Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia

Introduction: Implementation quality management principles in the National Health Surveillance System (SNVS) by developing planning, monitoring, and evaluation strategies, models, and managerial tools, has been presented as a structural requirement for qualifying health promotion and protection actions, aiming at national and international regulatory convergence, as well as continuous improvement of the very actions perpetrated by SNVS. Objective: Analyzing factors deemed favorable or unfavorable for the implementation of Quality Management System (QMS) in four SNVS institutions. Method: Descriptive, bibliographic, and documentary study aimed at identifying and describing aspects related to the implementation of QMS in four SNVS institutions, using documents prepared by its representatives. Results: Favorable and unfavorable factors have been grouped according to three dimensions: organizational, methodological, and conjunctural. The commitment of leadership to the implementation of QMS, the commitment of the teams, and the support of an external consultancy have prevailed as favorable factors, whereas the difficulty in understanding the quality management technical language used in the QMS model was the most unfavorable factor. Conclusions: The favorable factors may have been previously organized and dealt with by the teams, in order to strengthen the implementation and its effects on the performance of the SNVS. Unfavorable factors, even those related to the intrinsic characteristics of public administration, are equally liable to be overcome, so as not hamper the implementation of the management model based on the continuous improvement of processes.

Danila Augusta Accioly Varella Barca

Claudio Medeiros Santos

Artur Iuri Alves de Sousa

Monica Baeta Silveira Santos

Igor Da Costa Borysow

Wilma Madeira da Silva

Bruno Lopes Zanetta

Vigilância Sanitária em Debate

Fatores favoráveis e desfavoráveis à implantação de Sistema de Gestão da Qualidade em órgãos do Sistema Nacional de Vigilância Sanitária: a experiência piloto em dois estados e dois municípios brasileiros

国家卫生监督系统机构实施质量管理体系的利弊因素：巴西两个州和两个市的试点经验

Introduction: The National Health Surveillance Agency, through Technical Note No. 40/2017, emphasizes that household drills used in orthopedic surgeries lack adequate safety mechanisms, as they do not allow for effective sterilization and do not ensure patient safety during surgical procedures. Objective: This study presented how a multidisciplinary team from the Health Surveillance addressed hospital establishments that were using domestic drills in orthopedic surgeries. Method: This is an account of the experiences of a team of health inspectors during inspections carried out in the first semester of 2023 at three hospitals in Ceará. For these inspections, instruments or guidelines based on Anvisa and the Ministry of Health regulations were used. Results: Inspectors found domestic drills in the sterilized material centers, which were exposed both in the disinfection rooms and in the storage and distribution rooms of the already processed instruments, available for immediate use in surgeries. Conclusions: This experience highlighted the need to train health inspection technicians in the state’s health services so that they could identify and differentiate the appropriate equipment used in surgeries.

José Reginaldo Pinto

Eliel Pinheiro Fernandes

Arlete Cavalcante Girão

Idinez Yury Aguiar Costa

Sofia Almeida Costa

Régila Maria Farias Pinto

Recorrência do uso de “furadeiras domésticas” como instrumental cirúrgico em hospitais que realizam cirurgias ortopédicas: relato de experiência

骨科手术医院中“家用电钻”作为手术器械的重复使用：经验报告

Introduction: This paper reports on the experience of the Vaccine Development and Production Course, an initiative promoted by Fiocruz within the framework of the MERCOSUR Health Ministers’ Meetings. The experience was developed in the second half of 2023, with the participation of students from Argentina, Brazil, Paraguay, and Uruguay as member states of the bloc and Chile as an associate state. Objective: To support the hypothesis that we will only be able to advance health sovereignty in the field of vaccines if we simultaneously implement sovereignty in terms of strategy and the process of training human resources, articulating the region’s capabilities in a network. Method: This is a report that presents reflections onhealth sovereignty in the production of biological products, based on a training experience that involved the mobilisation of existing capacities at Fiocruz, Instituto Butantan and Nortec, based on synchronous remote classes and personal technical visits. Results: Details of this experience were presented and based on this, we sought to outline appropriate strategies for continuing professional development in the region, with the aim of achieving health sovereignty in terms of regional vaccine production with a view to self-sufficiency. Conclusions: It is noted that despite the language barriers and institutional differences between the bloc and the associated countries, the evaluation carried out at the end of the course confirms the relevance and the need to expand experiences such as the one developed. The need to create capacities in the region to effectively achieve health sovereignty is evident, as well as the importance of incorporating some strategic themes identified by the students to continue the qualification of professionals in the region, in a continuous and permanent training process.

Sebastián Tobar

Jorge Carlos Santos da Costa

Mirian Nakamura Gouvea

Marco Alberto Medeiros

Isabella Fernandes Delgado

Construindo a soberania sanitária no Mercosul: a experiência do curso de desenvolvimento e produção de vacinas

