of HBV DNA

viral loads to very low levels within weeks or months of initiating

therapy (25). The newer medications are effective in suppressing

viral replication, and it is expected that they will be used for a newly

identified HBV-infected health-care provider who is performing

exposure-prone procedures and who has HBV virus levels above the

threshold suggested in this report (1,000 IU/ml [i.e., about 5,000

genome equivalents (GE)/ml]) or as adopted by his or her institution’s

expert review panel. However, clinicians caring for infected health-

care providers or students who are not performing exposure-prone

procedures and who are not subject to expert panel review should

consider both the benefits and risks associated with life-long antiviral

therapy for chronic HBV started at young ages (25).

Consistency with Other Guidelines

Recommendations for the management of HBV-infected

health-care providers and students have evolved in the United

States and other developed countries (Table 2). In 2010, the

Society for Healthcare Epidemiology of America (SHEA)

issued updated guidelines that recommended a process

for ensuring safe clinical practice by HBV-infected health-

care providers and students (28). These separate guidelines

classify many invasive procedures and list those associated

with potentially increased risk for provider-to-patient blood

exposures (Category III procedures, in the SHEA guidelines).

SHEA recommends restricting a provider’s practice on the

basis of the provider’s HBV DNA blood levels and the conduct

of certain invasive procedures considered exposure prone.

The SHEA guidelines also address the current therapeutic

interventions that reduce the viral loads and the infectiousness

of HBV-infected personnel. For providers practicing certain

exposure-prone procedures, SHEA recommends that they

maintain HBV blood levels <10

GE/ml, i.e., depending on

the assay used, approximately 2,000 IU/ml (exposure prone,

Category III) procedures, or cease surgery until they can

reestablish a viral load level below that threshold.

Restrictions based on the provider’s HBV DNA blood levels

also exist in guidelines published by some European countries

and Canada (Table 2) (21,29–36). No guidelines from any

developed country recommend the systematic prohibition of

invasive surgical or dental practices by qualified health-care

providers whose chronic HBV infection is monitored.

Please note: An erratum has been published for this issue. To view the erratum, please click here.

Recommendations and Reports

MMWR / July 6, 2012 / Vol. 61 / No. 3 5

The generally permissive principles delineated in the CDC

1991 recommendations also have been reiterated in recent

Advisory Committee on Immunization Practices (ACIP)

recommendations on immunization of health-care personnel in

the United States for HBV infection (37). ACIP recommends

that HBV-infected persons who perform highly exposure-prone

procedures should be monitored by a panel of experts drawn

from diverse disciplines and perspectives to ensure balanced

recommendations. However, the ACIP recommendations do

not require that HBV-infected persons who do not perform

such procedures have their clinical duties restricted or managed

by a special panel because of HBV infection alone.

Prevention Strategies

Standard Precautions

Strategies to promote patient safety and to prevent

transmission of bloodborne viruses in health-care settings

include hepatitis B vaccination of susceptible health-care

personnel and the use of primary prevention (i.e., preventing

exposures and therefore infection) by strict adherence to the

tenets of standard (universal) infection control precautions,

the use of safer devices (engineering controls), and the

implementation of work practice controls (e.g., not recapping

needles) to prevent injuries that confer risks for HBV

transmission to patients and their providers. Public health

officials in the United States base Standard Precautions on the

premise that all blood and blood-containing body fluids are

potentially infectious (3,4). Since 1996, CDC has specified

the routine use of Standard Precautions (38,39) that include

use of protective equipment in appropriate circumstances,

implementation of both work practice controls and

engineering controls, and adherence to meticulous standards

for cleaning and reusing patient care equipment. For example,

double-gloving now is practiced widely, and the evidence

to demonstrate the feasibility and efficacy of this and other

interventions is extensive (40–44).

