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Dermatology is one of the medical fields outside the radiology service that uses image acquisition and analysis in its daily medical practice, mostly through digital dermoscopy imaging modality. The acquisition, transfer, and storage of dermatology images has become an important issue to resolve. We aimed to describe our experience in integrating dermoscopic images into PACS using DICOM as a guide for the health informatics and dermatology community. During 2022 we integrated the video dermoscopy equipment through a strategic plan with an 8-step procedure. We used the DICOM standard with Modality Worklist and Storage commitment. Three systems were involved (video dermoscopy software, the EHR, and PACS). We identified critical steps and faced many challenges, such as the lack of a final model of DICOM standard for dermatology images.

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Purpose: The main objective of this paper is to analyze the Brazilian Ministry of Health (MoH) efforts in the management of medical equipment, with a specific approach for lung ventilators in the pandemic scenario of COVID-19. Methods: The methodology included a review of the normative framework and literature on technological management and research on the database of the Ministry of Health. Results: As a promoter for acquiring medical equipment, the MoH role is highlighted and added to this competence; its function as the coordinator of the National Policy on Health Technology Management (PNGTS). According to the PNGTS the MoH has to support health managers in the implementing, monitoring, and maintaining health technologies. The scenario of lung ventilators in the pandemic was discussed, with research to verify demands, offers, installed capacity, and investments. In less than one year, the Ministry of Health acquired several pulmonary ventilators, 8.55 times greater than the annual averages of equipment acquired from 2016 to 2019. So far, there is still no maintenance plans or strategy of management for that equipment, especially in a post-pandemic scenario. Conclusion: It is possible to conclude that the Ministry of Health needs to improve health technology management systems. On the scale of the Policy, it is necessary to commit to permanent and long-term actions to ensure sustainability and reduce the technological vulnerabilities of the SUS.

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BACKGROUND: Infusion Pumps (IP) are medical devices that were developed in the 1960s and generate fluid flow at pressures higher than that of normal blood pressure. Various hospital sectors make use of them, and they have become indispensable in therapies requiring continuity and precision in the administration of medication and/or food. As they are classified Class III (high risk) equipment, their maintenance is crucial for proper performance of the device, as well as patient and operator safety. The principal consideration of the pump is the volume infused, and the device demands great attention to detail when being calibrated. A lack of necessary care with this equipment can lead to uncertainty in volume and precision during the administration of substances. Because of this, it is essential to evaluate its reliability, to prevent possible failures at time of execution. This control aims at the quality of the intended infusion result, becoming an indication of quality. METHODS: This systematic review summarizes studies done over the last 10 years (2011 to December 2021) that address the reliability and accuracy of hospital infusion pumps, in order to identify planning of maintenance and/or other techniques used in management of the equipment. The Prisma method was applied and the databases utilized were Embase, MEDLINE/Pubmed, Web of Science, Scopus, IEEE Xplore, and Science Direct. In addition, similar reviews were studied in Prospero and the Cochrane Library. For data analysis, softwares such as Mendeley, Excel, RStudio, and VOSviewer were used, and Robvis helped in plotting risk of bias results for studies performed with Cochrane tools. RESULTS: The six databases selected produced 824 studies. After applying eligibility criteria (inclusion and exclusion), removing duplicates, and applying filters 1 and 2, 15 studies were included in the present review. It was found that the most relevant sources came from the Institute of Electrical and Electronics Engineers (IEEE) and that the most relevant keywords revolved around the terms ("device failure", "infusion pumps", "adverse effects", "complications", etc.). These results made clear that there remains substantial room for improvement as it relates to the study of accuracy and reliability of infusion. CONCLUSIONS: We verified that the reliability and precision analysis of hospital infusion pumps need to be performed in a more detailed and consistent way. New developments, considering the model and IP specification, are intended, clearly explaining the adopted methodology.

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El presente estudio de factibilidad técnica realizado por docentes investigadores del Centro Regional MEGATEC Zacatecoluca se centró en desarrollar una investigación descriptiva y aplicada para escalar la comunicación de un Sistema Central de Monitoreo de Pacientes a dispositivos móviles. El objetivo principal del proyecto fue brindar alternativas para escalar y optimizar el acceso a la información de los signos vitales de pacientes, a través de la integración y desarrollo de herramientas informáticas y aplicaciones de terceros, con el software del sistema y componentes informáticos del Sistema Central de Monitoreo. El proyecto integró herramientas, conocimientos, habilidades, experiencias, métodos y procedimientos requeridos para el desarrollo e implementación de un sistema de comunicación interoperable entre aplicaciones heterogéneas. Se utilizaron protocolos y estándares para intercambiar información entre aplicaciones de salud HL7 y FHIR.

