Dissertations / Theses on the topic 'Medical device safety'

Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls.

Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 65-66).
The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic Accident Modeling and Processes.) Traditional accident models typically focus on component failure; in contrast, STAMP includes interactions between components as well as social, economic, and legal factors. In this thesis, the accident of the artificial heart at a level II hospital in China was used as a test case to study whether Causal Analysis based on STAMP (CAST) is used to outline the interactions between the different medical device system components, identify the safety control structure in place, and understand how this control structure failed to prevent artificial heart accident in a Chinese hospital. The analysis suggested that further changes might be necessary to protect the Chinese public and so, based on the results of the CAST, a new set of systemic recommendations was proposed.
by Qingyang Song.
S.M.in Engineering and Management

Safety-critical medical devices play an important role in improving patients health and lifestyle. Faulty behaviors of such devices can cause harm or even death. Often these faulty behaviors are caused due to bugs in software programs used for digital control of the device. We present a formal veri cation methodology that can be used to check the correctness of object code programs that implement the safety-critical control functions of these medical devices. Our methodology is based on the theory of Well-Founded Equivalence Bisimulation (WEB) re nement, where both formal speci cations and implementations are treated as transition systems. First, we present formal speci cation model for the medical device. Second, we develop correctness proof obligations that can be applied to validate object code programs used in these devices. Formal methods are not widely employed for the veri cation of safety critical medical devices. However, using our methodology we were able to bridge the gap between two very important phases of software life cycle: speci cation and veri cation.

The purchase of medical devices involves engaging various stakeholders as well as balancing clinical, technical and financial requirements. Failure to consider these requirements can lead to wider consequences in the delivery of care. This study first builds a general knowledge base of current purchasing practice in a sample of NHS Trusts, which confirms the direction and guidance given by policy documents and literature as to the extent of the challenges faced by purchasing stakeholders. This then leads to an analysis to identify inefficiencies in the purchasing process, and how such practice can lead to risks in the delivery of care. These risks range from injury to individuals, impacts to the healthcare delivery service, and financial and litigation risks. Finally, a framework that highlights these potential risks in the life-cycle of medical devices in hospitals is presented. Key policy guidance has encouraged both researchers and implementers of healthcare services to approach patient safety from a systems perspective, acknowledging that medical device errors are not only directly related to device design, but to the design of the healthcare delivery service system in which the device operates. Little evidence exists of successfully applying systems approaches specifically to medical device purchasing practice. Medical device purchasing, because of its implications to patient safety on the one hand, and the uniqueness of the healthcare context, requires a unique approach. By demonstrating the influence of purchasing practice to service delivery and patient care, the thesis made is that taking a holistic systems approach is one method to improve device purchasing practice, and hence influence better care.

Medical literature identifies a number of technology-driven improvements in disease management such as implantable medical devices (IMDs) that are a standard treatment for candidates with specific diseases. Among patients using implantable cardiac defibrillators (ICD), for example, problems and issues are being discovered faster compared to patients without monitoring, improving safety. What is not known is why patients report not feeling safer, creating a safety paradox, and why patients identify privacy concerns in ICD monitoring. There is a major gap in the literature regarding the factors that contribute to perceived safety and privacy in remote patient monitoring (RPM). To address this gap, the research goal of this study was to provide an interpretive account of the experience of RPM patients. This study investigated two research questions: 1) How did RPM recipients perceive safety concerns?, and 2) How did RPM recipients perceive privacy concerns? To address the research questions, in-depth, semi-structured interviews were conducted with six participants to explore individual perceptions in rich detail using interpretative phenomenological analysis (IPA). Four themes were identified and described based on the analysis of the interviews that include — comfort with perceived risk, control over information, education, and security — emerged from the iterative review and data analysis. Participants expressed comfort with perceived risk, however being scared and anxious were recurrent subordinate themes. The majority of participants expressed negative feelings as a result of an initial traumatic event related to their devices and lived in fear of being shocked in inopportune moments. Most of these concerns stem from lack of information and inadequate education. Uncertainties concerning treatment tends to be common, due to lack of feedback from ICD RPM status. Those who knew others with ICD RPM became worrisome after hearing about incidences of sudden cardiac death (SCD) when the device either failed or did not work adequately to save their friend’s life. Participants also expressed cybersecurity concerns that their ICD might be hacked, maladjusted, manipulated with magnets, or turned off. They believed ICD RPM security was in place but inadequate as well as reported feeling a lack of control over information. Participants expressed wanting the right to be left alone and in most cases wanted to limit others’ access to their information, which in turn, created conflict within families and loved ones. Geolocation was a contentious node in this study, with most of participants reporting they did not want to be tracked under any circumstances. This research was needed because few researchers have explored how people live and interact with these newer and more advanced devices. These findings have implications for practice relating to RPM safety and privacy such as identifying a gap between device companies, practitioners, and participants and provided directions for future research to discover better ways to live with ICD RPM and ICD shock.

