In recent years, efforts to fight HIV/AIDS have been seriously challenged by reports of condom manufacturers dumping substandard products on the African market, including supplies sold to public health programs. Not only did the presence of poor quality condoms pose risks in terms of HIV transmission, reports of their existence threatened to erode public confidence in public health condom distribution programs.
In 2012, the Ethiopian Food, Medicine, and Healthcare Administration and Control Authority (FMHACA) suspected problems with its ability to reliably test the quality of condoms. USAID tapped the experts at PQM to help devise a solution. To strengthen the FMHACA’s quality assurance capacity, PQM trained FMHACA staff, prepared and enhanced the condom testing machines—everything from missing parts to calibration—and instituted a much-needed quality-management system. PQM’s technical assistance and training will enable FMHACA to regulate condom defects identified through quality testing, thereby averting risks of HIV transmission in the population attributable to use of faulty, poor-quality condoms.
Ethiopia’s FMHACA national lab was successfully reassessed by the ANSI-ASQ National Accreditation Board for ISO/IEC 17025:2005 accreditation and through scope expansion was also found to be compliant with ISO 4074:2014 for technical competence in testing male condoms. This means the EFMHACA has the expertise to ensure condoms procured for public distribution programs meet international standards and pass a wide range of quality control tests for specific quality attributes including: freedom from holes; adequate inflation volume and pressure; lubricant quantity; dimension appropriate to the target population; and package seal integrity.