Profile of technical complaints and equipment-related adverse reactions in Brazil, 2018-2022: descriptive study

Fabrícia Tesolin Rodrigues, Sara Esther Freitas Ribeiro Marques, Geovan Ribeiro de Lima, Claudia Aparecida Godoy Rocha

Abstract

With the high rate of problems related to the health product (equipment), there is a probability of increasing the number of cases of adverse events and obstacles related to the health of the client. The research aims to carry out an exploratory analysis of technical complaints and adverse reactions related to equipment in Brazil, in the period 2018-2022. This is a descriptive, retrospective study on Technical Complaints (QT) and Adverse Events (AE) data obtained from the Information System (Notivisa) of the National Health Surveillance Agency in March 2023. There were 6078 notifications related to equipment, of which that 98.78% represent technical complaints and 1.22% adverse event. In 2019 there was the highest rate of notifications, with the southeast region accounting for the highest number of records when compared to other states in Brazil. The equipment is the medical device most used in health institutions to carry out procedures. Thus, if this product presents irregular quality, damage to the health of the user may occur, compromising the safety and effectiveness of the assistance provided, requiring the notification of adverse events and technical complaints.

Author Biographies

Fabrícia Tesolin Rodrigues, Faculdade Bezerra de Araújo

Student of Nursing at Faculdade Bezerra de Araújo. Business Administrator at Centro Universitário Moacyr Sreder Bastos. Specialist in Management and Teaching of Secondary, Technical and Higher Education by UniAlphaville. Postgraduate student in Health Management and Auditing at FAVEMI. Director of Research of the Academic League of Urgency and Emergency of Faculdade Bezerra de Araújo (LAUEN - FABA).

Sara Esther Freitas Ribeiro Marques, Universidade Federal do Vale do São Francisco

Student of the 4th period of the Medicine Course at the Federal University of Vale do São Francisco, Univasf, Petrolina, Brazil. She is currently a participant in the Neurosciences League of the Federal University of Vale do São Francisco (UNIVASF), works as a volunteer in the Extension Project of Permanent Education Actions on Risks and Prevention of Cerebrovascular Accident for Hospitalized Patients at HU-UNIVASF and in the Extension Project of the Paulo Freire Popular Course (CPPF) and as a monitor of the subject Introduction to Epidemiology in the Bachelor of Health.

Geovan Ribeiro de Lima, Universidade do Estado do Pará

Academic Nursing from the State University of Pará (UEPA)-Campus VII; Co-author of the book: "Food Choice and its Impact on Health: Contributions of Nutrition to Nursing Care". Volunteer in the Vaccination Campaign against Covid 19 (2021) in the Municipality of Conceição do Araguaia, Participant in the category of Organizing Committee of the VI HEALTH SYMPOSIUM OF THE ARAGUAIA REGION.

Claudia Aparecida Godoy Rocha, Faculdade São Lucas (FSL)

Nurse at the São Lucas University Center. Specialist in Occupational Nursing, Emergencies and Emergencies, Obstetrics, Cardiology and Hemodynamics. Researcher of the Vocational Training in Education and Health Research Group of the State University of Pará.

Published
2023-06-13