This technical feasibility study carried out by research professors from the Centro Regional MEGATEC Zacatecoluca focused on the developing of a descriptive and applied research to scale the communication of a Central Patient Monitoring System to mobile devices. The main objective of the project was to provide alternatives to scale and optimize access to information on the vital signs of patients, through the integration and development of computer tools, and third-party applications with the system software and computer components of the Central System Monitoring. The project integrated tools, knowledge, skills, experiences, methods and procedures required for the development and implementation of an interoperable communication system between heterogeneous applications. Protocols and standards were used to exchange information between HL7 and FHIR health applications.

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Introdução: A pandemia causada pelo coronavírus SARS-CoV-2 trouxe uma pressão descomunal sobre os sistemas de saúde, especialmente sobre a disponibilidade de leitos, equipamentos e recursos humanos das unidades de terapia intensiva (UTI), que mesmo antes desse cenário já apresentavam dificuldades, em especial na gestão de equipamentos. Embora se tenha passado mais de 10 anos do início da obrigatoriedade da gestão de tecnologias em serviços de saúde, a sua implementação na prática ainda é um desafio e um problema de saúde pública. Objetivo: Verificar a implantação do Plano de Gerenciamento de Tecnologias de equipamentos médico-assistenciais nas UTI de Goiânia, parte integrante da gestão de tecnologias. Método: Como base utilizou-se dados secundários coletados em um guia elaborado pela Vigilância Sanitária, aplicado em dois momentos durante as inspeções em UTI. Os dados foram analisados de forma comparativa e os resultados apresentados por meio de frequência absoluta, relativa e de análise estatística. Resultados: Os níveis de implantação do Plano de Gerenciamento de Tecnologias encontrados foram de 25,8% e 40,9% na 1ª e 2ª inspeção, respectivamente. Conclusões: Investimentos em treinamento e em programa de educação permanente podem levar a uma melhoria na implantação do plano e, consequentemente, a um avanço na qualidade do serviço oferecido ao usuário. Considerando que a Vigilância Sanitária é um importante catalisador dessa mudança, este estudo traz dados importantes para os gestores priorizarem ações e formularem políticas públicas na Saúde Coletiva que servirão para melhorar a segurança dos pacientes e, por consequência, ajudar no enfrentamento da COVID-19.

Introduction: The pandemic caused by the SARS-CoV-2 coronavirus has brought a huge pressure on health systems, in particular the availability of beds, equipment and human resources in Intensive Care Units (ICU), which even before this scenario already had difficulties, especially in equipment management. Although more than 10 years have passed since the beginning of mandatory technology management in health services, its implementation in practice is still a challenge and a public health problem. Objective: To verify the implementation of the Medical Equipment Technology Management Plan in the ICUs of Goiânia, Goiás, an integral part of technology management. Method: As a basis, secondary data collected in a Guide prepared by the Sanitary Surveillance was used, applied in two moments during inspections in the ICU. The data were analyzed comparatively and the results presented through absolute and relative frequency and statistical analysis. Results: The levels of implementation of the Technology Management Plan found were 25.8% and 40.9% in the 1st and 2nd inspection, respectively. Conclusions: Investments in training and in a permanent education program can be a direction to improve the implementation of the plan and, consequently, an advance in the quality of the service offered to the user. Considering that Health Surveillance is an important catalyst for this change, this study provides important data for managers to prioritize actions and formulate public policies in Public Health that will serve to improve patient safety and, consequently, help in coping with COVID-19.

