Resumo

ZAVALETA MARTINEZ-VARGAS, Alfonso. Control de calidad de preservativos masculinos en el Perú. Rev. perú. med. exp. salud publica [online]. 1997, vol.14, n.1, pp.50-54. ISSN 1726-4634.

The quality of male latex prophylactics (condom) used in sexually transmitted diseases and birth control programs is a key factor for their efficacy. Nevertheless, reports on their quality control are scarce. We present the results of quality control performed on twenty three different commercial lots of condoms performed along a seven years period (1988-1994) by the Centro Nacional de Control de Calidad (CNCC) of the Instituto Nacional de Salud (Lima, Perú). The lots were classified in two groups, depending on the legal system applicable at the date of arrival of the sample to be tested to the INS: PRS group (pre-Sanitary Registration quality control System, applicable before July 1992, 6 lots) and PES group (post-Sanitary Registration quality control System, applicable after July 1992, 17 lots). Five out of six lots from the PRS group, whereas 1 out of 17 from the PES group passed the controls. The lot rejection causes were: labeling faults in 20 lots (expiring date not declared in 7), deficiencies in physical characters in 12 lots (deficient impermeability due to holes in 8; presence of particulate materials in 2, of bubbles in 1; of folds in 1 lot, and thickness greater than that declared by manufacturer in 1 lot). All twenty of the 23 lots which were subjected to a microbial limit test passed it. A high proportion of the tested lots of condoms (20 of 23) fail to pass quality control. The rejection rate was higher among condom samples taken after the regulations stopped requiring passing quality control before inscription in the Sanitary Register, which allows the product to enter the Peruvian market, to a system performing quality control of products after inscription in the Sanitary Register, while they are already in the market. Our findings strongly suggest that Health Authorities should enhance the quality control of male latex prophylactics sold or distributed in the Peruvian market.

Palavras-chave : Condom.

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