构建南方共同市场中的卫生主权：疫苗开发与生产课程的经验

Introduction: The risks in vaccination rooms imply not only damage to users, but also to vaccination coverage. Objective: to analyze structural conditions and factors that facilitate and hinder risk management in vaccine rooms. Methods: This cross-sectional study was conducted in the vaccination rooms of the Basic Health Units (UBS) of a health district in Salvador, BA. Data collection: form for interview with the responsible professional and on-site observation of these services. The following were analyzed: physical-structural conditions; care for the refrigeration chamber and thermal boxes; Nursing conduct; and training of professionals. Results: 91.3% vaccination rooms were studied. These services operate in exclusive spaces; immunobiologicals stored in refrigerated chambers. Vaccines are packaged and used according to the expiration date. Professional team: one nurse and two nursing technicians were present in 66.6% of the rooms; the hand hygiene practice of the professionals was 76.1%. Nursing team training was observed in 19%, annual training in 14.2%, and participation in scientific events in 19%. Of the 21 vaccine rooms, 5 (23.8%) had adequate risk management practices, 14 (66.6%) had risk management practices requiring adjustment, and 2 (9.6%) had inadequate risk management. Statistical correlation was identified between risk management practices and individual items from the categories analyzed to ratify the good practices in the vaccination room presented here. Conclusion: This study highlights inadequacies in vaccination rooms and the need to review work processes, as well as to incorporate systematic strategies for managing the numerous risks related to these services, to guarantee user safety.

Eliana Auxiliadora Magalhães Costa

Cristina Campos dos Santos

William Mendes Lobão

Angela Gabriela da Silva Santana

Flávia Almeida dos Santos

Natália Santana Pereira

Elisabeth Do Espírito Santo da Silva

Alexandra Santos da Silva

Gerenciando riscos em salas de vacina: um estudo de segurança em Unidades Básicas de Saúde de Salvador, BA

管理疫苗接种室的风险：一项关于萨尔瓦多市基本卫生单位安全性的研究

Introduction: Since the identification of atypical pneumonia of unknown etiology in Wuhan, China, in December 2019, called COVID-19, the disease caused by SARS-CoV-2 requires scientists and governments to take urgent and decisive measures for monitoring and control. Objective: To present the results of post-market monitoring of COVID-19 rapid antigen detection tests (AgTR) regarding clinical or diagnostic sensitivity and specificity. Method: Analysis of AgTR performance results were made available on the electronic panel of Microsoft® Power BI platform on the Brazilian National Health Surveillance Agency (Anvisa) portal from 04/06/2020 to 12/28/2021. Results: 504 results relating to performance analysis were identified: 366 (72.6%) rapid tests (RT), 56 (11.0%) chemiluminescence tests, 31 (6.15%) molecular tests, 22 (4.4%) immunoenzymatic assays, and 29 (5.7%) auxiliary products for the diagnosis of COVID-19. Of the 366 RT results, 304 (83.1%) were RT for antibody detection (AcTR) and 62 (16.9%) were AgTR. Of the 62 AgTR monitored, 49 (79.1%) presented compliant results and 13 (20.9%) did not. The 62 AgTR results corresponded to 50 lots from 42 manufacturers. Conclusions: Monitoring post-market products in compliance with RDC No. 379/2020 enabled the analysis and monitoring of COVID-19 tests. The analyses carried out (guidance and fiscal) in accordance with current legislation (Law No. 6360/1976, Law No. 6437/1977) guaranteed the transparency of the process and reinforced the precepts of health surveillance regarding resolving or preventing health risks. Non-compliant products were not sold, thus guaranteeing the safety and effectiveness of the tests available in the country.

Gabrielle Rodrigues Conceição

Helena Cristina Balthazar Guedes Borges

Marisa Coelho Adati Adati

Monitoramento pós-mercado dos testes rápidos para detecção de antígenos da COVID-19 no enfrentamento à pandemia

COVID-19抗原快速检测在应对大流行中的市场后监测

Abbreviation
Journal Impact	0.37
Quartiles(Global)	HEALTH CARE SCIENCES & SERVICES(Q4)

Publication Information	Publisher: Fundação Oswaldo Cruz (FIOCRUZ)，Publishing cycle: ，Journal Type: journal，Open Access Journals: Yes
Basic data	Year of publication: 2013，Proportion of original research papers: 90.48%，Self Citation Rate:50.00%， Gold OA Rate: 93.28%
Average review cycle	网友分享经验：24 Weeks

Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia

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Fatores favoráveis e desfavoráveis à implantação de Sistema de Gestão da Qualidade em órgãos do Sistema Nacional de Vigilância Sanitária: a experiência piloto em dois estados e dois municípios brasileiros

Recorrência do uso de “furadeiras domésticas” como instrumental cirúrgico em hospitais que realizam cirurgias ortopédicas: relato de experiência

Construindo a soberania sanitária no Mercosul: a experiência do curso de desenvolvimento e produção de vacinas

Gerenciando riscos em salas de vacina: um estudo de segurança em Unidades Básicas de Saúde de Salvador, BA

Monitoramento pós-mercado dos testes rápidos para detecção de antígenos da COVID-19 no enfrentamento à pandemia

Fatores favoráveis e desfavoráveis à implantação de Sistema de Gestão da Qualidade em órgãos do Sistema Nacional de Vigilância Sanitária: a experiência piloto em dois estados e dois municípios brasileiros

Recorrência do uso de “furadeiras domésticas” como instrumental cirúrgico em hospitais que realizam cirurgias ortopédicas: relato de experiência

Construindo a soberania sanitária no Mercosul: a experiência do curso de desenvolvimento e produção de vacinas

Gerenciando riscos em salas de vacina: um estudo de segurança em Unidades Básicas de Saúde de Salvador, BA

Monitoramento pós-mercado dos testes rápidos para detecção de antígenos da COVID-19 no enfrentamento à pandemia