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El mantenimiento preventivo en las instituciones hospitalarias se ejecuta para minimizar las acciones correctivas. Esto trae consigo una disminución de los gastos, una reducción de los riesgos y un aumento de la disponibilidad técnica de los equipos médicos, con la disminución de los tiempos de parada de los servicios, lo cual redunda en la excelencia de los servicios médicos prestados. En el campo de las tecnologías médicas ocurre un gran avance cada día, por lo que los equipos son más sofisticados y costosos. Este artículo tiene el objetivo de exponer la importancia de la capacitación ineludible del personal de Electromedicina en la actividad de gestión de mantenimiento a equipos médicos, a partir de las necesidades que ofrece la interpretación de su inventario. Se brindan pautas básicas sobre la preparación permanente y continuada del electromédico en mantenimiento a equipos médicos y se demuestra lo útil que resulta un inventario para gestionar la capacitación de los recursos humanos, lo cual se debe a la consulta, el análisis-síntesis y la sistematización de múltiples fuentes bibliográficas impresas e insertadas en la web: bases de datos Medline, Scielo, Redalyc y Google Académico. De ellas se revisó el material de 62 y, finalmente, se seleccionaron 24 artículos. Se concluyó que la capacitación en esta temática es fundamental para que las tareas de mantenimiento constituyan en verdad herramientas eficaces, que beneficien no solo a la institución prestadora de servicios de salud, sino al paciente y al personal médico(AU)

Preventive maintenance in hospital institutions is carried out to minimize corrective actions. This brings about a decrease in expenses, a reduction of risks and an increase in the technical availability of medical equipment, with a reduction in the times that services stop, which results in the excellence of the medical services provided. In the field of medical technologies, great advances occur every day, the reason why pieces of equipment are more sophisticated and expensive. This article aims to expose the importance of the unavoidable training of electromedicine personnel in the activity of maintenance management for medical equipment, based on the needs offered by the interpretation of its stock. Basic guidelines are provided about the permanent and continuous training of the electromedicine technologist in maintenance of medical equipment, while it is demonstrated how useful an equipment stock is to manage the training of human resources, which responds to the work developed after consultation, analysis-synthesis and systematization from multiple bibliographic sources printed and inserted on the databases of Medline, Scielo, Redalyc and Google Scholar. Of these sources, the material of 62 was reviewed and, finally, 24 articles were selected. It was concluded that training on this subject is essential for maintenance tasks, which truly constitute effective tools, benefiting not only the institution that provides health services, but also the patient and the medical personnel(AU)

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We propose an index to prioritize preventive maintenance for medical equipment. Our index considers seven variables: type of equipment, equipment function, maintenance requirements, calibration, equipment age, equipment location, and equipment hazards. We developed a mathematical model using these variables, and its result is interpreted as an index of equipment maintenance priority. The numerical output of the index was classified into three categories: high, medium, and low priority. We proposed our index model to technical staff at the Department of Biomedical Engineering of the National Institute of Respiratory Diseases in Mexico as a protocol for scheduling appropriate preventive maintenance for medical equipment during the year. The index was tested in a sample of 16 different medical equipment. Our model provides a guide to define the priority and the number of preventive maintenance routines required for medical equipment per year.

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Resumen En esta revisión, se describen los retos que el Sistema Nacional de Salud debe afrontar para cumplir la agenda internacional mediante resoluciones emitidas por organismos líderes, una de ellas por la Organización Mundial de la Salud y la otra por la Organización de las Naciones Unidas que tiene que ver con las metas para el año 2030, a través del tercer Objetivo de Desarrollo Sustentable: Salud y Bienestar. México ha reformado estructuralmente su Sistema Nacional de Salud para poder cumplir como país miembro. Con la reforma, se establecieron las bases de la Cobertura Sanitaria Universal al crear el Sistema de Protección Social en Salud. Los dos últimos Planes Nacionales de Salud pretendierón fortalecerlo, modificarlo y mejorarlo incluyendo a la calidad como eje transversal incidiendo en la atención de la salud de las unides hospitalarias. Para apoyar esta acción, el Consejo de Salubridad General crea la Certificación de Hospitales con estándares homologados a la Joint Commission, uno de los estándares indispensables tienen que ver con la gestión de equipo médico, la cual debe realizarse bajo lineamientos dictados por estándares nacionales e internacionales que permitan establecer políticas, objetivos, procesos y gobernanza estructurados y alineados a otros estándares internacionales.

Abstract In this review, we describe the challenges that the National Health System must face in order to comply with the international agenda with resolutions issued by leading organizations, one of them by the World Health Organization and the other by the United Nations, it has to do with the goals for the year 2030, with the third Sustainable Development Goal: Good Health and Well-being. Mexico has structurally reformed its National Health System in order to comply as a member country. With the reform, the bases of the Universal Health Coverage were established when creating the Social Protection System in Health, the last two National Health Plans pretended to strengthen it, modify it and improve it including quality as a transversal axis to influence the attention of the health of the hospital units. To support this action, the General Health Council creates the Certification of Hospitals with standards approved by the Joint Commission, one of the indispensable standards related to the management of medical equipment, which must be carried out under guidelines dictated by national and international standards. that allow establishing policies, objectives, processes and governance structured and aligned to other international standards.