TABLE 2. Recommendations for the management of health-care providers (HCP) with hepatitis B virus (HBV) infection*

HBV-infected HCP SHEA (2010) ACS (2004) Europe (2003)

†

Canada (2000) United Kingdom (2000) United States (1991)

Screening —

All surgeons All who do EPP

and who do

not respond to

vaccination

— All who do EPP All who do EPP

Vaccination — All surgeons All who do EPP — All who do EPP All who do EPP

Management of HBV-infected HCP performing EPP

Hepatitis B e-antigen Not required

to be negative

Not required

to be negative

Required to

be negative

Required to

be negative

Required to

be negative

Required to

be negative

HBV DNA <10

GE/ml — Variable

by country

<10

–<10

GE/ml

<10

GE/ml

initially and

<10

GE/ml

on therapy

<10

GE/ml (test not

available)

Frequency of

monitoring

6 mos — 3 mos if doing

EPP; 12 mos for

other HCP

— 12 mos —

Expert panel Yes Yes Yes Yes — Yes

Abbreviations: ACS = American College of Surgeons; EPP = exposure-prone procedures; GE/ml = genome equivalents/ml (roughly equal to 5 International Units/ml

depending on assay used); SHEA = Society for Healthcare Epidemiology of America.

* Sources: CDC. Recommendations for preventing transmission of HIV and HBV virus to patients during exposure-prone invasive procedures. MMWR 1991;40(No.

RR-8); Henderson DK, Dembry L, Fishman NO, et al. SHEA guideline for management of healthcare workers who are infected with hepatitis B virus, hepatitis C virus

and/or human immunodeficiency virus. Infect Control Hosp Epidemiol 2010;31:203–32; American College of Surgeons. Statement on the surgeon and hepatitis.

Available at http://www.facs.org/fellows_info/statements/st-22.html; Health Canada. Proceedings of the consensus conference on infected health care worker risk

for transmission of bloodborne pathogens. Can Commun Dis Rep 1998;24(suppl 4):1–28. Available at http://www.collectionscanada.gc.ca/webarchives/20071124025757/

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/98vol24/24s4/index.html; UK Department of Health. Hepatitis B infected healthcare workers: guidance on

implementation of health service circular 2000/020. UK Department of Health. Hepatitis B infected healthcare workers and antiviral therapy. 2007. Available at http://

www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_073164; U.K. Department of Health. Health Services Guidelines HSG

(93)40. Protecting health care workers and patients from hepatitis B. Available at http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/

documents/digitalasset/dh_4088384.pdf; Gunson RN, Shouval D, Roggendorf M, et al. Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections in health care

workers (HCWs): guidelines for prevention of transmission of HBV and HCV from HCW to patients. J Clin Virol 2003;27:213–30.

†

Consensus conference included representatives from Austria, Belgium, France, Germany, Greece, Holland, Israel, Italy, Portugal, The Republic of Ireland, Sweden, the

United Kingdom, and the United States.

Issue not addressed in recommendation or guideline.

Recommendations and Reports

6 MMWR / July 6, 2012 / Vol. 61 / No. 3

Work Practice and Engineering Controls

Parenteral exposures are mainly responsible for HBV

transmission in health-care settings. Work practice modifications

in the past 20 years have been important in mitigating such

exposures. Examples of such modifications include the practice

of not resheathing needles, the use of puncture-resistant needle

and sharp object disposal containers, avoidance of unnecessary

phlebotomies and other unnecessary needle and sharp object

use, the use of ports and other needleless vascular access

when practical or possible, and the avoidance of unnecessary

intravenous catheters by using needleless or protected needle

infusion systems.

Testing and Vaccination of

Health-Care Providers

Recommendations generated over the past 20 years, both

in the United States and other developed countries, urge all

health-care providers to know their HBV and other bloodborne

virus infection status (21), especially if they are at risk for HBV

infection (37,45). OSHA mandates that hepatitis B vaccine

be made available to health-care providers who are susceptible

to HBV infection and that they be urged to be vaccinated

(Bloodborne Pathogens Standard [29 CFR 1910.1030 and 29

CFR 1910.030f]) These guidelines stipulate that the employer

make available the hepatitis B vaccine and vaccination series

to all employees who have occupational exposure and that

postexposure evaluation and follow-up be provided to all

employees who have an exposure incident.

Approximately 25% or more of medical and dental students

(46,47) and many physicians, surgeons, and dentists in the

United States have been born to mothers in or from countries

in Asia (including India), Africa, and the Middle East with high

and intermediate endemicity for HBV. CDC recommends that

all health-care providers at risk for HBV infection be tested and

that all those found to be susceptible should receive vaccine

(37). Such testing is likely to detect chronically infected health-

care providers and students. Recommendations to ensure safe

practice of health-care providers identified as chronic carriers

of HBV should have reasonable and feasible oversight by the

relevant school, hospital, or other health-care facility.

