FDA Labeling Requirements for Disinfection of Endoscopes: A Counterpoint
- 1 April 1995
- journal article
- Published by Cambridge University Press (CUP) in Infection Control & Hospital Epidemiology
- Vol. 16 (4), 231-235
- https://doi.org/10.2307/30140983
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.Keywords
This publication has 19 references indexed in Scilit:
- APIC guideline for infection prevention and control in flexible endoscopyAmerican Journal of Infection Control, 1994
- Significant factors in the disinfection and sterilization of flexible endoscopesAmerican Journal of Infection Control, 1992
- A study of glutaraldehyde disinfection of fibreoptic bronchoscopes experimentally contaminated with Mycobacterium tuberculosisJournal of Hospital Infection, 1992
- Viral transmission and fibreoptic endoscopyJournal of Hospital Infection, 1991
- Recovery of the human immunodeficiency virus from fibreoptic bronchoscopes.Thorax, 1991
- Elimination of high titre HIV from fibreoptic endoscopes.Gut, 1990
- APIC guideline for selection and use of disinfectantsAmerican Journal of Infection Control, 1990
- CONTAMINATION OF ENDOSCOPES USED IN AIDS PATIENTSThe Lancet, 1989
- Bactericidal activity of alkaline glutaraldehyde solution against a number of atypical mycobacterial speciesJournal of Applied Bacteriology, 1986
- Kinetics of the tuberculocidal response by alkaline glutaraldehyde in solution and on an inert surfaceJournal of Applied Bacteriology, 1986