Considerations Regarding Re-use of the Female Condom: Information Update, 10 July 2002^☆

☆ Reprinted with kind permission of WHO.

Abstract

The World Health Organization (WHO) recommends use of a new male or female condom for every act of intercourse where there is a risk of unplanned pregnancy and/or sexually transmitted infection, including HIV. Since access to female condoms may be limited and re-use of female condoms has been reported, WHO has convened two consultations to address considerations regarding such re-use. Based on these consultations, WHO does not recommend or promote re-use of female condoms. Recognizing the urgent need for risk-reduction strategies for women who cannot or do not access new condoms, the consultation developed a draft protocol for safe handling and preparation of female condoms intended for re-use. This protocol, outlined in this paper, is based on the best available evidence, but has not yet been extensively studied for safety or evaluated for efficacy in human use. Given the diversity of cultural and social contexts and personal circumstances under which female condom re-use may be acceptable, feasible and safe, and since the balance of risks and benefits varies according to individual settings, the final decision on whether or not to support re-use of the female condom must ultimately be taken locally. WHO continues to support research on female condom re-use and will disseminate relevant information, study results and guidelines for policy makers as additional data on re-use become available.

Résumé

L’OMS recommande l’emploi d’un préservatif masculin ou féminin neuf pour tout acte rapport sexuel comportant un risque de grossesse non-désirée et/ou d’infection sexuellement transmissible, en incluant notamment le VIH. Consciente de l’accés parfois restreint aux préservatifs féminins et du fait qu’ils sont parfois réutilisés, l’OMS a organisé deux consultations sur la question de leur réutilisation. Elle ne recommande ni ne fait pas la promotion de la réutilisation des préservatifs féminins. Néanmoins, reconnaissant qu’il est urgent de mettre en place des stratégies visant à réduire les risques chez les femmes n’ayant pas accès à des préservatifs neufs, les participants à la consultation ont développé un projet de protocole préliminaire pour le traitement et la préparation de préservatifs féminins réutilisables. Ce protocole est basé sur les meilleures données disponibles, mais sa sûreté et son efficacité n’ont pas encore été évaluées chez l’humain. Compte tenu des diversités culturelles, sociales et de circonstances personnelles dans lesquelles la réutilisation du préservatif féminin peut être acceptable, réalisable et sûre, et puisque le poids des risques et des avantages varie selon les circonstances individuelles, la décision finale de soutenir ou non la réutilisation du préservatif féminin doit être prise localement. L’OMS continue de soutenir des les recherches sur la question et diffusera aux décideurs les informations, les résultats d’études et des directives pour les décideurs à mesure de la disponibilité de données complémentaires dés que de nouvelles seront disponibles.

Resumen

La OMS recomienda el uso de un condón nuevo, ya sea masculino o femenino, para cada acto sexual que implique el riesgo de un embarazo y/o una infección de transmisión sexual, incluyendo el VIH. Dado que el acceso a los condones femeninos puede ser limitado y que se ha reportado su re-uso, la OMS convocó dos consultas para abordar el tema del re-uso. En base a estas consultas, la OMS no recomienda ni promueve el re-uso del condón femenino. Reconociendo la urgencia de formular estrategias de reducción de riesgo para mujeres que no tienen acceso a nuevos condones, se produjo un protocolo preliminar para la manipulación y la preparación seguras de los condones femeninos destinados al re-uso. Dicho protocolo se basa en la mejor evidencia disponible pero no ha sido estudiado en profundidad para determinar su seguridad, ni ha sido evaluada su eficacia para uso humano. Tomando en cuenta la diversidad de contextos culturales y sociales y de circunstancias personales en las que el re-uso del condón femenino es aceptable, factible y seguro, y como el balance de riesgos y beneficios varı́a según los individuos, la decisión sobre si se promueve o no su re-uso debe ser tomada a nivel local. La OMS continúa apoyando la investigación sobre el re-uso del condón femenino y divulgará oportunamente cualquier información relevante, resultados de estudios e instrucciones para los encargados de la toma de decisiones a medida que se obtenga información adicional sobre re-uso.

Key Words:

• female condom re-use
• guidelines and protocols

The burden of sexually transmitted infections (STIs), including infection with the human immunodeficiency virus (HIV), continues to increase worldwide. Use of barrier methods, in particular consistent and correct use of the male latex condom, is strongly recommended as a primary means to reduce the spread of STIs, including HIV. Because of the difficulties many women face in negotiating male condom use, the female condom may be an important option for women to protect themselves and their partners from both unplanned pregnancy and STI.

