Актуальность обусловлена увеличением объемов обрабатываемой информации, и повышением качества услуг в области здравоохранения. Безусловно, актуальность связана с ростом внедрений автоматизированных информационных систем в области здравоохранения, это обусловлено Федеральным законом «Об основах охраны здоровья граждан в Российской Федерации» № 323-ФЗ от 21.11.2011. Цель магистерской работы: внедрить и адаптировать автоматизированную информационную систему «АИС ММИ» с целью улучшения программной и информационной поддержки административно-хозяйственных процессов медицинского учреждения. Задачи магистерской работы: провести сравнительный анализ информационных систем, сформировать требования для внедрения системы, провести оценку внедрения, произвести расчет экономической эффективности. Объектом исследования является информационная система «АИС ММИ». Предмет исследования – информационное и программное обеспечение основных процессов административно-хозяйственной деятельности медицинского учреждения. Практическая значимость исследования: в диссертации были разработаны требования к информационной системе административно-хозяйственной части. Произведен анализ нормативной документации, в результате исследования была сформирована таблица сравнений информационных систем. / The relevance is due to the increase in the volume of processed information, and improving the quality of health services. Of course, the relevance is associated with the increase in the introduction of automated information systems in the field of health, this is due to the Federal law "On the basics of public health in the Russian Federation" № 323-FZ of 21.11.2011. The purpose of the master's work: to implement and adapt the automated information system "AIS MMI" in order to improve the software and information support of administrative and economic processes of medical institutions. Objectives of the master's work: to conduct a comparative analysis of information systems, to form the requirements for the implementation of the system, to assess the implementation, to calculate the economic efficiency. The object of the study is the information system "AIS MMI". The subject of the research is information and software support of the main processes of administrative and economic activity of medical institutions. Practical significance of the research: the requirements for the information system of the administrative and economic part were developed in the thesis. The analysis of normative documentation is made, as a result of research the table of comparisons of information systems has been formed.

<p>Subcutaneous injection through devices such as autoinjectors is a preferred delivery method for wide array of pharmaceuticals such as monoclonal antibodies. Needle insertion during drug delivery involves large deformation, damage, and fracture of the skin tissue and affects drug transport and uptake. Yet, our understanding of needle insertion biomechanics is limited, but is crucially important to create autoinjectors that lead to the least amount of pain, penetrate the skin to a desired depth, produce small lesions that minimize back flow of drug, and operate robustly even given the variability in the skin mechanics among individuals. Computational models of needle insertion lends itself as an excellent avenue for studying the biomechanics of injector- skin interactions and for proposing better device designs. This work is focused on introducing a comprehensive computational modeling framework for optimizing needle insertion by autoinjector devices, while addressing limitations in experimental data and constitutive modeling of damage and fracture mechanisms in skin</p>

<p dir="ltr">The gastrointestinal tract harbors a diverse range of microorganisms, collectively constituting the gut microbiome. <a href="" target="_blank">The maintenance of a symbiotic relationship between the host and these microorganisms is essential to gastrointestinal health. Disruption of the ecological balance within the gut microbiome can result in discomfort or pathological conditions.</a> <a href="" target="_blank">This dissertation explores these alterations within the gastrointestinal tract as potential indicators for specific gastrointestinal diseases.</a> <a href="" target="_blank">In pursuit of this, I collaborated with others to develop a smart ingestible capsule that offers a non-invasive method for enhancing the effectiveness of differential diagnosis and treatment strategies for Inflammatory Bowel Disease (IBD). </a>My contributions encompassed conducting <i>in vitro</i> protein sampling and extraction experiments, as well as enteric coating dissolution tests. Following thorough characterization of the capsule, I advanced to <i>ex vivo</i> sampling experiments. As a proof of concept, the capsule's sampling capabilities have been rigorously validated both <i>in vitro</i> and <i>ex vivo</i> using calprotectin, a key biomarker for monitoring and managing IBD. Future research may explore integrating this technology with other sensors for diverse chemical and gas sensing capabilities, aiming to refine the differential diagnostics of Irritable Bowel Syndrome (IBS) and IBD.</p><p dir="ltr">Simultaneously, the potential transmission of pathogenic microorganisms from the gastrointestinal tract to the environment through fecal matter can lead to substantial public health implications if adequate surveillance is not in place. These pathogens can contaminate water and food sources from various origins, exacerbating the problem. Furthermore, conventional laboratory-based assays, while effective, have extensive turnaround times and require skilled scientists to operate them. In response to this challenge, I have undertaken the development of point-of-care assays, aiming to streamline the detection of fecal contamination. This innovation is designed to mitigate the limitations associated with traditional methods by offering a more rapid and user-friendly approach. The primary objective is to enhance the accessibility of these assays, enabling on-site personnel with varying levels of expertise to utilize them effectively. Through the widespread adoption of these point-of-care assays, the overarching goal is to ensure the consistent provision of safe and reliable water and food supplies to the public.</p>