Aims: To study practices and procedures with respect to electrotherapy in physiotherapy departments and to study physiotherapists’ perception of health risk, health consequences and protection of health from different risks including electromagnetic field emissions from electrotherapy devices. Methods: This cross-sectional study was conducted in three phases from June 2002 to December 2003. The first phase was an audit of the practices and procedures regarding electrotherapy in National Health Service physiotherapy departments (N = 46 including 7 departments in pilot study) located in 12 counties in the southeast and southwest of England including Greater London. The second phase comprised one observational visit to each of the same physiotherapy departments to characterise their occupational environment. The third phase was a questionnaire survey of 584 physiotherapists working in these departments. Variables concerned perception of health risk, health consequences and protection of health associated with different risk factors. Results: In the first two phases, the recruitment rate of the departments was 80.7% (46 out of 57) and response rate of those recruited was 100% (n=46). The response rate for the last phase of the study was 66.8% (390 out of 584). Results of the practices and procedures audit show that ultrasound was the most common form of electrotherapy while microwave diathermy was neither available nor used in these departments. Pulsed shortwave diathermy was used 4-5 days per week while continuous shortwave diathermy was used rarely. Electrotherapy was provided to up to 50% of patients per week in the departments. The observational visits to the departments revealed that there were metallic objects within close proximity of diathermy equipment and wooden treatment couches for treatment with PSWD and CSWD were rare. The risk perception survey showed that physiotherapists generally perceived a moderate health risk and health consequences (harm) from exposure to EMF emissions from electrotherapy devices. Protection from EMFs in physiotherapy departments was generally perceived as ‘usually’ possible. Conclusions: Physiotherapy departments report safe electrotherapy practices. Use of diathermy devices that use RF EMFs is declining. The key predictors of physiotherapists’ perception of health risk were perception of health consequences and vice versa. Gender was a significant predictor of the perception of health risks and health consequences. The main predictor of perception of protection against risk was the knowledge of environmental and health issues. Latent dimensions of perceptions of health risk, health consequences and protection from risk were identified and confirmed and their predictors were determined.

