Combined application of simulated reuse and quantitative carrier tests to assess high-level disinfection: experiments with an accelerated hydrogen peroxide-based formulation.

BACKGROUND

Heat-sensitive medical devices require chemical disinfection between patients, and certain formulations for this purpose can be reused for several days. Because dilution, evaporation, and breakdown or neutralization of active ingredients can occur during reuse, it is vital to ensure that the solution retains its broad-spectrum germicidal activity even at the end of the recommended reuse period.

OBJECTIVE

The purpose of this study was to combine the US Environmental Protection Agency's and the Food and Drug Administration's recommended simulated reuse method with recently developed quantitative carrier tests (QCT) to assess the broad-spectrum germicidal activity of a 7% solution of accelerated hydrogen peroxide (pH 2.9) stressed for 14 days.

MATERIALS AND METHODS

On alternate days baths with 3 lots of the test formulation were stressed by the addition of bacteria (Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa ) on glass beads and spores (Bacillus subtilis and Clostridium sporogenes ) on metallic penicylinders. In addition, one set of respiratory therapy equipment was subjected to 3 daily cycles of disinfection in each bath. The pH and H(2)O(2) levels in the test samples were measured, and they were also subjected to QCTs for their sporicidal, bactericidal, virucidal, fungicidal, and mycobactericidal activities.

RESULTS

After 14 days of reuse, the pH of the test solutions remained essentially unchanged. Although the level of H(2)O(2) dropped from a high of 7.66% to as low as 6.40%, all lots showed the required level of broad-spectrum germicidal activity after 14 days of stress.

CONCLUSIONS

The stress test and QCT were successfully combined in demonstrating the broad-spectrum germicidal activity of a high-level disinfectant subjected to 14 days of simulated reuse.