This thesis explores a methodology to quantify trust in wearable medical devices (WMD) by addressing two main challenges: identifying key factors influencing trust and developing a formal framework for precise trust quantification under uncertainty. The work empirically validates trust factors and uses a Bayesian network to quantify trust. The thesis further employs a data-driven approach to estimate Bayesian parameters, facilitating query-based inference and validating the trust model with real and synthetic datasets, culminating in a customizable parameterized trust evaluation prototype for WMD. / Advances in sensor and digital communication technologies have revolutionized the capabilities of wearable medical device (WMD) to monitor patients’ health remotely, raising growing concerns about trust in these devices. There is a need to quantify trust in WMD for their continued acceptance and adoption by different users. Quantifying trust in WMD poses two significant challenges due to their subjective and stochastic nature. The first challenge is identifying the factors that influence trust in WMD, and the second is developing a formal framework for precise quantification of trust while taking into account the uncertainty and variability of trust factors. This thesis proposes a methodology to quantify trust in WMD, addressing these challenges. In this thesis, first, we devise a method to empirically validate dominant factors that influence the trustworthiness of WMD from the perspective of device users. We identified the users’ awareness of trust factors reported in the literature and additional user concerns influencing their trust. These factors are stepping stones for defining the specifications and quantification of trust in WMD. Second, we develop a probabilistic graph using Bayesian network to quantify trust in WMD. Using the Bayesian network, the stochastic nature of trust is viewed in terms of probabilities as subjective degrees of belief by a set of random variables in the domain. We define each random variable in the network by the trust factors that are identified from the literature and validated by our empirical study. We construct the trust structure as an acyclic-directed graph to represent the relationship between the variables compactly and transparently. We set the inter-node relationships, using the goal refinement technique, by refining a high-level goal of trustworthiness to lower-level goals that can be objectively implemented as measurable factors. Third, to learn and estimate the parameters of the Bayesian network, we need access to the probabilities of all nodes, as assuming a uniform Gaussian distribution or using values based on expert opinions may not fully represent the complexities of the factors influencing trust. We propose a data-driven approach to generate priors and estimate Bayesian parameters, in which we use data collected from WMD for all the measurable factors (nodes) to generate priors. We use non-functional requirement engineering techniques to quantify the impacts between the node relationships in the Bayesian network. We design propagation rules to aggregate the quantified relationships within the nodes of the network. This approach facilitates the computation of conditional probability distributions and enables query-based inference on any node, including the high-level trust node, based on the given evidence. The results of this thesis are evaluated through several experimental validations. The factors influencing trust in WMD are empirically validated by an extensive survey of 187 potential users. The learnability, and generalizability of the proposed trust network are validated with a real dataset collected from three users of WMD in two conditions, performing predefined activities and performing regular daily activities. To extend the variability of conditions, we generated an extensive and representative synthetic dataset and validated the trust network accordingly. Finally, to test the practicality of our approach, we implemented a user-configurable, parameterized prototype that allows users of WMD to construct a customizable trust network and effectively compare the trustworthiness of different devices. The prototype enables the healthcare industry to adapt and adopt this method to evaluate the trustworthiness of WMD for their own specific use cases. / Thesis / Doctor of Philosophy (PhD) / In this thesis, two challenges in quantifying trust in wearable medical devices, are addressed. The first challenge is the identification of factors influencing trust which are inherently subjective and vary widely among users. To address this challenge, we conducted an extensive survey to identify and validate the trust factors. These factors are stepping stones for defining the specifications and quantifying trust in wearable medical devices. The second challenge is to develop a precise method for quantification of trust while taking into account the uncertainty and variability of trust factors. We constructed a Bayesian network, that captures the complexities of trust as probabilities of the trust factors (identified from the survey) and developed a data-driven approach to estimate the parameters of the Bayesian network to compute the measure of trust. The findings of this thesis are empirically and experimentally validated across multiple use cases, incorporating real and synthetic data, various testing conditions, and diverse Bayesian network configurations. Additionally, we developed a customizable, parameterized prototype that empowers users and healthcare providers to effectively assess and compare the trustworthiness of different wearable medical devices.

