Orientador: Saide Jorge Calil / Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Engenharia Eletrica e de Computação / Made available in DSpace on 2018-08-05T15:28:52Z (GMT). No. of bitstreams: 1 Azevedo_GersonFlorenceCarvalheirade_M.pdf: 4985539 bytes, checksum: 6a64bdd99eb03ba28e978bd8aadcf336 (MD5) Previous issue date: 2004 / Resumo: Existe uma preocupação crescente dos profissionais de saúde com a segurança de suas equipes e dos pacientes no ambiente hospitalar. Dentre os fatores que afetam a segurança estão os perigos decorrentes de problemas funcionais dos equipamentos eletromédicos (EEMs), que podem ocorrer durante sua vida útil. Com o intuito de reduzir os riscos funcionais desses equipamentos nos hospitais, a engenharia clinica tem desenvolvido programas de manutenção preventiva, rotinas de ensaios de desempenho e calibração de equipamentos eletromédicos (PEDROSO & CAL/L, 2002). Aliado a isto, a introdução do gerenciamento de risco contribui para a eficiência do controle destes riscos. Através da implementação de suas etapas de gerenciamento (análise de risco, avaliação de risco e controle de risco), os problemas de segurança podem ser identificados e as ações da engenharia clínica direcionadas para a redução dos riscos, eliminando, na medida do possível, as causas dos riscos existentes. Neste sentido, foi apresentada aqui uma proposta de modelo de gerenciamento de risco aplicado ao desempenho de EEMs em estabelecimentos assistenciais de saúde (EAS), elaborado por meio da adaptação de preceitos, técnicas e procedimentos definidos pela literatura e pela Norma ISSO 14971:2000. O modelo desenvolvido foi sistematizado em uma seqüência de atividades divididas em três etapas definidas pela Norma anterior - análise de risco, avaliação de risco e controle de risco. Após a elaboração do modelo de gerenciamento, foi realizado um estudo de caso no centro cirúrgico do Hospital de Clínicas - UNICAMP, onde foram avaliados os riscos que podem ser produzidos pela utilização de desfibriladores. O modelo proposto de gerenciamento mostrou ser um sistema gerencial com metodologia investigativa, lógica e estruturada. A sua aplicação fornece argumentos rastreados e baseados no conhecimento para a tomada de decisão acerca dos procedimentos de controle de risco, com vistas a manter o risco dentro de níveis estabelecidos pelo comitê de gerenciamento de risco / Abstract: There is growing concern of the health professionals for the safety of their teams and the patients in the hospital environment. Among the factors that affect the safety are the hazards resulting from functional problems of medical electrical equipments (MEEs), that can happen during its useful life. With the objective of reducing the functional risks of those equipments in the hospitals, the clinical engineering has been developing programs of preventive maintenance, routines of performance and calibration tests of medical electrical equipment (PEDROSO & CALlL, 2002). Associated to this programs, the introduction of the risk management comes to contribute for the efficiency of these risks control. Through the implementation of its management stages (risk analysis, risk evaluation and risk control), safety problems can be identified and the actions of the clinical engineering group can be taken for the risk reduction. Thus, it was presented here a proposal of risk management model applied to the MEEs performance at the hospitals, elaborated through the adaptation of precepts, techniques and procedures defined by the literature and by the Standard ISO 14971:2000. The developed model was systematized in a sequence of activities divided in three stages defined by the previous Standard - risk analysis, risk evaluation and risk control. After the elaboration of the management model, a case study was carried out in the surgical center of the "Hospital das Clínicas UNICAMP", where the risks that can be produced by the use of defibrillators were evaluated. The proposed management model proved to be a management system with investigative, logic and structured methodology. Its application supplies traced arguments and based on the knowledge for the taking decision concerning the procedures of risk control, with views to maintain the risk in established levels by the risk management committee / Mestrado / Engenharia Biomedica / Mestre em Engenharia Elétrica

The issue of launching medical devices on the market became more intense in the last few decades in connection to the expansion of the pharmaceutical industry and legal area. This legal area is still mostly undescribed and it stands in the shadow of known and more discussed medical products. Proper legal theoretical analysis is often completely absent. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the launching of the medical devices on the market, including other processes related to this issue. Emphasis is places on the concept of medical device, the responsibility of the manufacturer and the nature of notified body. The author focuses on the subsequent conformity assessment process and process of registration. The process of notification and exemption from this obligation and administrative nature of selected documents. The thesis is divided into eleven chapters and the introductory chapter focuses on a general introduction to the field of pharmaceutical law, namely the regulation of medical devices, including the definition of basic questions in the work under study. The second chapter deals with the analysis of sources of legal regulation of medical devices. The chapter is divided into sources of the law of the Czech Republic and...

