Test Method Development for Cleaning Chemistry Performance Determination.

Abstract

Currently, manufacturers of cleaning agents are not obligated to verify the efficacy of formulations used in detergents. Because of a lack of standards, companies can market cleaning agents to healthcare systems for cleaning purposes without substantiated evidence that the agents meet minimum performance criteria, as validated by medical device manufacturers. Absence of standards and regulatory oversight on the performance assessment of cleaning agents exacerbates the risk to patient safety for reusable medical devices. The aim of the current work was to develop a standard test method for reliably assessing the performance of cleaning agents. Water was used as the test method control to normalize cleaning agent performance. Cleaning agents, which were advertised as economy (i.e., minimal performance) and premium (i.e., high performance), were challenged as independent variables in the test system. Control variables were modified for each experiment to isolate the highest performing variable combination, and robustness was evaluated by performance testing at multiple independent laboratories. By controlling variables such as soil type, application, drying, and exposure time, a standardized, reproducible test method for evaluating the performance of cleaning agents used in medical device processing was developed. This approach can allow for reliable comparisons of cleaning agents to empower medical device manufacturers and healthcare facilities to make informed choices, ultimately contributing to improved patient safety through more effective cleaning validation.