Orientador: Vera Lúcia da Silveira Nantes Button / Tese (doutorado) - Universidade Estadual de Campinas, Faculdade de Engenharia Elétrica e de Computação / Made available in DSpace on 2018-08-16T23:21:30Z (GMT). No. of bitstreams: 1 Oliveira_EduardoJorgeValadares_D.pdf: 36894396 bytes, checksum: 09b65cc50b4dadf0dcdbfc05e59d0414 (MD5) Previous issue date: 2018-08-16T20:21:18Z / Resumo: A saúde configura um complexo de atividades produtivas de bens e serviços que alavanca segmentos-chave da sociedade contemporânea. Além de sua dimensão social vinculada à própria cidadania, a saúde possui uma dimensão econômica própria, articulando entidades públicas e privadas em uma ampla rede de assistência à saúde - pelo Sistema Único de Saúde (SUS) e Sistema Nacional de Saúde Suplementar - além de um parque industrial responsável pelo fornecimento de uma vasta cadeia de produtos destinados aos cuidados da saúde humana. É uma oportunidade única para o desenvolvimento nacional no contexto das políticas de saúde e de desenvolvimento. Os conhecimentos e as ferramentas em Engenharia Clínica aqui utilizados, permitiram realizar uma análise diferenciada do contexto sócio-econômico do setor, a sistematização e a percepção dos fatores e atores que induzem ou retardam o crescimento tecnológico do setor. Acredita-se que a atuação da Engenharia Clínica permite propor uma abordagem desenvolvimentista para o setor diferente daquelas de cunho estritamente economicista, tecnológica ou sanitarista. O trabalho busca mostrar a inter-relação entre os diversos atores do Sistema Nacional de Inovação de Produtos Médicos (SNIPM) e como intervenções em pontos específicos deste sistema podem gerar inflexões promotoras do setor de produtos médicos. A motivação para a elaboração e execução deste trabalho recaiu sobre a necessidade de se definir uma estratégia para promover o desenvolvimento do SNIPM considerando as atuais políticas desenvolvimentistas e a constante expansão do mercado brasileiro de produtos médicos que, nos últimos anos, posicionou o Brasil como o segundo maior produtor mundial entre os países emergentes. Esta conjuntura promove no Ministério da Saúde o surgimento de o novo contexto institucional, onde o conceito de Complexo Industrial da Saúde surge como um dos pilares da atual política de saúde onde as ações assistenciais do SUS podem ser utilizadas como indutor da produção local de produtos estratégicos. Desta forma, pretende-se que o Programa proposto se constitua 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. / Abstract: The health configurates a complex set of productive activities of goods and services that leverage key segments of the modern society. Beyond its social dimension linked to citizenship, health has its own economic dimension, articulating public and private entities in a wide network of health care - through the Brazilian Unified Health System (SUS) and the Brazilian Health Insurance System - besides an industrial park that provides a wide chain of products designated to health care activities, including medical devices. It is a unique source of opportunity to promote national development in the context of both the health and development policies. The Clinical Engineering knowledge and the tools used here, allowed performing a differentiated analysis of the secto socio-economic context, the systematization and the perception of factors and actors that induce or retard the technological growth of the sector. It is believed that the role of Clinical Engineering allows the proposition of a developmental approach for the sector different than those of strictly economistic, technological or sanitarist nature. The work seeks to show the interrelationship between the various actors of the Brazilian National Medical Devices Innovation System (SNIPM) and how interventions at specific points of this system can generate inflections to promote the medical devices sector. The motivation for the development and execution of this work fell on the need to define a strategy to promote the development of SNIPM, considering the current national development policies and the constant expansion of the Brazilian market for medical devices which, in recent years, ranked Brazil as the second largest producer among the developing countries. This conjuncture promoted in the Ministry of Health the emerge of a new institutional context, where the concept of Health Industrial Complex appears as one of the pillars of the current health policy where SUS healthcare actions can be used as an inducer for local production of strategic products. Thus, it is intended that the proposed program constitutes one of the tools within the SUS to strengthen and modernize the sector of equipment and materials for health use, aiming the increase the innovative capacity of firms and change in its competitive standing. / Doutorado / Engenharia Biomedica / Doutor em Engenharia Elétrica

