Date post: | 18-Dec-2015 |
Category: |
Documents |
View: | 215 times |
Download: | 1 times |
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
HAND HYGIENE: VIRAL SURROGATES TO DEMONSTRATE EFFICACY OF TOPICALS
AGAINST VIRUSES
M. Khalid Ijaz, D.V.M., Ph.D.
Director and Vice PresidentDivision of Aerobiology, Protozoology and Virology
MICROBIOTEST, INC., Sterling, VA 20164
and
Affiliate Professor Department of Molecular and Microbiology
George Mason University, Fairfax, VA 22030
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
VIRUSES, PUBLIC HEALTH AND HAND HYGIENE: HISTORICAL PERSPECTIVE MAJOR FACTORS IN TESTING THE ANTIVIRAL ACTIVITY OF HANDWASH & HANDRUB AGENTS IN VIVO TESTING OF TOPICALS TESING OF HYGIENIC HANDWASH AGENTS AGAINST VIRUSES IN VIVO THE FINGERPAD METHOD AND DATA GENERATED AT MICROBIOTEST ISSUES, RECOMMENDATIONS AND CONCLUDING REMARKS ACKNOWLEDGEMENTS
OUTLINE
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
Major Etiological Agents of Infectious Diseases Identified since 1972*
Over the > 30 years, a number of emerging and re-emerging viruses has dominated the scientific literature.
In 70s, enteric (rotavirus, Norwalk), Ebola, Hantaan viruses
In 80s, retroviruses including HIV AIDS and hepatitis C
In 90s, Sin Nombre, HEV, HGV, HFV, Nipah & Hendra, West Nile viruses and Prion)
In 2000s, FMDV, avian influenza, SARS-HCoV
(Partly from Desselberger, 2000
FACTORS PREDISPOSING TO SPREAD OF NEW, EMERGING AND RE-EMERGING VIRAL DISEASES INCLUDE BUT NOT LIMITED TO GLOBAL TRAVEL AND MASS MOVEMENTS, HUMAN DEMOGRAPHICS AND BEHAVIOUR, VIRAL GENOME CHANGE AND ADAPTATION AND ANIMAL HUSBANDRY INTENSIFICATION ETC.
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
VIRUSES, PUBLIC HEALTH AND HAND HYGIENE:
HISTORICAL PERSPECTIVE
FOLLOWING HISTORICAL INTERVENTION TRIALS BY SEMMELWEIS
IN 1846 @ VIENA, A NUMBER OF INTERVENTION TRIALS HAVE
BEEN SHOWN TO REDUCE THE RISK OF INFECTION.
VIRUSES ARE IMPORTANT ETIOLOGIC AGENT FOR MORBIDTY AND
MORTALITY GLOBALLY.
NEW EMERGING AND RE-EMERGING VIRUSES ARE ON THE RISE
(WEST NILE, SARS-HCoV).
IN THE US 5% OF NOSOCOMIAL CASES DUE TO VIRUSES, ~32% IN
PEDIATRIC, of which RSV was most common
(Aitken and Jeffries, 2001)
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
VIRUSES, PUBLIC HEALTH AND HAND HYGIENE:
HISTORICAL PERSPECTIVE (cont’d)
HANDS PLAY AN IMPORTANT ROLE IN THE SPREAD OF MANY VIRAL
INFECTIONS AND PROPER HAND WASHING BY CAREGIVERS,
FOOD HANDLERS FOR INTERRUPTION OF SPREAD OF VIRUSES
AND OTHER TYPES OF PATHOGENS IS UNIVERSALLY
RECOGNIZED
THIS HAS BEEN DEMONSTRATED IN INTERVENTION EXPERIMENTAL
AS WELL AS STUDIES CONDUCTED IN CLINICAL SETTINGS
(Black et al., 1981, Hendley & Gwaltney, 1988; Ward et al., 1991)
INFECTIOUS VIRUS HAVE BEEN RECOVERED FROM NATUALLY
CONTAMINATED HANDS. CASES IN POINT – HCV, RSV, RHINO-,
ROTAVIRUSES (Alfurayh et al., 2000; Hall & Douglas, 1981;
Keswick et al., 1983 and Hendley & Gwaltney, 1988)
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
VIRUSES, PUBLIC HEALTH AND HAND HYGIENE:
HISTORICAL PERSPECTIVE (cont’d)
Although the FDA Center for Food Safety and Nutrition (CFSAN)
recognize the significance of viruses being disseminated by food
handlers and healthcare worker and role played by hands in this regard, the
Tentative Final Monograph (TFM) of FDA does not address viruses at all.
