ABSTRACT Background: Bloodstream infections (BSI) are a global health issue, leading to high mortality and morbidity among hospitalized patients. Methods: A retrospective, observational and descriptive study was conducted by reviewing blood culture records collected from patients with suspected BSI, between January 2017 and December 2019. Results: The most frequent antimicrobial resistant (AMR) pathogens were methicillin-resistantStaphylococcus aureus(MRSA) (40%), methicillin-resistantS. epidermidis (MRSE) (9.5%), and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae (35.3%). Conclusions: Our findings underscore the importance of continued vigilance and advocate for the rational use of antimicrobial agents. Background BSI (BSI issue Methods retrospective 201 2019 Results AMR (AMR methicillinresistantStaphylococcus methicillin resistantStaphylococcus aureusMRSA aureus MRSA aureus(MRSA 40%, 40 40% , (40%) methicillinresistantS. methicillinresistantS resistantS. resistantS methicillin-resistantS MRSE (MRSE 9.5%, 95 9.5% 9 5 (9.5%) extendedspectrum extended spectrum betalactamase beta lactamase ESBLproducing ESBL producing 35.3%. 353 35.3% . 35 3 (35.3%) Conclusions agents 20 4 (40% 9.5 (9.5% 35.3 (35.3% 2 (40 9. (9.5 35. (35.3 (4 (9. (35. ( (9 (35 (3

Resumo Atrasos são um dos problemas mais recorrentes na indústria da construção, causas de consequências negativas em projetos de construção e, muitas vezes, motivo principal de fracassos de projetos. Ainda existe a necessidade de estudar as causas dos atrasos em obras de construção. O objetivo deste trabalho é determinar as causas mais influentes nos atrasos dos projetos de construção civil da indústria privada, colaborando com a lista acadêmica geral das causas dos atrasos na construção civil. Uma lista com 24 causas foi compilada e submetida como questionário para 47 profissionais em papéis administrativos em obras do setor privado da construção. Os resultados foram processados por meio do Índice de Importância Relativa (Relative Importance Index – RII). As causas mais importantes de atraso foram: retrabalho, baixa produtividade da mão-de-obra, falta de mão-de-obra qualificada, e mudanças de projeto. Os resultados indicam que existem diferenças significativas entre as opiniões dos profissionais de diferentes posições hierárquicas. As contribuições mais significativas desse estudo são que as causas dos atrasos na construção variam dependendo dos profissionais em cada nível hierárquico da obra, demonstrando a importância de entender o problema em prol de uma visão sistêmica e profunda do fenômeno.

Abstract Delay is one of the most recurrent problems in the construction industry. It is the cause of major negative consequences on construction projects and it can be the main reason for project failures. Still, there is a need for studies focusing on causes of these delays. The objective of this article is to determine the factors with greatest influence on the backlog of real estate developments, improving the collective list of causes of delays in construction projects. A list of 24 probable causes was assembled and submitted as a survey for 47 professionals in administrative rolls from the building construction sector, more precisely, from private companies. The results were processed utilizing the Relative Importance Index (RII) ranking approach. The outcome shows that the most important delay causes are: rework, poor labor productivity, lack of qualified labor, unqualified labor, and project changes. The results also indicate that there are significant differences of opinion between the professionals of distinct hierarchy positions. The results obtained indicate that there is a transition between the opinions of professionals in different roles regarding the importance of influential factors in the delay of works, according to the managerial level of each group.

According to Anvisa risk rating, hypodermic needles offer medium risk to the user’s health. This study discussed the importance of the corrosion resistance test in tubes of hypodermic needles, in the product quality control. A review of cannulas of hypodermic needles was carried out according to ISO 9626:2003 and 9259:1997 ABNT NBR. For the results evaluation, a scale which classifies the extent of corrosion was adjusted. 174 samples of PNI needles from 17 States and 9 different record holders were analyzed. According to the methodology of ISO 9626:2003, 100% of the samples were considered satisfactory. However, in accordance with the methodology of ISO 9259:1997, 97.1% of the samples were rejected. Irregularities can lead to impairment of product quality, resulting in risks to the consumer’s health. Since 2011 the product has undergone certification, so it is necessary to reflect on the importance of corrosion resistance testing and mandatory certification for health monitoring.

