The profile of technical complaints related to infusion sets sold in Brazil and the impact on patient safety

• Autor(a) principal: Ramirez, Sonia Silva
• Data de Publicação: 2022
• Outros Autores: Leandro, Katia Chistina, Feitoza-Silva, Michele
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: RECIIS (Online)
• Texto Completo: https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/3167
• topic: Equipo; Segurança do paciente; Tecnovigilância; Vigilância sanitária; Gestão de riscos; Infusion set; Patient safety; Technovigilance; Health surveillance; Risk management; Equipo; Seguridad del paciente; Vigilancia sanitaria; Tecnovigilancia; Gestión de riesgos

Infusion sets are medical devices that, when presenting quality deviations, can cause harm to a large number of people. This study aimed to evaluate the profile of technical complaint notifications made on the Notivisa System, developed by Anvisa – Agência Nacional de Vigilância Sanitária (National Agency for Health Surveillance), so as to discuss its impact on patient safety. By means of quantitative methodology, devices sold from 2016 to 2017 was evaluated, five years after the establishment of compulsory metrological certification. The main technical complaints referred to integrity problems (82.70%): mechanical defect, leaks, flow shutdown issues, fluid obstruction and detachment, packaging or labeling problems (8.54%) and presence of foreign bodies and dirt (7.97%). Such failures can interfere with diagnostic and/or treatment procedures such as the administration of chemotherapy drugs, antibiotics and also the transfusion process. Thus, the technovigilance is essential for health safety in the market, based on the identification of risks and the possibility of mitigating them, thus promoting the patient safety.