PROPER ANTISEPTICS PROCEDURES FOR USED DECONTAMINATION OF
HANDS CAN INTERRUPT SUCH DISSEMINATION
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
DO VIRUSES SURVIVE ON HANDS?DO VIRUSES SURVIVE ON HANDS?
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD,
March 23, 2004
0
10
20
30
40
50
60
70
80
90
Rhinovirus BVDV/HCV
Rhinovirus
BVDV/HCV
SURVIVAL OF SELECTED VIRUSES ON FINGERPADS OF ADULTS AFTER 20 MINUTES
% S
urv
ival
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
PREVENTIONIS PRIMARY!
Protect patients…protect healthcare personnel…
promote quality healthcare!
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
IN VIVO TESTING OF TOPICALSIN VIVO TESTING OF TOPICALS
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
TESTING OF HYGIENIC HANDWASHING AGENTS AGAINST VIRUSES IN VIVO
The Whole-Hand Method
The Fingertip Method
The Fingerpad Method
The Whole-Hand Method
The Fingertip Method
The Fingerpad Method
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
ASTM STANDARD FOR HAND ANTISEPTICSASTM STANDARD FOR HAND ANTISEPTICS
E2011-99 - METHOD FOR EVALUATION OF HANDWASHING
FORMULATIONS FOR VIRUS-ELIMINATING ACTIVITY USING THE ENTIRE
HAND
E1838-02 - METHOD FOR DETERMINING THE VIRUS-ELIMINATING
EFFECTIVENESS OF LIQUID HYGIENIC HANDWASH AND HANDRUB
AGENTS USING THE FINGERPADS OF ADULT VOLUNTEERS
E2011-99 - METHOD FOR EVALUATION OF HANDWASHING
FORMULATIONS FOR VIRUS-ELIMINATING ACTIVITY USING THE ENTIRE
HAND
E1838-02 - METHOD FOR DETERMINING THE VIRUS-ELIMINATING
EFFECTIVENESS OF LIQUID HYGIENIC HANDWASH AND HANDRUB
AGENTS USING THE FINGERPADS OF ADULT VOLUNTEERS
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
MAIN STEPS IN THE FINGERPAD METHOD MAIN STEPS IN THE FINGERPAD METHOD WITH IRB PERMISSION, SUBJECTS RECEIVE DETAILS ON STUDY & REQUESTED
WRITTEN CONSENT; JUST BEFORE TESTING, HANDS OF SUBJECT
SCREENED FOR ANY DAMAGE TO SKIN; MAIN STEPS IN TESTING ARE:
WITH IRB PERMISSION, SUBJECTS RECEIVE DETAILS ON STUDY & REQUESTED
WRITTEN CONSENT; JUST BEFORE TESTING, HANDS OF SUBJECT
SCREENED FOR ANY DAMAGE TO SKIN; MAIN STEPS IN TESTING ARE:
1. SUBJECT WASHES HANDS WITH UN-MEDICATED SOAP & WATER
1. SUBJECT WASHES HANDS WITH UN-MEDICATED SOAP & WATER
2. DRIES HANDS WELL WITH PAPER TOWEL
2. DRIES HANDS WELL WITH PAPER TOWEL 3. HANDS RUBBED WITH 70-
75% ETHANOL TILL DRY
3. HANDS RUBBED WITH 70-75% ETHANOL TILL DRY
Dr. Sattar – CREM, University of Ottawa
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
FINGERPAD METHOD (CONT’D.)FINGERPAD METHOD (CONT’D.)
