- 1. Please note: An erratum has been published for this issue.
To view the erratum, please click here. Morbidity and Mortality
Weekly ReportRecommendations and Reports / Vol. 61 / No. 3July 6,
2012 Updated CDC Recommendations for the Management of Hepatitis
BVirusInfected Health-Care Providers and StudentsU.S. Department of
Health and Human ServicesCenters for Disease Control and
Prevention
2. Recommendations and ReportsCONTENTSCONTENTS
(Continued)Introduction
............................................................................................................1Recommendations
for Chronically HBV-Infected Health-CareMethods
....................................................................................................................2Providers
and Students
.....................................................................................9Major
Trends in Regard to Providers with HBV Infection
........................2 Practice Scope
.....................................................................................................9
Health-Care Provider-to-Patient Transmission of HBV
.........................2Hepatitis B Vaccination and Screening
......................................................9 National
Trends in Acute Hepatitis B Incidence and Prevalence ......4Expert
Panel Oversight Not Needed
....................................................... 10
Treatments for Chronic Hepatitis B Infection
..........................................4Expert Panel Oversight
Recommended ................................................. 10
Consistency with Other Guidelines
.............................................................4Institutional
Policies and Procedures
...................................................... 10Prevention
Strategies
...........................................................................................5
Standard Precautions
.......................................................................................5
Work Practice and Engineering Controls
..................................................6 Testing and
Vaccination of Health-Care Providers
.................................6Actions Taken Against
HBV-Infected Health-Care Providers and Students
..............................................................................................................6Technical
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
Disclosure of Relationship Fluctuating HBV DNA Levels
..........................................................................7
CDC, our planners, and our content experts wish to disclosethat
they have no financial interests or other relationships Specifying
Exposure-Prone Procedures
....................................................7 with the
manufacturers of commercial products, suppliers of Notification of
Patients of HBV-Infected Health-Care Providers .......8commercial
services, or commercial supporters. Presentations Ethical
Considerations
.....................................................................................8will
not include any discussion of the unlabeled use of a productor a
product under investigational use. CDC does not accept Guidance for
Expert Review Panels at Institutions
................................9commercial support.The MMWR series
of publications is published by the Office of Surveillance,
Epidemiology, and Laboratory Services, Centers for Disease Control
and Prevention (CDC),U.S. Department of Health and Human Services,
Atlanta, GA 30333.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 ServicesStephanie Zaza,
MD, MPH, Director, Epidemiology and Analysis Program OfficeMMWR
Editorial and Production StaffRonald L. Moolenaar, MD, MPH, Editor,
MMWR SeriesMartha F. Boyd, Lead Visual Information Specialist
Christine G. Casey, MD, Deputy Editor, MMWR SeriesMaureen A. Leahy,
Julia C. Martinroe,Teresa F. Rutledge, Managing Editor, MMWR
SeriesStephen R. Spriggs, Terraye M. StarrDavid C. Johnson, Lead
Technical Writer-Editor Visual Information Specialists Jeffrey D.
Sokolow, MA, Project Editor Quang M. Doan, MBA, Phyllis H. King
Information Technology SpecialistsMMWR Editorial BoardWilliam L.
Roper, MD, MPH, Chapel Hill, NC, ChairmanMatthew L. Boulton, MD,
MPH, Ann Arbor, MI Dennis G. Maki, MD, Madison, WIVirginia A.
Caine, MD, Indianapolis, IN Patricia Quinlisk, MD, MPH, Des Moines,
IAJonathan E. Fielding, MD, MPH, MBA, Los Angeles, CAPatrick L.
Remington, MD, MPH, Madison, WIDavid W. Fleming, MD, Seattle, WA
John V. Rullan, MD, MPH, San Juan, PRWilliam E. Halperin, MD, DrPH,
MPH, Newark, NJWilliam Schaffner, MD, Nashville, TNKing K. Holmes,
MD, PhD, Seattle, WA Dixie E. Snider, MD, MPH, Atlanta, GA Deborah
Holtzman, PhD, Atlanta, GAJohn W. Ward, MD, Atlanta, GA Timothy F.
