1National Institute for Quality Control in Health (INCQS)/Fiocruz, Brazil
2Fiocruz Mato Grosso do Sul, Brazil
*Corresponding author:Janete Duarte, Oswaldo Cruz Foundation Av., Manguinhos, Rio de Janeiro, Brazil
Submission: July 21, 2022Published: August 05, 2022
Volume5 Issue2 August , 2022
Background: The increase in the incidence of Sexually Transmitted Infections (STIs) represents an
important public health problem. The natural latex male condom is a resource available to men and
women that fulfills a dual protective function. In Brazil, male condoms are compulsorily certified. Although
the certification process evaluates the manufacturing process in detail until the final product, it does not
address commercialization issues, as it is a function of the sanitary surveillance.
Methods: Two different brands of male condoms, purchased in the Rio de Janeiro city trade (Sample A) (Sample B) were evaluated. The quality control of the male condom involves one important insufflation test, which evaluates the resistance determining the volumetric capacity and the rupture pressure. For the insufflation test, we tested 200 units per brand, according to the criteria established in the Resolution of the National Agency of Sanitary Surveillance nº. RDC 554/2021 that allows up to seven nonconforming units.
Results and Conclusion: Both the two brands met the criteria established in the Resolution of the National Health Surveillance Agency no. RDC 554/2021 for the inflation test, which allows up to seven nonconforming units, however, we found nonconformities in both. We conclude that, in addition to certification, there is a need to monitor this product in view of the sanitary risk observed
Keywords: Male condoms; Public health; Sanitary surveillance
Abbreviations: STIs: Sexually Transmitted Infections; SBD: Brazilian Society of Dermatology; WHO: World Health Organization; MPT: Multi-Purpose Prevention Technology; AQL: Acceptable Quality LevelInjection; HER: Electronic Health Records -->