Die aktuelle Gesundheitsversorgung ist geprägt durch eine steigende Komplexität, die durch die Verzahnung verschiedener medizinischer Bereiche und die Nutzung immer komplexerer, technisch unterstützter Behandlungsmöglichkeiten bedingt ist. Gleichzeitig stehen Kliniken und das medizinische Fachpersonal unter einem hohen Kosten- und Zeitdruck. Für das Erreichen einer optimalen Behandlung des Patienten durch minimalinvasive und mikrochirurgische Eingriffe sind zunehmend Ansätze notwendig, die auf eine Interoperabilität verschiedener Systeme setzen und die Verwendung von zusätzlichen (semi )automatischen Unterstützungssystemen ermöglichen. Diese Arbeit beschäftigt sich mit Herausforderungen bei der Prozessunterstützung im Operationssaal. Dabei liegt der Fokus auf der Aktivitätserfassung und Datenspeicherung als Grundlage zur Erkennung des chirurgischen Prozesses. In einem ersten Schritt wurde ein theoretisches Vorgehensmodell für die intraoperative Prozessunterstützung auf der Basis eines geschlossenen Regelkreises entwickelt. Dabei steht der chirurgische Prozess im Zentrum. In weiteren Schritten wurden ein System zur Erfassung des aktuellen Arbeitsschrittes auf Basis der vorhandenen Videodaten (z.B. Mikroskopie, Ultraschall) sowie eine zentrale Speicherlösung für den Operationssaal entwickelt. Diese zentralen Komponenten sollen es Systemen ermöglichen, während des Eingriffs Daten an die verschiedenen Nutzer bereitzustellen und diese gleichzeitig für eine spätere Dokumentation vorzuhalten. Im weiteren Verlauf der Arbeit werden Ansätze zum Erreichen einer Interoperabilität von Medizingeräten und IT-Systemen im Gesundheitswesen vorgestellt, da technische Systeme neben zusätzlicher Sensorik eine wertvolle Informationsquelle für die Erfassung des aktuellen Prozesses im Operationssaal darstellen. Im Rahmen der Arbeiten des Projektes OR.NET (BMBF, 2012-2016) wurde mit der IEEE 11073-SDC-Standardfamilie eine Möglichkeit zur offenen Vernetzung geschaffen. Konzeptionell integriert werden die Systeme durch eine Beschreibung von Mehrwertdiensten von der einfachen Anzeige von Geräteparametern bis hin zur Teilautomatisierung von technischen Arbeitsschritten auf Basis des Kommunikationsstandards IEEE11073-SDC. Diese wurden basierend auf dieser Basistechnologie gemeinsam mit verschiedenen Projektpartnern entwickelt und mit Klinikern und Klinikbetreibern evaluiert. Die Ergebnisse der Evaluation zeigen, dass durch eine syntaktische und semantische Interoperabilität neue, nutzbringende Funktionen umgesetzt und die Arbeit der verschiedenen Nutzergruppen im Gesundheitssystem effektiv unterstützt werden können.:Inhalt Abstract Abkürzungsverzeichnis Abbildungsverzeichnis Tabellenverzeichnis 1 Einleitung 1.1 Motivation für diese Arbeit 1.2 Zielsetzung der Arbeit 2 Grundlagen der Arbeit 2.1 Aktuelle Operationssäle 2.2 Prozessunterstützung 2.2.1 Workflow und Prozessmodellierung 2.2.2 Workflow in der Medizin 2.2.3 Kontextsensitive Systeme 2.3 Klinische Anwendungsfälle im Rahmen der Arbeit 2.3.1 Intrakranielle Eingriffe am Gehirn 2.3.2 Transsphenoidale Hypophysenadenomentfernung 2.3.3 Sanierende Ohr-OP 3 Vorgehensmodell zur Prozessunterstützung 3.1 Interpretation und Action 3.2 Data analysis und Monitoring 3.3 Mögliche Herangehensweisen bei der Umsetzung einer Prozessunterstützung 4 Erfassung prozessrelevanter Daten im