Cette thèse a pour objet l'obligation de sécurité en matière la responsabilité contractuelle à la lumière du droit français et du droit libyen. La recherche tend à répondre aux questions suivantes : Qu'entend-on par sécurité des produits médicaux ? Sur quel fondement juridique peut-on justifier cette obligation ? Quelles sont les difficultés d'application de cette obligation pour traiter les problèmes de produits de santé ? C'est quoi le produits de santé ? Et Le droit de la responsabilité civile libyen est-il parfaitement adapté à la protection de la victime des produits de santé comme dans le droit de la responsabilité français ? Ce questionnement a conduit l'auteur à développer une analyse approfondie de l'obligation de sécurité en manière de la responsabilité contractuelle et le droit de la santé français et libyen. Dans la première partie de la thèse, on constate que la notion d'obligation de sécurité, y compris en matière de la responsabilité contractuelle, a connu une évolution majeure par rapport à l'époque précédant. En fait, l'apparition de la notion d'obligation de sécurité est ancienne puisqu'elle a été créée en France le 21 novembre 1911 à l'occasion du contrat de transport. Elle peut être définie comme « l'obligation de veiller à la sécurité d'une personne ou d'un bien, qui peut être une obligation de résultat ou de moyen ». Certains codes du monde proche-oriental ont adopté la résolution que la Cour de cassation française a prise en 1911 dans le domaine du transport de personnes, comme l'Egypte et le Liban. En 1956, la Cour d'Appel à Alexandrie a conformé l'obligation de sécurité dans le domaine du transport de personnes / This thesis focuses on the safety obligation regarding contractual liability in the light of French law and Libyan law. Research tends to answer the following questions: What is safety of medical products? On what legal basis can we justify that obligation? What are the difficulties in applying this requirement to address issues of health products? What is the health products? The law and civil liability Libya is it perfectly suited to the protection of the victim of health products as in the French liability law? This questioning has led the author to develop a thorough analysis of the safety obligation by way of contractual liability and health law French and Libyan. In the first part of the thesis, we see that the notion of bond security, including with respect to contractual liability, has experienced a major change from the time before. In fact, the emergence of the concept of safety obligation is old since it was founded in France 21 November 1911 at the contract of carriage. It can be defined as "the obligation to ensure the safety of any person or property which may be an obligation of result or means." Some codes of Near Eastern world have adopted the resolution that the French Supreme Court has taken in 1911 in the transportation of persons, such as Egypt and Lebanon. In 1956, the Appeal Court in Alexandria has complied with the requirement of safety in the transportation of persons. Similarly, in Lebanon in the Code of Obligations and Contracts provides in Article 688 that the contract of carriage of persons is the responsibility of the carrier's obligation to lead the traveler, unharmed, to the destination

O procedimento cirúrgico para implantes mamários inclui os chamados medidores, utilizados para a mensuração de volume e geometria antes colocação do implante definitivo na paciente. Esses dispositivos são constituídos por um invólucro de elastômero de silicone grau médico da classe siloxano ou poliuretano e cheios com volumes pré-estabelecidos de gel ou elastômero de silicone, grau médico, sendo apresentados em diversos volumes e formas equivalentes ao volume e forma do implante correspondente. Este trabalho avaliou o processo de limpeza manual dos medidores para implantes, sob o ponto de vista da redução da carga microbiana, propiciando a eficácia do processo de esterilização, nas condições encontradas nos Centros Cirúrgicos Hospitalares e utilizando seus equipamentos usuais. Foram realizados testes de desafio microbiológico em amostras de medidores com superfície texturizada e superfície revestida com poliuretano, utilizando cinco microrganismos (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans e Aspergillus niger) e dois tipos de detergente para comparação: não enzimático e enzimático. Determinou-se a biocarga antes e após a limpeza, e em seguida realizou-se a esterilização a 126°C por 30 minutos (1,4 kgf/cm2) das amostras, que foi avaliada por teste de esterilidade. Os resultados mostraram que a etapa de lavagem contribuiu para a redução de 4 ciclos logarítmicos da população inicialmente considerada e não houve diferença entre os resultados de biocarga dos medidores com superfície texturizada e superfície revestida com poliuretano. O processo de limpeza dos medidores com detergente