Analysis of current status and risk of development in occupational medical examination institutions in Guangdong Province / 中国职业医学

Objective: To analyze the status of occupational medical examination (OME) institutions in Guangdong Province and the critical control points affecting their future development. Methods: A total of 211 OME institutions registered in Guangdong Province were selected as the research subjects. Their current statue was investigated, and the risk assessment of their future development was carried out based on hazard analysis and critical control point theory. Results: The OME institutions were mainly concentrated in the Pearl River Delta, accounting for 72.0%. The public and private medical and health institutions accounted for 70.6% and 29.4% respectively. The filing rates of different OME categories from high to low in the order were physical factors, chemical factors, dust, other, radiation factors, biological factors (P<0.01), and the filing rates were 89.6%, 88.6%, 84.8%, 63.0%, 7.1% and 1.0%, respectively. The rates of excellence in the field assessment from high to low in the order were hearing atlas analysis personnel, lung function examination operators, chest film reading personnel, chief examination physician, technical director, quality director (P<0.01), and the rates of excellence were 49.4%, 26.2%, 20.6%, 10.8%, 8.2% and 4.6%, respectively. A total of 37 institutions did not submit OME information, of which 23 institutions did not carry out OME work after filing. The required diagnosis rate and confirmed diagnosis rate of suspected occupational diseases in 2020 were 34.3% and 55.3%, respectively. In 2021, the detection rate of suspected occupational diseases was only 1.1‰. Among the institutions with biological monitoring records, 64.1% did not participate in external quality assessment program in laboratory, and the unqualified rate of 38 participating institutions was 55.3%. The risk assessment results show that the future development of OME institutions needs to focus on private institutions, institutions that have not reported OME information, institutions that have missed diagnosis and missed reporting of suspected occupational diseases, institutions that have not participated in external quality assessment program in laboratory and core personnel such as quality managers, technical leaders, and main inspection physicians. Conclusion: OME institutions in Guangdong Province show the characteristics of centralized filing category, centralized filing region and centralized filing institution nature. Combined with the potential risks of OME institutional capacity building, it is necessary to implement classified management, strengthen information construction, supervision and management, implement post responsibilities, and promote the high-quality development of OME institutions.

An evaluation of occupational health risk assessment methodologies from South African enterprises: noise risk assessment field study

Background: The South African occupational health and safety regulations, prescribing risk assessments be conducted by employers, are non-prescriptive with regard to the tools and techniques to be used. Consequently, companies freely adopt the numerous available tools and techniques from which risk management decisions are derived. Thus, risk management, ensuing from the results derived from these tools and techniques, is likely to vary from company to company. Objective: The objective of the study was to evaluate risk assessment processes and methodologies that are used and recorded in noise risk assessment reports, in four manufacturing companies. Methods: This was a case study, whereby risk assessment records were obtained from four South African companies with different operational units, from the manufacturing and utilities sectors. Results: There were inter- and intra-company variations in the processes related to the legal context in which the risk assessments were conducted, the risk assessment tools and techniques used, the risk criteria definitions, the statements about the effectiveness of controls in use, and the risk evaluation outcomes. Inter- and intra-company variations in risk rankings and risk prioritisation outcomes were also observed ­ a consequence of the risk perceptions of the assessors assigning a risk level to the noise hazard. In some instances, the adopted risk assessment tools and techniques categorised the risk from noise that was at or above regulated health and safety standards as 'insignificant', which those companies used as justification for taking no further measures to eliminate or reduce the risk. Conclusion: The use of different risk assessment processes, tools and techniques resulted in some facilities categorising noise as an insignificant hazard, which may contribute to high noise emissions and uncontrolled exposures.

Factores relacionados con la letalidad de la enfermedad pulmonar obstructiva crónica exacerbada

Introducción: La letalidad de la enfermedad pulmonar obstructiva crónica agudizada es un problema no resuelto en las unidades de cuidados intensivos. Objetivo: Identificar los factores relacionados con la letalidad de pacientes con exacerbación de la enfermedad pulmonar obstructiva crónica, egresados de la unidad de cuidados intensivos en el Hospital Dr. "Agostinho Netoˮ de Guantánamo, en el período comprendido de 2019 a 2020. Métodos: Se realizó un estudio tipo caso-control donde se utilizaron variables sociodemográficas (edad, sexo, estado nutricional, comorbilidad, hábitos tóxicos), y otras en relación con la enfermedad pulmonar obstructiva crónica (fenotipo, severidad, diagnósticos asociados, indicadores gasométricos, tratamiento con ventilación mecánica, complicaciones, estado al egreso, causas de muerte). Resultados: El mayor número de pacientes se caracterizó por: tener más de 60 años (n=45), ser hombres (n=46), con más de 10 años de evolución de la enfermedad (n=37), bajo peso (n=35), y tres o más comorbilidades (n=41) y la más común fue el corazón pulmonar crónico (n=36), una puntuación Sequential Organ Failure Assessment Score y Acute Physiology and Chronic Health Evaluation II) elevada, fumadores (n=47), entre otro aspectos. Conclusiones: Los factores más asociados con la letalidad fueron la puntuación de la escala Sequential Organ Failure Assessment Score) igual o mayor de 16 puntos, la hipoxemia igual o mayor de 60 mmHg y la realización de traqueostomía 5 días o más de ventilación mecánica.

