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FHI Research Briefs on the Female Condom — No. 3:Can the Female Condom Be Used Safely More than Once? |
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The female condom is currently approved by the U.S. Food and Drug Administration for one-time use. Some experts believe that if safe reuse were possible, it could reduce the cost of the device to users and result in more protected sex acts. Reuse of female condoms has been reported in a number of countries, particularly in resource-poor settings.1 Although the World Health Organization (WHO) does not recommend or promote reuse of the device, WHO stated in July 2002 that "… the final decision on whether or not to support reuse of the female condom must ultimately be taken locally."2 WHO continues to recommend the use of a new male or female condom for every act of sexual intercourse where there is risk of unplanned pregnancy or of acquiring a sexually transmitted infection (STI), such as HIV. Acknowledging that some women may not have access to new female condoms, however, WHO has also developed a protocol for cleaning and handling female condoms so that they can be reused safely.3 A single female condom may be used up to five times, provided that after each use it is cleaned and handled according to WHO guidelines, the protocol states. The protocol includes a disinfection step that involves soaking the device for one minute in a 1-to-20 dilution of bleach (sodium hypochlorite) to water as soon as possible after use. The device must then be washed, dried, stored and re-lubricated before it can be used again. This protocol only applies to the polyurethane female condom manufactured by the Female Health Company.* Since disinfection and cleaning agents, resources, and cultural and social circumstances vary in different settings, WHO recommends that program managers adapt this protocol to local conditions — while retaining all the steps — and then test its feasibility, efficacy and usefulness in their settings before recommending reuse. Research on structural integrity Research has found that the female condom remains structurally sound after repeated cycles of bleach disinfection and washing. A WHO-funded study showed that the structural integrity parameters of the device remained well above the manufacturer's standards for integrity of new condoms after being disinfected for 30 minutes in a 1-to-5 dilution of bleach in water, washed in soap, dried and re-lubricated up to seven times. Three batches of 300 unused condoms were tested in a laboratory for water leakage, seam strength and burst pressure after being subjected to the washing procedure. Three of the 900 devices tested were found to contain holes, but these defects were thought to have been caused by handling rather than chemical deterioriation.4 FHI and the Reproductive Health Research Unit (RHRU) at the University of Witwatersrand in Johannesburg, South Africa, have also researched structural integrity in separate studies. FHI's study found that unused female condoms exposed to one bleach disinfection and up to 10 soap washings remained structurally sound, as did devices that were washed with soap, disinfected with bleach and patted dry after a single act of vaginal intercourse. More than 300 condoms were washed after being used during one act of vaginal intercourse, and about 1,000 unused female condoms were washed in a laboratory. 5 The RHRU's study found that 295 of the 300 female condoms remained structurally sound after being used, washed, dried and re-lubricated up to seven times. Disinfection was not part of the latter study's washing protocol.6 FHI is conducting similar studies with the Female Health Company's new "FC2" synthetic latex female condom, examining its structural integrity after multiple washings. Research on safety and disinfection A study on the effect of reuse on human genitalia, which was supported by the U.S. Agency for International Development (USAID), found that couples who disinfected, washed, dried, relubricated and reused the same female condom five times experienced no more adverse findings in the vagina, on the cervix or on the penis than did couples who used five female condoms one time each. The study, conducted by FHI in collaboration with the U.S.-based Eastern Virginia Medical School in Norfolk, VA, used colposcopy to examine the vaginal wall and cervix and used magnification to inspect the penis.7 Reuse safety research has also involved testing cleaning methods to determine which ones effectively remove sexually transmitted pathogens from female condoms. A WHO-supported study explored the minimum bleach soak necessary to inactivate HIV, Chlamydia trachomatis, Neisseria gonorrhoeae and herpes simplex virus type 2 (HSV-2). Results showed that a one-minute soak in a 1-to-20 dilution of bleach to water is the minimum concentration and duration necessary to kill all four pathogens.8 Because some women may not have access to bleach, USAID supported additional research to assess the safety and feasibility of cleaning used female condoms with soap and water and eliminating the bleach disinfection step. One study, conducted by FHI, tested a solution of dish detergent and water based on volumes typically used to wash dishes: 7.5 milliliters of detergent per one liter of water, or about two squirts of detergent in a basin of water. It found that the dish detergent and water was just as effective as the 1:20 bleach solution in removing the organisms that cause gonorrhea, chlamydia, herpes and HIV infection from the surfaces of both new and pre-washed, relubricated condoms.9 * The product is referred to by various brand names in different countries, including FC Female Condom, Reality, Femidom, Dominique, Femy, Myfemy, Protectiv' and Care. Endnotes
FHI produced these research briefs as part of an information dissemination effort supported by the Bureau for Africa/Office of Sustainable Development, U.S. Agency for International Development. |
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