não enzimático ou enzimático seguido de esterilização apresenta eficiência suficiente para garantir a esterilidade requerida para a utilização dos medidores. / The surgical procedure for mammary implants include the so called sizers, used to measure both volume and geometry prior to the definitive placement in the womans breast. These devices present a silicon elastomer or polyurethane external capsule, medical grade, siloxan class filled with predetermined gel or silicon elastomer volumes, also medical grade and are presented in several shapes and volumes equivalent to the shapes and volumes of the corresponding final implant. This study evaluated the manual cleaning process of the sizers focusing in the bioburden thus rendering an effective sterilization process, under the usual equipment and conditions found in the hospital surgery centers. Microbial challenge tests were performed using 5 microorganisms (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus niger) and two types of detergent , non enzymatic and enzymatic for comparison. Bioburden was determined before and after the cleaning procedure and after that samples were sterilized at 126°C (1,4 kgf/cm2) for 30 minutes, which was evaluated through sterility testing. Results shown that the cleaning step contributed to a 4 log cycle reduction in the samples initial bioburden and that there was no difference between bioburden results in both types of sizers (textured or polyurethane capsule). The cleaning process using non enzymatic or enzymatic detergents followed by sterilization shows enough effectiveness to ensure the required sterility for using the sizers.

O procedimento cirúrgico para implantes mamários inclui os chamados medidores, utilizados para a mensuração de volume e geometria antes colocação do implante definitivo na paciente. Esses dispositivos são constituídos por um invólucro de elastômero de silicone grau médico da classe siloxano ou poliuretano e cheios com volumes pré-estabelecidos de gel ou elastômero de silicone, grau médico, sendo apresentados em diversos volumes e formas equivalentes ao volume e forma do implante correspondente. Este trabalho avaliou o processo de limpeza manual dos medidores para implantes, sob o ponto de vista da redução da carga microbiana, propiciando a eficácia do processo de esterilização, nas condições encontradas nos Centros Cirúrgicos Hospitalares e utilizando seus equipamentos usuais. Foram realizados testes de desafio microbiológico em amostras de medidores com superfície texturizada e superfície revestida com poliuretano, utilizando cinco microrganismos (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans e Aspergillus niger) e dois tipos de detergente para comparação: não enzimático e enzimático. Determinou-se a biocarga antes e após a limpeza, e em seguida realizou-se a esterilização a 126°C por 30 minutos (1,4 kgf/cm2) das amostras, que foi avaliada por teste de esterilidade. Os resultados mostraram que a etapa de lavagem contribuiu para a redução de 4 ciclos logarítmicos da população inicialmente considerada e não houve diferença entre os resultados de biocarga dos medidores com superfície texturizada e superfície revestida com poliuretano. O processo de limpeza dos medidores com detergente não enzimático ou enzimático seguido de esterilização apresenta eficiência suficiente para garantir a esterilidade requerida para a utilização dos medidores. / The surgical procedure for mammary implants include the so called sizers, used to measure both volume and geometry prior to the definitive placement in the womans breast. These devices present a silicon elastomer or polyurethane external capsule, medical grade, siloxan class filled with predetermined gel or silicon elastomer volumes, also medical grade and are presented in several shapes and volumes equivalent to the shapes and volumes of the corresponding final implant. This study evaluated the manual cleaning process of the sizers focusing in the bioburden thus rendering an effective sterilization process, under the usual equipment and conditions found in the hospital surgery centers. Microbial challenge tests were performed using 5 microorganisms (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans and Aspergillus niger) and two types of detergent , non enzymatic and enzymatic for comparison. Bioburden was determined before and after the cleaning procedure and after that samples were sterilized at 126°C (1,4 kgf/cm2) for 30 minutes, which was evaluated through sterility testing. Results shown that the cleaning step contributed to a 4 log cycle reduction in the samples initial bioburden and that there was no difference between bioburden results in both types of sizers (textured or polyurethane capsule). The cleaning process using non enzymatic or enzymatic detergents followed by sterilization shows enough effectiveness to ensure the required sterility for using the sizers.