RESUMO A certificação metrológica é uma importante ferramenta de Vigilância Sanitária. O objetivo deste estudo foi avaliar o perfil das notificações de queixas técnicas de seringas hipodérmicas realizadas no Notivisa/Anvisa (Sistema Nacional de Notificações de Eventos Adversos e Queixas Técnicas/Agência Nacional de Vigilância Sanitária) entre 2012 e 2015. As notificações foram analisadas individualmente e classificadas conforme os motivos relatados. Foram avaliadas 4181 notificações, e as queixas mais prevalentes foram: 'produto quebrado na embalagem lacrada' (22%) e 'sujidade/manchas no interior do produto/embalagem' (15,8%). Não foram observadas alterações significativas no perfil das queixas após a certificação compulsória, que, embora imprescindível, não é capaz de substituir o monitoramento pós-comercialização.

ABSTRACT Metrological certification is an important Sanitary Surveillance tool. The objective of this study was to evaluate the profile of notifications of technical complaints of hypodermic syringes performed in Notivisa/Anvisa (Sistema Nacional de Notificações de Eventos Adversos e Queixas Técnicas/Agência Nacional de Vigilância Sanitária) between 2012 and 2015. The notifications were analyzed individually and classified according to the reasons reported. 4181 notifications were evaluated and the most prevalent complaints were: 'broken product in the sealed package' (22%) and 'dirt/stains inside the product/packaging' (15.8%). There were no significant changes in the profile of the complaints after compulsory certification, which, although indispensable, is not capable of replacing post-marketing monitoring.

RESUMO Garrafadas, em geral, são combinações de plantas medicinais veiculadas em bebidas alcoólicas, utilizadas com diversas finalidades na medicina popular. O presente estudo apresentou um panorama das garrafadas, relacionando-as à regulamentação sanitária no Brasil. Para tal, foi realizada uma pesquisa descritiva exploratória das garrafadas divulgadas na internet, bem como das notificações de queixas técnicas e eventos adversos junto à Agência Nacional de Vigilância Sanitária (Anvisa). A pesquisa mostrou que as garrafadas são amplamente divulgadas na internet. Concluiu-se que as garrafadas são comercializadas em todo País, sem nenhuma barreira, sendo órfãs de regulamentação sanitária específica, mas legitimadas pela cultura popular.

ABSTRACT Garrafadas, in general, are combinations of medicinal plants conveyed in alcoholic beverages, used for a variety of purposes in popular medicine. The present study presented an overview of the garrafadas, relating them to sanitary legislation in Brazil. For this, an exploratory descriptive research was carried out on garrafadas advertised on the internet, as well as notifications of technical complaints and adverse events with Anvisa (National Agency of Sanitary Inspection). The research has shown that garrafadas are widely spread on the internet. It was concluded that garrafadas are commercialized throughout the Country, without any barriers, being orphaned by specific sanitary legislation, but legitimized by popular culture.

RESUMO Garrafadas, em geral, são combinações de plantas medicinais veiculadas em bebidas alcoólicas, utilizadas com diversas finalidades na medicina popular. O presente estudo apresentou um panorama das garrafadas, relacionando-as à regulamentação sanitária no Brasil. Para tal, foi realizada uma pesquisa descritiva exploratória das garrafadas divulgadas na internet, bem como das notificações de queixas técnicas e eventos adversos junto à Agência Nacional de Vigilância Sanitária (Anvisa). A pesquisa mostrou que as garrafadas são amplamente divulgadas na internet. Concluiu-se que as garrafadas são comercializadas em todo País, sem nenhuma barreira, sendo órfãs de regulamentação sanitária específica, mas legitimadas pela cultura popular.

ABSTRACT Garrafadas, in general, are combinations of medicinal plants conveyed in alcoholic beverages, used for a variety of purposes in popular medicine. The present study presented an overview of the garrafadas, relating them to sanitary legislation in Brazil. For this, an exploratory descriptive research was carried out on garrafadas advertised on the internet, as well as notifications of technical complaints and adverse events with Anvisa (National Agency of Sanitary Inspection). The research has shown that garrafadas are widely spread on the internet. It was concluded that garrafadas are commercialized throughout the Country, without any barriers, being orphaned by specific sanitary legislation, but legitimized by popular culture.