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OBJECTIVE: To compare health care use and spending in children using vs not using respiratory medical equipment and supplies (RMES). STUDY DESIGN: Cohort study of 20 352 children age 1-18 years continuously enrolled in Medicaid in 2013 from 12 states in the Truven Medicaid MarketScan Database; 7060 children using RMES were propensity score matched with 13 292 without RMES. Home RMES use was identified with Healthcare Common Procedure Coding System and International Classification of Diseases codes. RMES use was regressed on annual per-member-per-year Medicaid payments, adjusting for demographic and clinical characteristics, including underlying respiratory and other complex chronic conditions. RESULTS: Of children requiring RMES, 47% used oxygen, 28% suction, 22% noninvasive positive-pressure ventilation, 17% tracheostomy, 8% ventilator, 5% mechanical in-exsufflator, and 4% high-frequency chest wall oscillator. Most children (93%) using RMES had a chronic condition; 26% had ≥6. The median per-member-per-year payments in matched children with vs without RMES were $24 359 vs $13 949 (P < .001). In adjusted analyses, payment increased significantly (P < .001 for all) with mechanical in-exsufflator (+$2657), tracheostomy (+$6447), suction (+$7341), chest wall oscillator (+$8925), and ventilator (+$20 530). Those increased payments were greater than the increase associated with a coded respiratory chronic condition (+$2709). Hospital and home health care were responsible for the greatest differences in payment (+$3799 and +$3320, respectively) between children with and without RMES. CONCLUSION: The use of RMES is associated with high health care spending, especially with hospital and home health care. Population health initiatives in children may benefit from consideration of RMES in comprehensive risk assessment for health care spending.

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Se efectuó una revisión bibliográfica para determinar el impacto de la mecatrónica en el sector de la salud. Se valoró el desarrollo de esta desde la visión de diferentes investigadores, lo cual ha permitido su inserción en dicho sector. También se comprobó que la robótica y el procesamiento digital de imágenes y señales tienen mayor incidencia en la medicina. Asimismo, se hizo un análisis de la mecatrónica aplicada a esta ciencia, el cual demostró que las áreas quirúrgica y terapéutica son las más favorecidas y se nutren de técnicas innovadoras, que resultan más fiables y menos invasivas para el paciente

A literature review was carried out to determine the impact of mechatronic in the health sector. Its development was evaluated from the point of view of different investigators, which has allowed its insertion in this sector. It was also proven that robotics and digital processing of images and signs have higher incidence in medicine. Also, an analysis of mechatronic applied to this science was carried out, which demonstrated that the surgical and therapeutical areas are the most favored and receive nourishment through innovative techniques that are more reliable and less invasive for the patient

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RESUMEN: En nuestro México las Instituciones de salud han ganado experiencia en la administración de sus procesos; para muchos la clave del éxito está en la gestión de los recursos existentes, a medida que estos sean los adecuados, su eficacia será mayor. El presente documento pretende brindar un procedimiento que apoye las funciones de planeación y toma de decisiones de equipos de imagenología, bajo el criterio de contar con un inventario funcional de equipo de Rayos X en las unidades de atención médica de la Delegación Sur del Instituto Mexicano del Seguro Social (IMSS) de la Ciudad de México. Los resultados obtenidos permiten conocer las necesidades de modernización de la infraestructura tecnológica instalada y su distribución; así como planear su renovación y conservación para contribuir en el proceso de mejora de la calidad de los servicios de salud. Se analiza su distribución geográfica, edad media de funcionamiento y su productividad. En el inventario se detectaron 198 equipos relevantes, de los cuales los equipos de Rayos X de 500 y 300 mA son los más abundantes (43.94%) seguidos de los de Ultrasonógrafia (29.80%) y las unidades de radiología y fluoroscopia (21.21%). Los datos presentados deben ayudar a una mejor planeación en la adquisición de los equipos médicos dentro de la Delegación.

