In vitro assessment of the structural integrity of the female condom after multiple wash, dry, and re-lubrication cycles

Abstract

Since the introduction of the female condom in the early 90s, there have been numerous reports of reuse of the device. In response to these reports, studies were undertaken to evaluate the safety of female condom reuse. If reuse were shown to be safe, then programmatic costs of introduction of the female condom would be reduced allowing it to be more widely available. This article outlines the results of in vitro structural integrity testing of the female condom after multiple wash, dry, and re-lubrication cycles. Devices were tested up to 10 washes using water leakage, burst, and tensile seam testing. All results were compared to the United States Food and Drug Administration (US FDA) standards for an unused female condom. The results of the structural integrity tests for all 6 washing procedures examined in this study were above the FDA minimum standards for seam strength and burst tests. For the water leakage test, 3 of 6 washing procedures tested passed the required FDA minimum standards (no holes detected). From the results of the study, it seems that washing, drying, and re-lubricating the female condom up to 10 times leads to some deterioration in the structural integrity of the device for specified washing procedures. Further studies are currently being conducted to establish the safety of female condom reuse with respect to microbial retention, structural integrity after in vivo use, and viral permeability.