Female condom reuse issues explored.

For female condom users, use of a new female condom for every act of sexual intercourse continues to be recommended by the World Health Organization (WHO). (1) Likewise, the female condom (a potential alternative for the male condom) is approved only for one-time use by the U.S. Food and Drug Administration. Such positions by public health experts reflect, in part, concerns that women may be unable to clean the device adequately to make its reuse safe.

However, female condom reuse has been reported in a number of settings, likely because many women cannot afford to buy multiple female condoms. Recognition that reuse is occurring--and may be acceptable, feasible, and safe in some circumstances--led WHO to declare in July 2002 that "the final decision on whether or not to support reuse of the female condom must ultimately be taken locally." (2)

This declaration came six months after WHO released a female condom cleaning and handling draft protocol based on two expert meetings to discuss the reuse issue. (3) The protocol, which outlines steps for preparing female condoms for reuse, stated that a single female condom may be used up to five times as long as it is:

* Disinfected by soaking it, as soon as possible after use, for one minute in a 1-to-20 dilution of sodium hypochlorite (liquid household bleach) in water; and

* Washed, dried, stored, and relubricated--following protocol procedures--before being used again.

WHO recommends that, on the local level, program managers not recommend female condom reuse until they have adapted the protocol (retaining all the procedural steps) to local conditions and then tested the protocol's feasibility, efficacy, and usefulness in their settings. (4) WHO will provide guidance for program managers on programmatic implications of reuse. This protocol only applies to the polyurethane female condom manufactured by the Female Health Company. The product's brand names include FC Female Condom, Reality, Femidom, Dominique, Femy, Myfemy, Protectiv', and Care.

WHO does not promote female condom reuse, in part because the female condom cleaning and handling protocol has not been extensively studied for safety or evaluated for efficacy in humans. But WHO-funded research is under way in South Africa to explore the structural integrity of female condoms disinfected, washed, and reused in accordance with the protocol, as well as users' ability to follow the protocol correctly.

Meanwhile, female condom reuse issues have been explored in numerous studies, many of which have been conducted by FHI with funding from the U.S. Agency for International Development (USAID). Research has found that the female condom remains structurally sound after repeated cycles of bleach disinfection and washing. (5) A USAID-supported study by FHI found that couples who disinfected, washed, dried, relubricated, and reused the same female condom five times experienced no more adverse effects in the vagina, on the cervix, or on the penis than did couples who used five female condoms one time each. (6) And a WHO-supported study of the effect of disinfection on common STIs found that the female condom must be soaked at least one minute in a 1-to-20 dilution of bleach in water to kill the organisms that cause gonorrhea, chlamydial, herpes, and HIV infections. (7) Since some women may not have access to bleach, research is under way to assess the safety and feasibility of cleaning used devices with only detergent and water. This USAID-supported study, to be conducted by FHI and completed by July 2003, will test the effect of Sunlight- and Omo-brand detergents on the organisms that cause gonorrhea, chlamydial, herpes, and HIV infections.

"These products were chosen for their widespread availability," says Carol Joanis, an FHI associate director and the study's principal investigator. "Sunlight dishwashing liquid is available worldwide, and Omo is available in most developing countries, except for certain parts of Latin America and Asia. Notably, where Omo is unavailable, Surf detergent--which is identical in formulation--is commonly offered."

REFERENCES

(1.) World Health Organization. WHO information update: considerations regarding reuse of the female condom. Unpublished paper. World Health Organization, 2002. Available: http://www.who.int/reproductive-health/rtis/reuse.en.html.

(2.) World Health Organization.

(3.) World Health Organization. The safety and feasibility of female condom reuse: report of a WHO consultation. Unpublished paper. World Health Organization, 2002. Available: http://www.who.int/reproductive-health/rtis/report_reuse.doc

(4.) World Health Organization. WHO information update: considerations regarding reuse of the female condom.

(5.) Potter B, Gerofi J, Pope M, et al. Structural integrity of the polyurethane female condom after multiple cycles of disinfection, washing, drying and relubrication. Contraception 2003;67(1):65-72; Joanis C, Latka M, Glover LH, et al. Structural integrity of the female condom after a single use, washing, and disinfection. Contraception 2000;62(2):63-72.

(6.) Joanis C, Ballagh S. Female condom re-use: in vivo safety. WHO consultation on re-use of the female condom. Geneva, Switzerland, January 28, 2002; Ballagh S, Joanis C. Reuse of Reality female condom: colposcopy and adverse events. WHO consultation on re-use of the female condom. Geneva, Switzerland, January 28, 2002.

(7.) Ballard R, Fehler G, Htun Y, et al. Re-use of the female condom--effectiveness of disinfection procedures. WHO consultation on re-use of the female condom. Geneva, Switzerland, January 28, 2002.