Operationssaal 4.1 Stand der Forschung 4.1.1 Team Assessment und Performanzüberwachung 4.1.2 OP-Dokumentation, Qualitätssicherung und Elektronische Patientenakte (EPA) 4.1.3 Workflow Recognition 4.2 Erkennung der Interaktion zwischen Medizingerät und medizinischem Personal basierend auf der Analyse von Videodaten 4.2.1 Methode 4.2.2 Evaluation 4.2.3 Diskussion 4.3 Erfassung von Informationen durch OP-Integration 4.3.1 Stand der Forschung 4.3.2 Grundlagen des Projektes OR.NET 4.3.3 Zusammenfassung 5 Datenspeicherung im Operationssaal (Surgical Data Recorder und die Erweiterungen auf Basis von OR.NET) 5.1 Surgical Data Recorder 5.1.1 Anforderungsanalyse 5.1.2 Systemkonzept 5.1.3 Evaluationsstudie 5.2 Anpassungen des Datenaufzeichnungskonzeptes im Rahmen des OR.NET-Projekts 5.3 Diskussion und Vergleich der Ansätze 6 Mehrwertdienste auf Basis einer offenen Vernetzung 6.1 Setzen von eingriffsspezifischen Informationen auf den angeschlossenen Geräten 6.2 Anzeige von Informationen im Sichtfeld des Chirurgen 6.3 Mehrwerte durch Datenintegration 6.4 Funktionen mit Nutzung von Prozessinformationen 7 Entwicklung der OP-Demonstratoren und Evaluation der implementierten Mehrwertdienste mit verschiedenen Anwendergruppen 7.1 Anforderungsanalyse für den Leipziger Demonstrator 7.2 Infrastruktur des Demonstrators 7.3 Integrationsszenarien in den Demonstratoren 7.4 Umgesetzte Mehrwertdienste im Leipziger Demonstrator 7.5 Vorgehen bei der Evaluation des Leipziger Demonstrators 7.5.1 Technische Evaluation 7.5.2 Klinische Evaluation 7.6 Ergebnisse der Evaluation 7.6.1 Technische Evaluation 7.6.2 Klinische Evaluation 7.7 Diskussion der Ergebnisse 8 Ausblick auf Weiterentwicklungen der offenen Vernetzung im Operationssaal 9 Zusammenfassung 10 Literatur 11 Anhang 11.1 Modellierung der sanierenden Ohr-OP als EPK inkl. möglicher Vernetzungsszenarien 11.2 Übersicht der umgesetzten Use-Cases im Leipziger Demonstrator 136 11.3 Fragenkatalog OP-Personal 11.4 Fragebogen Betreiber 12 Eigenständigkeitserklärung 13 Eigene Literatur 14 Danksagung

Le troisième Plan Cancer lancé en 2013 désigne la précocité du diagnostic comme l'un des enjeux majeurs pour l'amélioration de la prise en charge des patients. Malgré l’essor des modalités et des performances de l’imagerie médicale, il reste des défis à relever pour l’aide au diagnostic et optimiser le recourt à la biopsie.L’imagerie photonique et spécialement la fluorescence résolue spectralement a déjà été éprouvée pour la caractérisation ex vivo des tumeurs mammaires et pulmonaires, sans agent de contraste ou traitement des échantillons. Notre objectif est de caractériser les capacités d'un dispositif médical innovant, développé au laboratoire, utilisant une aiguille fibrée de faible calibre pour l’analyse spectrale de la fluorescence endogène de ces lésions in situ. Nos premiers travaux dans le cadre d’études précliniques et cliniques ont montré des différences significatives de signatures spectrales entre tumeurs bénignes et malignes ex vivo et in vivo. Nos résultats ont également mis en évidence les limites d’utilisation du dispositif, en termes de spécificité, pour certains types de lésions.Une étude secondaire a été entreprise sur des tumeurs mammaires afin d'identifier les entités tissulaires majeures à l'origine des signatures spectrales obtenues avec notre dispositif fibré. L'imagerie