ABSTRACT: Healthcare institutions in Mexico have gained experience in the administration of their processes. The key to success lies in the management of existing resources, as long as these are adequate, their effectiveness will be greater. This document is aims to provide a procedure that supports the planning and decision-making functions of imaging equipments, under the criterion of having a functional inventory of X Ray equipment in medical care units of South Delegation of the Mexican Institute of Social Security (IMSS) of Mexico City. In this report it is described the type of equipment used in radiology and other imaging services. Its geographical distribution, average functional age and its productivity are analyzed. The Inventory reported 198 pieces of radiology equipment, equipments of 300 mA or 500 mA the most common type (43.94%) followed by ultrasound (29.80%) and fluoroscopy units (21.21%). Follow-up in the inventory should help in planning the acquisition and maintenance of medical equipment within the Delegation.

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La Evaluación de Tecnologías en Salud es una práctica que permite a las Instituciones de Salud valorar de forma integral las consecuencias del uso de una tecnología, sin embargo, la falta de estandarización y de metodologías que guíen el proceso sigue siendo un reto por superar. Este trabajo presenta el desarrollo y la validación de una herramienta de Evaluación de Tecnologías en Salud la cual se realizó en tres fases: primero se desarrolló la herramienta que permite valorar el proceso de adquisición de equipos biomédicos, después se conformó un grupo de discusión para obtener diferentes percepciones frente a la metodología empleada, el diseño y desarrollo de la herramienta para finalmente implementarla mediante casos de estudio evaluando su uso real y aplicando una encuesta que permitió valorar su utilidad en los procesos de adquisición de equipos biomédicos. Se ponderó la importancia de cada tipo de evaluación de tecnologías seleccionada y se desarrollaron los módulos para las evaluaciones técnica, clínica, económica y ética, social y organizacional. Por su parte, la validación con expertos demostró la utilidad de la herramienta en los procesos de selección y adquisición de equipos biomédicos de manera que se disminuyan costos y se realicen mejores inversiones.

Health Technologies Assessment is a practice that enablesthe evaluation of the consequences of the use of a technology. However, the lack of standardization and methodologies that guide the process remains a challenge. This paper presents the development and validation of a Health Technology Assessment tool which process was carried out in three phases. First, the tool was developed to assess the acquisition process of medical equipment, after which a discussion group was formed to obtain different perceptions regarding the tool. Finally,was the implementation through case studies, evaluating its real use and applying an evaluation survey to measure its usefulness in the processes of acquisition of medical equipment. The importance of each type of technology assessment was weighed and modules for technical, clinical, economic, ethical, social and organizational evaluation were developed. In addition, validation with experts demonstrated the usefulness of the tool in the selection and acquisition processes of medical equipment in a way that will reduce costs and enable better investments.

A Avaliação de Tecnologias em Saúde é uma prática que permite às Instituições de Saúde valorizar de forma integral as consequências do uso de uma tecnologia, no entanto, a falta de estandardização e de metodologias que guiem o processo segue sendo um desafio por superar. Este trabalho apresenta o desenvolvimento e a validação de uma ferramenta de Avaliação de Tecnologias em Saúde a qual se realizou em três fases: primeiro desenvolveu-se a ferramenta que permite valorizar o processo de aquisição de equipamentos biomédicos, depois se conformou um grupo de discussão para obter diferentes percepções em frente à metodologia empregada, o desenho e desenvolvimento da ferramenta para finalmente implementá-la mediante casos de estudo avaliando seu uso real e aplicando uma pesquisa que permitiu valorizar sua utilidade nos processos de aquisição de equipamentos biomédicos. Ponderou-se a importância de cada tipo de avaliação de tecnologias selecionadas e desenvolveram-se os módulos para as avaliações técnica, clínica, económica, ética, social e organizacional. Por sua vez, a validação com experientes demonstrou a utilidade da ferramenta nos processos de seleção e aquisição de equipamentos biomédicos de maneira que se diminuam custos e se realizem melhores investimentos.

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OBJECTIVE: To assess interrater reliability of the Power Mobility Road Test (PMRT) when administered through the Virtual Reality-based SIMulator-version 2 (VRSIM-2). DESIGN: Within-subjects repeated-measures design. SETTING: Participants interacted with VRSIM-2 through 2 display options (desktop monitor vs immersive virtual reality screens) using 2 control interfaces (roller system vs conventional movement-sensing joystick), providing 4 different driving scenarios (driving conditions 1-4). Participants performed 3 virtual driving sessions for each of the 2 display screens and 1 session through a real-world driving course (driving condition 5). The virtual PMRT was conducted in a simulated indoor office space, and an equivalent course was charted in an open space for the real-world assessment. After every change in driving condition, participants completed a self-reported workload assessment questionnaire, the Task Load Index, developed by the National Aeronautics and Space Administration. PARTICIPANTS: A convenience sample of electric-powered wheelchair (EPW) athletes (N=21) recruited at the 31st National Veterans Wheelchair Games. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Total composite PMRT score. RESULTS: The PMRT had high interrater reliability (intraclass correlation coefficient [ICC]>.75) between the 2 raters in all 5 driving conditions. Post hoc analyses revealed that the reliability analyses had >80% power to detect high ICCs in driving conditions 1 and 4. CONCLUSIONS: The PMRT has high interrater reliability in conditions 1 and 4 and could be used to assess EPW driving performance virtually in VRSIM-2. However, further psychometric assessment is necessary to assess the feasibility of administering the PMRT using the different interfaces of VRSIM-2.