Actions Taken Against HBV-Infected

Health-Care Providers and Students

CDC is aware of several recent instances in which

HBV-infected persons have been threatened with dismissal

or actually dismissed from surgical practice on the basis of

their HBV infection, and others have had their acceptances

to medical or dental schools rescinded or deferred because of

their infection (Joan M. Block, Hepatitis B Foundation, Anna

S. F. Lok, University of Michigan Medical Center, personal

communications, 2011). Some of these instances have involved

requirements that the infected provider, applicant, or student

demonstrate undetectable HBV viral load or hepatitis B

e-antigen negativity and, in at least one case, that this be

demonstrated continuously by weekly testing. These actions

might not be based on clear written guidance and procedures

at the institutions involved (48,49).

Technical and Ethical Issues in

Developing Recommendations

Monitoring HBV DNA Level and

Hepatitis B e Antigen (HBeAg)

Whereas the 1991 recommendations assessed the infectivity

of surgeons and others performing invasive procedures based on

the presence of HBeAg, documented transmissions of HBV to

patients from several HBeAg-negative surgeons (12,15,50) led

to examination of correlations between HBeAg and HBV viral

load. Some of these HBeAg-negative persons, despite high rates

of viral replication, might harbor pre-core mutants of the virus:

that is, loss of HBeAg expression might result from a single

nucleotide substitution that results in a stop codon preventing

transcription (51,52). Persons with such HBV strains who test

HBeAg-negative might nonetheless be infectious (despite the

mutation) and even have a high concentration of virions in

their blood.

Recent guidelines from other bodies (Table 2) have

recommended using HBV DNA serum levels in preference

to HBeAg in determining infectivity. Several studies have

documented numerous HBeAg-negative persons who have high

circulating levels of HBV DNA, i.e., viral loads often 10

IU/

ml or more by various commercial assays: 78 HBeAg-negative

Australian patients with median HBV DNA of 38,000 IU/

ml (determined by the Siemens Versant HBV DNA 3.0 assay)

(53); 48 HBeAg-negative Greek patients with a median HBV

DNA of 76,000 IU/ml (by Roche Amplicor HBV-Monitor)

(54); 165 HBeAg-negative Korean patients with a mean HBV

DNA of 155,000 IU/ml (by Roche COBAS TaqMan) (55);

and 47 HBeAg-negative Chinese patients with median HBV

DNA blood levels of 960,000 copies/ml (about 200,000 IU/

ml) (by PG Biotech [Shenzhan, China] PCR) (56). On the

basis of these data, monitoring quantitative HBV DNA levels

provides better information to serve as a predictive indicator of

infectivity than is provided by monitoring HBeAg status alone.

Recommendations and Reports

MMWR / July 6, 2012 / Vol. 61 / No. 3 7

Specifying Exposure-Prone Procedures

In general, three conditions are necessary for health-care

personnel to pose a risk for bloodborne virus transmission to

patients. First, the health-care provider must be sufficiently

viremic (i.e., have infectious virus circulating in the

bloodstream). Second, the health-care provider must have an

injury (e.g., a puncture wound) or a condition (e.g., nonintact

skin) that allows exposure to his/her blood or other infectious

body fluids. Third, the provider’s blood or infectious body

fluid must come in direct contact with a patient’s wound,

traumatized tissue, mucous membranes, or similar portal of

entry during an exposure-prone procedure. The vast majority

of HBV-infected health-care personnel pose no risk for patients

because they do not perform activities in which both the second

and third conditions are met.

Beyond meeting these three basic conditions, defining

exposure-prone invasive procedures that pose a risk for HBV

transmission between infected provider and patient has been

problematic in the development of all recommendations and

guidelines; this process is made especially difficult by varying

surgical techniques used by health-care providers doing the

same procedure. More recent guidelines and published articles

indicate that exposure-prone procedures can be defined

broadly, and lists of potentially exposure-prone procedures have

been developed (28,31,60). Principles cited are that exposure-

prone procedures include those in which access for surgery is

difficult (28) or those in which needlestick injuries are likely to

occur (60), typically in very closed and unvisualized operating

spaces in which double gloving and the skin integrity of the

operator might be compromised (Box).

