Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide.

Abstract

The United States Food and Drug Administration (FDA) recently announced an update to their 510(k) medical device sterility guidance to include vapor phase hydrogen peroxide (VH2O2) as an established 'Category A' sterilization process. This places VH2O2 in the same category as ethylene oxide (EO or EtO), which has demonstrated user and patient safety as well as microbiocidal effectiveness through scientific literature and FDA-recognized consensus standards. For some implantable medical devices, t