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OBJECTIVE: To assess the stability of clinicians' and users' rating of electric-powered wheelchair (EPW) driving while using 4 different human-machine interfaces (HMIs) within the Virtual Reality-based SIMulator-version 2 (VRSIM-2) and in the real world (accounting for a total of 5 unique driving conditions). DESIGN: Within-subjects repeated-measures design. SETTING: Simulation-based assessment in a research laboratory. PARTICIPANTS: A convenience sample of EPW athletes (N=21) recruited at the 31st National Veterans Wheelchair Games. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Composite PMRT scores from the Power Mobility Road Test (PMRT); Raw Task Load Index; and the 6 subscale scores from the Task Load Index developed by the National Aeronautics and Space Administration (NASA-TLX). RESULTS: There was moderate stability (intraclass correlation coefficient between .50 and .75) in the total composite PMRT scores (P<.001) and the users' self-reported performance scores (P<.001) among the 5 driving conditions. There was a significant difference in the workload among the 5 different driving conditions as reflected by the Raw Task Load Index (P=.009). Subanalyses revealed this difference was due to the difference in the mental demand (P=.007) and frustration (P=.007) subscales. Post hoc analyses revealed that these differences in the NASA-TLX subscale scores were due to the differences between real-world and virtual driving scores, particularly attributable to the conditions (1 and 3) that lacked the rollers as a part of the simulation. CONCLUSIONS: Further design improvements in the simulator to increase immersion experienced by the EPW user, along with a standardized training program for clinicians to deliver PMRT in VRSIM-2, could improve the stability between the different HMIs and real-world driving.

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Safety challenges related to the use of medical equipment were investigated during the training of nurse anaesthetists in Haiti, using a systems approach to Human Factors and Ergonomics (HFE). The Observable Performance Obstacles tool, based on the Systems Engineering Initiative for Patient Safety (SEIPS) model, was used in combination with exploratory observations during 13 surgical procedures, to identify performance obstacles created by the systemic interrelationships of medical equipment. The identification of performance obstacles is an effective way to study the accumulation of latent factors and risk hazards, and understand its implications in practice and behaviour of healthcare practitioners. In total, 123 performance obstacles were identified, of which the majority was related to environmental and organizational aspects. These findings show how the performance of nurse anaesthetists and their relation to medical equipment is continuously affected by more than user-related aspects. The contribution of systemic performance obstacles and coping strategies to enrich system design interventions and improve healthcare system is highlighted. In addition, methodological challenges of HFE research in low-resource settings related to professional culture and habits, and the potential of community ergonomics as a problem-managing approach are described.

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INTRODUCTION: Decision-making on medical equipment management is a daily task for clinical engineers, but it may prove difficult to easily extract relevant information from the large amount of data from computerized maintenance management systems. This article describes a simple method of medical equipment classification based on corrective maintenance indicators. METHODS: Three indicators were calculated based on the number of events, duration and cost of corrective maintenance. Three classes were defined according to the indicator values of different equipment ages: class A for 0-4 years, class B for 5-9 years, and class C for equipment older than 10 years. The method was applied to 2,134 pieces of equipment from the Health Service system of the University of Campinas. RESULTS: From the total, 51.7% of the equipment were classified as C, 4.2% as B and 44.1% as A. The infusion pump for general use was the type of equipment of which most units were in the C class (84.7%), even though almost 50% of them were acquired within less than 9 years, and would thus be expected to be classified as A and B. Among the pumps in class C, 39.5% were from a single manufacturer, although the equipments were acquired recently. CONCLUSION: The developed classification may be an important tool for raising alerts about equipment more prone to maintenance problems, as well as for identification of equipments with acceptable maintenance history, supporting decision-making on equipment replacement.

