AFRO-NETS> Female condom re-use: WHO-UNAIDS information update

Female condom re-use: WHO-UNAIDS information update
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The World Health Organization (WHO) and the Joint United Nations Pro-
gramme on HIV/AIDS (UNAIDS) convened a consultation on the re-use of
the female condom in Geneva, Switzerland on 5-7 June 2000. The con-
sultation brought together experts in microbiology, sexually trans-
mitted infections, condom production and quality assurance testing
and programmatic issues. The primary objective of this meeting was to
evaluate data relevant to the safety and feasibility of re-use of the
female condom.

Following this consultation, WHO and UNAIDS has drafted an "informa-
tion update" on the safety of re-use of the female condom. This in-
formation update can be found on the WHO Department of Reproductive
Health and Research (RHR) webpage at the following address:

http://www.who.int/reproductive-health/

[produced below for those without internet access]

For further information about re-use of the female condom, please
contact:

Dr. Tim Farley
Surveillance and Evaluation
Human Reproduction Programme
Department of Reproductive Health and Research
Family and Community Health
World Health Organization
1211 Geneva 27, Switzerland
mailto:farleyt@who.int

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July 2000 - WHO/UNAIDS Information Update:
Consultation on Re-use of the Female Condom
  
Background

The burden of sexually transmitted infections, including infection
with the Human Immunodeficiency Virus (HIV), the cause of the Ac-
quired Immunodeficiency Syndrome (AIDS), continues to increase world-
wide. Use of barrier methods, most notably consistent and correct use
of the male latex condom, is advocated as a primary means of inter-
rupting the spread of sexually transmitted infections, including
HIV/AIDS. Because of the difficulties many women face negotiating the
use of male condoms, the female condom is an important option to as-
sist women in protecting themselves and their partners from both un-
wanted pregnancy and sexually transmitted infections.

The only female condom currently available is a strong, soft, trans-
parent polyurethane sheath inserted in the vagina before sexual in-
tercourse. This device has been approved and marketed for single-use
only.

Re-use of the device by women who are unable to access a new female
condom has been reported in a number of countries. WHO and UNAIDS
have been requested to advise countries, programme managers and indi-
viduals who are using this female condom on the safety of re-use
practices.

Consultation on Re-use of the Female Condom

WHO and UNAIDS convened a consultation on the safety and feasibility
of re-use of the female condom which was held in Geneva on 5-7 June
2000. The consultation brought together experts in microbiology,
sexually transmitted infections, condom production and quality assur-
ance testing, and programmatic issues. The primary objective of this
meeting was to evaluate data relevant to the safety and feasibility
of re-use of the female condom, considering both the structural in-
tegrity (i.e., the ability of the condom to withstand washing and re-
use without breaking or developing holes) and the potential risks of
infection related to re-use. Participants were also asked to consider
what policy recommendations and programme guidance, if any, could be
made at present.

The consultation recognized the urgent need for risk-reduction
strategies for women with limited resources who may be at risk for
sexually transmitted infections including HIV. While use of a new
male or female condom is a key prevention strategy, it is recognised
that situations may exist when individuals are unable to use a new
condom. The alternative to re-use for some may be unprotected inter-
course. Re-use of the female condom is likely to occur in situations
where women and men may be at high risk of sexually transmitted in-
fections, and thus women or their partners could be at risk for expo-
sure to pathogens from prior acts of intercourse, either during wash-
ing or subsequent re-use of the female condom.

Available Evidence and Unresolved Questions

The consultation reviewed relevant data, including the two sets of
studies which have been conducted to date on re-use of the female
condom. These studies investigated the structural integrity and mi-
crobial retention of female condoms which had been used, washed with
soap and water and, in one study, re-used.

There is currently insufficient evidence available to determine
whether a broad range of sexually transmitted pathogens, including
HIV, can be inactivated and safely removed with a soap and water wash
alone. Experts in microbiology were of the opinion that washing with
soap and water alone could present potential risks to women during
washing and/or to them or their partner during subsequent use.

While disinfection of the female condom has not been studied, it was
agreed that standard disinfection procedures (e.g., soaking in a
bleach solution), followed by washing with soap and water and drying,
would be likely to inactivate and remove sexually transmitted patho-
gens from the device. However, concerns remain that disinfecting con-
doms may adversely affect their structural integrity.

The available evidence suggests that the structural integrity of the
female condom can withstand several washes in soap and water, drying,
relubrication and re-use. However, the studies also suggest that such
condoms may be more likely to have holes than new condoms.

Normal vaginal flora provide important natural protection against in-
fection. Disruption to normal vaginal flora can increase the risk for
acquisition of sexually transmitted infections, including HIV. Avail-
able data indicate that use of new female condoms does not lead to
changes in the normal vaginal flora. However, there are no data con-
cerning the effect on normal vaginal flora of any residuals from dis-
infecting or washing with soap, or damage or contamination resulting
from storing or relubricating.

Conclusions

The consultation emphasized that, given the available data and re-
maining gaps in knowledge, the use of a new male or female condom for
every act of intercourse will continue to be recommended. However,
the consultation recognized the urgent need for guidance to women or
couples who are re-using female condoms and potentially placing them-
selves and their partners at higher risk of pregnancy and/or infec-
tion.

The consultation concluded that currently available evidence was not
conclusive. Therefore, re-use of the female condom is not recom-
mended. A draft protocol for disinfection, washing, drying, storage
and relubrication was formulated and is currently being tested.

This protocol was based on theoretical considerations regarding in-
fection control and the data from the two re-use studies on struc-
tural integrity. However, it is not known whether the proposed proto-
col is safe and effective in eliminating micro-organisms while main-
taining the structural integrity of the female condom. Research to
evaluate this protocol has already commenced with funding from WHO
and findings from these studies are expected in the near future. When
these results are available, WHO and UNAIDS will provide further
guidance on the safety of re-use of the female condom.

July 2000

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