4. THUMB- & FINGERPADS DEMARCATED WITH PLASTIC VIAL
4. THUMB- & FINGERPADS DEMARCATED WITH PLASTIC VIAL
5. TEN µL TEST MICROBE IN SOIL LOAD PLACED
5. TEN µL TEST MICROBE IN SOIL LOAD PLACED
6. THUMBPADS ELUTED IMMEDIATELY (INPUT CONTROL)
6. THUMBPADS ELUTED IMMEDIATELY (INPUT CONTROL)
9. WHEN INOCULUM DRIES, TWO FINGERPADS ELUTED (BASELINE)
9. WHEN INOCULUM DRIES, TWO FINGERPADS ELUTED (BASELINE)
7. THUMBPADS IMMEDIATELY DECONTAMINATED
7. THUMBPADS IMMEDIATELY DECONTAMINATED
8. INOCULUM ON FINGERPADS ALLOWED TO DRY
8. INOCULUM ON FINGERPADS ALLOWED TO DRY
Dr. Sattar – CREM, University of Ottawa
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
FINGERPAD METHOD (CONT’D.)FINGERPAD METHOD (CONT’D.)10. FINGERPAD TREATED
WITH 1 mL OF TEST SUBSTANCE OR CONTROL
SOLUTION
10. FINGERPAD TREATED WITH 1 mL OF TEST
SUBSTANCE OR CONTROL SOLUTION
11. FINGERPAD ELUTED WITH 1 mL OF ELUENT WITH OR WITHOUT
WATER RINSE OR DRYING
11. FINGERPAD ELUTED WITH 1 mL OF ELUENT WITH OR WITHOUT
WATER RINSE OR DRYING
12. SKIN SURFACE SCRAPED ON INSIDE LIP OF VIAL TO
RECOVER MOST OF ELUATE
12. SKIN SURFACE SCRAPED ON INSIDE LIP OF VIAL TO
RECOVER MOST OF ELUATE
13. FINGERPADS DECONTAMINATED
13. FINGERPADS DECONTAMINATED 14. HANDS WASHED WITH
SOAP & WATER
14. HANDS WASHED WITH SOAP & WATER
15. HANDS DRIED WELL WITH PAPER TOWEL
15. HANDS DRIED WELL WITH PAPER TOWEL
Dr. Sattar – CREM, University of Ottawa
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
ADVANTAGES OF THE FINGERPAD METHODADVANTAGES OF THE FINGERPAD METHOD
MEASURED VOLUME OF TEST INOCULUM PLACED ON A WELL
DEFINED AREA & DRIED
DRIED INOCULUM EXPOSED TO A KNOWN VOLUME OF TEST
FORMULATION FOR A DEFINED & SHORT CONTACT TIME
INFECTIOUS AGENT STAYS WHERE IT WAS PLACED
CONTROL & REFERENCE SOLUTION CAN BE INCLUDED IN
THE SAME TEST ALONG TEST FORMULATION
MEASURED VOLUME OF TEST INOCULUM PLACED ON A WELL
DEFINED AREA & DRIED
DRIED INOCULUM EXPOSED TO A KNOWN VOLUME OF TEST
FORMULATION FOR A DEFINED & SHORT CONTACT TIME
INFECTIOUS AGENT STAYS WHERE IT WAS PLACED
CONTROL & REFERENCE SOLUTION CAN BE INCLUDED IN
THE SAME TEST ALONG TEST FORMULATION
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
ADVANTAGES (CONT’D.)ADVANTAGES (CONT’D.)
CAN DISTINGUISH BETWEEN PATHOGEN LOSS DUE TO MECHANICAL REMOVAL, IN SITU INACTIVATION & POST-TREATMENT WATER RINSING & TOWEL OR AIR-DRYING
CAN BE USED WITH CONVENTIONAL OR HANDRUB FORMULATIONS
SUITABLE FOR WORK WITH ALL MAJOR CLASSES OF MICROORGANISMS
GIVES RESULTS COMPARABLE TO THOSE WITH THE WHOLE-HAND METHOD
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
ADVANTAGES (CONT’D.)ADVANTAGES (CONT’D.)
