Manejo de corpos no contexto do novo Coronavírus COVID-19 / Body management in the context of the new Coronavírus COVID-19

Em dezembro de 2019, em Wuhan, China, um novo coronavírus (SARS-COV-2) foi identificado como causa de doença respiratória aguda grave (COVID-19). Em janeiro de 2020, a Organização Mundial da Saúde (OMS) declarou o surto como uma emergência de saúde pública de interesse internacional (ESPII) e, em março de 2020, com a disseminação do vírus em diferentes países, foi declarada a pandemia. As definições de caso suspeito e confirmado de COVID-19 adotadas pelo Ministério da Saúde estão disponíveis neste endereço eletrônico: https://coronavirus.saude.gov.br/sobre-a-doenca#casossuspeito. A transmissão da COVID-19 se dá pelo contato pessoa-a-pessoa e por meio de fômites. Salientamos que o vírus SARS-COV-2 pode permanecer viável em superfícies ambientais por 24 horas ou mais. A transmissão de doenças infecciosas também pode ocorrer por meio do manejo de corpos, sobretudo em equipamentos de saúde. Isso é agravado por uma situação de ausência ou uso inadequado dos equipamentos de proteção individual (EPI). Nesse contexto, os profissionais envolvidos com os cuidados com o corpo ficam expostos ao risco de infecção. Os velórios e funerais de pacientes confirmados/suspeitos da COVID-19 NÃO são recomendados devido à aglomeração de pessoas em ambientes fechados. Nesse caso, o risco de transmissão também está associado ao contato entre familiares e amigos. Essa recomendação deverá ser observada durante os períodos com indicação de isolamento social e quarentena. A autópsia NÃO deve ser realizada e é desnecessária em caso de confirmação ante-mortemda COVID-19. Devido ao risco aumentado de complicações de piores prognósticos da COVID-19, reco-menda-se que profissionais com idade igual ou acima de 60 anos, gestantes, lactantes, portadores de doenças crônicas, cardiopulmonares, oncológicas ou imunodeprimidos não sejam expostos às atividades relacionadas ao manejo de corpos de casos confirmados/suspeitos pela COVID-19. Considerando a possibilidade de monitoramento, recomenda-se que sejam registrados nomes, datas e atividades de todos os trabalhadores que participaram dos cuidados post-mortem,incluindo a limpeza do quarto/enfermaria. É necessário fornecer explicações adequadas aos familiares/responsáveis sobre os cuidados com o corpo do ente falecido.

Development of Hospital Medical Instrumentation Management System Based on Cloud Computing / 中国医疗器械杂志

In order to improve the efficiency of medical instrumentation management in hospital, reduce the management cost and save the human cost, this study analyzes the problems in the traditional hospital medical instrumentation management system, and develops a new system based on cloud computing. Through the characters of the SaaS Service Platform, the system improves the flow efficiency of the medical instrumentation in hospital, saves deployment and operating system costs, and improves the people's work efficiency.

Aplicación de conceptos de ingeniería biomédica en la gestión de los equipos médicos en el Hospital Nacional "San Pedro", enero-septiembre 2019 / Application of biomedical engineering concepts in the management of medical equipment at the "San Pedro" National Hospital, January-September 2019

Propósito: identificar la aplicación de conceptos de ingeniería biomédica en la gestión de los equipos médicos, los cuales permitieran establecer comparaciones entre la gestión de los equipos médicos desarrollada y lo establecido en la teoría, con el fin de identificar aspectos contraproducentes que puedan afectar los servicios de salud prestados y la vulnerabilidad en la seguridad del paciente. Materiales y Métodos: la recolección de datos se ejecutó a través de los instrumentos de entrevista semiestructurada por medio de un muestreo teórico o intencional de los autores. Resultados: entre los principales resultados obtenidos se identifica que existe una limitación en cuanto a recurso humano y la formación continua sistemática y actualización del personal del departamento de biomédica, no se desarrollan evaluaciones de diseño y gestión de proyectos que involucren la infraestructura y sistemas hospitalarios en torno a los equipos médicos, no se cuenta con inventario técnico de los equipos médicos, ni existen programas desarrollados de tecnovigilancia. Conclusiones: la aplicación de los conceptos de ingeniería biomédica en la gestión de los equipos médicos dentro del hospital Nacional "San Pedro" se encuentra muy limitada, identificándose un desarrollo prácticamente nulo, lo cual puede conllevar a la ocurrencia de múltiples eventos adversos Recomendaciones: se recomienda Implementar un programa de tecnovigilancia y capacitar al personal de salud y personal del departamento de biomédica en el desarrollo de la tecnovigilancia. Asimismo, se recomienda capacitar al personal de biomédica en actualización de tecnología médica y herramientas de gestión de los equipos médicos, incluyendo la ejecución de las labores de mantenimiento preventivo, correctivo y calibraciones e inspecciones periódicas

