Hostname: page-component-78c5997874-g7gxr Total loading time: 0 Render date: 2024-11-02T19:53:26.442Z Has data issue: false hasContentIssue false
  • English
  • Français

FDA Labeling Requirements for Disinfection of Endoscopes: A Counterpoint

Published online by Cambridge University Press:  02 January 2015

William A. Rutala  and
David J. Weber
William A. Rutala*
Affiliation:
Division of infectious Diseases, Department of Medicine, University of North Carolina (UNC) at Chapel Hill, and the Department of Hospital Epidemiology, UNC Hospitals, Chapel Hill, North Carolina
David J. Weber
Affiliation:
Division of infectious Diseases, Department of Medicine, University of North Carolina (UNC) at Chapel Hill, and the Department of Hospital Epidemiology, UNC Hospitals, Chapel Hill, North Carolina
*
547 Burnett-Womack Bldg., CB #7030, UNC at Chapel Hill, Chapel Hill, NC 27599-7030
Get access Rights & Permissions [Opens in a new window]

Abstract

Endoscopes are used widely for the diagnosis and therapy of medical disorders. To prevent spread ofnosocomial infection, all endoscopes should undergo thorough cleaning and high-level disinfection following each use. The Food and Drug Administration (FDA) has approved a user-friendly package label for one liquid chemical germicide that requires a 45-minute immersion at 25°C to support a high-level disinfection label claim. Scientific data reviewed here suggest that one can achieve at least an 8-log reduction in M tuberculosis contamination with cleaning (4 logs) followed by chemical disinfection for 20 minutes (4 to 6 logs). The FDA should modify the label to state that if cleaning is accomplished using a standardized cleaning protocol, then a 20-minute immersion at 20°C will be sufficient to achieve high-level disinfection.

Type
Readers' Forum
Information
Infection Control & Hospital Epidemiology , Volume 16 , Issue 4 , April 1995 , pp. 231 - 235
Copyright
Copyright © The Society for Healthcare Epidemiology of America 1995

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Spach, DH, Silverstein, FE, Stamm, WE. Transmission of infection by gastrointestinal endoscopy and bronchoscopy. Ann Intern Med 1993;118:117–128.CrossRefGoogle ScholarPubMed
2. Weber, DJ, Rutala, WA Environmental issues and nosocomial infections. In: Wenzel, RP, ed. Prevention and Control of Nosocomial Infections, 2nd ed. Baltimore: Williams&Wilkins; 1993:420–449.Google Scholar
3. Rutala, WA. APIC guideline for selection and use of disinfectants. Am/Infect Control. 1990;18:99–117.Google Scholar
4. Martin, MA, Reichelderfer, M. APIC guideline for infection prevention and control in flexible endoscopy. Am J Infect Control 1994;22:19–38.CrossRefGoogle ScholarPubMed
5. Society of Gastroenterology Nurses and Associates. Recommended Guidelines for Infection Control in Gastrointestinal Endoscopy Settings. Rochester, NY; 1990.Google Scholar
6. Memorandum of Understanding Between the Food and Drug Administration, Public Health Service, and the Environmental Protection Agency. June 4, 1993.Google Scholar
7. Food and Drug Administration, Infection Control Devices Branch, Division of General and Restorative Devices, Office of Device Evaluation. Guidance on the Content and Format of Premarket Notification (510[k]) Submissions for Liquid Chemical Germicides. January 31, 1992.Google Scholar
8. Alvarado, C. Current label claims for liquid chemical sterilants/high level disinfectants. In: Association for Professionals in Infection Control and Epidemiology, Inc. APIC News. 1994;13(6):2,22–23.Google Scholar
9. Rutala, WA, Clontz, EP, Weber, DJ, Hoffmann, KK. Disinfection practices for endoscopes and other semicritical items. Infect Control Hosp Epidemiol 1991;12:282–288.CrossRefGoogle ScholarPubMed
10. Hanson, PJV, Gor, D, Clarke, JR, et al. Contamination of endoscopes used in AIDS patients. Lancet 1989:86–88.Google Scholar
11. Hanson, PJV, Gor, D, Jeffries, DJ, Collins, JV. Elimination of high titre HIV from fibreoptic endoscopes. Gut 1990;31:657–659.Google Scholar
12. Hanson, PJV, Gor, D, Clarke, JR, et al. Recovery of the human immunodeficiency virus from fibreoptic bronchoscopes. Thorax 1991;46:410–412.Google Scholar
13. Hanson, PJV, Chadwick, MV, Gaya, H, Collins, JV. A study of glutaraldehyde disinfection of fibreoptic bronchoscopes experimentally contaminated with Mycobacterium tuberculosis . J Hosp Infect 1992;22:137–142.CrossRefGoogle ScholarPubMed
14. Vesley, D, Norlien, KG, Nelson, B, Ott, B, Streifel, AJ. Significant factors in the disinfection and sterilization of flexible endoscopes. Am J Infect Control 1992;20:291–300.Google Scholar
15. Collins, FM. Bactericidal activity of alkaline glutaraldehyde solution against a number of atypical mycobacterial species. J Appl Bacteriol 1986;61:247–251.Google Scholar
16. Collins, FM. Kinetics of the tuberculocidal response by alkaline glutaraldehyde in solution and on an inert surface. J Appl Bacteriol 1986;61:87–93.Google Scholar
17. Collins, FM. Use of membrane filters for measurement of mycobactericidal activity of alkaline glutaraldehyde solution. Appl Environ Microbiol 1987;53:737–739.CrossRefGoogle ScholarPubMed
18. Ascenzi, JM, Ezzell, RJ, Wendt, TM. A more accurate method for measurement of tuberculocidal activity of disinfectants. Appl Environ Microbiol 1987;53:2189–2192.CrossRefGoogle ScholarPubMed
19. Best, M, Sattar, SA, Springthorpe, VS, Kennedy, ME. Efficacies of selected disinfectants against Mycobacterium tuberculosis . J Clin Microbiol 1990;28:2234–2239.CrossRefGoogle ScholarPubMed
20. Cole, EC, Rutala, WA, Nessen, L, Wannamaker, NS, Weber, DJ. Effect of methodology, dilution, and exposure time on the tuberculocidal activity of glutaraldehyde-based disinfectants. Appl Environ Microbiol 1990;56:1813–1817.Google Scholar
21. Rutala, WA, Cole, EC, Wannamaker, NS, Weber, DJ. Inactivation of Mycobacterium tuberculosis and Mycobacterium bovis by 14 hospital disinfectants. Am J Med 1991;91(3B):267S–271S.10.1016/0002-9343(91)90380-GGoogle Scholar
22. Best, M. Development of a combined carrier test for disinfectant efficacy. Thesis. Ottawa, Canada: University of Ottawa, 1994, p 65.Google Scholar
23. Mbithi, JN, Springthorpe, VS, Sattar, SA, Pacquette, M. Bactericidal, virucidal, and mycobactericidal activities of reused alkaline glutaraldehyde in an endoscopy unit. J Clin Microbiol 1993;31:2988–2995.Google Scholar
24. Collins, FM, Montalbine, V. Mycobactericidal activity of glutaraldehyde solutions. J Clin Microbiol 1976;4:408–412.Google Scholar
25. Masferrer, R, Marquez, R Comparison of two activated glutaraldehyde solutions: Cidex solution and Sonacide. Respiratory Cure. 1977;22:257–262.Google Scholar
26. Hanson, PJV, Jeffries, DJ, Collins, JV. Viral transmission and fibreoptic endoscopy. J Hosp Infect 1991;18:136–140.Google Scholar