There is an increased need for complete medical device traceability in the healthcare industry. The two main reasons are the healthcare industry's global supply chain and decentralised adverse events reporting, where different laws apply for each country and where each country has their own database for incidents without international governance. The idea of improving traceability procedures in the surgical department at Karolinska University Hospital was formed in the light of a near miss event where guidelines regarding incident management of a Single-Use Medical Device (SUMD) were not followed properly. Hence, this thesis project will investigate the issue of finding an effective way to trace SUMDs at Karolinska University Hospital, in order to improve the incident management process and suggest improvements of patient safety at other Swedish hospitals as well. The collection of data consisted of different data sources; observations at the research site and interviews with relevant participants. By employing multiple sources to this study, a more holistic approach could be achieved. In addition to observing the current situation of device registration, it was of importance to ask individuals with competence and different perspectives on the issue of traceability of SUMDs. To answer the research questions, the acquired data was categorized into the different identified cornerstones of traceability of SUMDs. These were registration process, perioperative supply chain and incidents management. Each section was divided into an investigation of the current process, issues and suggested improvements, in order to clearly answer to the research questions. Furthermore, these acquired answers and insights, from observations and interviews, were translated and summarized to form a basis for the results. Based on the data acquisition and compilation from the different perspectives, key findings and themes are presented in the results. The thesis proposal include a visual representation that show the physical flow of a SUMD from the point of being delivered to the hospital by the distributor, through different entities where registration occur, until it is either discarded or saved for incidents reporting. In order to avoid many of the current issues and to realize the acquired suggestions from this thesis, interoperability between the systems within the healthcare organization as well as between the different entities throughout the entire supply chain is an essential part of the solution, which should be further studied.

Intravenous infusion devices - commonly known as infusion pumps - provide clinicians with mechanisms to automate the accurate dosing of potent fluid therapies to critically ill patients. In critical care applications, fluid dosing must be both accurate and safe since unwanted flow disturbance can cause physiological harm to the patient. This study consists of three discrete projects based on these vital themes of safe device design and accurate fluid delivery. The first project, commissioned by Medical Magnetics Ltd during the period 1998 onwards, proposed that the fail-safe design philosophy universally used in the design of infusion pumps, and implemented in embedded software, is lengthy and provides the manufacturer with difficulties in demonstrating the exhaustive fail-safe validation needed for an instrument to be released speedily for sale. An alternative and innovative strategy employing the design of hardware modules and using re-configurable VLSI, is proposed and shown to offer a significant reduction of the design and validation phase of development with consequent financial benefit to the manufacturer. The second project conducted as part of the Manukau Institute Research Programme for 2003 examined the manner in which dosing accuracy is assessed for infusion pumps. The International Standard used by clinicians to select apparatus suitable for treatment of 'critically-ill' patients is shown to be flawed and potentially misleading - a finding of international significance. An innovative mathematical simulation model is described that enables prediction of flow accuracy for various expected operating scenarios previously impossible to investigate using current laboratory measurement techniques. Use of this simulation model indicates that various mechanical design factors influencing system compliance and hence dosing accuracy have been previously ignored by designers and suggests that contemporary infusion pump designs are far from optimum. These findings offer an explanation for instances of dosing error previously reported in the clinical literature and are of international value. The third project of the study utilises the findings of, and is subsequent to, the second project. An innovative design is proposed for an infusion therapy device in which dosing accuracy may be maintained under operating conditions such as height change and patient venous pressure variation that cause unwanted errors in conventional equipment designs. This design is the subject of patent application, commercial exploitation and further development.