Mobiliários e instalações sanitárias em unidades de saúde da família: acessibilidade física para pessoas com deficiência / Furniture and sanitary facilities in family health units: accessibility for physical disability

Objetivo: Investigar a acessibilidade física de mobiliários, equipamentos e instalações sanitárias em Unidades de Saúde de Família. Método: Trata-se de pesquisa descritiva exploratória, de base populacional, realizada nas Unidades de Saúde da Família do município de João Pessoa, Paraíba, Brasil. Utilizou-se um checklist fundamentado na Norma Brasileira 9050. Resultados: Dos 90 prédios avaliados, 83,3% dos balcões e das mesas de trabalho e 85,6% dos assentos ambulatoriais estão adequados, como preconizado pela legislação. Entretanto, apenas 24,4% dos bebedouros estão instalados adequadamente. Nenhuma das unidades apresentou textos contendo orientações e instruções escritas em braille; 60,0% não têm sanitários adequados, e 92,2% não estão devidamente sinalizados. Conclusão: Ainda são muitas as barreiras encontradas pelas pessoas com deficiência para o uso dos serviços de atenção básica à saúde. Nesse sentido, se faz necessário, intervenções específicas a esse grupo populacional e a avaliação das políticas públicas, para efetivar tudo o que é garantido por lei

Objective: To investigate the physical accessibility of furniture, equipment and sanitary facilities in Family Health Units. Method: This is an exploratory descriptive research, population-based, carried out in the Family health units of João Pessoa, Paraíba, Brazil. We used a checklist based on the Brazilian Standard 9050. Results: From the 90 assessed buildings, 83.3% of branches and desks and 85.6% of outpatient seats are adequate, as recommended by law. However, only 24.4% of the drinking fountains are installed properly. None of the units presented texts containing guidelines and instructions written in braille; 60.0% do not have adequate sanitation, and 92.2% are not properly signed. Conclusion: There are still many barriers faced by people with disabilities for the use of primary care services to health. In this sense, specific interventions are necessary to this population group and evaluation of public policies, to accomplish all that is guaranteed by law

Objetivo: Investigar la accesibilidad física de los muebles, equipos e instalaciones sanitarias en las Unidades de Salud de la Familia. Método: Se trata de un estudio exploratorio descriptivo, una basada en la población, llevado a cabo en las unidades de salud del município John Familia Pessoa, Paraíba, Brasil. Se utilizó una lista de control basado en el estándar de Brasil 9050. Resultados: 90 edificios evaluados, el 83,3% de las oficinas y los escritorios y el 85,6% de los puestos de consulta externa son adecuados, según lo recomendado por la ley. Sin embargo, sólo el 24,4% de las fuentes de agua potable están instalados correctamente. Ninguna de las unidades presenta textos que contienen directrices e instrucciones escritas en Braille; 60.0% no cuenta com saneamiento adecuado, y el 92,2% no ha iniciado correctamente. Conclusión: Todavía hay muchas barreras que enfrentan las personas con discapacidad a la utilización de los servicios de atención primaria a la salud. En este sentido, es necesario, intervenciones específicas para este grupo de población y la evaluación de políticas públicas, para llevar a cabo todo lo que está garantizado por la ley

Discussion on Quality Evaluation Method of Medical Device During Life-Cycle in Operation Based on the Analytic Hierarchy Process / 中国医疗器械杂志

The content related to the quality during life-cycle in operation of medical device includes daily use, repair volume, preventive maintenance, quality control and adverse event monitoring. In view of this, the article aims at discussion on the quality evaluation method of medical devices during their life cycle in operation based on the Analytic Hierarchy Process (AHP). The presented method is proved to be effective by evaluating patient monitors as example. The method presented in can promote and guide the device quality control work, and it can provide valuable inputs to decisions about purchase of new device.