This information update relates only to the female condom that is currently available: a polyurethane device marketed by the Female Health Company for single use only. Re-use of the female condom has been reported, and may be motivated in part by lack of access to the device as well as its apparent robustness.

In response to requests to advise countries, programme managers and individuals on the safety of re-use practices, WHO and UNAIDS convened a consultation on the safety and feasibility of re-use of the female condom in June 2000. The consultation recognized the urgent need for risk-reduction strategies for women with limited resources who may be at risk of unplanned pregnancy and/or STIs, including HIV. However, because re-use of the female condom may expose women and their partners to pathogens from prior acts of intercourse, either during washing or subsequent use, the meeting concluded with the determination that insufficient information on the safety of the practice existed to recommend re-use of the female condom. WHO and UNAIDS released a statement to that effect in July 2000 [1].

At the June 2000 consultation, a draft protocol for re-use was outlined and additional research to test the safety and efficacy of this protocol was commissioned. A critical feature of the protocol was a disinfection step, incorporated as the only known means of inactivating potentially infectious organisms.

Consultation on female condom re-use January 2002

WHO convened a consultation in January 2002 to review the results of the new research and to discuss programmatic issues related to re-use of the female condom [2].

Key new information was reviewed at the meeting; highlights are as follows:

•	Batches of new, unused female condoms were subjected to seven cycles of disinfection, washing, drying and re-lubrication, reflecting the steps and procedures in the draft protocol, but at considerably higher concentrations of bleach and for longer durations. All female condom batches met the manufacturing quality assessment specifications for structural integrity after the test cycles. (WHO-sponsored research conducted in London, UK).
•	The organisms that cause gonorrhoea, chlamydia, herpes and AIDS, when added in high titres to bull semen, were killed by a solution of common household bleach in two minutes (1:40 dilution of bleach in water) or one minute (1:20 dilution). (WHO-sponsored research conducted in Johannesburg, South Africa.)
•	No significant adverse effects were associated with up to five uses of a single female condom in couples not at risk of pregnancy or STI or HIV infection. Disinfection, washing, drying, re-lubrication and re-use of the device were not associated with penile discharge, symptomatic vaginal irritation or adverse colposcopic findings in study volunteers. (USAID-sponsored research conducted by Family Health International in Norfolk VA, USA).

Based on the new research results, the draft protocol to prepare female condoms for re-use developed in 2000 was revised, retaining the bleach disinfection step in order to ensure safety (Box 1).

Box 1. Protocol for Preparing Female Condoms for Reuse (January 2002)

The present protocol is provided so that local authorities can determine the feasibility, benefits, and suitability of its use through field-testing. It is applicable only to the polyurethane female condom as manufactured by the Female Health Company.

Implementation of this protocol, while retaining all steps of the procedures, should be adapted to local conditions. Comments contained in brackets [ ] below were raised at the consultation and should be incorporated into a companion document for programme managers, to guide them in the development of context-specific instructions.

Remove the condom from the vagina, taking care to avoid spillage of semen.

Disinfection

As soon as possible, prepare about 250 ml of approximately 1:20 dilution of sodium hypochlorite (household) bleach, giving a final concentration of 0.25% sodium hypochlorite. Tip about half of this into the female condom and then drop the female condom into the remainder of the solution. Swirl and ensure that the bleach solution covers all the surfaces of the condom. Soak condom for 2–5 minutes.

-	Do not attempt to remove the ejaculate or otherwise cleanse the condom prior to submersion in the bleach/water solution.
-	Handle the used condom in a manner that minimizes exposure to the ejaculate until it is placed in the bleach/water solution.
-	[Do not soak the condom in bleach overnight, as the extended exposure to bleach can degrade the condom material.]
-	Do not attempt to disinfect the condom by boiling it or otherwise applying heat as high temperatures can degrade the condom material.

Washing

Handle condoms gently. Remove disinfected female condom from bleach solution and wash with soap and water in order to remove bleach and any residual lubricant.

-	Remove the inner ring.
-	Hands should be lathered with non-abrasive soap. [Avoid washing female condom with any abrasive material.]
-	The external surfaces of the female condom should be washed carefully, using lathered hands and taking care to avoid tearing the condom.
-	Turn the condom inside out, and wash condom and ring with soap and water.
-	Make sure all lubricant is removed by washing.
-	Rinse both sides of the condom and the ring carefully with clean water to remove residual soap.

Drying

The female condom and ring should be dried completely inside and outside by blotting with a clean cloth. Alternatively, the condom can be air-dried.