THE FINGERPAD METHOD HAS BEEN USED FOR EVALUATION OF VARIETY OF HAND WASH AGENTS BY A NUMBER OF DIFFERENT LABS HERE IN NORTH AMERICA INCLUDING EUROPE.
Woolwine and Gerberding (1995)
Steinmann et al., (1995)
Mbithi et al., (1993)
At MICROBIOTEST, WE HAVE TESTED AN ALCOHOL-BASED PRODUCT AGAINST RHINOVIRUS AND BVDV/HCV
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
ALCOHOL-BASED ANTISEPTICSALCOHOL-BASED ANTISEPTICS
MAJOR RELEVANCE IN HAND ANTISEPSIS
INCREASING ACCEPTANCE EVEN IN U.S. & CANADA
CONVENIENT, SAFE, FAST-ACTING & ENVIRONMENTALLY-FRIENDLY
FOR USE BETWEEN HANDWASHINGS
FORMULATIONS WITH >60% ALCOHOL BROAD-SPECTRUM
GERMICIDES, INCLUDING ACTIVITY AGAINST MANY
NON-ENVELOPED VIRUSES
HEPATITIS A, CALICI- & PARVOVIRUSES MAY BE RESISTANT
SOME CONCERNS WITH AIR QUALITY
MAJOR RELEVANCE IN HAND ANTISEPSIS
INCREASING ACCEPTANCE EVEN IN U.S. & CANADA
CONVENIENT, SAFE, FAST-ACTING & ENVIRONMENTALLY-FRIENDLY
FOR USE BETWEEN HANDWASHINGS
FORMULATIONS WITH >60% ALCOHOL BROAD-SPECTRUM
GERMICIDES, INCLUDING ACTIVITY AGAINST MANY
NON-ENVELOPED VIRUSES
HEPATITIS A, CALICI- & PARVOVIRUSES MAY BE RESISTANT
SOME CONCERNS WITH AIR QUALITY
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
FOR RHINOVIRUS 12 & FOR BVDV 6 SUBJECTS WERE USED. 10 uL OF EACH VIRAL INOCULA WAS PLACED ON EACH DIGIT & DRIED. EXPOSED TO 1 mL OF THE PRODUCT FOR 15 S. POST-EXPOSURE, ELUATE WERE ASSAYED FOR RESIDUALINFECTIOUS VIRUS AND LOG 10 REDUCTION WAS CALCULATED.
THE EFFECTIVENESS OF AN ALCOHAL-BASED HAND GEL AGAINST RHINOVIRUS AND BOVINE VIRAL DIARRHEA
VIRUS (SURROGATE FOR HEPATITIS C VIRUS)
VIRUSTESTED
REDUCTION VIRUS TITER
IN VITRO
BASELINE CONTROL
TEST PRODUCT
REDUCTION VIRUS TITER WITH TEST PRODUCT
P VALUE
Bovine viral
diarrhea virus
10 4.88
10 4.57 0.34
10 0.50
10 4.07
<0.001
Rhinovirus Type 14
10 4.00 10 3.750.48 10 0.50 10 3.25 <0.0005
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
TESING ANTI-VIRAL ACTIVITY OF HAND ANTISEPTICS:
POTENTIAL SURROGATE VIRUSES
VIRUSES ASSAY SKIN SAFETY SURVIVAL=======================================================================
Adenovirus Yes Yes Good
Bovine viral diarrhea virus/HCV Yes Yes Good
Feline calicivirus/Norwalk Yes Yes Good
Hepatitis A virus Yes Yes Very Good
Rhinovirus Yes Yes Good
Rotavirus Yes Yes Very Good
Respiratory syncytial virus Yes Yes Very Poor========================================================================
Ansari & Sattar, 2003; Ijaz et al., unpublished data
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
ISSUES TO BE RESOLVEDISSUES TO BE RESOLVED IS IN SITU PATHOGEN INACTIVATION NECESSARY?
SHOULD WE ACCOUNT FOR PATHOGEN REMOVAL WITH POST-
TREATMENT RINSE & DRYING?
WHAT SHOULD BE THE PERFORMANCE CRITERIA FOR HANDWASH &
HAND RUBS?