spectrale en microscopie confocale et seconde harmonique (SHG), en multiphoton, ont été mises en œuvre afin d’établir une cartographie de biomarqueurs endogènes des tissus mammaires. Nous avons confronter ses résultats aux données obtenues avec le dispositif d'aiguille fibrée afin de pouvoir le positionner non seulement comme une aide au diagnostic mais aussi comme une méthode prometteuse pour l’histopathologie in situ. / The third Cancer Plan, launched in 2013, identifies early diagnosis as one of the major challenges for improving patient care. Despite the growth in medical imaging modalities and performance, challenges remain in diagnosis aid and optimizing the use of biopsy.Photonic imaging and especially spectrally resolved fluorescence has already been tested for the ex vivo characterization of breast and lung tumors, without contrast agent or sample processing. Our goal is to characterize the capabilities of an innovative medical device, developed in the laboratory, using a low-caliber fibered needle for the spectral analysis of the endogenous fluorescence of these lesions in situ. Our early work in preclinical and clinical studies showed significant differences in spectral signatures between benign and malignant tumors ex vivo and in vivo. Our results also highlighted the limits the device, in terms of specificity, for certain types of lesions.Another study was conducted on mammary tumors in order to identify the major tissue entities at the origin of the spectral signatures obtained with our fibered device. Spectral imaging in confocal and second harmonic microscopy (SHG), in multiphoton, has been implemented in order to establish a mapping of endogenous biomarkers of mammary tissues. We compare its results with the data obtained with the fibered needle device in order to position it not only as an aid to diagnosis but also as a promising method for in situ histopathology.

The medical device industry has for a long time lagged behind other industries in terms of adopting new tools for process improvements. Despite showing promising results from various industries, some more heavily regulated than others, modelling and simulation has not yet gained traction within the medical device industry for performing production improvements. The industry has instead relied upon proven improvement philosophies which are believed to generate a desirable outcome. With the purpose of investigating how this novel tool can be combined with current improvement efforts as well as understanding why it has not yet been accepted, a case study was conducted at the Uppsala facility of Johnson & Johnson Vision. A mixed methodological approach was used, where quantitative and qualitative data was analyzed in combination. Semi-structured interviews and structed observations provided empirical evidence for a thematic analysis and a simulation-based bottleneck analysis. Rather than proving that a simulation-based bottleneck was possible in this particular setting, it was used to confirm its applicability in combination with other tools and improvement philosophies. The study concludes that the issue is not strictly related to the use of modelling and simulation but is rather related to the reactive mind-set which has become a consequence of the rigorous regulatory landscape that the industry is encompassed by.