Com a redução das barreiras tarifárias ao comércio internacional, as normas técnicas, regulamentos técnicos e procedimentos de avaliação da conformidade vêm se tornando importantes mecanismos protecionistas e de restrição ao comércio. Esse trabalho tem por objetivo estudar essas questões, tendo como foco principal a exportação para a União Européia dos equipamentos eletromédicos produzidos por pequenas e médias empresas brasileiras. Realiza-se uma revisão bibliográfica buscando-se identificar e comparar as normas técnicas, os regulamentos técnicos e os mecanismos de avaliação da conformidade para os dispositivos eletromédicos, praticados pela União Européia e os vigentes no Brasil. É desenvolvida uma pesquisa junto a PMEs Pequenas e Médias Empresas fabricantes de dispositivos eletromédicos e exportadores para a União Européia, buscando-se identificar as dificuldades encontradas, as formas de superação dessas e os apoios recebidos. É elaborado um método, baseado nas experiências estudadas e adquiridas a partir da pesquisa junto às PMEs, para a identificação e superação das dificuldades técnicas para a exportação dos equipamentos eletromédicos para a União Européia. Conclui-se que não existem propriamente barreiras técnicas e que as dificuldades enfrentadas pelas empresas podem ser superadas com a participação nos fóruns de normalização, apoio técnico dos institutos tecnológicos, apoio financeiro das agências governamentais de fomento e investimentos em pesquisa, desenvolvimento e inovação. / With the reduction of the tariff barriers to international trade, the technical standards, technical regulations and conformity assessment proceedings are becoming important protectionist and trade restriction mechanisms. This work aims to study these questions, focusing mainly the case of medical devices produced by the small and medium Brazilians companies and exported to European Union. A bibliography revision is done to identify and to compare the technical standards, technical regulations and conformity assessment proceedings for the medical devices, in European Union and Brazil. A survey is developed with the small and medium producers and exporters of medical devices, searching the difficulties, ways of overcoming them, and the support obtained. A method is proposed to identify and overcome the technical difficulties to export medical devices to European Union, based on the experiences studied and obtained from the small and medium producers. The conclusion is that there are no technical barriers and the difficulties faced by the producers can be overcome through the participation in standardization forum, the technical support of the technological institutes, the financial support of the governmental promotion agencies, and investment in research, development and innovation.

[pt] Nas últimas décadas, vem ocorrendo uma importante revolução na área da tecnologia médica, em particular nos equipamentos de diagnóstico por imagem. O propósito central da presente tese concentra-se na análise e compreensão das estratégias e sistemas produtivos empregados na produção desses equipamentos, com enfoque específico na produção de equipamentos de Ressonância Magnética, pela importância de se dispor de dados e informações principalmente em países como o Brasil que, apesar de ainda não apresentarem produção nacional, fazem uso de toda essa tecnologia e necessitam preparar recursos humanos não só para a sua própria utilização, mas também para o desenvolvimento e produção de componentes e periféricos específicos. Um grande motivador para esta pesquisa foi o Projeto ToRM, desenvolvido pela Universidade de São Paulo. O projeto constava do desenvolvimento local de um equipamento de ressonância para que fosse possível a formação de mão-de-obra especializada e a realização de estudos para acessórios e componentes. A metodologia empregada neste estudo, o qual é de caráter exploratório, envolve uma pesquisa bibliográfica e dois estudos de casos realizados em empresas produtoras de equipamentos de diagnóstico por imagem - Philips Medical Systems e Siemens Medical. Assim, com a compreensão dos sistemas produtivos aplicados, objetiva-se subsidiar as empresas e universidades com informações atualizadas referentes a essa indústria, principalmente pela falta de material acadêmico sobre o assunto. / [en] In the last decades, an important revolution has taken place in the medical technology field, particularly in image diagnosis equipment. The central purpose of the present thesis is to analyze and understand the strategies and productive systems used in the production of such equipment, with specific focus on the production of Magnetic Resonance equipment. It is important to make data and information available especially in countries like Brazil, which, despite still not having a national production, make use of this technology and need to prepare human resources not only for its own use but also for the development and production of specific components. A great motivation to this research was the ToRM Project, developed by the University of São Paulo. This project consisted in the local development of a resonance machine, which would allow for the preparation of specialized professionals and the development of studies about accessories and components. The methodology used in the present study, which is exploratory in character, involves a literature review and case studies performed in two major manufacturers of image diagnosis equipment - Philips Medical Systems and Siemens Medical. Thus, by understanding the productive systems applied, our goal is to provide companies and universities with updated information about this industry, especially considering the lack of academic material on this subject.

