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