Evaluation of Medical Instruments Cleaning Effect of Fluorescence Detection Technique / 中国医疗器械杂志

<p><b>OBJECTIVE</b>To compare the cleaning effect of automatic cleaning machine and manual cleaning on coupling type surgical instruments.</p><p><b>METHODS</b>A total of 32 cleaned medical instruments were randomly sampled from medical institutions in Putuo District medical institutions disinfection supply center. Hygiena System SUREII ATP was used to monitor the ATP value, and the cleaning effect was evaluated.</p><p><b>RESULTS</b>The surface ATP values of the medical instrument of manual cleaning were higher than that of the automatic cleaning machine.</p><p><b>CONCLUSION</b>Coupling type surgical instruments has better cleaning effect of automatic cleaning machine before disinfection, the application is recommended.</p>

Injetor intravascular de CO2: estudo in vivo de viabilidade inicial do dispositivo e de qualidade de imagem / C02 intravascu/ar injector: in vivo ear/y feasibility study of the device and image quality assessment

INTRODUÇÃO: Durante procedimentos endovasculares, estão presentes os riscos relacionados ao uso dos contrastes iodados, tais como a nefropatia por contraste, uma vez que é fundamental o emprego de um meio de contraste para a obtenção das imagens radiológicas vasculares. A injeção intravascular de gás CO2 purificado é reconhecidamente uma alternativa relativamente mais segura ao contraste iodado, contudo, seu manuseio artesanal pode também trazer dificuldades técnicas e riscos aos pacientes. Para contemplar estas questões, foi desenvolvido o protótipo de um injetor intravascular de CO2 medicinal, microprocessado, dedicado à obtenção de imagens angiográficas. OBJETIVOS: Realizar os testes de viabilidade técnica inicial do protótipo em modelo in vivo. MÉTODOS: Realizar a angioplastia da artéria renal esquerda de 10 porcos, divididos em 2 grupos: Grupo 1 (n=5) injeção de contraste iodado, Grupo 2 (n=5) injeção de CO2 através do protótipo. Monitorização clínica e laboratorial dos animais no pré, intra e pós-operatório, com exames de função renal na véspera e 48h após os procedimentos e 3 gasometrias arteriais seriadas no intra-operatório. Observação clínica foi mantida por 48h no pós- operatório. RESULTADOS: Os procedimentos de angioplastia com CO2 foram realizados com sucesso técnico de 100%, sem necessidade de complementação com injeção de contraste iodado no Grupo 2. Não foram identificadas falhas no protótipo em funcionamento. Não foram identificadas alterações clínicas ou radiológicas sugestivas de contaminação por ar ambiente do sistema de CO2 e nem alterações laboratoriais nos animais. As imagens angiográficas obtidas no Grupo 2 foram consideradas, numa avaliação subjetiva, relativamente inferiores às imagens obtidas no Grupo 1. DISCUSSÃO: A qualidade inferior de imagem no Grupo 2 pode ser atribuída ao equipamento de fluoroscopia utilizado, com software desatualizado em relação aos equipamentos atuais, que incluem pré-configurações para...