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OBJETIVO: Políticas de fomento à pesquisa em saúde foram estabelecidas na última década, avançando a produção científica nacional. Tal movimento não foi acompanhado do aperfeiçoamento do arcabouço legal-institucional, dificultando o desenvolvimento dos projetos de pesquisa. Isso inclusive no que tange às atividades de importação de equipamentos. O objetivo deste artigo foi analisar o processo de importação de equipamentos para o Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil). MÉTODOS: Trata-se de estudo de caso, com dados coletados em documentos internos do ELSA-Brasil em cinco Centros de Investigação e respectivas fundações de apoio. Foram analisados documentos de importação de: velocidade de onda de pulso, bioimagem e retinografia. Adicionalmente, foram realizadas entrevistas não estruturadas com pesquisadores e informantes chave nas fundações. Os dados foram tratados e organizados em três etapas: administrativa-operacional, cambial e fiscal. Foram calculados os intervalos de duração dessas etapas de modo comparativo entre os centros. RESULTADOS: A necessidade de padronização dos equipamentos em estudo multicêntrico exigiu atuação conjunta de instituições executoras e fundações. Dos equipamentos analisados, a primeira etapa, a administrativa-operacional, teve duração variada (mínimo 8 e máximo de 101, com média de 55 dias), sendo mais demorada quando incluía pareceres jurídicos. A segunda etapa, a cambial, mais longa que a primeira, não apresentou entraves ao processo (mínimo 11 e máximo 381, média de 196 dias). A terceira etapa, a fiscal, foi a mais longa (mínimo 43 e máximo 388 dias, média de 215,5 dias), ...

OBJECTIVE: Policies that promote research in health were established in the last decade, developing the Brazilian scientific production. This development has not been accompanied by an improvement in the legal-institutional framework, thus hindering the development of research projects, including equipment importation activities. The present study aimed to analyze the equipment importation process for the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil). METHODS: A case study was performed with data collected from internal ELSA-Brasil documents in five Investigation Centers and their respective supporting foundations. The following importation documents were analyzed: pulse wave velocity, bioimaging and retinography. Additionally, non-structured interviews with researchers and key informers were conducted in the foundations. Data were treated and organized into three stages: administrative-operational, exchange rate, and fiscal. Lengths of duration of these stages were calculated comparatively among centers. RESULTS: The need to standardize equipment in a multicenter study required a joint action of implementing institutions and foundations. Of all pieces of equipment analyzed, the first stage was administrative-operational, with a varying duration (minimum of eight, maximum of 101, and mean of 55 days) which was longer when legal opinions were included. The second stage was the exchange rate, which was longer than the former and did not pose any obstacles to the process (minimum of 11, maximum of 381, and mean of 196 days). The third stage was fiscal, which was the longest one (minimum of 43, maximum of 388, and mean of 215.5 days), due to the release of equipment without registration into the country. There were other factors that posed obstacles: inexperience of investigation centers and institutions in networking; inadequacy of the national legislation on scientific ...

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O presente trabalho apresenta a proposta de um Programa para o desenvolvimento do Sistema Nacional de Inovação de Produtos Médicos  –   SNIPM no âmbito do Sistema Único de Saúde  – SUS, de forma integrada e alinhada com as ações do Ministério da Saúde. Os conhecimentos e as ferramentas em engenharia clínica permitiram realizar uma análise diferenciada do contexto socioeconômico do setor, a sistematização e a percepção dos fatores e atores que induzem ou retardam o crescimento tecnológico do setor. Neste artigo, buscou-se contextualizar o setor de produtos médicos no Brasil à luz da atual conjuntura socioeconômica nacional e mundial, caracterizando-o como de grande indutor de atividades inovadoras. Posteriormente, são abordadas as definições e teorias sobre os Sistemas Nacionais de Inovação e as especificidades do SNIPM no Brasil, apresentando seus atores incluindo suas atribuições e competências. A metodologia utilizada para a coleta e análises de dados econômicos é apresentada, de modo a caracterizar a importância deste segmento para a economia nacional e suas potencialidades na indução do surgimento de tecnologias inovadoras no SNIPM. A análise dos dados setoriais coletados durante a pesquisa é apresentada, como o objetivo de quantificar e apresentar os números socioeconômicos do setor de produtos. Por fim, é apresentado o delineamento de um Programa destinado acatalisar o desenvolvimento do SNIPM considerando as demandas tecnológicas e prioridades do SUS e as dos mercados-alvo do setor produtivo. A proposta, que foi desenvolvida e implementada no Ministério da Saúde, pode se constituir como uma das ferramentas no âmbito do SUS destinadas a fortalecer e modernizar o setor de equipamentos e materiais de uso em saúde, visando à ampliação da capacidade inovadora das empresas e mudança do seu patamar competitivo.