Accidents related to medical devices are a worldwide problem and result in many deaths each year. It affects patients, relatives, health care workers and society. Due to the complexity of intensive care units (ICUs), such accidents lead to particularly serious consequences. The aim of this thesis was to identify patient safety aspects at ICUs in public and private hospitals in Bangladesh, in order to provide a basis for improving the quality of performance of devices as well as personnel, care and cost effectiveness. The objectives were to a)      compare the conditions of medical devices at ICUs in private and public hospitals, b)      increase understanding of errors, risks and accidents related to medical devices, c)      study reporting systems and communication between staff at ICUs and d)      find ways to minimize hazards related to medical equipment to ensure effective and safe use of devices. Data was collected through interviews during field visits to six hospitals in Dhaka, Bangladesh. Interviews were held with the chiefs of the ICUs, physicians, nurses and technicians. It was noticed that the admission fees to the public hospitals were lower and had more limited resources. Differences between public and private hospitals could be seen in the aspects of finance, the existence of a Biomedical Engineering Department, maintenance and calibration of medical equipment, further education of staff, working environment and infection control. The reporting systems for adverse events and communication about patients’ conditions between coworkers were weak at all hospitals. The procurement process was lengthy at all hospitals. Access to disposable items was limited at several hospitals. The lower admission fee at the government hospitals results in the patients of these hospitals often having a lower income and status, thus less inclined to be critical of the received care. A number of suggestions have been proposed in order to improve the work in the ICU. These include a)      following up rules made by the authorities to ensure they are implemented at each hospital, b)      increasing documentation of malfunctioning devices and adverse events, c)      nurses and physicians taking part in the procurement process, d)      establishing a Biomedical Engineering Department at all hospitals, e)      organizing workshops for health care workers, f)       developing biomedical products adapted for multiple time use and with less need for calibration, g)      providing more education for health care workers in infection control, management of specific devices, solutions to common technical problems, patient safety and user safety, for example using Information and Communication Technology tools (audio and audiovisual material) and discussion platforms as well as h)      constructing an internet forum for consultation on the abovementioned subjects for technicians.
Olyckor relaterade till medicinteknisk utrustning är ett globalt problem som leder till många dödsfall varje år. Det påverkar patienter, anhöriga, sjukvårdspersonal och samhället. Den komplexa miljön på intensivvårdsavdelningar gör att olyckorna leder till allvarliga konsekvenser. Uppsatsen syftade till att identifiera patientsäkerhetsaspekter på intensivvårdsavdelningar i Bangladesh för att skapa en grund för prestandaförbättring, både gällande utrustning och gällande personal. Det ska också öka vård- och konstandseffektiviteten. Målet uppnåddes genom att a)      jämföra användandemiljön för medicinteknisk utrustning på intensivvårdsavdelningar på statliga och privata sjukhus, b)      öka förståelsen för fel, risker och olyckor relaterade till medicinteknisk utrustning, c)      studera rapporteringssystem samt kommunikation mellan personal på intensivvårdsavdelningar och d)      hitta sätt att minimera faror relaterade till medicinteknisk utrustning för att försäkra en effektiv och säker användning av utrustningen. Data samlades in genom intervjuer under en fältstudie på sex sjukhus i Dhaka, Bangladesh. Intervjuer hölls med cheferna på intensivvårdsavdelningarna, läkare, sjuksköterskor och tekniker. Det upptäcktes att patientavgiften på de statliga sjukhusen var lägre och resurserna var mer begränsade. Skillnader mellan statliga och privata sjukhus kunde ses inom ekonomiska resurser, förekomsten av medicintekniskavdelning, underhåll och kalibrering av medicinteknisk utrustning, vidareutbildning av personal, arbetsmiljö och infektionskontroll. Rapporteringssystemen för olyckor samt kommunikationen om patienters tillstånd mellan medarbetare var bristfällig på alla sjukhus. Upphandlingsprocesserna av ny medicintekniskutrustning var lång på alla sjukhus. Tillgången på engångsartiklar var begränsad på flera utav sjukhusen. Den lägre avgiften på de statliga sjukhusen resulterar i att patienterna på dessa sjukhus ofta har lägre inkomst samt status i samhället och är därför mindre benägna att vara kritiska till den mottagna vården. Ett antal ändringar föreslogs för att förbättra arbetet på intensivvårdsavdelningarna. Dessa inkluderar att a)      följa upp de av myndigheterna satta reglerna för att försäkra att de är implementerade på varje sjukhus, b)      öka dokumentationen av icke fungerande utrustning tillika olyckor, c)      sjuksköterskor och läkare skall delta i upphandlingsprocesserna, d)      starta medicintekniska avdelningar på alla sjukhus, e)      organisera workshops för vårdpersonal, f)       utveckla medicintekniska produkter som är anpassade för att användas flera gånger och som behöver kalibreras mer sällan, g)      ge mer utbildning till sjukvårdspersonal om infektionskontroll, hantering av specifika maskiner, lösningar till vanligt förekommande tekniska problem, patientsäkerhet och användarsäkerhet till exempel genom att använda information- och kommunikationsteknik-verktyg (audio och audiovisuellt material) och diskussionsplattformar samt h)      konstruera ett internetforum där tekniker kan få konsultation angående ovannämnda ämnen.
To develop patient safety system to improve the safety and quality of patient care at the Intensive Care Units