Introduction: The lethality of exacerbated chronic obstructive pulmonary disease is an unresolved problem in intensive care units. Objective: To identify the factors related to the lethality of patients with exacerbation of chronic obstructive pulmonary disease, discharged from the intensive care unit in the Dr. "Agostinho Netoˮ Hospital of Guantánamo, from 2019 to 2020. Methods: A case-control study was carried out using sociodemographic variables (age, gender, nutritional status, comorbidity, toxic habits), and other variables related to chronic obstructive pulmonary disease (phenotype, severity, associated diagnoses, gasometric indicators, treatment with mechanical ventilation, complications, status at discharge, causes of death). Results: The largest number of patients were characterized by: being over 60 years old (n=45), male (n=46), with more than 10 years of disease evolution (n=37), underweight (n=35), and three or more comorbidities (n=41) and the most common was chronic pulmonary heart (n=36), high Sequential Organ Failure Assessment Score and Acute Physiology and Chronic Health Evaluation II), smokers (n=47), among other aspects. Conclusions: The factors most associated with lethality were Sequential Organ Failure Assessment Score) score equal to or greater than 16 points, hypoxemia equal to or greater than 60 mmHg, and performance of tracheostomy 5 or more days of mechanical ventilation.

Analysis of laboratory parameters and death risk in patients with thrombotic thrombocytopenic purpura / 中华检验医学杂志

Objective:To analyze the laboratory parameters and clinical characteristics of TTP patients, so as to provide reference for the timely diagnosis and death risk assessment or TTP.Methods:83 patients with TTP from June 2016 to March 2022 in our hospital were analyzed retrospectively. They were divided into survival and death groups. The differences in general information, clinical symptoms and laboratory parameters were compared between the two groups. The prognostic prediction score was constructed by combining parameters which differ between the two groups to calculate the corresponding mortality risk.Results:83 patients were included in the study, of whom 81.1% (60/74), 91.1% (72/79) and 86.2% (50/58) had increased AST, IBIL and cTnI results, and all (78/78) had higher LDH at admission. Hb was decreased in 97.5% (79/81) patients, and PLT of 97.5% (79/81) patients was less than 30×10 9/L. There were no significant differences in gender, age, blood type, presence of fever, ADAMTS-13 activity and PLASMIC score between the survival group (58 cases) and the death group (25 cases), but the proportion of neurologic symptoms in the death group was significantly higher than that in the survival group. AST, IBIL, cTnI and APTT at admission were significantly higher in the death group than in the survival group ( P<0.05). The risk of death was 4.86, 9.74, 3.71, and 5.33 for those with high AST, IBIL, APTT, and cTnI levels, respectively, compared with those with low levels at admission. At last, AST, IBIL, APTT, cTnI and neurological symptoms were included to construct a score model. For each 1 point increase, the risk of short-term death in TTP patients was 3.24. Conclusions:Multiple laboratory markers have high negative exclusion value for TTP. For TTP patients with high AST, IBIL, cTnI and APTT and neurologic symptoms, more attention and active treatment should be paid to reduce mortality.

Análisis de riesgo de un microorganismo objetable en un suplemento dietario para la liberación de lotes

RESUMEN La contaminación con microorganismos objetables en los productos farmacéuticos no estériles puede tener el potencial de disminuir o inactivar la actividad farmacológica y terapéutica del principio activo y por ende representar un peligro de gran riesgo para la salud de la persona que está en tratamiento con fármacos; adicionalmente la presencia de estos microorganismos dependiendo de su capacidad para producir enfermedad en huéspedes susceptibles pueden ocasionar infecciones no esperadas o enfermedades que afecten al paciente o consumidor de estos medicamentos no estériles. El objetivo del trabajo fue desarrollar un análisis de riesgo microbiológico de microorganismos objetables en un suplemento dietario de una industria farmacéutica como herramienta en la gestión de seguridad. La metodología fue observacional-descriptivo de corte transverso. En la industria farmacéutica (en el suplemento dietario) se desarrolló un análisis de riesgo estudiando todos los parámetros, teniendo como resultado, que las cápsulas blandas con aceite de Krill, no presentan microorganismo objetable del tipo patógeno, como producto de bajo riesgo, por lo que es aprobado para la liberación del lote siguiendo estos parámetros. En Paraguay no existen normativas acerca del análisis de microorganismos objetables, en comparación con otros países como Argentina, y desde hace tiempo en EE. UU y países europeos (por reportes de la FDA) por lo cual, este trabajo es relevante y de vital importancia para establecer legislaciones nacionales con miras a la fabricación de medicamentos seguros, confiables y eficaces.