The project was carried out for Semcon’s product development department. The aim of the project was to develop a concept that illustrates Semcon’s competences in their Total Design Office offer. The concept was to be developed within the medical device sector, with the purpose to self-monitor the user's health. The concept should also emphasize Semcon’s focus of being futuristic by analyzing and implementing emerging trends in health care and the medical device industry. At the start of the project a study of Semcon and its competitors was preformed to clarify the development goals. During the development process the Swedish health care system was investigated in order to identify openings for a self-monitoring device for private use. Applications were identified and evaluated according to societal importance and the result was a focus on heartmonitoring devices. The findings shows that heart disease is the most common cause of death and that a large portion of the population suffer from heart-related complications during their lives. The idea was to develop a concept that helped people discover heart problems and to motivate them to improve their lifestyle. Preventive treatment of diseases was identified as a future trend in the healthcare, due to the constant need for cost efficiency and improvements towards patient treatment. The development process was influenced by user involvement to strive for high usability in the concept. Users were identified and invited in two focus groups where their needs and ideas on thetopic of self-monitoring were discussed. By generating ideas from the user’s needs, concepts were formed and developed in several iterations of ideation methods to improved the early ideas of clearly formulated concepts. A workshop was conducted at Semcon were employees shared their expertise to verify and refine the concepts. After a selection process a final concept was chosen, the result was a wristband with an accelerometer and an ECG to provide the user with a quick evaluation of their heart and health condition. A key feature of the concept is the link it provides between user and the physician. The user will get feedback on their collected data and the physician has the ability to monitor patient condition from a distance. A user interface was developed to give the user an easy way to assimilate data without interpret medicinal values. / Examensarbetet genomfördes för Semcons produktutvecklingsavdelning i Göteborg. Syftet med projektet var att utveckla ett koncept som visar på Semcons in-house kompetenser i deras Total Design Office. Konceptet skulle utvecklas inom den medicinska sektorn och ha funktioner riktade mot privatpersoner för att göra egenkontroller av sin hälsa. Konceptet skulle också framhäva Semcons framtidsnisch genom att ligga i tiden och följa etablerade trender. Vid starten av projektet studerades Semcon och deras konkurrenter för att klargöra utvecklingsmålen för produkten. I utvecklingsprocessen undersöktes det svenska sjukvårdssystemet efter eventuella öppningar för ett egenkontrollskoncept riktat mot privat bruk. Öppningar identifierades genom läkarintervjuer på Sahlgrenska och Solna ASiH. Öppningarna utvärderades utefter samhällsnyttig betydelse och resultatet blev att inrikta sig vidare mot hjärtövervakning. Grundtanken var att utveckla ett koncept för att hjälpa människor att upptäcka hjärtproblem i tid och motivera till en förbättrad livsstil. Preventiv vård av sjukdomar hade identifierats som en framtida trend inom vården, på grund av vården konstanta behov av kostnadseffektivisering och förbättra patientnyttan inom vården. Utvecklingsprocessen var influerad av brukarmedverkan då en hög användarvänlighet var eftersträvad i konceptet. Användare var identifierade och inbjudna till två fokusgrupper där användarbehoven och idéer inom egenkontrollen av hälsa diskuterades. Insikterna från förstudien och fokusgrupperna användes i en idégenereringsprocess för att ta fram lösningar på användarnasproblem. Genom flera iterationer av idegenereringsmetoder utvecklades och förbättrades de tidiga idéerna till tydligt formulerade koncept. I denna process anordnades en workshop på Semcons däranställda bidrog med sin egen expertis för att verifiera och utveckla koncepten. Efter en urvalsprocess kunde ett slutkoncept identifieras, det blev ett armband med en inbyggd accelerometer och EKG för att utvärdera användarens hjärta och allmänna hälsotillstånd. En centralfunktion i armbandet var att kunna skicka information mellan användaren och läkare. Användaren får då möjlighet till feedback på sina insamlade data och läkaren får möjligheten att övervaka patientens tillstånd från ett avstånd. Ett användargränssnitt utvecklades för att ge användaren ett enkelt sätt att ta del av det insamlade data utan att bli tvungen att tolka medicinska värden.

The field of hematology involves the analysis of blood and its components like platelets, red blood cells, white blood cells. The outcome of this analysis can be vital in determining the condition of the human body and it is important to obtain accurate results. A deep learning algorithm scans over the given input data for unique features and learns them. Then it identifies these features and correlates them to give the result. This can save a significant amount of time and manual work. In contrast, a traditional machine learning algorithm requires the developer to carry-out the feature engineering. This thesis involves the analysis of white blood cells (WBC) using deep learning techniques. In collaboration with a hematology company HemoCue AB based in Angelholm, we will be developing deep learning algorithms for the analysis of white blood cells in the HemoCue R WBC DIFF System. Predominantly, there are two stages in this thesis. The first stage is white blood cell identification, which is used to calculate the number of white blood cells in the given blood sample. The next stage is to identify the different types of white blood cells with which the concentration of each type of WBC in the given blood sample is calculated. We have explored different classification approaches like ’one vs all’ and ’4-class classifier’, and have developed two CNN architectural designs i.e. ’multi-input’ and ’multi-channel’. On comparing the performance of all these design approaches, a final integrated model is put forth for the analysis of WBCs in the company’s device. The proposed ’one vs all’ classification approach combined with a 3-class CNN classifier has yielded very promising results with a combined accuracy 95.45% in WBC identification and 90.49% in WBC differential classification.