WOULD SURROGATES BE ACCEPTABLE?
IS RESIDUAL ANTI-VIRAL ACTIVITY NEEDED?
HARMONIZATION OF TEST METHODS
FDA MONOGRAPH?
CTFA/SDA CITIZEN’S PETITION TO FDA ON VIRUCIDAL ACTIVITY OF
HAND ANTISPETICS
MICROBIOTEST’s PROTOCOL TO TO FDA ON VIRUCIDAL ACTIVITY OF
HAND ANTISPETICS
ASTM organized a symposium in October, 2004
IS IN SITU PATHOGEN INACTIVATION NECESSARY?
SHOULD WE ACCOUNT FOR PATHOGEN REMOVAL WITH POST-
TREATMENT RINSE & DRYING?
WHAT SHOULD BE THE PERFORMANCE CRITERIA FOR HANDWASH &
HAND RUBS?
WOULD SURROGATES BE ACCEPTABLE?
IS RESIDUAL ANTI-VIRAL ACTIVITY NEEDED?
HARMONIZATION OF TEST METHODS
FDA MONOGRAPH?
CTFA/SDA CITIZEN’S PETITION TO FDA ON VIRUCIDAL ACTIVITY OF
HAND ANTISPETICS
MICROBIOTEST’s PROTOCOL TO TO FDA ON VIRUCIDAL ACTIVITY OF
HAND ANTISPETICS
ASTM organized a symposium in October, 2004
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD,
March 23, 2004
Hand Hygiene Guideline
Exposure to healthcare workers to variety of viral pathogens warranted a discussion of antiviral activity of hand antiseptic agents
Discussion of antiseptic agents included information about
in vitro evidence of antiviral activityresults of in vivo testing (finger pad method)
mimics conditions under which products will be used by healthcare workers
controls for differing survival of viruses on skin
Dr. Boyce, 2004
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD,
March 23, 2004
CONCLUSIONS HAND ANTISEPTIC AGENTS PLAY AN IMPORTANT ROLE IN INTERRUPTION OF VIRAL DISSEMINATION FROM SURAFCE-TO- HAND-TO-HAND AND FINGERTIPS TO MOUTH FROM THE ENVIRONMENT TO HUMAN POPULATIONS. GLP VIRUCIDAL METHODS FOR TESTING EFFICACY OF HAND ANTISEPTIC AGENTS ARE AVAILABLE. DATA GENERATED BY FINGERPAD METHOD HERE IN NORTH AMERICA AND EUROPE CONFIRMED THE VIRUCIDAL DATA GENERATED BY THE WHOLE-HAND METHOD.
SURVIVAL AND DISINFECTION STUDIES OF VIRUSES IN BLOOD AND CELL-ASSOCIATED VIRUSES UNDERWAY.
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD,
March 23, 2004
CONCLUSIONS CANADA HAS STARTED PRODUCT REGISTRATION.
WORLD HEALTH ORGANIZATION (WHO) IS IN THE PROCESS OF FINALIZING GUIDELINES
FDA SHOULD REVISIT ISSUE OF LABEL CLAIMS AGAINST VIRUSES FOR FORMULATIONS TO BE USED IN:
NOSOCOMIAL SETTINGS
FOOD HANDLING ESTABLISHMENTS
FDA’S CURRENT EXPERTISE ARE IN THE ANTI-VIRAL THERPEUTIC EVALUATION. FDA SHOULD SEEK EITHER OUTSIDE EXPTERISE OR HIRE SOMEONE TO LOOK INTO THIS MATTER
TOPICALS ARE MEANT TO BE USED FOR INTACT SKIN AND ONLY FOR PREVENTATIVE PURPOSES NOT FOR TREATMENT
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
LITERATURE FOR FURTHER READINGLITERATURE FOR FURTHER READINGAnsari S.A. & Sattar, S.A. (2002). The Need and Methods for Assessing the Activity of Topical Agents against Viruses. In Handbook of Topical
Antimicrobials: Industrial Applications in Consumer Products and Pharmaceuticals, D. Paulson (ed.), Marcel Dekker, New York, NY. Pages 411-445.