Jones, MD, Nashville, TN 3. Recommendations and Reports Updated CDC
Recommendations for the Management of Hepatitis BVirusInfected
Health-Care Providers and StudentsPrepared by Scott D. Holmberg,
MDAnil Suryaprasad, MD John W. Ward, MD Division of Viral
Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and
TB Prevention SummaryThis 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 providers or
students 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 (17 million IU/ml) (9)
transmitted HBV to betweento quantify the strength-of-evidence or
enable the grading of a two and eight patients during August
2008May 2009 (10).recommendation (5). An international review of
HBV health-care provider-to-Nonetheless, CDC and state authorities
have been able topatient transmissions in other countries in which
the HBVdetect instances of patient-to-patient transfer of HBV (and
DNA levels (viral load) of the providers were measured hasHCV) from
unsafe injection and dialysis practices, sharing of determined that
4 x 104 genome equivalents per ml (GE/ml)blood-glucose monitoring
equipment, and other unsanitary(roughly comparable to 8,000
international units (IU)/ml)practices and techniques (6). One
report from an oral surgery was the lowest level of HBV DNA in any
of several surgeonspractice documented patient-to-patient HBV
transmission,implicated in transmission of HBV to patients between
1992although a retrospective assessment did not identifyand 2008
(915; Table 1). This lowest measurement wasinappropriate procedures
(7). However, despite detectingtaken >3 months after the
suspected transmission event, sopatient-to-patient transmission,
there is only one publishedthe relevance of the HBV DNA viral load
to transmissibilityTABLE 1. Cases of surgeon-to-patient
transmission of hepatitis B virus (HBV) in which the surgeons HBV
DNA was quantified HBV DNA HBV Time sample takenLocation of
reported case (yr) Profession(GE/ml)* e-antigen Quantification
technique after transmissionUnited States (1992)Thoracic surgery
resident1.0 X 109PositiveSemi-quantitative PCR dot-blot4 mos
hybridization, with comparison serum containing 108 chimpanzee-
infectious particlesUnited Kingdom Cardiothoracic surgeon
109PositiveSemi-quantification by end-point6 mos (19901997)General
surgeon108Positivedilution>8 wks General
surgeon109PositiveUnknown General surgeon107PositiveUnknown
Cardiothoracic surgeon 105PositiveUnknownUnited Kingdom General
surgeon1.0 X 107NegativeLiquid hybridization and enzyme-12 wks
(1988, 19931995)Gynecologist 4.4 X 106Negativelinked
oligonucleotide assayUnknown Gynecologist 5.5 X 106NegativeUnknown
General surgeon2.5 X 105Negative12 wksUnited Kingdom
(1999)**Surgeon1.03 X 106 NegativeLightcycler PCR
UnknownNetherlands (19981999)Surgeon5.0 X 109PositiveLimited
dilution PCR1 yrUnited Kingdom Surgeon1.12 X 108 NegativeChiron
Quantiplex Branched DNAAt least 3 (19881997) Surgeon2.55 X 105
assay and Roche Amplicor HBVmos after Surgeon6.72 X 105 DNA monitor
assay transmission in Surgeon6.35 X 104 all surgeons Surgeon4.20 X
108 Surgeon9.47 X 108United States (2008)***Orthopedic surgeon 1.79
X 107 PositiveVersant 3.0 third generation14 wks branched DNA assay
*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;334:54954. Source: Ngui SL, Watkins RPF, Heptonstall J, Teo
CG. Selective transmission of hepatitis B after percutaneous
exposure. J Infect Dis 2000;181:83843.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;336:17884. **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;3:2502. 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;23:30612. 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;27:528. 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 1820, 2010. Available at
http://shea.confex.com/shea/2010/
webprogram/Paper2428.html.MMWR/July 6, 2012/Vol. 61/No. 3 3 6.