ABSTRACT Contamination with objectionable microorganisms in non sterile pharmaceutical products may have the potential to decrease or inactivate the pharmacological and therapeutic activity of the active principle and therefore represent a danger of great risk to the health of the person who is being treated with drugs, additionally, the presence of these microorganisms, depending on their ability to produce disease in susceptible hosts, can cause unexpected infections or diseases that affect the patient or consumer of these non sterile drugs. The objective of the work was to develop a microbiological risk analysis of objectionable microorganisms in a dietary supplement of a pharmaceutical industry as a tool in safety management. This was an observational-descriptive cross-sectional study. In the pharmaceutical industry (in the dietary supplement) a risk analysis was developed studying all the parameters, having as a result that the soft capsules with Krill oil do not present objectionable microorganisms of the pathogenic type, as a low risk product, therefore it is approved for batch release following these parameters. In Paraguay there are no regulations about the analysis of objectionable microorganisms, in comparison with other countries such as Argentina, and for a long time in the US and European countries (due to FDA reports). Therefore, this work is relevant and very vital important to establish national legislation with a view of the manufacture of safe, reliable and effective drugs.

Índices de Riesgo en relación a la transmisión de gastroenteritis aguda a partir de alimentos contaminados con Norovirus

RESUMEN La investigación de virus en los alimentos se convirtió en una necesidad de salud pública como consecuencia de la aparición de epidemias víricas, relacionadas al consumo de frutas y vegetales, carnes, agua y pescados contaminados. Entre los agentes virales responsables de enfermedades transmitidas por alimentos (ETAs), el Norovirus (NoV) se destaca como principal causante de gastroenteritis aguda (GEA) en el mundo. Un virus entérico, con elevada persistencia ambiental y bajas dosis mínimas infecciosas (1-100 partículas). En Argentina, el NoV se identificó en más del 60% de los brotes de GEA informados desde 2004. Actualmente la detección de virus patógenos en alimentos no está regulada en Argentina y la información en particular de NoV y ETAs es escasa o desactualizada. En este contexto, el presente trabajo abordó la determinación de índices de riesgo en relación al consumo de distintas matrices alimentarias contaminadas con NoV, identificando y caracterizando el virus y sus consecuencias en la salud humana. Durante el año 2019 se registraron brotes de NoV con más de 4000 personas afectadas en el territorio argentino. A partir de los índices obtenidos, se estima que los datos hallados no son representativos de todas las personas infectadas. Se considera esencial generar un sistema de notificación de brotes de alto impacto, posibilitando estimar el riesgo de la presencia de NoV en matrices alimentarias, identificando genotipos y genogrupos. Un mejor conocimiento de la virología y epidemiología de este agente infeccioso permitiría a los organismos pertinentes la toma de medidas preventivas y decisiones de mejora.

ABSTRACT The investigation of viruses in foods has become a prime concern for public health as a consequence of viral diseases outbreaks linked to the consumption of contaminated fresh fruits and vegetables, meats, water and fish. Norovirus (NoV) stands out as the main virus responsible for foodborne disease and the leading cause of acute gastroenteritis (AGE) in the world. It is an enteric virus, with high environmental persistence and low infectious dose (1-100 particles). NoV has been identified in over 60% of AGE outbreaks recorded in Argentine since 2004. Currently, food testing for the detection of pathogenic viruses is not mandatory in Argentine and the information available on the prevalence of NoV and foodborne diseases is scarce and outdated. In this context, the present work addresses the risk assessment of different foodstuff contaminated with NoV, identifying and characterizing the virus and its effects on human health. In 2019, registered outbreaks of NoV in Argentine affected more than 4000 people. According to the indices obtained, it was estimated that the given data does not accurately represent all infected cases. It is considered essential to generate a high impact outbreak reporting system, which could allow the estimation of the risk of presence of NoV in different foods, identifying the genotypes and genogroups. A better understanding of the virology and epidemiology of this infectious agent will allow the implementation of preventive measures and better decision making by the responsible organizations.

Factores protectores y de riesgo asociados a las conductas delictivas en adolescentes: una revisión sistemática / Risk and Protective Factors Associated with Criminal Behaviors in Adolescents: A Systematic Review / Fatores de proteção e risco associados ao comportamento deliti em adolescentes: uma revisão sistemática

Resumen La delincuencia juvenil implica la concreción de conductas tipificadas como delito según un marco legal, por una población exenta de responsabilidades jurídicas plenas. Dados los cambios biológicos, cognitivos y sociales que confluyen durante la adolescencia, es preciso que desde la psicología se enriquezca el contexto teórico sobre las variables que inciden en la aparición de conductas tipificadas como delito durante este periodo vital. Por tal razón, el presente trabajo tuvo por objetivo describir los factores de riesgo y de protección para la manifestación de conductas delictivas durante la adolescencia. El método desarrollado consistió en una revisión sistemática de la literatura, concretamente de artículos empíricos publicados en español e inglés en las bases de datos Scopus y Redalyc en una ventana de tiempo comprendida entre enero de 1998 y junio de 2019. Como resultado se encontró un total de 2,202 estudios, después del proceso de cribado y verificación de los criterios de exclusión e inclusión se seleccionaron 41 artículos como unidades de análisis. Con base en el modelo ecológico de Bronfenbrenner (1987), en la lectura a texto completo de los artículos seleccionados se identificaron 16 factores de riesgo en el microsistema y cuatro en el exosistema, además de 13 factores de la dimensión personal. Del mismo modo, se hallaron factores de protección, siete enmarcados en el microsistema, uno en el exosistema, y siete dentro de la dimensión personal. La discusión de los resultados está centrada en las consideraciones a tener en cuenta en los programas de prevención e intervención de las conductas tipificadas como delito en la adolescencia.