Innovation fuels American business. Commonly, innovation is judged as good. Yet, many of the new medical devices that come on the U.S. market every year are later deemed unsafe. Regulation is distorted in that 98% of medical devices are never evaluated in human trials before being introduced to the marketplace. Instead, the U.S. Food and Drug Administration (FDA) approves a new medical device through a designated 501(k) process, based upon the identification of a predicate or substantially equivalent (SE) device. This is an investigation of the tension between product innovation, government regulation, and public safety in the American healthcare industry. It is a research project in two parts. The first draws upon established methodologies and utilizes the FDA’s 501(k) database to provide an illustrated example of the sequence and dependency between generations of implanted surgical mesh devices. The analysis reveals that the 501(k) approval process reliance on predicate devices facilitates medical device innovation that is problematic in several aspects, including patient safety. To further examine medical device innovation and patient safety, the second study develops a proof-of-concept exercise to evaluate data on recorded adverse events (AEs) found in the FDA’s Total Product Lifecyle (TPLC) database for surgical mesh products. The adverse events were mapped to the Association for the Advancement of Automotive Medicine’s (AAAM’s) Abbreviate Injury Scale (AIS), following precedents found in the medico-legal literature and military injury biomechanics standards. This approach forges a path forward to determine the relative frequency and severity of adverse events of a specific medical device, compared to that of the overall FDA product category. These two research projects combine to contribute to the understanding of safety of the FDA’s approval process and by extension the medical device industry’s innovation practices. / Business Administration/Accounting

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Wireless communication for biomedical equipment is rapidly improving with the invention of new technologies. Due to the absence of cables, wireless technology is a growing area of interest for biomedical applications. As technology advances, many gadgets are becoming smaller and more portable. Often, there is a need for these medical devices to transfer data in real-time. However, it is critical to recognize the special obstacles connected with the creation of novel products that need in-body to off-body communication. Unlike standard wireless communication scenarios, such as Wi-Fi or cellular networks, where data passes through the air; in-body to off-body communication occurs within or on the surface of the human body. Itis a significant technological challenge to provide dependable and secure communication inside the body’s dynamic and changing environment. The human body’s dielectric characteristics, attenuation, received power, transmitted power, and distance to the receiver must be considered when designing any wireless implantable device. In this thesis, we designed tests with a lossy medium that simulates the human body and a few test protocols that can facilitate the testing and development of wireless communications from in-body to off-body for a medical device intended to support pelvic muscle floor training. We designed the test protocols based on this application and safety requirements. These tests were then used to evaluate and compare two commercially available transceivers operating at 433MHz and 2.4 GHz.We created and implemented several experiments using the communication models. This thesis investigated the properties of a lossy medium in the context of electromagnetic signals in wireless communication. The tests included a study of connectivity, range, latency, and packet errors that occur during signal transmission across the medium. The findings indicate that BLE modules might be more favorable for future advances. The outcomes of this thesis can be utilized as a starting point for the future development of the intended application.BLE technology is distinctive largely by its low power consumption, which is critical for applications where energy efficiency is the main concern. Especially important in the context of IoT (Internet of Things) and wearable devices, where long-lasting battery life is required. Furthermore, BLE provides a more robust and standardized communication protocol, making it easy to integrate and compatible with a wide range of devices and platforms. While 433 MHz modules have advantages such as a longer range and simpler technology, BLE’s increased transmission rate capabilities and broad acceptance in current smartphones and tablets make it more adaptable for applications that require frequent data exchange and compatibility with consumer devices.