Defining exposure-prone procedures in dentistry and

oral surgery has been particularly difficult. Many intra-oral

procedures (e.g., injection or scaling) occur in a confined

cavity and might lead to injuries to the operator (61), so some

institutions have considered these procedures to be exposure-

prone. However, no transmission of HBV from a U.S. dentist

to a patient has been reported since 1987, and no transmission

has ever been reported from a dental or medical student. Thus,

Category I Procedures (Box) include only major oral surgery,

and do not include the procedures that medical and dental

students or most dentists would be performing or assisting.

In addition to these lists of specific procedures, an

institutional expert review panel convened to oversee an HBV-

infected surgeon or other health-care provider performing

exposure-prone procedures may consult the classification

of such procedures (Box) for guidance. Given the variety

of procedures, practices, and providers, each HBV-infected

health-care provider performing potentially exposure-prone

procedures will need individual consideration. However, this

Assessing a Safe Level of HBV DNA

Review of information concerning six HBeAg-negative

surgeons who had transmitted hepatitis B to patients and

whose HBV DNA had been determined (using both Chiron

Quantiplex Branched DNA assay and Roche Amplicor

HBV DNA Monitor assay) showed the lowest value (at

one laboratory) in one surgeon to be 40,000

copies/ml

(approximately 8,000 IU/ml) (9). However, because this

quantification was performed more than 3 months after the

transmission had taken place, correlative relevance is uncertain.

In 2003, recommendations from the Netherlands set the level

above which health-care providers should not be performing

exposure prone procedures at HBV DNA levels 10

GE/ml

or above (approximately 20,000 IU/ml). A larger European

consortium set this restriction at HBV DNA levels ≥10

GE/ml (approximately 2,000 IU/ml) (33) for persons who

are HBeAg-negative. In 2010, this latter threshold, without a

requirement for e-antigen negativity, was adopted in the U.S.

SHEA Guidelines (28). U.K. guidelines for HBV-infected

providers who are HBeAg-negative require these providers to

achieve or maintain HBV DNA levels of <10

GE/ml (less

than approximately 200 IU/ml) (31,57).

Although newer assays such as real-time polymerase chain

reaction (PCR) tests are expected to reduce the level of detection

for HBV DNA to 10–20 IU/ml, this level could be undetectable

in some assays in use in the United States. The lower limit

of detection for four assays currently in use are 200 IU/ml

(qualitative assay); 30–350 IU/ml (branched DNA assay); 30 IU/

ml (real-time PCR assay); and 10 IU/ml (real-time PCR assay).

Thus, any requirement for demonstration of a viral load <200

IU/ml will need to specify the use of an assay (usually real-time

PCR) that can detect loads well below that threshold.

Fluctuating HBV DNA Levels

Persons who achieve and maintain HBV DNA blood concentrations

below some designated threshold level or attain an undetectable level

might have HBV DNA that is transiently elevated and detectable

but not necessarily transmissible. Such instances might represent

infrequent detections of virus at very low levels despite long-term

suppression of virus on therapy (58) but also could represent, especially

for persons taking older therapies, breakthrough of antiviral-drug

resistant HBV (59). As assays become increasingly sensitive (newer

ones can detect circulating HBV DNA down to 20–30 IU/ml), such

transient elevations will be recognized increasingly and will trigger

more frequent follow-up. If such an elevation in detectable HBV

DNA represents not spontaneous fluctuation (sometimes referred

to as a blip) but rather therapeutic drug failure (i.e., breakthrough),

then appropriate change in therapy may be considered.

Recommendations and Reports

8 MMWR / July 6, 2012 / Vol. 61 / No. 3

evaluation should not define exposure-prone procedures too

broadly; the great majority of surgical and dental procedures

have not been associated with the transmission of HBV.

