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FDA Labeling Requirements for Disinfection of Endoscopes: A Counterpoint

William A. Rutala and David J. Weber
Infection Control and Hospital Epidemiology
Vol. 16, No. 4 (Apr., 1995), pp. 231-235
DOI: 10.2307/30140983
Stable URL: http://www.jstor.org/stable/30140983
Page Count: 5
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Since scans are not currently available to screen readers, please contact JSTOR User Support for access. We'll provide a PDF copy for your screen reader.
FDA Labeling Requirements for Disinfection of Endoscopes: A Counterpoint
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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.

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