Medical products of all kinds have to comply with regulations to satisfy the demand for public health and safety. Medicinal products (drugs) were the first medical products to be regulated in most countries and regulations for medical devices - generally derived from drug regulations - followed. This thesis reviews the development of safety regulation for medical devices from its relatively recent introduction in the 1960s to the present day. The emphasis is on the situation in countries of the European Community but events in these countries are placed in a world-wide context. Landmark events in this process - notably the US Medical Device Amendments of 1976 and the EC Medical Device Directive of 1994 - are analysed and compared. An examination of current regulations in the three major markets for medical devices: Europe, Japan and USA, leads to the identification of quality systems, product standards, effectiveness/performance and post-market controls as key factors in modern regulatory approaches. The emergence of these key factors illustrates the movement towards an engineering, rather than a pharmaceutical, approach to regulation and their place in current and emerging regulations world-wide is discussed. Manufacturers have long pressed for uniformity in national regulations to reduce the time and cost involved in obtaining market approval and their case has been largely accepted by the regulatory authorities. Harmonization in Europe has been achieved as part of the Single Market programme. The last decade has seen remarkable progress towards the further harmonizing of national and regional regulations. The outstanding difficulties, notably controversy over the need for "effectiveness" determination and relative roles of clinical and laboratory testing, are discussed and solutions proposed. The prospects for achieving global harmonization are examined and a possible future global system is described.

Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 87-89).
In today's environment, medical technology is rapidly advancing to deliver tremendous value to physicians, nurses, and medical staff in order to support them to ultimately serve a common goal: provide safe and effective medical care for patients. However, these complex medical systems are contributing to the increasing number of healthcare accidents each year. These accidents present unnecessary risk and injury to the very population these systems are designed to help. Thus the current safety engineering techniques that are widely practiced by the healthcare industry during medical system development are inadequate in preventing these tragic accidents. Therefore, there is a need for a new approach to design safety into medical systems. This thesis demonstrated that a holistic approach to safety design using the Systems Theoretic Accident Model and Process (STAMP) and Causal Analysis based on STAMP (CAST) was more effective than the traditional, linear chain-of-events model of Failure Mode Effects and Criticality Analysis (FMECA). The CAST technique was applied to a medical case accident involving a complex diagnostic analyzer system. The results of the CAST analysis were then compared to the original FMECA hazards. By treating safety as a control problem, the CAST analysis was capable of identifying an array of hazards beyond what was detected by the current regulatory approved technique. From these hazards, new safety design requirements and recommendations were generated for the case system that could have prevented the case accident. These safety design requirements can also be utilized in new medical diagnostic system development efforts to prevent future medical accidents, and protect the patient from unnecessary harm.
by Vincent H. Balgos.
S.M.in Engineering and Management