Wireless operation, near-field or far-field, is a core functionality of any mobile or autonomous system. These systems are battery operated or most often utilize energy scavenging as a means of power generation. Limited access to power, expected long and uninterrupted operation, and constrained physical parameters (e.g. weight and size), which limit overall power harvesting capabilities, are factors that outline the importance for innovative low-power approaches and designs in advanced low-power wireless applications. Low-power approaches become especially important for the wireless transceiver, the block in charge of wireless/remote functionality of the system, as this block is usually the most power hungry component in an integrated system-on-chip (SoC). Three such advanced applications with stringent power requirements are examined including space-based exploratory remote sensing probes and their associated radiation effects, millimeter-wave phased-array radar for high-altitude tactical and geological imaging, and implantable biomedical devices (IMDs), leading to the proposal and implementation of low-power wireless solutions for these applications in SiGe BiCMOS and CMOS and platforms.

Η αντιμετώπιση των χρόνιων ασθενών αποτελεί σήμερα για τα συστήματα υγείας και κοινωνικής φροντίδας ένα από τα πιο δύσκολα προβλήματα διεθνώς, τόσο από ιατρικής όσο και από κοινωνικό-οικονομικής πλευράς. Για το λόγο αυτό, τα αντίστοιχα συστήματα στις ΗΠΑ και ΕΕ έχουν αποδυθεί τα τελευταία χρόνια σε ένα εντατικό αγώνα για την αναδόμηση (reengineering) της συνολικής αντιμετώπισής τους, με στόχο τη βελτιστοποίηση των παρεχομένων υπηρεσιών και τον εξορθολογισμό του κόστους. Στρατηγικό εργαλείο για τη παροχή των νέων υπηρεσιών αποτελούν οι νέες Τεχνολογίες Πληροφορικής και Επικοινωνιών (ΤΠΕ). Στο πλαίσιο της παρούσας ερευνητικής εργασίας εξετάζεται η αξιοποίηση σύγχρονων και ευρέως διαθέσιμων τεχνολογιών επικοινωνιών (ευρυζωνικότητα, δίκτυα κινητής τηλεφωνίας κ.ά.), σε συνδυασμό με τη χρήση καινοτόμων προϊόντων, όπως αυτά των «ηλεκτρονικών» υφασμάτων (e-Textiles) για την παροχή καινοτόμων υπηρεσιών παρακολούθησης από απόσταση. Η παρούσα διπλωματική είχε σαν στόχο την εφαρμογή και αξιολόγηση ενός προγράμματος πρώιμης εξόδου από νοσοκομείο και κατ’ οίκον νοσηλείας σε χρόνιους αναπνευστικούς ασθενείς στο Νοσοκομείο «Η Σωτηρία» και διεξήχθη στο πλαίσιο του Ευρωπαϊκού Ερευνητικού Προγράμματος ‘HealthWear’. Η μεθοδολογική προσέγγιση έγινε αφενός με την ευρεία βιβλιογραφική ανασκόπηση αναλόγων παρεμβάσεων και αφετέρου με την αξιολόγηση ενός προγράμματος κλινικής εφαρμογής του σε πραγματικές συνθήκες. Στο πρόγραμμα συμμετείχαν 48 ασθενείς με Χρόνια Αποφρακτική Πνευμονοπάθεια, διαχωρισμένοι τυχαία σε ομάδα ελέγχου (ενδονοσοκομειακή φροντίδα), και ομάδα παρέμβασης (πρώιμη έξοδος και παρακολούθηση με τη χρήση φορετών και φορητών, μη επεμβατικών συσκευών). Παρουσιάζονται αναλυτικά ο σχεδιασμός του συστήματος και της υπηρεσίας, η μεθοδολογία και ο τρόπος παρακολούθησης των ασθενών της ομάδας παρέμβασης καθώς και τα αποτελέσματα της αξιολόγησης. Η εφαρμογή του προγράμματος στην καθ’ ημέρα κλινική πράξη κατέδειξε τη χρήση φορητών και φορετών συστημάτων ως αξιόπιστη εναλλακτική μέθοδο για την πρώιμη έξοδο και συνέχεια της φροντίδας των ασθενών με Χ.Α.Π. Παράλληλα διερευνήθηκαν μελλοντικές προοπτικές εφαρμογών για την εξ αποστάσεως παρακολούθηση κατά τη διάρκεια του ύπνου ή ταυτόχρονα με εκτέλεση άσκησης σε εξωτερικούς χώρους. / Treatment of chronic patients is currently one of the most difficult international issues that health and social care systems need to address, both medically and by socio-economic terms. For this reason, the corresponding systems in the U.S. and EU have engaged the last years a lot of effort, in an intense struggle, for the restructuring (reengineering) of the total care management process, in order to optimize service and streamline costs. Strategic tool for providing new services is Information and Communication Technologies (ICTs). In the current study, the usage of modern and widely available communication technologies (broadband internet, mobile telephony, etc.), combined with innovative products, such as the 'electronic' fabrics (e-Textiles), in order to provide advanced remote monitoring services, were thoroughly examined. This thesis aimed to implement and evaluate a program of early hospital discharge, followed by a home hospitalization program, in chronic respiratory patients of ‘Sotiria’ Hospital in the region of Attica - Greece, conducted within the framework of a European Research Project named 'HealthWear'. The methodological approach followed was first to establish an in-depth background for this type of interventions, through a broad, thorough systematic literature review, and secondly to evaluate a clinical trial, in the real everyday life of a public hospital. The program involved 48 patients with Chronic Obstructive Pulmonary Disease (COPD), separated randomly into control group (traditional care) and intervention group (early discharge and follow up by using wearable, portable, non-invasive devices). A comprehensive presentation of the ICT system used, the clinical protocol of the service and the methodology for the remote monitoring the intervention group patients, are followed by the assessment results of the trial. Our experience from this trial allows the prediction that wearable and wireless systems can be proved as new era’s tools in patients’ remote follow up and personalized care, especially valuable in early discharge, as well as in home based monitoring during sleep and outdoor activities.

p. 1-290 / Submitted by Santiago Fabio (fabio.ssantiago@hotmail.com) on 2013-04-30T20:35:03Z No. of bitstreams: 1 3333333333333333.pdf: 2022341 bytes, checksum: 509258a28eae8740edd814fa04c095a7 (MD5) / Approved for entry into archive by Maria Creuza Silva(mariakreuza@yahoo.com.br) on 2013-05-04T17:41:44Z (GMT) No. of bitstreams: 1 3333333333333333.pdf: 2022341 bytes, checksum: 509258a28eae8740edd814fa04c095a7 (MD5) / Made available in DSpace on 2013-05-04T17:41:44Z (GMT). No. of bitstreams: 1 3333333333333333.pdf: 2022341 bytes, checksum: 509258a28eae8740edd814fa04c095a7 (MD5) Previous issue date: 2007 / Este estudo analisa a regulação sanitária de equipamentos eletromédicos no Brasil e no Reino Unido. Busca identificar e analisar as semelhanças e diferenças entre os dois regimes e discutir em que medida eles protegem a saúde da população dos riscos decorrentes desses equipamentos. Optou-se por realizar pesquisa qualitativa exploratória com coleta de dados através de entrevistas, observação participante e análise de documentos, tomando-se bombas de infusão como equipamentos traçadores. Utilizando-se a Teoria dos Grupos de Interesse e a abordagem cibernética, é possível concluir que ambos os regimes estão implantados sob o modelo corporatista bipartite, priorizando a participação apenas de dois grupos de interesse, reguladores e aqueles representantes do segmento regulado. Apesar de terem legislação diferente, quanto à organização, o funcionamento deles se dá de modo fragmentado, implicando ocorrência de falhas regulatórias dos tipos captura e atenuação da ação regulatória. Têm estruturados de modo diferente os instrumentos regulatórios, controle sobre a entrada de empreendimentos no mercado, certificação de conformidade, revisão de pré-comercialização, tecnovigilância, mas guardam certa semelhança, no que diz respeito ao elemento central da ação regulatória - o equipamento em si, e não o paciente. Não utilizam os instrumentos regulatórios de forma balanceada, parecendo dar prioridade às atividades que geram recursos orçamentários para o órgão regulador e evitam conflito com o segmento regulado. Como conseqüência, aparenta que a regulação sanitária de equipamentos eletromédicos no Brasil e no Reino Unido ainda está distante de atender às necessidades de proteção da saúde da população. Para que esse objetivo seja alcançado, faz-se necessário investir em medidas educativas, esclarecendo a população sobre os riscos desses produtos e fomentando sua participação na organização do regime de regulação de risco à saúde. / Salvador