RESUMO A certificação metrológica é uma importante ferramenta de Vigilância Sanitária. O objetivo deste estudo foi avaliar o perfil das notificações de queixas técnicas de seringas hipodérmicas realizadas no Notivisa/Anvisa (Sistema Nacional de Notificações de Eventos Adversos e Queixas Técnicas/Agência Nacional de Vigilância Sanitária) entre 2012 e 2015. As notificações foram analisadas individualmente e classificadas conforme os motivos relatados. Foram avaliadas 4181 notificações, e as queixas mais prevalentes foram: 'produto quebrado na embalagem lacrada' (22%) e 'sujidade/manchas no interior do produto/embalagem' (15,8%). Não foram observadas alterações significativas no perfil das queixas após a certificação compulsória, que, embora imprescindível, não é capaz de substituir o monitoramento pós-comercialização.

ABSTRACT Metrological certification is an important Sanitary Surveillance tool. The objective of this study was to evaluate the profile of notifications of technical complaints of hypodermic syringes performed in Notivisa/Anvisa (Sistema Nacional de Notificações de Eventos Adversos e Queixas Técnicas/Agência Nacional de Vigilância Sanitária) between 2012 and 2015. The notifications were analyzed individually and classified according to the reasons reported. 4181 notifications were evaluated and the most prevalent complaints were: 'broken product in the sealed package' (22%) and 'dirt/stains inside the product/packaging' (15.8%). There were no significant changes in the profile of the complaints after compulsory certification, which, although indispensable, is not capable of replacing post-marketing monitoring.

Aim: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. Methods: Notifications were categorized and evaluated to: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data. Results: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. Conclusion: These data support a necessity for cooperation between all entities of the National Health Surveillance System to check compliance of this type of product and to properly report adverse events and technical complaints. It is also important to incorporate minimum standards for the management of technologies in health services, including in the acquisition of products and training of staff.

Para que um medicamento fitoterápico seja comercializado no Brasil, este deve ser registrado junto à ANVISA, onde são avaliados todos os aspectos referentes à qualidade, segurança e eficácia do produto, além de verificar se estes atendem alguns requisitos, sendo um deles a adequação da bula. Por esta razão, neste estudo foram avaliadas as bulas de todos os fitoterápicos elaborados à base do extrato padronizado de Pelargonium sidoides, registrados e disponíveis no mercado brasileiro, com o intuito de verificar se estas atendem aos requisitos exigidos pela RDC 140/03. No presente trabalho, as informações exigidas pela RDC 140/03 foram avaliadas através de um formulário padrão previamente elaborado. Após avaliação das bulas pode ser verificado que nenhuma das duas marcas atendia por completo as exigências da legislação, sendo que o fabricante "A" atendeu apenas 37,0% dos requisitos exigidos de forma satisfatória, enquanto 16,0% das informações foram consideradas insatisfatórias e em 47,0% as informações estavam ausentes. Com relação ao fabricante "B", 64,2% dos itens analisados foram considerados satisfatórios, enquanto 16,0% foram considerados insatisfatório e em 19,8% as informações estavam ausentes. A bula deveria conter informações sobre o medicamento para consumidores, farmacêuticos e médicos, no entanto, os resultados obtidos neste estudo mostram que as informações apresentadas nas bulas foram insatisfatórias, e em muitos casos, violavam a legislação vigente.

In order for a phytotherapeutic drug be approved and sold in Brazil, it must be registered with the National Sanitary Surveillance Agency (ANVISA), where the quality, safety and efficacy of the product are carefully appraised. In addition, the drug must also meet a number of criteria one of which is the adequacy of the package inserts. Therefore, the aim of this study was to appraise the package inserts of all phytotherapeutic drugs produced using a standardized extract of Pelargonium sidoides, which were registered and available from Brazilian pharmacies. This checking was to ascertain whether these inserts fulfilled the requirements stipulated by RDC 140/03. The information required under RDC 140/03 was appraised through a previously devised standard form. Evaluation of the package inserts revealed that neither of the two brands fully met the requirements of the legislation. Manufacturer 'A' met only 37.0% of the requirements satisfactorily, while 16.0% of the information was considered unsatisfactory and 47.0% of the information was absent. Regarding manufacturer 'B', 64.2% of the analyzed requirements were considered satisfactory, while 16.0% were considered unsatisfactory and 19.8% of the information was absent. A package insert should contain information about medicine for consumers, pharmacists and doctors. However, the results obtained in this study showed that the information presented in the package insert of both medicines was unsatisfactory, and in many cases, violates the legislation.