Abstract Juvenile crime implies a population exempt from full legal responsibilities performing behaviors defined as a crime according to a legal framework. Due to the biological, cognitive and social changes that coalesce during adolescence, it is necessary to enrich the theoretical context of the variables that influence the appearance of these criminal behaviors during this vital period from a psychological perspective. For this reason, this study's objective was to describe the risk and protective factors of demonstrating criminal behaviors during adolescence. The developed method consisted of a systematic review of literature, specifically empirical articles published in English and Spanish in the Scopus and Redalyc databases in a period of time between January 1998 and June 2019. As a result, 2,202 studies were found. After the screening process and having verified exclusion and inclusion criteria, 41 articles were selected as units of analysis. Based on the Bronfenbrenner's ecological systems theory (1987), after having fully read the selected articles, 16 risk factors were identified in the microsystem and four in the exosystem, in addition to 13 factors in the personal dimension. In the same way, protective factors were observed - seven in the microsystem, one in the exosystem and seven in the personal dimension. The discussion on these results focuses on the considerations to be taken into account in prevention and intervention programs for criminal behaviors during adolescence.

Resumo A delinquência juvenil implica a realização de condutas classificadas como crime, segundo um marco legal, por uma população isenta de plenas responsabilidades jurídicas. Dadas as mudanças biológicas, cognitivas e sociais que convergem durante a adolescência, é necessário que a partir da psicologia seja enriquecido o contexto teórico sobre as variáveis que afetam o aparecimento de condutas classificadas como crime neste período vital. Por esse motivo, o presente trabalho teve como objetivo descrever os fatores de risco e proteção para a manifestação de comportamentos delitivos na adolescência. O método desenvolvido consistiu em uma revisão sistemática de literatura, especificamente de artigos empíricos publicados em espanhol e inglês nas bases de datos Scopus e Redalyc no período de janeiro de 1998 a junho de 2019. Como resultado, foram encontrados 2.202 estudos e, após o processo de triagem e verificação dos critérios de exclusão e inclusão, foram selecionados 41 artigos como unidades de análise. Na leitura dos textos completos dos artigos selecionados, com base no modelo bioecológico de Bronfenbrenner (1987), foram identificados 16 fatores de risco no microssistema e quatro no exossistema, além de 13 fatores da dimensão pessoal. Da mesma forma, foram encontrados fatores de proteção, sete enquadrados no microssistema, um no exossistema e sete na dimensão pessoal. A discussão dos resultados está centrada nas considerações a levar em conta nos programas de prevenção e intervenção das condutas classificadas como crime na adolescência.

Progress of vector surveillance in Zhejiang Province / 预防医学

@#Began from the investigation of the hosts and vectors of plague, epidemic haemorrhagic fever and leptospirosis, mosquitoes, and flies, Zhejiang Province gradually implemented the ecological surveillance of mosquitoes, flies, cockroaches, rats, ticks and bed bugs, the drug resistance surveillance of mosquitoes, flies and cockroaches, the pathogenic surveillance of rats, mosquitoes and ticks. We carried out the comprehensive surveillance research into rats, mosquitoes, ticks and so on, and should further strengthen the analysis and utilization of surveillance data through the development of surveillance on ecological, drug-resistant, pathogenic and epidemic characteristics. We thoroughly implemented the concept of vector sustainable control, actively carried out the analysis and risk warning research of surveillance, to escort vector-borne diseases prevention and control, National Health City construction, and public health protection for big events; explored the technology of vector surveillance in rural areas, to serve for vector sustainable control for the rural revitalization strategy and beautiful countryside construction. This paper reviewed the progress of vector surveillance and related research in Zhejiang Province since 1930s, summarized the experience, and put forward to strengthen the technical areas of weakness and personnel training, to promote scientific and technological innovation, and to accelerate the construction of a information integrated system for vector surveillance of the new era in Zhejiang Province.

Risk analysis and the current status of the epidemic of human important parasitic diseases in Hubei Province / 公共卫生与预防医学

The general epidemic characteristics of seven key human parasitic diseases in Hubei Province, including schistosomiasis, malaria, filariasis, kala-azar (visceral leishmaniasis), soil-transmitted helminth infection, food-borne parasitic diseases, and echinococcosis, is reviewed in order to analyze the current epidemic situation and trend. At present, the epidemic of parasitic diseases has dropped to the lowest level in history in Hubei Province, but there still exists high risk of infections in some local areas. Along with the deepening of global economic integration and the implementation of the strategy of "the Belt and Road", and the expanding of dietary spectrum for human pursuing diversified material and cultural life, we are facing the transmission risk from imported parasitic diseases and rare parasitic diseases. Current monitoring efforts have been weakened due to the decline in work supporting measures. There will be potential risks of local outbreaks if an epidemic is not effectively controlled in time. It is recommended to maintain the multi-sectoral cooperation mechanism under the leadership of the government, further improve capacity building to ensure a capable and stable professional team for the prevention and control of parasitic diseases, and to increase the monitoring of parasitic diseases during the "14th Five-Year Plan" period, so as to consolidate the achievements of parasitic disease prevention and control and promote the health of people in Hubei Province.

Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States / 中国医疗器械杂志

OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.

Identification of critical influencing factors in dropping process of Xuesaitong Dropping Pills / 中国中药杂志

With the dropping process of Xuesaitong Dropping Pills(XDP) as the study object, critical factors affecting the quality indicators of pill pass rate, average weight of drop pills and roundness were screened out, so as to deepen the understanding of the dropping process. The critical process units, critical quality attributes and potential critical process influencing factors of XDP were determined by risk analysis and prior knowledge, and then the critical influencing factors were screened out by Plackett-Burman design. First, according to the risk assessment, the critical technique of XDP preparation process was dropping, and then the critical quality attributes of dropping process were pill pass rate, average weight of drop pills and roundness. Then, according to fishbone diagram and failure mode and effects analysis(FMEA), potential critical influencing factors were determined as flow rate, matrix ratio, solid-liquid ratio, feed-liquid temperature, top temperature of condensate, bottom temperature of condensate and dropping distance. Finally, among these seven potential factors, the critical influencing factors were determined as material liquid ratio, dropping distance, top temperature of condensate, bottom temperature of condensate. This study revealed the potential of Plackett-Burman design in screening and understanding the influence of selected factors on XDP dropping process, which could provide a reference for studying the dropping process.

Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process / 中国医疗器械杂志

In order to strengthen the supervision and management of medical devices, China implements pre-market registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.

El ciclo evolutivo de parásitos de la familia anisakidae. Hacia una prospectiva de medidas sanitarias de control / The evolutionary cycle of parasites of the anisakidae family. towards a prospective of sanitary control measures

Las larvas de nematodos en los peces, generalmente corresponde a especies de la familia Anisakidae, son gusanos redondos, sin segmentación; con hospedadores intermediarios y definitivos y un huésped accidental que es el humano, en quién va producir una enfermedad parasitaria del tacto digestivo, mundialmente conocida como anisakiasis, asociada a reacciones de hipersensibilidad debido a los alérgenos del parásito. La presencia de estos parásitos en los productos de la pesca, deberá ser controlada con medidas preventivas establecidas en la legislación sanitaria de países; estableciendo profilaxis, medidas higiénicas como consumir el pescado cocido, o sometido previamente a congelación a -20°C por 48 a 72 horas, para prevenir la enfermedad. Cuando enfocamos hacia una prospectiva de medidas sanitarias de control preventivo, se plantea el establecimiento de un plan de requerimientos de alimentos seguros, basado en el análisis de riesgos y control de puntos críticos (HACCP), constituido por un paquete de documentos escritos basados en los principios de seguridad de alimentos; que contendrá: el análisis de riesgos; controles preventivos; programas en la cadena de suministros; delineamiento de los procedimientos para ser seguidos por monitoreo, acciones correctivas y verificación. Estará basado en las obligaciones que se puedan establecer bajo jurisdicción regulatoria para el pescado, en cuanto a la pesca o captura, manipulación a bordo o en la orilla y mecanismos de conservación hasta el expendio; que dé lugar a un manual de buenas prácticas de manufactura, análisis de riesgo y controles preventivos de riesgos para la regulación de alimentos de origen marino para consumo humano

The larvae of nematodes in fish generally correspond to species of the Anisakidae family, they are round worms, without segmentation; with intermediate and definitive hosts and an accidental host that is human, in whom it will produce a parasitic disease of the digestive tract, worldwide known as anisakiasis, associated with hypersensitivity reactions due to parasite allergens. The presence of these Parasites in fishery products should be controlled with preventive measures established in the sanitary legislation of countries; establishing prophylaxis, hygienic measures such as consuming the cooked fish, or previously subjected to freezing at -20 ° C for 48 to 72 hours to prevent the disease. When we focus on a prospective of preventive control sanitary measures, the establishment of a plan for safe food requirements based on risk analysis and control of critical points (HACCP), constituted by a package of written documents based on the principles, is considered food safety; which will contain: risk analysis; preventive controls; programs in the supply chain; delineation of the procedures to be followed by monitoring, corrective actions and verification. It will be based on the obligations that can be established under the regulatory jurisdiction for fish, in terms of fishing or capture, handling on board or on the shore and conservation mechanisms up to the sale; that results in a manual of good manufacturing practices, risk analysis and preventive risk controls for the regulation of food of marine origin for human consumption

Evaluación del riesgo biológico en el área quirúrgica de una instalación de salud / Assessment of Biological Risk in the Surgical Area of a Health Facility