Medical devices are used to diagnose, treat, or prevent a disease or abnormal physical condition without any chemical action in the body. They can also result in unintended incidents and other errors. This thesis was divided into three chapters: i) a systematic review on the recognition, reporting and resolution of incidents related to medical devices and other health technologies; ii) telephone interviews with physicians and registered nurses (RNs) to solicit information on the resolution, reporting and resolution of medical device-related incidents based on their professional experience; and iii) a case study to review the continuous quality improvement (CQI) data retrieved from the wireless smart infusion pump system at The Ottawa Hospital (TOH) and to propose a CQI data analysis process. The systematic review included 30 studies on factors that influence the recognition, reporting and resolution of incidents in hospitals and interventions to improve patient safety. Central themes that emerged for incident reporting were personal attitudes, awareness and perception of incident reporting systems, organizational culture, and feedback to healthcare professionals. In our telephone interviews, physicians and RNs attributed incident recognition to devices not operating based on the manufacturer’s instructions, and to the hospital staff’s knowledge of and professional experience with the use of the medical device, and clinical manifestations of patients. Suggestions to improve medical device safety surveillance centered on education and training to ensure that the staff is able to use the medical device properly and know what would be considered an error, and how to report these errors. The results of the systematic review and interviews helped to inform the design of a medical device surveillance framework in a hospital setting. Our case study assessed the Dose Error Reduction Software compliance and frequency of soft and hard limit alerts with wireless smart infusion pump systems over a one year period. A CQI data analysis process to monitor the performance of wireless smart infusion pumps is proposed. The findings of this doctoral thesis can contribute to the development of a medical device surveillance system that would help to improve health care delivery and patient safety in a health care institution.

L’implantation de lentilles intraoculaires est le traitement substitutif standard de la cataracte toutes origines confondues. L’implantation est faite à la suite de l’extraction du cristallin par phacoémulsification. Les implants souples, en acrylates hydrophobes, à bord carrés et « 1 pièce » sont recommandés pour prévenir la survenue de complications post-opératoires telles que l’opacification capsulaire postérieure. Cette complication multifactorielle est associée à un défaut de biocompatibilité. L’acte chirurgical, la physiopathologie du patient ainsi que la forme de la lentille intraoculaire modifient l’incidence. Malgré plusieurs mesures préventives, l’incidence n’est pas nulle et la prévalence continue d’augmenter avec le temps. Des cas tardifs d’opacifications surviennent jusqu’à 9 ans après la chirurgie. Un de nos objectifs dans le cadre de ce travail était de relier cette complication tardive au mécanisme de vieillissement des implants intraoculaires. Les résultats obtenus après hydrolyse et photo-oxydation, ont montré une altération des caractéristiques du polymère avec formation de composés néoformés de faibles masses moléculaires, qui diffusent au travers du polymère et migrent vers la surface en fonction de leur polarité et leur masse moléculaire. Il en résulte la création d’un gradient de concentrations de composés hydrophiles en surface et de composés hydrophobes dans les couches inférieures de l’implant. La vitesse du mécanisme de vieillissement est directement liée aux conditions (température, intensité de photo-oxydation). Par ailleurs, nous avons démontré l’existence d’une variation inter et intra lots des caractéristiques physico-chimiques de ces implants. Ces modifications de propriétés de surface constituent une explication à la survenue des complications tardives qui est liées à une modification de la biocompatibilité des implants intraoculaires, après vieillissement / Intraocular lenses are the main treatment for cataract surgery whatever the origin. The implantation is done in the same surgical time as the lens extraction by phacoemulsification. Today, the recommended lenses are foldable acrylic copolymers with square edges and “1-piece”. This design decreases the incidence of adverse events as posterior capsular opacification (POC). This complication is multifactorial and is associated with a poor biocompatibility. The surgery and physiopathology are two others factor that impact the incidence of PCO. Despite many preventive actions, the incidence is not null and prevalence keep on increasing each year after the surgery. The late PCO cases occur until 9 years after the surgery. One of our objectives in the context of this work was to link this late complication to the aging mechanism of intraocular implants. The results obtained after hydrolysis and photo-oxidation have showed the characteristic modifications of the polymer with formation of low molecular weight compounds, which diffuse through the polymer and migrate to the surface, as a function of their polarity and their molecular weight. All these modifications have created concentration gradient. Indeed, the hydrophilic compounds have diffused on the surface and hydrophobic compounds in the implant matrix. The kinetic of the aging process is directly related to the aging conditions applied (temperature, intensity of photo-oxidation). Furthermore, we have demonstrated the existence of the variability between and within batches, of the physicochemical characteristics of these implants. These surface property modifications are an explanation for the occurrence of late complications that is related to a modification of the intraocular lenses biocompatibility after aging.

