FDA labeling requirements for disinfection of endoscopes: a counterpoint.
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 degrees 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 degrees C will be sufficient to achieve high-level disinfection.
Rutala
W A
WA
Department of Medicine, University of North Carolina, Chapel Hill 27599-7030, USA.
Weber
D J
DJ
D003428:Cross Infection / Q000517:prevention & control; D004203:Disinfection / Q000379:methods* / Q000592:standards; D019723:Endoscopes; D006801:Humans; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration