An expert panel report of a proposed scientific model demonstrating the effectiveness of antibacterial handwash products

American Journal of Infection Control

Volumn 40, Issue 8, 2012, Pages 742-749

  Boyce, John M ^a,b   Dupont, Herbert L ^c,d,e   Massaro, Joseph ^f   Sack, David ^g   Schaffner, Donald W ^h  

^a HOSPITAL OF SAINT RAPHAEL   (United States)

^b YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF TEXAS SCHOOL OF PUBLIC HEALTH   (United States)

^d ST LUKE S EPISCOPAL HOSPITAL   (United States)

^e BAYLOR COLLEGE OF MEDICINE   (United States)

^f BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH   (United States)

^g JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^h RUTGERS UNIVERSITY   (United States)

Author keywords

Community; Hand hygiene; Hand microbiology; Handwashing; Handwashing model; Methods; Soaps

Indexed keywords

ANTIINFECTIVE AGENT;

ARTICLE; BACTERIUM CONTAMINATION; HAND WASHING; INFECTION CONTROL; SHIGELLA FLEXNERI;

ANTI-INFECTIVE AGENTS, LOCAL; CHLORHEXIDINE; CROSS INFECTION; CROSS-OVER STUDIES; CUCUMIS MELO; DOSE-RESPONSE RELATIONSHIP, DRUG; ESCHERICHIA COLI; ETHANOL; FOOD MICROBIOLOGY; HAND; HAND DISINFECTION; HUMANS; NONPRESCRIPTION DRUGS; SERRATIA MARCESCENS; SHIGELLA FLEXNERI; SOAPS; TRICLOSAN;

EID: 84867044689     PISSN: 01966553     EISSN: 15273296     Source Type: Journal    
DOI: 10.1016/j.ajic.2011.09.016     Document Type: Article

References (38)