Notification of Patients of HBV-Infected

Health-Care Providers

There is no clear justification for or benefit from routine

notification of the HBV infection status of a health-care provider

to his or her patient with the exception of instances in which

an infected provider transmits HBV to one or more patients or

documented instances in which a provider exposes a patient to a

bloodborne infection. Routine mandatory disclosure might actually

be counterproductive to public health, as providers and students

might perceive that a positive test would lead to loss of practice

or educational opportunities. This misperception might lead to

avoidance of HBV testing, of hepatitis B vaccination (if susceptible),

of treatment and management (if infected), or of compliance with

practice oversight from an expert panel (if infected and practicing

exposure-prone procedures). In general, a requirement for disclosure

is accepted to be an insurmountable barrier to practice and might

limit patient and community access to quality medical care.

Ethical Considerations

On July 18, 2011, the Consult Subcommittee of CDC’s

Public Health Ethics Committee reviewed these proposed

recommendations. The reviewing team also included three

external ethicists. The opinion of the Consult Subcommittee

was that guidelines that allow providers with HBV to practice

while requiring those doing exposure-prone procedures to

be monitored to maintain low load strikes the right balance

between protecting patients’ interests and providers’ rights.

The Consult Subcommittee also noted that providers have an

ethical and professional obligation to know their HBV status

and to act on such knowledge accordingly (CDC Public Health

Ethics Committee, personal communication, 2011). The

Consult Subcommittee supported the new recommendation

that mandatory disclosure of provider HBV status to patients

was no longer warranted and that the 1991 recommendation

for disclosure was discriminatory and unwarranted.

In addition, the Consult Subcommittee determined that

there was no scientific or ethical basis for the restrictions that

some medical and dental schools have placed on HBV-infected

students and concluded that such restrictions were detrimental

to the professions as well as to the individual students.

BOX. CDC classification of exposure-prone patient care procedures

Category I. Procedures known or likely to pose an

Category II. All other invasive and noninvasive procedures

increased risk of percutaneous injury to a health-care

These and similar procedures are not included in Category I as

provider that have resulted in provider-to-patient

they pose low or no risk for percutaneous injury to a health-care

transmission of hepatitis B virus (HBV)

provider or, if a percutaneous injury occurs, it usually happens

These procedures are limited to major abdominal, cardiothoracic,

outside a patient’s body and generally does not pose a risk for

and orthopedic surgery, repair of major traumatic injuries,

provider-to-patient blood exposure. These include

abdominal and vaginal hysterectomy, caesarean section, vaginal

• surgical and obstetrical/gynecologic procedures that do

deliveries, and major oral or maxillofacial surgery (e.g., fracture

not involve the techniques listed for Category I;

reductions). Techniques that have been demonstrated to increase

• the use of needles or other sharp devices when the health-care

the risk for health-care provider percutaneous injury and provider-

provider’s hands are outside a body cavity (e.g., phlebotomy,

to-patient blood exposure include

placing and maintaining peripheral and central intravascular

• digital palpation of a needle tip in a body cavity and/or

lines, administering medication by injection, performing

• the simultaneous presence of a health care provider’s

needle biopsies, or lumbar puncture);

fingers and a needle or other sharp instrument or object

• dental procedures other than major oral or maxillofacial

(e.g., bone spicule) in a poorly visualized or highly

surgery;

confined anatomic site.

• insertion of tubes (e.g., nasogastric, endotracheal, rectal, or

Category I procedures, especially those that have been

urinary catheters);

implicated in HBV transmission, are not ordinarily

• endoscopic or bronchoscopic procedures;

performed by students fulfilling the essential functions of a

• internal examination with a gloved hand that does not

medical or dental school education.

involve the use of sharp devices (e.g., vaginal, oral, and

rectal examination; and

• procedures that involve external physical touch (e.g., general

physical or eye examinations or blood pressure checks).

Recommendations and Reports

MMWR / July 6, 2012 / Vol. 61 / No. 3 9

Guidance for Expert Review

Panels at Institutions

HBV infection in health-care providers and students who

do not perform invasive exposure-prone procedures should

be managed as a personal health issue and does not require

special panel oversight. However, for providers who perform

exposure-prone procedures, all recent guidelines advocate the

constitution of an expert panel to provide oversight of the

infected health-care provider’s practice (Table 2).

