Revista de SIDA e investigación clínica

Products Sanitary Surveillance: Latex Condom on the Bias of the Sanitary Risk

Abstract

Janete Teixeira Duarte

Objective: Health products can be marketed in Brazil after registration in the Health Ministry. Male condoms are considered health products and are compulsorily certified following RDC 62/2008 regulation. Condom sanitary control must follow the certification regulation however is impractical due to great sample size (548 units for each lot). An appropriate technical surveillance should be designed to condom sanitary control. Methods: Two different batches were purchased directly from the manufacturer. And three different brands, being one of them similar to the batches acquired directly from the manufacturer, were acquired in several establishments in Brazil, and the total amount was the sum of several different lots for each of the chosen brands. It was incorporated geoprocessing technique to maintain the traceability of the lots collected in the trade. Analyzes were performed according to the criteria established in Brazilian National Health Oversight Agency Resolution no. RDC 62/2008. Non compliant samples results were sent to Sanitary Surveillance and actions were requested to collect non compliant lots samples, according to the sampling established by RDC 62/2008. Samples were analyzed by the laboratory. The reports are sent to the Sanitary Surveillance for the necessary measures. Results: It was observed that three different lots found nonconformity in at least one of the analyzes and, in some cases, as our sample N is a variation of lots of a given brand, the non-compliance occurred in a lot that was considered separately, do not we would have enough to perform the analyzes. Conclusion: The development of this technical surveillance model provides the monitoring actions of male condoms throughout the country, since from a perspective of Sanitary Surveillance, a unique nonconforming unit has serious implications for public health.