En Perú el gasto de bolsillo es el principal financiamiento de los servicios de salud (MINSA, 2018), siendo la botica el principal punto de contacto. Lima Metropolitana tiene un 22.5% de la población con hipertensión arterial (INEI, 2019), 5.1% con diabetes (INEI, 2019) y 33% con triglicéridos y colesterol total elevados (INS, 2020), quienes requieren tratamiento con medicamentos y el uso de dispositivos médicos. Adicionalmente, el volumen de ventas del 2020 de medicamentos creció entre 2% y 3%, y el canal online aumentó un 42%, mostrando un importante cambio en las tendencias de compra (Gestión.pe, 2021). Una Botica digital con entrega por delivery mejoraría el acceso a medicamentos y dispositivos médicos requeridos para estas enfermedades; los pacientes podrían solicitar su tratamiento desde la comodidad de su hogar, recibiéndolos de manera oportuna y mejorando la adherencia al tratamiento, evitando las complicaciones de las distancias, tiempos de traslados y riesgos de acudir personalmente. Lima moderna tiene más población de los niveles socioeconómicos A, B y C, quienes mayormente compran productos por internet (APEIM, 2020). Pharma Place, presenta una estrategia de enfoque debido a la especialización de los productos, la venta por canal digital y la entrega por delivery. Dentro de las ventajas competitivas se consideran la innovación tecnológica y ser la primera botica digital especializada en Lima. La inversión requerida es S/ 325,000.00 los cuales serán financiados por los socios y entidades bancarias, el análisis de factibilidad financiera muestra un VAN de S/ 329,491.90 y TIR de 46.10% en un escenario conservador. / In Peru, the health out-of-pocket spending is the main financing for health services (MINSA, 2018), with the drugstore being the main point of contact. Metropolitan Lima has 22.5% of the population with arterial hypertension (INEI, 2019), 5.1% with diabetes (INEI, 2019) and 33% with high triglycerides and total cholesterol (INS, 2020), who require drug treatment and the use of medical devices. Additionally, the 2020 sales volume of medicines grew between 2% and 3%, and the online channel increased by 42%, showing an important change in purchasing trends (Gestión.pe, 2021). A digital drugstore with the supply by delivery would improve access to medicines and medical devices required for these diseases; patients could request their treatment from the comfort of their home, receiving them in a timely manner and improving adherence to treatment; thus avoiding the complications of distances, travel times and risks of going in person. Modern Lima has a larger population of socioeconomic levels A, B and C, who mostly purchase products through the internet. Pharma Place presents a focus strategy due to the specialization of the products and the sale through the digital channel; the main competitive advantages are technological innovation and being the first specialized digital drugstore in Lima. The required investment is S/ 325,000.00 which will be financed by the associates and banks; the financial feasibility analysis shows an NPV of S/ 329,491.90 and IRR of 46.10% in a conservative scenario. / Trabajo de investigación

