Ae. Pettifor et al., In vitro assessment of the structural integrity of the female condom aftermultiple wash, dry, and re-lubrication cycles, CONTRACEPT, 61(4), 2000, pp. 271-276
Since the introduction of the female condom in the early 90s, there have be
en numerous reports of reuse of the device. in response to these reports, s
tudies were undertaken to evaluate the safety of female condom reuse. if re
use were shown to be safe, then programmatic costs of introduction of the f
emale condom would be reduced allowing it to be more widely available. This
article outlines the results of in vitro structural integrity testing of t
he female condom after multiple wash, dry, and re-lubrication cycles. Devic
es 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 Admi
nistration (US FDA) standards for an unused female condom. The results of t
he structural integrity tests for all 6 washing procedures examined in this
study were above the FDA minimum standards for seam strength and burst tes
ts. For the water leakage test, 3 of 6 washing procedures tested passed the
required FDA minimum standards (no holes detected). From the results of th
e study, it seems that washing, drying, and re-lubricating the female condo
m 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 respec
t to microbial retention, structural integrity after in vivo use, and viral
permeability. (C) 2000 Elsevier Science Inc. All rights reserved.