-	Turn condom inside out to dry both sides.

Visual inspection

Some colour change may be noted. This is normal and does not affect the function of the female condom. After complete drying, hold the condom up to the light to inspect for holes. If any holes or tears are observed, the condom should be discarded. If no holes are observed, replace the inner ring.

Storage

The clean, unlubricated condom should be stored in a clean dry place, taking care to avoid exposure to sunlight, direct heat and/or sharp objects.

-	[Extended exposure to direct sunlight and heat sources may degrade the female condom and may lead to breakage during use.]

Relubrication

Lubrication is necessary to replace the lubricants removed by disinfection and washing. Relubricate just prior to reuse.

-	Optimal lubricants include silicone and water-based lubricants. [Examples to be identified and provided in-country.]
-	Inert oil-based lubricants (petroleum jelly, baby oil, vegetable oil or shortening) may be used. [Although these cannot be used with male latex condoms.]
-	Lubricants which contain substances which may induce allergies or inflammation, such as peanut or groundnut oil or hand or body lotions containing lanolins or fragrances, should not be used.

Number of re-uses possible

Each female condom may be used at most 5 times, with the appropriate disinfection, washing and other preparation steps after each use. [With additional use, the condom material may weaken and may tear during use. It may be difficult for users to track the number of times any individual device is used. During handling during disinfection, washing, drying and relubrication, condoms may tear at any time. Tearing is most likely when condoms are not handled gently.]

Unresolved issues

While correctly following the revised protocol may reduce the risk associated with female condom re-use, there are a number of unresolved safety questions that warrant additional clinical and laboratory testing. These include:

•	How does the structural integrity of female condoms that are actually used and re-used according to the protocol compare with that of unused devices?
•	Following disinfection and washing, are used or re-used female condoms completely free of potentially infectious organisms?
•	Does the use of alternative disinfectants, washing agents or lubricants irritate or damage cervical, vaginal, or penile tissue or alter vaginal flora?

Programmatic issues regarding re-use

Given the diversity of cultural and social contexts and personal circumstances under which female condom re-use may occur, and the potential complexity of the re-use protocol, it was agreed that the final decision on whether or not to support re-use of the female condom ultimately will need to be taken locally, since the balance of risks and benefits vary according to individual settings. Programme managers should be encouraged to conduct formative and programmatic research in specific settings prior to consideration of a recommendation for re-use of female condoms, in order to establish the feasibility, benefits, risks and suitability of the practice. Some relevant questions include:

•	How can the re-use protocol be best adapted to local circumstances so that potential users can easily understand and follow the instructions?
•	What are the safety or health risks associated with failure to follow all of the steps of the protocol, including disinfection?
•	What are the implications of female condom re-use on the correct use of other single use health care products, including male condoms?

Next steps

WHO is sponsoring research in South Africa to adapt the protocol to local conditions and evaluate the ability and willingness of sex workers and family planning clients to follow the instructions. Batches of condoms used and re-used according to the instructions will be tested for structural integrity and for the presence of infectious organisms.

WHO has drafted a summary of issues for programme managers to consider when making decisions regarding female condom re-use in their local contexts. This document is currently under review and will be released as soon as it is available.

Conclusion

Given the available data and remaining gaps in knowledge, WHO recommends use of a new male or female condom for every act of intercourse, where there is a risk of unplanned pregnancy and/or STI/HIV infection. Recognizing the urgent need for risk-reduction strategies for women who cannot or do not access new condoms, WHO has developed a draft protocol for the safe handling and preparation of used female condoms intended for re-use. The protocol was developed using the best available evidence in order to protect the woman and her partner who have used the device, the person who washes the device, and those who may subsequently re-use the device. According to established microbiological principles, the protocol includes a disinfection step. Other practices are not known to be safe or effective in removing pathogens from the surface of the female condom or from the environment, including the water in which the devices have been washed. This protocol has not yet been studied extensively for safety or evaluated for efficacy in human use.

The feasibility and usefulness of such a protocol must be tested and established in specific contexts and settings. Decisions about the utility and risks and benefits of introducing such a protocol must ultimately be made at the country or local level.

Based on the recommendations of the January 2002 consultation, WHO does not recommend or promote re-use of female condoms, but will make available the protocol, together with guidelines on programmatic issues, to programme managers who intend to evaluate its feasibility and application in local settings. The Organization continues to support research on female condom re-use and will disseminate relevant information, study results and guidelines for policymakers as additional data on re-use become available.

Notes

☆ Reprinted with kind permission of WHO.