Ansari, S.A. et al. (1989). In vivo protocol for testing efficacy of hand-washing agents against viruses & bacteria: Expts. with rotavirus & Escherichia coli. Appl. Environ. Microbiol. 55 (12):3113-3118.
Ansari, S.A. et al. (1991). Potential role of hands in the spread of respiratory viral infections: Studies with human parainfluenzavirus 3 & rhinovirus 14. J. Clin. Microbiol. 29:2115-2119.
ASTM (2002). Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Volunteers (#E-1838-02).
Aitken, C and Jeffries, D. Nosocomial spread of viral diseases. Clin. Microbiol. Rev. 2001; 14: 528-546 Bidawid, S. et al. (2000). Contamination of foods by food handlers: experiments on hepatitis A virus transfer to food its interruption. Appl. Environ. Microbiol. 66: 2759-2763. Desselberger U. Emerging and re-emerging infectious diseases. J. Infect. 2000, 40:3-15.Ijaz, MK, AH Brunner, SA Sattar, and CM Johnson-Lussenburg. Survival characteristics of airborne human coronavirus 229E. Journal of Gen. Virology 66:2843-2748, 1985.Ijaz, MK, MI Sabara, PJ Frenchick, and LA Babiuk. Assessment of intestinal damage in rotavirus infected newborn mice by D-xylose absorption test. Journal of Virological Methods 18: 153-157, 1987.Ijaz, MK, D Dent, D Haines, and LA Babiuk. Development of a murine model to study the pathogenesis of rotavirus infection. Experimental and
Molecular Pathology 51:186-204, 1989. Sattar, SA, Ijaz, MK. Transmission of viral infections through airborne route. CRC Critical Reviews in Environmental Control 17: 89-131, 1987.Sattar SA, Tetro J, Springthorpe VS, Giulivi A. (2001). Preventing the spread of hepatitis B and C viruses: where are germicides relevant? Am J Infect Control 2001, 29:187-97.Sattar, SA and MK Ijaz. Airborne Viruses. In: Manual of Environmental Microbiology. P Wilkes and LD Stenzenbach (eds.) ASM press,
Washington, USA, p. 871-883,2002.Sattar, S.A. et al. (2002). Hygienic hand antiseptics: should they not have activity and label claims against viruses? Am. J. Infect. Control. 30:
355-372.Westwood, JCN and Sattar, SA. The minimal infectious dose. In: G Berg et al., eds. Viruses in Water. Washington, DC: American Public Health Association. 1976, pp.61-69.
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
Hand-Hygiene WebsitesHand-Hygiene Websites
Guideline for Hand Hygiene in Healthcare Settings – CDC, 2002
http://www.cdc.gov/handhygiene/materials.htm
Hand Hygiene in Retail & Food service Establishments, CFSAN, FDA, 2003
http://vm.cfsan.fda.gov/~comm/handhyg.html
MICROBIOTEST PROTOCOL submitted to FDA on June 26, 2003
http://www.fda.gov/ohrms/dockets/dailys/03/Aug03/081403/75N-0183H_emc-000001-01.pdf
Guideline for Hand Hygiene in Healthcare Settings – CDC, 2002
http://www.cdc.gov/handhygiene/materials.htm
Hand Hygiene in Retail & Food service Establishments, CFSAN, FDA, 2003
http://vm.cfsan.fda.gov/~comm/handhyg.html
MICROBIOTEST PROTOCOL submitted to FDA on June 26, 2003
http://www.fda.gov/ohrms/dockets/dailys/03/Aug03/081403/75N-0183H_emc-000001-01.pdf
Ijaz, 2000. Division of Biofilms, Protozoology and Virology
Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004
MICROBIOTEST, INC.
Donna B. SUCHMANN
ACKNOWLEDGMENTS
WWW. MICROBIOTEST.COM
CREM- UNIVERSITY OF OTTAWA
Dr. Syed A. SATTAR
ASTM – International
Dr. John MITCHELL
Ms. Kathy BAXTER
Mr. Dan SMITH
Yale University
Dr. John BOYCE