For HBV-infected providers performing exposure-prone

procedures, expert review panels should evaluate the infected

provider’s clinical and viral burden status; assess his or

her practices, procedures and techniques, experience, and

adherence to recommended surgical and dental technique;

provide recommendations, counseling, and oversight of the

provider’s continued practice or study within the institution; and

investigate and notify appropriate persons and authorities (e.g.,

risk management or, if need be, licensure boards) for suspected

and documented breaches (62) in procedure or incidents

resulting in patient exposure. The panel should reinforce the

need for Standard Precautions (e.g., double gloving, regular

glove changes, and use of blunt surgical needles). Panels may

appropriately provide counseling about alternate procedures

or specialty paths, especially for providers, students, residents,

and others early in their careers, as long as this is not coercion

or limitation (perceived or actual) of the provider or student.

The members of the expert review panel may be selected

from, but should not necessarily be limited to, the following:

one or more persons with expertise in the provider’s specialty;

infectious disease and hospital epidemiology specialists; liver

disease specialists (gastroenterologists); the infected providers’

occupational health, student health, or primary care physicians;

ethicists; human resource professionals; hospital or school

administrators; and legal counsel. Certain members of the

panel should be familiar with issues relating to bloodborne

pathogens and their infectivity.

In instances when it is generally accepted (or thought)

that a patient might have been exposed to the blood of an

infected health-care provider, institutions should have in

place a protocol for communicating to the patient that such

an exposure might have occurred. The patient should receive

appropriate follow-up including post-exposure vaccination or

receipt of hepatitis B immune globulin and testing (i.e., similar

to the reverse situation of prophylaxis for providers exposed to

the blood of an HBV-infected patient).

The confidentiality of the infected provider or student

should be respected. Certain expert review panels might elect

to consider cases without knowledge of the name of the infected

provider or student. However, awareness of the infected

provider’s or student’s identity might be unavoidable. In such

cases, respect for the confidentiality of the person under review

should be accorded as it is for any other patient.

Recommendations for Chronically

HBV-Infected Health-Care Providers

and Students

CDC recommends the following measures for the management

of hepatitis B virus–infected health-care providers and students:

Practice Scope

• Chronic HBV infection in itself should not preclude the

practice or study of medicine, surgery, dentistry, or allied

health professions. Standard Precautions should be adhered

to rigorously in all health-care settings for the protection

of both patient and provider.

• CDC discourages constraints that restrict chronically HBV-

infected health-care providers and students from the practice

or study of medicine, dentistry, or surgery, such as

– repeated demonstration of persistently nondetectable

viral loads on a greater than semiannual frequency;

– prenotification of patients of the HBV-infection status

of their care giver;

– mandatory antiviral therapy with no other option such

as maintenance of low viral load without therapy; and

– forced change of practice, arbitrary exclusion from

exposure-prone procedures, or any other restriction

that essentially prohibits the health-care provider from

practice or the student from study.

Hepatitis B Vaccination and Screening

• All health-care providers and students should receive hepatitis B

vaccine according to current CDC recommendations

(37,45,63). Vaccination (3-dose series) should be followed by

assessment of hepatitis B surface antibody to determine

vaccination immunogenicity and, if necessary, revaccination.

Health-care providers who do not have protective concentration

of anti-HBs (>10 mIU/ml) after revaccination (i.e., after

receiving a total of 6 doses) should be tested for HBsAg and

anti-HBc to determine their infection status (37).

• Prevaccination serologic testing is not indicated for most

persons being vaccinated, except for those providers and

students at increased risk for HBV infection (37), such as

those born to mothers in or from endemic countries and

sexually active men who have sex with men (64).

Recommendations and Reports

10 MMWR / July 6, 2012 / Vol. 61 / No. 3

• Providers who are performing exposure-prone procedures

also should receive prevaccination testing for chronic HBV

infection. Exposure of a patient to the blood of an

HBV-infected health-care provider, in the performance of

any procedure, should be handled with postexposure

prophylaxis and testing of the patient in a manner similar

to the reverse situation (i.e., prophylaxis for providers

exposed to the blood of an HBV-infected patient) (65).

Expert Panel Oversight Not Needed

• Providers, residents, and medical and dental students with

active HBV infection (i.e., those who are HBsAg-positive)

who do not perform exposure-prone procedures but who

practice non- or minimally invasive procedures (Category

II, Box) should not be subject to any restrictions of their

activities or study. They do not need to achieve low or

undetectable levels of circulating HBV DNA, hepatitis

e-antigen negativity, or have review and oversight by an

expert review panel, as recommended for those performing

exposure-prone procedures. However, they should receive

medical care for their condition by clinicians, which might

be in the setting of student or occupational health.

