Reconciliation of FDA and societal guidelines for endoscope reprocessing.

摘要

Chemical sterilants are used to high-level disinfect semicritical medical devices such as flexible endoscopes. For the chemosterilant to obtain a high level disinfection claim, The Food and Drug Administration requires demonstration of a 6-log reduction of myobacterial inoculum under worst case conditions (2% horse serum added to test sterilant). This testing requirement has led to label product claims of 45 minutes immersion times at 25 degrees C. Review of the scientific data suggests that at least an 8-log reduction in contamination with thorough instrument cleaning, followed by chemical disinfection for 20 minutes immersion at 20 degrees C will achieve high-level disinfection.