<p>  </p> <p>Infections of dermal wounds is a growing burden for the healthcare industry, with a 2017 market exceeding $17.5 USD. As the number of patients with severe infections continues to increase year after year, there is an alarming downward trend in efficacy for traditional antibiotic treatments. In large part, this is due to the increasing development of antibiotic resistance within common bacteria strains. As microbes evolve to protect themselves from previously effective drugs, there is a growing need for new antimicrobial therapies. While alternatives exist in the market, they are largely impaired by non-selective toxicity which can cause further damage to the cells in the wound bed, as is the case with silver and other strong antiseptics, or the need for high energy, specialized equipment, as with cold atmospheric surface treatments. Gaseous ozone is a promising alternative therapy for treating these wound infections. Because ozone is a strong natural oxidant, it exhibits significant antimicrobial properties, and has also been shown to help stimulate natural wound healing in many cases. Herein is presented the design of a portable system for the topical delivery of gaseous ozone as an antimicrobial treatment for infected dermal wounds. This includes the design and characterization of the portable system and a custom ozone application dressing, the characterization of the safety and efficacy of the system using <em>in vitro</em> and <em>in vivo</em> models, and a disposable system for wound infection monitoring. The system utilizes a portable corona discharge generator to produce gaseous ozone from the ambient environment. The ozone gas is delivered through a dressing engineered to have a hydrophobic interface at the wound bed and disperse the ozone gas across the patch surface for more uniform application. The antimicrobial strength and biocompatibility of the system was optimized at varying ozone output levels. Additionally, an adjunct therapy of topical antibiotics was shown to significantly increase the strength of the treatment without leading to greater cytotoxicity. This synergistic effect between ozone and antibiotics was shown to circumvent natural bacterial resistances to antibiotics, which will have a major impact on the wound care industry. This adjunct treatment was then validated on a porcine animal model for safety and pilot results for efficacy testing. Finally, the pH sensor which can be incorporated with use of the ozone therapy enables objective monitoring of wound condition and is able to signal when appropriate infection therapy should begin. As it stands, this portable ozone wound treatment system shows great promise as an alternative therapy to improve the quality of live for millions of patients.</p>

The newly introduced regulation (EU) 2017/746 aims to make In Vitro Diagnostic Medical Devices (IVDMD), which include companion diagnostic tests (CDx), a widespread method of authorising medicinal products in the European market. However, European SmPCs (Summary of Product Characteristics) currently do not explicitly refer to the term or classify tests associated with medicinal products as CDx. This paper is the first to examine and classify tests for medicinal products currently authorised in Sweden as being potential CDx, under the definitions of the new regulatory paradigm. The aim is to serve as the foundation for future research. 141 medicinal products with potential associated CDx are identified in the database of the Swedish Medical Products Agency (MPA). These products are then classified under the major ATC (Anatomical Therapeutic Chemical) therapeutic areas to search for commonalities and patterns in their usage and are later examined in conjunction with the techniques they use. The results reveal that a majority are concentrated in the Antineoplastic and immunomodulating agents and Antiinfectives for systemic use therapeutic areas. The methods used by these tests reveal diversity among the test technique usage, including instances where multiple techniques comprise a single CDx product, which may focus on detecting several biomarkers.

<p>  </p> <p>In this study, we present advancements in smart contact lenses, highlighting their potential as minimally or non-invasive diagnostic and drug delivery platforms. The eyes, rich in physiological and diagnostic data, make contact lens sensors an effective tool for disease diagnosis. These sensors, particularly smart contact lenses, can measure various biomolecules like glucose, urea, ascorbate, and electrolytes (Na+, K+, Cl-, HCO3-) in ocular fluids, along with physical biomarkers such as movement of the eye, intraocular pressure (IOP) and ocular surface temperature (OST).</p> <p>The study explores the use of continuous, non-invasive contact lens sensors in clinical or point-of-care settings. Although promising, their practical application is hindered by the developmental stage of the field. This thesis addresses these challenges by examining the integration of contact lens sensors, covering their working principle, fabrication, sensitivity, and readout mechanisms, with a focus on monitoring glaucoma and eye health conditions like dry eye syndrome and inflammation.</p> <p>Our design adapts these sensors to fit various corneal curvatures and thicknesses. The lenses can visually indicate IOP through microfluidic channels' mechanical deformation under ambulatory conditions. We also introduce a colorimetric hydrogel tear fluid sensor that detects pH, electrolytes, and ocular surface temperature, indicating conditions like dry eye disease and inflammation.</p> <p>The evaluation of these contact lens sensors includes in vivo/vitro biocompatibility, ex vivo functionality studies, and in vivo safety assessments. Our comprehensive analysis aims to enhance the practicality and effectiveness of smart contact lenses in ophthalmic diagnostics and therapeutics.</p>

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