RESUMEN Introducción: El personal que labora en el área quirúrgica de un hospital, está expuesto a riesgos biológicos que requieren más que un tratamiento médico. Para la prevención, además, de ocuparse de la integridad del paciente, se le ha agregado la de proteger la salud del equipo quirúrgico, susceptibles a contaminarse con objetos infectados. Estos aspectos no son de estricto cumplimiento por el personal que labora en los salones o salas quirúrgicas de hospitales y centros de salud. Objetivo: Realizar un análisis de riesgo biológico en el área quirúrgica de una instalación de salud. Métodos: Se realizó el análisis de riesgo, que consistió en tres procesos generales: evaluación del riesgo, gestión del riesgo y comunicación del riesgo. Resultados: Se identificaron y caracterizaron los peligros de contaminación a los que pueden estar sometidos los trabajadores. Se identificaron las vulnerabilidades presentes, empleándose para ello, una lista de chequeo diseñada, teniéndose en cuenta los principios de la bioseguridad y, se evaluaron los riesgos biológicos empleándose una matriz de estimación del riesgo (posibilidad por consecuencia). Conclusiones: Se discuten medidas aplicables para la gestión de la bioseguridad en áreas quirúrgicas de instituciones de salud cubanas(AU)

ABSTRACT Introduction: The personnel working in the surgical area of a hospital are exposed to biological risks requiring more than medical treatment. In view of prevention, apart from taking care of the integrity of the patient, they have been assigned protecting the health of the surgical team, which are susceptible to becoming contaminated with infected objects. These aspects are not strictly complied with by the personnel working in the operating or surgical rooms of hospitals and health centers. Objective: To assess the biological risk in the surgical area of a health facility. Methods: The risk analysis was carried out, which consisted of three general processes: risk assessment, risk management, and risk communication. Results: The contamination hazards to which workers may be subjected were identified and characterized. The existing vulnerabilities were identified using a checklist designed taking into account the biosecurity principles. The biological risks were evaluated, using a risk estimation matrix (possibility by consequence). Conclusions: Measures are discussed that can be applied for the management of biosecurity in surgical areas of Cuban health institutions(AU)

Regresión logística y redes neuronales como herramientas para realizar un modelo Scoring / Logistic regression and neural networks as tools to perform a Scoring model / Regressão logística e redes neuronais como ferramentas para realizar Scoring

Resumen Introducción. El propósito de esta investigación es analizar el riesgo crediticio de una institución financiera no vigilada por la Superintendencia Financiera de Colombia en torno a un modelo scoring que permita determinar el incumplimiento de los clientes correspondiente a su cartera de consumo. Objetivo. Confrontar el poder de pronosticación de dos modelos scoring obtenidos a través de regresión logística y red neuronal. Materiales y métodos. Los modelos se desarrollan con base en una muestra de 43.086 obligaciones correspondiente a una cartera de consumo, utilizando las técnicas estadísticas de regresión logística y red neuronal. La primera está enmarcada en el grupo de los modelos lineales generalizados, los cuales utilizan una función logit y son útiles para modelar probabilidades referentes a un evento en función de otras variables, mientras que la segunda son modelos computacionales cuyo objetivo es resolver problemas utilizando relaciones ya estipuladas y para ello utiliza una muestra base del proceso que se ampara en el éxito del autoaprendizaje producto del entrenamiento. Resultados. Para ambos modelos se logra una precisión del 71% en la base de entrenamiento y del 72 % en la base de comprobación, sin embargo, a pesar de obtener resultados similares, la regresión logística arrojó la menor tasa de malos en la zona de aceptación. Conclusión. Las dos técnicas utilizadas son adecuadas para el estudio y predicción de la probabilidad de incumplimiento de un cliente correspondiente a una cartera de consumo, lo anterior, respaldado por el alto índice de eficacia predictiva en ambos modelos.

Abstract Introduction. The purpose of this research is to analyze the credit risk of a financial institution not supervised by the Financial Superintendence of Colombia around a scoring model that allows determining the default of clients corresponding to their consumer portfolio. Objective. Confront the forecasting power of two scoring models obtained through logistic regression and neural network. Materials and methods. The models are developed based on a sample of 43,086 obligations corresponding to a consumer portfolio, using the statistical techniques of logistic regression and neural network. The first is framed in the group of generalized linear models, which use a logit function and are useful for modeling probabilities related to an event based on other variables; while the second consists in computational models whose objective is to solve problems using relationships already stipulated, employing for this purpose a base sample of the process that is based on the success of the self-learning resulting from training. Results. For both models, an accuracy of 71 % in the training base and 72 % in the testing base is achieved. However, despite obtaining similar results, the logistic regression yielded the lowest rate of bad in the acceptance zone. Conclusion. The two techniques used are suitable for the study and prediction of the probability of default of a client corresponding to a consumer portfolio; the foregoing is supported by the high index of predictive effectiveness in both models.

Resumo Introdução. O propósito de esta pesquisa é analisar o risco creditício de uma instituição financeira não vigilada pela Superintendência Financeira da Colômbia em torno de um modelo scoring que permita determinar o incumprimento dos clientes correspondentes à sua carteira de consumidores. Objetivo. Confrontar o poder de previsão de dois modelos scoring obtidos através de regressão logística e rede neuronal. Materiais e métodos. Os modelos desenvolvam-se com base em uma amostra de 43.086 obrigações correspondentes à una carteira de consumidores, utilizando as técnicas estatísticas de regressão logística e rede neuronal. A primeira está enquadrada no grupo dos modelos lineais generalizados, os quais utilizam uma função logit e são úteis para modelar probabilidades referentes à um evento em função de outras variáveis, em quanto que, a segunda são modelos computacionais cujo objetivo é resolver problemas utilizando relações já estipuladas e para isso utiliza-se uma amostra base do processo que ampara-se no sucesso do autoaprendizagem produto do treinamento. Resultados. Para ambos os modelos se consegue uma precisão do 71% na base do treinamento e do 72% na base da comprovação, mas, não obstante isso, a pesar de obterem resultados semelhantes, a regressão logística mostrou a menor taxa ruim na zona de aceitação. Conclusão. As duas técnicas utilizadas são adequadas para o estudo e previsão da probabilidade do incumprimento de um cliente correspondente à una carteira de consumidores, o que precede, respaldado pelo alto índice de eficiência preditiva em ambos os modelos.

