Carrier Tests to Assess Microbicidal Activities of Chemical Disinfectants for Use on Medical Devices and Environmental Surfaces

Abstract

Abstract For well over a decade, many deficiencies have been identified in current AOAC methods used to assess the microbicidal activities of chemical disinfectants on medical devices and environmental surfaces. This report discusses the development of quantitative carrier tests (QCT) designed to address these concerns. Decontamination of surfaces with dried inocula is invariably more difficult than when microorganisms are in suspension. For medical device as well as environmental decontamination, microbicides are used on contaminated surfaces, thus making it necessary to evaluate their microbicidal action on representative carrier materials contaminated with a dried challenge microorganism(s). Our approach is a 2-tiered QCT. The first tier (QCT-1) uses relatively ideal conditions to assess performance of the microbicide for screening purposes; the test uses smooth glass surfaces and quantities of disinfectant in excess of those likely to be experienced in the field. The second tier of testing (QCT-2) is more stringent because it uses (1) disks of brushed stainless steel as carriers, (2) only 50 μL of the test formulation on each carrier as compared to 1 mL in QCT-1, and (3) an added soil load to simulate the presence of residual body fluids or accumulated surface dirt. This review also discusses the factors that affect disinfection of medical devices and environmental surfaces in the context of the methodology used to evaluate the potency of microbicides. Specific recommendations for discussion are included, and performance criteria are suggested based on a risk-reduction approach for different classes of disinfectants. The focus is on improving the relevance of the test methodology to actual field use of disinfectants for devices and facilities in health care, and potentially in other settings. It is hoped that this review and its recommendations will initiate needed discussion and resolution of the many issues identified.