A study on the microbial quality of sealed products for feminine hygiene

INTRODUCTION: Sanitary tampons have been in existence for over 60 years. Their use may present certain health risks, potentially associated with an abnormal change of microbial flora in the vagina (e.g., toxic shock syndrome). Tampon production and marketing are regulated differently in different countries. In Australia, Canada and the USA, tampons are classified as Class-II medical devices and their marketing requires pre-clinical and clinical studies, including microbiological trials. In Europe, tampons are considered consumer products and safety-related data are provided only if the manufacturer deems them to be useful. Sterility of these products is not requested by law; thus they may represent a potential vehicle for microorganisms. Due to the lack of data on microbial characteristics of tampons, an analytical investigation was carried out to characterize and quantify the microbial flora present on sealed tampons of various brands present on the market in Italy. METHODS: Traditional cultural methods were used to characterize and quantify bacteria and fungi. Identification of colonies was performed with biochemical techniques. RESULTS: Results showed low microbial concentrations in 93% of the positive samples. A rare presence of opportunistic pathogens was detected and a few samples (6%) were characterized by bacterial species of human origin. CONCLUSIONS: In the light of these data, the examined tampons were found to have good hygienic quality. Nevertheless, to minimize the microbial risks linked to the use of these products, strict hygienic rules during their production and manipulation have to be adopted.