Certificação compulsória e qualidade de agulhas e seringas em um Hospital Sentinela

Abstract

Syringes and hypodermic needles are health products. In addition to the processing of registration with Anvisa, it is essential to consider post-marketing surveillance to provide safe and effective products on the market. The high number of notifications to Anvisa leads to the publication of specific technical regulations and to the request of compulsory certification. This study analyzed the results obtained in the evaluation of primary package, label and appearance of syringes and needles available in the warehouse of a “Hospital Sentinela” before and after the compulsory certification request. The first collection took place in 2012, after the publication of technical regulations, and the second was carried out in 2014, after mandatory compulsory certification. For the label evaluation, all samples were considered as satisfactory. As for the analysis, 62.5% of the products analyzed in 2012, and 50% in 2014, were disapproved, generating a total of 56% disapproval in both years. The most common “non-conformities” were: excessive lubricant and vulnerable package. The study demonstrated that the mandatory certification, by itself, does not guarantee sanitary quality, but reaffirms the need for post-marketing activity, as well as the importance of a positive strategy of healthcare partnerships with government laboratories, and of rational purchase of reduced risk products.