INTRODUCTION: During endovascular procedures, several risks related to iodinated contrast media are taken, such as Contrast Induced Nephropathy, since these are fundamental to obtain radiological vascular images under fluoroscopy. Intravascular medical grade CO2 injection is a widely accepted and relatively safer alternative to iodinated contrast, but its handling and manual delivery system could as well bring risks to patients, such as room air injection. To address these problems, we developed a prototype for a micro processed intravascular medicinal CO2 injector, dedicated to help obtain angiographic images. OBJECTIVES: To perform the in vivo Early Feasibility Clinical Studies of the prototype. METHODS: Perform a left renal artery angioplasty of 10 pigs, divided in 2 groups: Group 1 (n=5) injection of iodinated contrast and Group 2 (n=5) injection of CO2 with the prototype. Clinical and laboratorial data were measured pre, peri and post-operatively, by pre-operative and 48h post- operative creatinine tests and 3 peri-operative serial arterial blood gas analysis. Animais were kept under clinical observation for 48h after procedures. RESUL TS: Angioplasty procedures had 100% technical success in both groups, without the need of extra imaging with iodinated contrast in Group 2. There were no technical failures with the prototype. There were no identifiable clinical or radiological signs of room air intravascular injections. Ali laboratorial measurements were under normal value ranges. Angiography images obtained in Group 2 were subjectively considered inferior to images from Group 1. DISCUSSION: The inferior image quality in Group 2 could be attributed to the employed fluoroscopy equipment, since its software is not up to date to current equipment, which includes a dedicated CO2 angiography preset. Nevertheless, ali procedures in Group 2 were successful, and images in this group were therefore considered satisfactory. Handling of the prototype proved to be...

The Application of Compound Tabletop in Medical Imaging Equipment / 中国医疗器械杂志

This paper mainly introduces the material composition and structure of two kinds of compound tabletop which currently used in large medical imaging equipment, also introduces the proper material choosing and production processing, together with the advantage and shortage of this two kinds of tabletop and different application occasion.

Wearable Medical Devices' MCU Selection Analysis Based on the ARM Cortex-MO+ Architecture / 中国医疗器械杂志

According to the characteristics of low cost, high performance, high integration and long battery life of wearable medical devices, the mainstream low-power microcontroller(MCU) series were compared, and came to the conclusion that the MCU series based on ARM Cortex-M0+ architecture were suitable for the development of wearable medical devices. In aspects of power consumption, operational performance, integrated peripherals and cost, the MCU series based on Cortex-M0+ architecture of primary semiconductor companies were compared, aimed at providing the guides of MCU selection for wearable medical devices.

The Preliminary Study on the Construction of Medical Device Naming System in China / 中国医疗器械杂志

The article has summarized the situation related to medical device naming, analyzed the problems of medical device naming in our country, put forward some new thinking in building the naming system of medical device in our country provided some reference on technical study of medical device naming.

Problems and Solutions on the Management of Medical Devices in Different Places / 中国医疗器械杂志

The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements.

Advices on Improving the Classification Method of Medical Devices / 中国医疗器械杂志

This article introduces the classifications of medical devices by FDA and EU and compares them with the situation in China. Towards the problems found, several reasonable advices are put forward.

The Application of the Fault Tree Analysis Method in Medical Equipment Maintenance / 中国医疗器械杂志

In this paper, the traditional fault tree analysis method is presented, detailed instructions for its application characteristics in medical instrument maintenance is made. It is made significant changes when the traditional fault tree analysis method is introduced into the medical instrument maintenance: gave up the logic symbolic, logic analysis and calculation, gave up its complicated programs, and only keep its image and practical fault tree diagram, and the fault tree diagram there are also differences: the fault tree is no longer a logical tree but the thinking tree in troubleshooting, the definition of the fault tree's nodes is different, the composition of the fault tree's branches is also different.

A method of medical device power supply maintenance / 中国医疗器械杂志

Based on the circuit board, we draw its circuit diagram. By analyzing the circuit diagram, we maintain medical device power supply and achieve the troubleshooting goal quickly.