Evaluación del riesgo radiológico en la radiosinoviortesis y el tratamiento mielosupresor de la policitemia vera / Radiological risk assessment in radiosynoviorthesis and the myelosupressor treatment of polycythemia vera

Introducción: La aplicación del método de la matriz de riesgo para la evaluación del riesgo radiológico en la medicina permite identificar de manera proactiva debilidades en las etapas del proceso y hacer un plan de acciones de mejora para la seguridad y calidad. Objetivo: Evaluar los riesgos radiológicos de la radiosinoviortesis y el tratamiento mielosupresor con Fósforo-32 de la policitemia vera. Método: Se utilizó el método de matriz de riesgo y se realizó el análisis y tratamiento de los riesgos radiológicos por medio del código cubano SECURE-MR-FMEA 3.0. Resultados: El 17 por ciento del riesgo alto se eliminó con las medidas adicionales adoptadas; predominaron las consecuencias medias para los trabajadores y el público, 30 por ciento y el 14 por ciento, respectivamente. Las defensas más importantes fueron: levantamiento radiológico inicial de las áreas del departamento; revisión independiente del proyecto con las regulaciones de seguridad aplicables; inspección de trabajos de construcción civil y montaje de equipos antes de iniciar la operación del departamento; capacitación de los médicos nucleares en los tratamientos; existencia de protocolos de tratamiento; análisis de lecciones aprendidas de incidentes radiológicos; levantamiento radiológico periódico de las áreas del servicio y procedimiento de emergencia para reducir la dosis en órganos críticos en caso de administración errónea de radiofármacos. Se creó una base de datos de incidentes utilizada como referencia para el modelo utilizado. El factor humano fue la causa mayor de los sucesos radiológicos analizados (88 por ciento). Conclusiones: Estos resultados facilitan la toma de decisiones para el mejor desempeño de la radiosinoviortesis y el tratamiento de la policitemia vera con Fósforo-32 en Cuba. Se sugiere elaborar el plan de mejora de la seguridad con especial atención a las operaciones de administración del radiofármaco en ambos casos.(AU)

Introduction: The application of risk matrix for ionizing radiation medicine allow identify in proactive way the weakness of the process' step, which implies in the design of safety and quality improvement plan for this. Method: Risk matrix method applied for radiosynoviorthesis and the myelosupressor treatment with Phosphorus-32 of polycythemia vera. The Cuban code SECURE-MR-FMEA 3.0 is used. Results: It was eliminated the 17 percent of the high risk with additional measures, and the medium consequences for workers and public are 30 percent and 14 percent, respectively. The most important identified safety measures were the initial radiological monitoring from different nuclear medicine department areas; the project revision based on the applicable safety regulations; a survey of civil construction works and equipment assembly before work began; training of nuclear medicine doctors in related aspects of nuclear medicine treatments; existence of treatment protocols; the analysis of learned lessons from radiological incidents; the periodical radiological monitoring from different services areas and the emergency procedure for the cases of mistake in the radiopharmaceuticals administration. Human factor was the major cause in analyzed radiological events (88 percent). Conclusions: These results facilitate taking decisions for the best performance of radiosynoviorthesis and the myelosupressor treatment with Phosphorus-32 of polycythemia vera in Cuba. It is recommended to elaborate the safety improvement plan from these and focussing in the radiopharmaceutical administration operations in both cases.(AU)

Risk Analysis of Radiotherapy Implementation Process Based on Failure Mode and Effect Analysis / 中国医疗器械杂志

OBJECTIVE@#Providing a risk assessment method for the implementation of radiotherapy to identify possible risks in the implementation of the treatment process, and proposing measures to reduce or prevent these risks.@*METHODS@#A multidisciplinary expert evaluation team was developed and the radiotherapy treatment process flow was drawn. Through the expert team, the failure mode analysis is carried out in each step of the flow chart. The results were summarized and the (risk priority ordinal) score was obtained, and the quantitative evaluation results of the whole process risk were obtained.@*RESULTS@#One hundred and six failure modes were obtained, risk assessment of (20%) high risk failure model are 22 and severity (≥ 8) high risk failure model are 27. The reasons for the failures were man-made errors or hardware and software failures.@*CONCLUSIONS@#Failure mode and effect analysis can be used to evaluate the risk assessment of radiotherapy, and it provides a new solution for risk control in radiotherapy field.

