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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
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Abstract

Endoscopes are used widely for the diagnosis and therapy of medical disorders. To prevent spread of nosocomial 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

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