An assessment of burst strength distribution data for monitoring quality of condom stocks in developing countries.

Laboratory tests were conducted on condoms to examine the changes that occur over time in indicators of condom burst strength, and to determine the relationship between laboratory-assessed condom burst strength and breakage during use in a developing country setting. Three groups of unaged condoms purchased directly from the manufacturer were used: one group exposed to UV light for 10 hours; one group exposed for five hours; and one group unexposed. A sample of each of these groups was tested according to ISO condom air burst test protocols. The remaining condoms were individually packaged in coded polyethylene bags for shipment to the developing country study site. Also used in the study was a group of condoms that had been aged for over 40 months under field conditions in a tropical climate; a sample from this group was tested by the ISO air burst test protocol and the remainder distributed to the study site. One-hundred-thirty Indonesian urban males participated in the double-blind study. Volunteers were not relying on the condom for contraceptive purposes. Each volunteer was given one individually packaged untreated condom, one condom from each treatment group, and four condoms aged in the field. Study participants were instructed to return all used condoms. Each condom that was returned after use was examined for breakage, and the unbroken condoms were subjected to an air inflation test to determine volume and pressure at burst. A comparison of the air burst volume data for a sample of unused and used condoms from the same treatment group indicates that most of the condoms that broke during use had air burst volumes below 11 liters. Therefore, a significant downward shift in the burst strength distribution as measured in the laboratory is likely to result in an increased breakage rate during use. A Condom Deterioration Index calculated from regular periodic testing of stored condom stocks is a convenient and sensitive means of monitoring trends in the distribution and deterioration of condom strength.