# Presentation: 405379

## HAND HYGIENE: VIRAL SURROGATES TO DEMONSTRATE EFFICACY OF TOPICALS AGAINST VIRUSES

**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 President**
**Division of Aerobiology, Protozoology and Virology**
**MICROBIOTEST, INC., Sterling, VA 20164**
**and**
**Affiliate Professor **
**Department of Molecular and Microbiology**
**George Mason University, Fairfax, VA 22030 **

## OUTLINE

**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**

## Major Etiological Agents of Infectious Diseases Identified since 1972*

**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.**

## VIRUSES, PUBLIC HEALTH AND HAND HYGIENE:

**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)**

## VIRUSES, PUBLIC HEALTH AND HAND HYGIENE:

**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****)**

## VIRUSES, PUBLIC HEALTH AND HAND HYGIENE:

**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**

## DO VIRUSES SURVIVE ON HANDS?

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

***DO VIRUSES SURVIVE ON HANDS?***

## SURVIVAL OF SELECTED VIRUSES ON FINGERPADS

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**SURVIVAL OF SELECTED VIRUSES ON FINGERPADS**
** ****OF ADULTS AFTER 20 MINUTES**

**% Survival**

## Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

## IN VIVO TESTING OF TOPICALS

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

***IN VIVO *****TESTING OF TOPICALS**

## TESTING OF HYGIENIC HANDWASHING 

**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**

## ASTM STANDARD FOR HAND ANTISEPTICS

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**ASTM 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**

## MAIN STEPS IN THE FINGERPAD METHOD 

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**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: **

- 1. SUBJECT WASHES HANDS WITH UN-MEDICATED SOAP & WATER

**2. **DRIES HANDS WELL WITH PAPER TOWEL

**3. **HANDS RUBBED WITH 70-75% ETHANOL TILL DRY

- Dr. Sattar – CREM, University of Ottawa

## FINGERPAD METHOD (CONT’D.)

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**FINGERPAD METHOD (CONT’D.)**

- 4. THUMB- & FINGERPADS DEMARCATED WITH PLASTIC VIAL

**5. **TEN μL TEST MICROBE IN SOIL LOAD PLACED

- 6. THUMBPADS ELUTED IMMEDIATELY (INPUT CONTROL**)**

**9. ****WHEN INOCULUM DRIES, TWO FINGERPADS ELUTED (BASELINE)**

**7. **THUMBPADS IMMEDIATELY DECONTAMINATED

**8. **INOCULUM ON FINGERPADS ALLOWED TO DRY

- Dr. Sattar – CREM, University of Ottawa

## FINGERPAD METHOD (CONT’D.)

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**FINGERPAD METHOD (CONT’D.)**

- 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

**12**. SKIN SURFACE SCRAPED ON INSIDE LIP OF VIAL TO RECOVER MOST OF ELUATE

**13. **FINGERPADS DECONTAMINATED

**14. **HANDS WASHED WITH SOAP &  WATER

- 15. HANDS DRIED WELL WITH PAPER TOWEL

- Dr. Sattar – CREM, University of Ottawa

## ADVANTAGES OF THE FINGERPAD METHOD

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**ADVANTAGES 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**

## ADVANTAGES (CONT’D.)

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**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**

## ADVANTAGES (CONT’D.)

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**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**

## ALCOHOL-BASED ANTISEPTICS

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**ALCOHOL-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**

## THE EFFECTIVENESS OF AN ALCOHAL-BASED HAND GEL AGAINST RHINOVIRUS AND BOVINE VIRAL DIARRHEA VIRUS (SURROGATE FOR HEPATITIS C VIRUS)

**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 RESIDUAL**
**INFECTIOUS 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)**

## TESING ANTI-VIRAL ACTIVITY OF HAND ANTISEPTICS: 

**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****	**

## ISSUES TO BE RESOLVED

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**ISSUES 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**

## Hand Hygiene Guideline

**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 activity**
**	****results 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

## CONCLUSIONS

**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. **
** **

## CONCLUSIONS

**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

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

## LITERATURE FOR FURTHER READING

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**LITERATURE FOR FURTHER READING**

- Ansari 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.

## Hand-Hygiene Websites

**Ijaz, MK, FDA’s Non-prescription Drugs Advisory Committee Meeting, Gaithersburg, MD, March 23, 2004**

**Hand-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**
** **

## WWW. MICROBIOTEST.COM

- 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**