Incidencia de eventos adversos asociados a dispositivos médicos en una institución de salud en Colombia / Incidence of adverse events associated with medical devices within a health institution in Colombia

Este artículo presenta los resultados de un estudio retrospectivo de eventos adversos asociados a dispositivos médicos (EADMS), presentados en el periodo de enero a junio de 2010 en el servicio de Cirugía de una institución prestadora de servicios de salud (IPS) en Colombia. Fueron identificados 29 EADMS, que según la gravedad de su desenlace se clasificaron en: 2 leves, 17 moderados, 4 serios y 6 potenciales (también llamados incidentes adversos). Las fuentes de información fueron el software institucional de reporte de eventos adversos y encuestas aplicadas al personal de la institución. Después de seleccionar los eventos adversos según los parámetros de inclusión del proyecto y a partir de los resultados de las encuestas, el análisis de las causas se hace en 21 EADMS. Los EADMS potenciales se determinaron prevenibles en su totalidad y los otros en una gran parte. Este estudio encontró que el uso incorrecto del dispositivo médico, es el principal factor contributivo en la incidencia de estos eventos, sin embargo, existen otros factores que también son representativos. Con este estudio se propone a la institución diversas estrategias y planes de mejoramiento que propenden a eliminar las causas de estos eventos y, además crear una herramienta para estandarizar, a nivel institucional, el análisis de EADMS.

This paper presents the results of a retrospective study of medical devices-associated adverse events (EADMS) presented during the period of January through June of 2010 in the Surgery Department of an IPS in the country. There were identified 29 medical devices-associated adverse events, which according to the severity of its outcome were classified as: 2 mild, 17 moderate, 4 serious, and 6 potential events (also called adverse incidents). The information sources were the institutional software for the report of adverse events, and surveys administered to the institution staff. After selecting the adverse events according the inclusion parameters from this project and from the survey results, the investigation of the causes considered 21 EADMS. The potential EADMS events were determined entirely preventable and the others in a large part. The incorrect use of the medical device is the most important contribution factor in the incidence of these events, however, there others factors that are representative. The study proposes to the institution some strategies and improvement plans that tend to delete the causes of these events and, also to create a tool to standardize, in an institutional level, the analysis of EADMS.

Introduce the quality control of equipment of hemodialysis center / 中国医疗器械杂志

This paper introduces the quality control of equipment of hemodialysis center, which includes the wate of hemodialysis, disinfection of the equipment, maintenance, check and calibration of the equipment.

Antimicrobial activity of a formulation for the low temperature disinfection of critical and semi-critical medical equipment and surfaces

The antimicrobial activity of the disinfectant formulation isopropyl-tridecyl-dimethyhl ammonium [UMONIUM38: Huckert's International, Nivelles, Belgium] planned for the low temperature disinfection of critical and semi-critical medical equipment and surfaces was evaluated under clean and dirty experimental conditions [high and low concentrations of organic material]. The formulation was obtained by a synergic combination of three different active compounds, two alcohols and a quaternary ammonium. The anti-mycobacterial [Mycobacterium avium and Mycobacterium terrae], and antiviral [Poliovirus type 1, Adenovirus type 5, hepatitis B virus, and human immunodeficiency virus type 1] activities of this formulation were addressed using suspension assays. In addition, surface assays were also used to test the antibacterial [Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Enterococcus hirae] and antimycotic [Candida albicans and Aspergillus niger] activities. Using standardised methods, a reduction of the virus titers higher than 4 Log10 required to document the virucidal activity of a disinfectant formulation was obtained using 2.5% isopropyltridecyl-dimethyl-ammonium for 10 minutes or more under dirty conditions, and for 1 minute or more under clean conditions for both viruses [Poliovirus I and Adenovirus 5]; using the 0.5% dilution a reduction of the virus titers higher than 4 Log10 was observed after incubation for 20 minutes or mote under clean and dirty conditions [both viruses]. A reduction of the HIV-1 titers higher that 4 Log10 was obtained using 2.5% isopropyl-tridecyl-dimethy1 ammonium for 10 minutes or more under dirty conditions, and 1 minute or more under clean conditions. 0.5% dilution reduced the titers after incubation for 10 minutes or more under clean and dirty conditions. The mycobactericidial activity of the disinfectant formulation at 20 °C for 60 minutes, 30 minutes, 10 minutes and 5 minutes was demonstrated. The bactericidal and fungicidal activities of Isopropyl-tridecyl-dimethyl ammonium were also evaluated using a quantitative non-porous surface test at various concentrations. The data document the dynamics of the antimicrobial activity of the disinfectant under investigation, under in vitro controlled conditions and highlight the relatively low influence of organic material on its activity