1. Center for Drug Evaluation and Research Consumer antiseptic drug products review. FDA Docket 75N-0183H July 8, 2005 US Department of Health and Human Services Available from: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005- 4184B1-01-06-FDA-TAB05 Accessed December 7, 2011
2. Center for Drug Evaluation and Research Healthcare consumer antiseptics. FDA Literature Review September 22, 2005 US Department of Health and Human Services Available from: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005- 4184B1-01-08-FDA-TAB07.pdf Accessed December 7, 2011
3. Center for Drug Evaluation Research Topical Antiseptic Review Team, Division of Nonprescription Regulations Development, Office of Nonprescription Products. Memorandum September 22, 2005 US Department of Health and Human Services Available from: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005- 4184B1-01-01-FDA-Executive%20Summary.pdf Accessed December 7, 2011
4. Center for Drug Evaluation and Research Healthcare antiseptic drug products: healthcare personnel hand wash. FDA Docket 75N-0183H December 20, 2004 FDA NDAC meetings (March and October 2005). US Department of Health and Human Services Available from: http://www.fda.gov/ohrms/dockets/ac/cder05. html#NonprescriptionDrugs
5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Technical Coordination. ICH Topic E9: statistical principles for clinical trials. European Agency for the Evaluation of Medical Products, Human Medicines Evaluation Unit CPMP/ICH/363/96, March 18, 1998. Available from: http://www.emea.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500002928.pdf. Accessed December 7, 2011.
6. Steering Committee Harmonized tripartite guidelines, choice of control group and related issues in clinical trials July 20, 2000 ICH Expert Working Group Available from: http://firstclinical.com/regdocs/doc/?db=ICH-E10 Accessed December 7, 2011
7. E. Larson A causal link between hand washing and risk of infection? Examination of the evidence Infect Control Hosp Epidemiol 9 1988 28 36
8. R. Prentice Surrogate endpoints in clinical trials: definition and operational criteria Stat Med 8 1989 431 440
9. M. Coleman, and H. Marks Topics in dose-response modeling J Food Prot 61 1998 1550 1559
10. Center for Drug Evaluation and Research Healthcare antiseptic drug products. FDA Docket 1980-N-0006 November 8, 2008 FDA feedback meeting, November 2008. US Department of Health and Human Services Available from: http://www.regulations.gov/#!documentDetail;D=FDA-1980-N-0006-0029
11. J. Englehardt, and J. Swartout Predictive Bayesian microbial dose-response assessment based on suggested self-organization in primary illness response: Cryptosporidium parvum Risk Anal 26 2006 543 554
12. C. Haas Conditional dose-response relationships for microorganisms: development and application Risk Anal 22 2002 455 463
13. C. Haas, R.J. Thayyar-Madabusi, and C. Gerba Development of dose-response relationship for Escherichia coli O157:H7 Int J Food Microbiol 1748 2000 153 159
14. D. Holcomb, M. Smith, G. Ware, Y. Hung, R. Brackett, and M. Doyle Comparison of six dose-response models for use with food-borne pathogens Risk Anal 19 1999 1091 1100
15. G. Medema, P. Teunis, A. Havelaar, and C. Haas Assessment of the dose-response relations of Campylobacter jejuni Int J Food Microbiol 30 1996 101 111
16. H. Moon, H. Kim, J. Chen, and R. Kodell Model averaging using the Kullback information criterion in estimating effective doses for microbial infection and illness Risk Anal 25 2005 291 299
17. T.J. Sandora, E.M. Taveras, M.-C. Shih, E.A. Resnick, G.M. Lee, and D. Ross-Degnan A randomized controlled trial of a multifaceted intervention including alcohol-based hand sanitizer and hand-hygiene education to reduce illness transmission in the home Pediatrics 116 2005 587 594
18. N.J.C. Strachan, M.P. Doyle, F. Kasuga, O. Rotariu, and I.D. Ogden Dose-response modeling of Escherichia coli O157:H7 incorporating data from food borne and environmental outbreaks Int J Food Microbiol 103 2005 35 47
19. P. Teunis, K. Takumi, and K. Shinagawa Dose response for infections by Escherichia coli O157:H7 for outbreak data Risk Anal 24 2004 401 407
20. R. Buchanan, J. Smith, and W. Long Microbial risk assessment; dose-response relations and risk characterization Int J Food Microbiol 58 2000 159 172
21. C.S. Crockett, C.N. Haas, A. Fazil, J.B. Rose, and C.P. Gerba Prevalence of shigellosis in the US: consistency with dose-response information Int J Food Microbiol 30 1996 87 99
22. H.L. Dupont, R.B. Hornick, A.T. Dawkins, M.J. Snyder, and S.B. Formal The response of man to virulent Shigella flexneri 2a J Infect Dis 119 1969 296 299
23. H.L. Dupont, R.B. Hornick, M.J. Snyder, S.B. Libonati, S.B. Formal, and E.J. Gangarosa Immunity in shigellosis, II: protection induced by oral live vaccine or primary infection J Infect Dis 125 1972 12 16
24. H.L. Dupont, M.M. Levine, R.B. Hornick, and S.B. Formal Inoculum size in shigellosis and implications for expected mode of transmission J Infect Dis 159 1989 1126 1128
25. E. Escartin, A. Ayala, and J. Lozano Survival and growth of Salmonella and Shigella on sliced fresh fruit J Food Prot 52 1989 471 472
26. C.W. Hedberg, W.C. Levine, K.E. White, R.H. Carlson, D.K. Winsor, and D.N. Cameron An international food-borne outbreak of shigellosis associated with a commercial airline JAMA 268 1992 3208 3212
27. D.N. Taylor, R. McKenzie, A. Durbin, C. Carpenter, C.B. Atzinger, and R. Haake Rifaximin, a nonabsorbed oral antibiotic, prevents shigellosis after experimental challenge Clin Infect Dis 42 2006 1283 1288
28. L. Zaika, J. Phillips, J. Fanelli, and J. Scullen Revised model for aerobic growth of Shigella flexneri to extend the validity of predictions at temperatures between 10 and 19 degrees C Int J Food Microbiol 41 1998 9 19
29. S. Baker Surrogate endpoints: wishful thinking or reality? J Nat Cancer Inst 98 2006 502 503
30. Campbell G; FDA Center for Devices and Radiological Health. Surrogate endpoints: a regulatory view. Available from: www.amstat.org/meetings/ fdaworkshop/presentations/2006/Greg%20Campbell%20Surrogate%20Endpoints.ppt. Accessed December 8, 2011.
31. H. Moon, J. Chen, D. Gaylor, and R. Kodell A comparison of microbial dose-response models fitted to human data Reg Toxicol Pharmacol 40 2004 177 184
32. J. Woodcock Biomarkers: physiological and laboratory markers of drug effects February 1, 2007 Food and Drug Administration Available from: www.clinicalcenter.nih.gov/researchers/training/principles/ppt/ woodcock-2006-2007.pdf Accessed December 7, 2011
33. American Society for Testing and Materials ASTM E1174 standard test method for evaluation of the effectiveness of health care personnel or consumer hand-wash formulations Annual book of ASTM standards, vol. 11.05 2006 American Society for Testing and Materials West Conshohocken [PA] 421 423
34. G.E. Fischler, J.L. Fuls, E.W. Dail, M.H. Duran, N.D. Rodgers, and A.L. Waggoner Effects of hand wash agents on controlling the transmission of pathogenic bacteria from hands to food J Food Prot 70 2007 2873 2877
35. J.L. Fuls, N.D. Rodgers, G.E. Fischler, J.M. Howard, M. Patel, and P.L. Weidner Alternative hand contamination technique to compare the activities of antimicrobial and nonantimicrobial soaps under different test conditions Appl Environ Microbiol 74 2008 3739 3744
36. J.C. deWitt The importance of hand hygiene in contamination of foods Ant Van Leeuw J Microbiol 51 1985 523 527
37. Center for Drug Evaluation Research Guidance for industry. Exposure-response relationships: study design, data analysis, and regulatory applications April 2003 US Department of Health and Human Services Available from: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf Accessed December 7, 2011
38. D. Schaffner, and K. Schaffner Management of risk of microbial cross-contamination for uncooked frozen hamburgers by alcohol-based hand sanitizer J Food Prot 70 2007 109 113