This paper presents a proposal of a program for the development of the Brazilian National Innovation System for Medical Products  (SNIPM) under the National Health System  (SUS) integrated and aligned with the actions of the Brazilian Ministry of Health. Clinical engineering knowledge and tools allowed performing a differentiated socio-economic analysis of the sector, the systematization and the perception of actors and factors that induce or retard the growth of the technology sector. In this article, the medical devices sector in Brazil was first contextualized to in the light of current national and global socio-economic conjuncture, in order to characterize it as a major inducer of innovative activities. The definitions and theories about the National Innovation Systems are described, followed by a discussion of the specifics of SNIPM in Brazil, with its actors, including their duties and responsibilities. The methodology for the collection and analysis of economic data, were shown, in order to characterize the importance of this sector to the national economy and its potential to induce the rising of innovative technologies whithin the SNIPM. The analysis of industry data is presented, which attempts to present and comment on some industry data collected during a survey. In the Results section, it is presented the design of a program used to to catalyze the development of the SNIPM considering the technological demands and priorities of the SUS and the target markets of the productive sector. The proposed program, which was developed and implemented within the Brazilian Ministry of Health, can become one of the tools within the SUS to strengthen and modernize the sector of medical equipments and materials, aiming to increase the innovative capacity of firms and change its competitive standing.

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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.

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A crescente inserção de tecnologia eletroeletrônica em estabelecimentos assistenciais de saúde (EAS), seja como equipamentos terapêuticos, de diagnóstico ou até mesmo suporte vital, tem sido vista pela comunidade científica como a grande responsável pelo aumento dos níveis de energia eletromagnética emitidos ao ambiente hospitalar. Dessa forma, quando a energia eletromagnética presente no ambiente atinge um determinado nível crítico, fica estabelecida uma situação que é propícia ao aparecimento de dois fenômenos indesejados: a interferência eletromagnética (EMI) em equipamentos médicos, e os riscos biológicos (RBL) em seres vivos. Um importante recurso para gerenciar a compatibilidade eletromagnética e evitar o aparecimento destes fenômenos é o conhecimento das características eletromagnéticas presentes nestes ambientes. O objetivo deste trabalho é diagnosticar o comportamento eletromagnético estabelecido em ambientes de grande concentração de fontes emissoras como, por exemplo, o encontrado em centros cirúrgicos, através de uma série de medições in situ das grandezas eletromagnéticas envolvidas nestes meios (campos elétricos, campos magnéticos, ruídos conduzidos). Com base nestas medidas é realizada uma avaliação crítica de modo a comparar a situação estabelecida nos EAS e os limites de segurança preconizados por organismos competentes, tanto para EMI quanto para RBL. Como resultado desta análise, começa a existir maior discernimento quanto à real situação do ambiente eletromagnético encontrado em EAS nacionais, subsidiando informações para a definição de diretrizes mais eficientes para implementação de programas de gestão tecnológica que são direcionados às necessidades específicas destes hospitais.

Advances in technology and the increased use of electro-medical equipment (EME) to support medical procedures such as monitoring, diagnosis, therapeutic or even life support are considered as greatly responsible for the increase of electromagnetic energy within health care facilities (HCF) environments. In such circumstances, when electromagnetic energy reaches a certain critical level, a dangerous situation is established and two undesirable phenomena can take place, both electromagnetic interference (EMI) in medical equipment, and biological risks (BLR) in living beings. The knowledge of electromagneticcharacteristics shown by these environments can represent an important tool in order to promote electromagnetic compatibility and avoid the appearance of undesirable phenomena. Therefore, this work aims to diagnose the electromagnetic profile established in critical areas, such as operating rooms, through a number of “in situ” measurements concerning electromagnetic quantities present in this environment (electric field, magnetic field, conducted noise). Moreover, a critical evaluation follows in order to compare the establishedsituation within HCF and the safety levels prescribed by regulatory organizations regarding EMI and BLR. As a result of this assessment, a better understanding on the actual situation concerning the electromagnetic environment in HCF can be achieved, allowing clinical engineers to define better directives in order to implement an adequate management programs in these hospitals.

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