Expert Panel Oversight Recommended

• Surgeons, including oral surgeons, obstetrician/gynecologists,

surgical residents, and others who perform exposure-prone

procedures, i.e., those listed under Category I activities

(Box), should fulfill the following criteria:

– Consonant with the 1991 recommendations and

Advisory Committee on Immunization Practices (ACIP)

recommendations (37), their procedures should be

guided by review of a duly constituted expert review

panel with a balanced perspective (i.e., providers’ and

students’ personal, occupational or student health

physicians, infectious disease specialists, epidemiologists,

ethicists and others as indicated above) regarding the

procedures that they can perform and prospective

oversight of their practice (28). Confidentiality of the

health-care provider’s or student’s HBV serologic status

should be maintained.

– HBV-infected providers can conduct exposure-prone

procedures if a low or undetectable HBV viral load is

documented by regular testing at least every 6 months

unless higher levels require more frequent testing; for

example, as drug therapy is added or modified or testing

is repeated to determine if elevations above a threshold

are transient.

– CDC recommends that an HBV level 1,000 IU/ml

(5,000 GE/ml) or its equivalent is an appropriate

threshold for a review panel to adopt. Monitoring should

be conducted with an assay that can detect as low as

10–30 IU/ml, especially if the individual institutional

expert review panel wishes to adopt a lower threshold.

– Spontaneous fluctuations (blips) of HBV DNA levels

and treatment failures might both present as higher-than-

threshold (1,000 IU/ml; 5,000 GE/ml) values. This will

require the HBV-infected provider to abstain from

performing exposure-prone procedures, while subsequent

retesting occurs, and if needed, modifications or

additions to the health-care provider’s drug therapy and

other reasonable steps are taken.

Institutional Policies and Procedures

• Hospitals, medical and dental schools, and other institutions

should have written policies and procedures for the

identification and management of HBV-infected health-care

providers, students, and school applicants. These policies

should include the ability to identify and convene an expert

review panel (see Guidance for Expert Review Panels) aware

of these and other relevant guidelines and recommendations

before considering the management of HBV-infected

providers performing exposure-prone procedures.

Acknowledgments

The following persons were consulted in the drafting of these

recommendations: Ronald Bayer, PhD, Columbia University; Kathy

Kinlaw, MDiv, Emory University; Bernard Lo, MD, University of

California at San Francisco; David K. Henderson, MD, National

Institutes of Health Clinical Center; Disability Rights Section, Civil

Rights Division, U.S. Department of Justice; David Thomas, MD,

Infectious Diseases Society of America; Anna S. F. Lok, MD, American

Association for the Study of Liver Disease; Joan M. Block, Hepatitis B

Foundation; Su H. Wang, MD, Charles B. Wang Community Health

Center; Samuel So, MD, Asian Liver Center/Stanford University; Gabriel

Garcia, MD, American Association of American Medical Colleges;

Kathleen T. O’Laughlin, DMD, American Dental Association; Stephen

C. Shannon, DO, American Association of Colleges of Osteopathic

Medicine; Anne Wells, EdD, American Dental Education Association;

Therese M. Long, MBA, Organization for Safety, Asepsis and Prevention;

Alfred DeMaria Jr, MD, Council of State and Territorial Epidemiologists;

Mark Russi, MD, American College of Occupational and Environmental

Medicine; Harold W. Jaffe, MD, Office of the Director, Drue H. Barrett,

PhD, Leonard Ortman, PhD, Public Health Ethics Unit, Office of

the Director, Trudy K. Murphy, MD, Division of Viral Hepatitis,

National Center for HIV, Viral Hepatitis, STDs and TB Prevention,

Denise Cardo, MD, David T. Kuhar, MD, Division of Health Quality

Promotion, National Center for Emerging and Zoonotic Infectious

Diseases, Amy S. Collins, MPH, Barbara F. Gooch, DMD, Division

of Oral Health, National Center for Chronic Disease Prevention and

Health Promotion, CDC.

Recommendations and Reports

MMWR / July 6, 2012 / Vol. 61 / No. 3 11

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