Please note: An erratum has been published for this issue. To view
the erratum, please click here. Recommendations and Reportsis
unclear. In general, those surgeons who transmitted HBV toalpha and
pegylated interferon) and five nucleoside or nucleotidepatients
appear to have had HBV DNA viral loads well above analogs
(lamuvidine, telbivudine, abacavir, entecavir, and tenofovir).105
GE/ml (or above 20,000 IU/ml) at the earliest time thatAmong the
approved analogs, both entecavir and tenofovir haveviral load was
tested after transmission (Table 1). However, the potent antiviral
activity as well as very low rates of drug resistance.few studies
conducted in nonhuman primates have reported Treatment with these
agents reduces HBV DNA levels to undetectabledifferent results
regarding the correlation between HBV DNAor nearly undetectable
levels in most treated persons (2527).levels in blood and
infectivity. One study found a correlation Virtually all treated
patients, even those few still receiving older agents(16), but
another did not (17).(e.g., lamuvidine), can expect to achieve a
reduction of HBV DNA In addition to the rarity of surgery-related
transmission ofviral loads to very low levels within weeks or
months of initiatingHBV since 1994 (one reported instance), the
most recenttherapy (25). The newer medications are effective in
suppressingcase of HBV transmission from a U.S. dental
health-careviral replication, and it is expected that they will be
used for a newlyprovider to patients was reported in 1987 (18,19).
Since thisidentified HBV-infected health-care provider who is
performingevent, certain infection control measures are thought to
haveexposure-prone procedures and who has HBV virus levels above
thecontributed to the absence of detected transmissions; such
threshold suggested in this report (1,000 IU/ml [i.e., about
5,000measures include widespread vaccination of dental
health-caregenome equivalents (GE)/ml]) or as adopted by his or her
institutionsprofessionals, universal glove use, and adherence to
the tenetsexpert review panel. However, clinicians caring for
infected health-of the 1991 Occupational Safety and Health
Administrationcare providers or students who are not performing
exposure-prone(OSHA) Bloodborne Pathogens Standard (20). Since
1991, noprocedures and who are not subject to expert panel review
shouldtransmission of HBV has been reported in the United States
consider both the benefits and risks associated with life-long
antiviralor other developed countries from primary care
providers,therapy for chronic HBV started at young ages
(25).clinicians, medical or dental students, residents, nurses,
otherhealth-care providers, or any others who would not normally
Consistency with Other Guidelinesperform exposure-prone procedures
(21).Recommendations for the management of HBV-infected health-care
providers and students have evolved in the United National Trends
in Acute Hepatitis BStates and other developed countries (Table 2).
In 2010, theIncidence and Prevalence Society for Healthcare
Epidemiology of America (SHEA) Symptomatic acute HBV infections in
the United States,issued updated guidelines that recommended a
processas reported through health departments to CDC, havefor
ensuring safe clinical practice by HBV-infected health-declined
approximately 85% from the early 1990s to 2009care providers and
students (28). These separate guidelines(22), following the
adoption of universal infant vaccination classify many invasive
procedures and list those associatedand catch-up vaccinations for
children and adolescents (23). with potentially increased risk for
provider-to-patient bloodIf declining trends continue, an
ever-increasing proportionexposures (Category III procedures, in
the SHEA guidelines).of patients receiving health care and their
providers will beSHEA recommends restricting a providers practice
on theprotected by receipt of hepatitis B vaccination. basis of the
providers HBV DNA blood levels and the conduct
Patient-to-health-care provider transmission of HBV also hasof
certain invasive procedures considered exposure prone.declined
markedly. Reflecting this finding, the reported numberThe SHEA
guidelines also address the current therapeuticof acute HBV
infections among providers in the United States,interventions that
reduce the viral loads and the infectiousnessnot all of which
reflect occupational exposure, decreased from of HBV-infected
personnel. For providers practicing certainapproximately 10,000 in
1983 to approximately 400 in 2002exposure-prone procedures, SHEA
recommends that they(24) and to approximately 100 by 2009
(22).maintain HBV blood levels
