Structural integrity of the polyurethane female condom after multiple cycles of disinfection, washing, drying and relubrication

Abstract

The female condom provides an important alternative means of protection against HIV and other sexually transmitted infections for women, particularly in situations where partners are reluctant or refuse to use male condoms. The relatively high cost of the device, however, is a barrier to its use in resource-poor environments. This has led to some reuse of the product and two studies have demonstrated that female condoms can withstand a limited level of reuse without an excessive loss of structural integrity when washed with soap and water. A consultation on female condom reuse convened by the World Health Organization and the Joint United Nations Programme on AIDS in June 2000 recommended that all used female condoms should be disinfected immediately after use, before washing. The effect of such treatments on the female condom was not known. This study was undertaken to assess the effect of the disinfection, washing, drying and relubrication on the properties of the condom. Samples from three batches of female condoms were subjected to seven treatment cycles before being tested for structural integrity. In all cases the batches of condoms complied with the manufacturer’s release specification for the product after treatment. Some minor changes in properties were seen but these were not considered important. There was evidence of a small increase in the number of condoms with holes following repeated disinfection and washing cycles, suggesting that excessive or rough handling can damage the condom. Condoms should therefore be handled carefully and inspected thoroughly for signs of damage after washing and drying before being stored with the intention of subsequently reusing the device.

Introduction

The polyurethane female condom, sold and distributed under a number of names, including Femidom, Femy, Reality and Care, by the Female Health Company, provides an important additional means of protection against HIV and other sexually transmitted infections for women, particularly in situations where partners are reluctant or refuse to use male condoms [1]. The relatively high cost of the device limits its acceptability, and reuse of the device is perceived as one way of reducing the cost per protected act of intercourse.

There have been some reports of reuse of the female condom [2], [3], and the structural integrity of the condoms has been assessed after multiple in vitro wash, dry, relubricate cycles [4], after a single in vivo use [5] and up to eight in vivo uses [6].

In response to requests for guidance, the World Health Organization (WHO) Department of Reproductive Health and Research and the Joint United Nations Programme on AIDS (UNAIDS) convened a consultation in June 2000 to consider the safety and feasibility of reuse of the female condom. The consultation included experts in microbiology, sexually transmitted infections, condom manufacture and quality assurance testing and programmatic issues. The objective was to evaluate data relevant to the safety of reusing the female condom, considering both the structural integrity (i.e., the ability of the condom to withstand washing and reuse without breaking or developing holes) and the potential risks of infection related to reuse. While the data suggested the condoms could withstand a limited level of reuse without loss of structural integrity when washed with soap and water between uses, the number of condoms tested was considered inadequate to provide guidance. In addition, there was insufficient evidence to determine whether sexually transmitted pathogens, including HIV, could be inactivated and safely removed from a used female condom with soap and water alone. The consultation considered that women could be at potential risk of infection when washing used condoms and that both the women and their partners could be at risk during subsequent use. The experts recommended that all used female condoms should be disinfected before washing with soap and water. Disinfection of the female condom had not been studied but it was agreed that standard disinfection procedures recommended for heavily contaminated materials—for example, soaking in 1% sodium hypochlorite solution (diluted household bleach) for at least 30 min [7]—followed by washing with soap and water and drying, would be likely to inactivate and remove sexually transmitted pathogens from the device. The impact of bleach on the structural integrity of the female condom had not been evaluated, although a preliminary study conducted by the Female Health Company had shown that seam strength and burst properties (peak pressure, burst pressure and burst volume) were essentially unaffected by five repeat immersions of 30 min duration in undiluted domestic bleach (5% sodium hypochlorite) and that seam strength was unaffected by soaking for 14 h in diluted bleach (0.5% sodium hypochlorite).

The consultation concluded that further research was required to assess whether sexually transmitted pathogens could be safely removed by disinfection, washing and drying, and whether condoms could withstand repeat cycles of disinfection, washing, drying and relubrication [8]. This paper reports the results of an experiment undertaken at the premises of the Female Health Company under the supervision of an independent expert to assess the effect of the proposed treatment cycles on the key specification attributes that determine structural integrity of the female condom, namely, freedom from holes, air inflation properties and seam tensile strength.