Valoraciones entorno al riesgo financiero en las medianas empresas de la Provincia de Manabí / Assessments about financial risk in the medium-sized companies of Manabí / Valorações meio ao risco financeiro nas médias empresas da Província de Manabí

Resumen Introducción: El riesgo financiero en las empresas es uno de los problemas científicos de relevancia, que preocupan a: empresarios, gerentes, emprendedores, entre otros. La sostenibilidad y eficiencia de las empresas, en especial de las medianas empresas, depende, en gran medida, del sistema financiero que adopten. Evaluar la probabilidad de riesgo, adquiere una gran relevancia. La presente investigación realizada en la provincia de Manabí, tiene como objetivo analizar la necesidad de la introducción del análisis del riesgo en el financiamiento de las medianas empresas (Me). Para el desarrollo de la investigación se utilizaron materiales y métodos, entre los que se puede mencionar: el análisis de documentos, el método hipotético deductivo, el método comparativo, la abstracción científica, el análisis de documentos y el método hermenéutico. En calidad de resultados fundamentales de la investigación se pueden citar: la determinación de las fuentes de financiamientos para la Me, el perfeccionamiento de la definición de riesgo financiero y las sugerencias para un uso racional de los recursos financieros y para obtención de crédito. Conclusión. Se caracterizó la mediana empresa de la provincia, determinando así las vías de financiamientos para las mismas.

Abstract Introduction: Financial risk in companies is one of the relevant scientific problems, which concern: entrepreneurs, managers, entrepreneurs, among others. The sustainability and efficiency of companies, especially medium-sized companies, depends to a large extent on the financial system they adopt. Assess the probability of risk, acquires great relevance. The present investigation carried out in the province of Manabí, has like objective analyze the necessity of the introduction of the analysis of the risk in the financing of the medium companies (Me). For the development of the research materials and methods were used, among which we can mention: the analysis of documents, the deductive hypothetical method, the comparative method, scientific abstraction, the analysis of documents and the hermeneutical method. The following are fundamental results of the research: the identification of financing sources for the Me, the improvement of the definition of financial risk and the suggestions for a rational use of financial resources and for obtaining credit. Conclusion. The medium-sized company of the province was characterized, thus determining the means of financing for them.

Resumo Introdução: O risco financeiro nas empresas é um dos problemas científicos relevantes, que dizem respeito a: empresários, gestores, empresários, entre outros. A sustentabilidade e a eficiência das empresas, especialmente as médias empresas, dependem em grande medida do sistema financeiro que adotam. Avalie a probabilidade de risco, adquira grande relevância. A presente investigação realizada na província de Manabí, tem como objetivo analisar a necessidade da introdução da análise do risco no financiamento das médias empresas (Me). Para o desenvolvimento dos materiais e métodos de pesquisa foram utilizados, dentre os quais podemos citar: a análise de documentos, o método hipotético-dedutivo, o método comparativo, a abstração científica, a análise de documentos e o método hermenêutico. A seguir, são apresentados os resultados fundamentais da pesquisa: a identificação de fontes de financiamento para o eu, o aprimoramento da definição de risco financeiro e as sugestões para o uso racional dos recursos financeiros e para obtenção de crédito. Conclusão A empresa de tamanho médio da província foi caracterizada, determinando assim os meios de financiamento para eles.

Análise de riscos potenciais associados à desinfecção de efluentes: o caso da ETE SJRP (SP) / Risk analysis applied to sewage disinfection: the case of the Sewage Treatment Plant of São José do Rio Preto (SP)

RESUMO A avaliação de risco é um processo no qual se determinam os riscos de natureza coletiva (social) e individual associados à instalação, operação ou desativação de uma atividade perigosa, levando-se em consideração a probabilidade de ocorrência de um determinado evento e a estimativa da extensão do dano que seria causado. No caso de estações de tratamento de esgoto (ETEs), em que pese a importância do aspecto locacional para assegurar a minimização de conflitos ambientais e sociais, a análise de risco deve ser parte integrante dos estudos de alternativas locacionais quando a concepção do projeto prever a utilização de substâncias perigosas armazenadas sob pressão, notadamente os sistemas de desinfecção por cloro. Entende-se, portanto, ser necessário avaliar o potencial de dano decorrente de falhas nos equipamentos e dispositivos de segurança que possam provocar vazamentos e/ou explosões. Nesse sentido, o presente artigo discute as contribuições dos estudos de análise de risco na implantação e operação de ETEs, valendo-se de um estudo de caso aplicado ao município de São José do Rio Preto, São Paulo. Os resultados obtidos destacam a relevância do estudo de análise de risco para a definição da localização do empreendimento e de medidas de segurança aplicadas ao gerenciamento da ETE e das áreas do entorno.

ABSTRACT Risk analysis allows for the identification of social and individual risks following the installation, operation or decommissioning of a hazardous activity, taking into account the probability of occurrence and the extension of damages. Sewage Treatment Plants with disinfection systems must be informed by a risk analysis in order to integrate social and environmental conflicts in decision-making. Therefore, it is relevant to assess the potential to cause relevant damage caused by failures in equipment or security devices that could lead to leakages and/or explosions. In this sense, the present paper discuss the results of a risk assessment applied to the Sewage Treatment Plant of São Jose do Rio Preto (SP). The results show the relevance of risk analysis in defining the locational alternative and the associated security measures applied to risk and conflict management, considering the plant itself, the environment and neighboring population.