L’Imagerie par Résonance Magnétique (IRM) est une technique d’imagerie de référence pour réaliser des diagnostics médicaux. Pour des patients implantés avec des dispositifs médicaux actifs, l’IRM peut engendrer des risques qui doivent être étudiés et minimisés. En effet, ces dispositifs sont constitués en partie de matériaux conducteurs et/ou magnétiques qui interagissent avec l’environnement électromagnétique d’une IRM. Lorsque ces dispositifs ont des câbles, une des interactions les plus problématiques est l’induction d’énergie dans ses câbles qui peut entrainer des stimulations, des dysfonctionnements ou des brûlures. Le premier objectif de cette thèse est de développer des outils pour étudier et quantifier ces interactions électromagnétiques d’une IRM sur un câble. Pour cela, des capteurs innovants compatibles IRM ont été développés pour mesurer la tension induite sur un câble, aux bornes de l’électronique d’entrée d’un dispositif médical actif. Des bancs de tests ont également été mis en place pour simuler les champs électromagnétiques d’une IRM. Le second objectif de cette thèse est de concevoir des câbles innovants qui réduisent au maximum ses interactions électromagnétiques avec une IRM. Nous avons réalisé un câble constitué d’un fil conducteur qui limite l’énergie induite par l’IRM grâce à son bobinage variable. Nous avons réalisé un deuxième câble avec un conducteur de fine épaisseur et des ruptures d’impédances sur sa longueur
Magnetic Resonance Imaging (MRI) is an established imaging technique for medical diagnostics but could expose patients with active medical devices to risks that need to be studied and minimized. In fact, these devices encompass conductive and/or magnetic materials which interact with the electromagnetic field of the MRI. When these devices contain leads, MRI induced energy within the lead is considered to be one of the most problematic interaction as it can lead to stimulations, malfunction or burns. The first goal of this thesis is to create tools to study and quantify the electromagnetic interactions between an MRI and a lead. This has led to the design of novel MRI compatible sensors that measure induced voltage within leads connected active medical device entry terminals. Experimental MRI set-ups were also developed to simulate the MRI’s electromagnetic field. The second goal of this thesis is to design new leads that are minimally affected by the MRI’s electromagnetic field. Two proofs of concept were achieved. On the one hand, a lead capable of reducing MRI induced energy thanks to its winding was made. On the second hand, a second lead with a thin conductor and impedance mismatches along its length was created

Prehospital emergency care is facing a paradigm shift. Spinal motion restriction (SMR) is a way to treat trauma patients with symptoms of spinal injury. It was earlier entitled as ‘routine SMR’, and included spine board and cervical collar. During the 2000s, it has been noted that there is a lack of scientific evidence that proves the benefits with ‘routine SMR’. This led an expert group to the development of the national guidelines, that were published in 2019. The national guidelines can be described as ‘selective SMR’, where the cervical collar and spine board is excluded. It means that the SMR shall be adapted to the patient and not the equipment. Furthermore, the patient should be involved as much as possible in the treatment. This master thesis has been conducted at the Luleå University of Technology (LTU), in collaboration with AB Germa. The objective was to enable paramedics (the users in this project) to provide trauma patients with safe and efficient SMR by improving the usability of available or future products for SMR. Therefore, the project aim was to deliver a conceptual suggestion with feedback from the users. Furthermore, a mapping with experienced problems was delivered, and a review of the available medical devices with recommendations on how the future product development of medical devices for SMR could head in a user-centred direction. The theoretical framework included both ergonomics, including anthropometry and anatomy, and semiotics to involve both the physical and cognitive aspects of good usability, as a complement to the contextual immersion to be able to develop a thought through conceptual suggestion. The contextual immersion involved contact with Sweden’s 21 regions, and 16 paramedics. Through visits, interviews, and observations information was gathered about available medical devices for SMR, and challenges that paramedics are facing with them where mapped. This was compiled in a user need specification, which formed the basis for the idea generation. The ideation resulted in over 200 ideas. Iterative feedback sessions together with the users generated five concepts, that by further feedback, and iterative work converged into one final concept. The project delivers a vest with vacuum technology that enables paramedics to perform safe and efficient SMR of trauma patients with various anatomy. The concept has the flexibility of a KED and the adaptability of a vacuum mattress. It enables ’selective SMR’ in confined spaces, and facilitates the patient to be more involved in the treatment. The project has generated insights about ’selective SMR’, and the meaning of it for future product development. Generally, we are moving towards medical devices for SMR that does not restrict movement as strictly as before. Many products in ambulance care have not been updated for a long time, and there is no doubt that there is a need for it.
Inom prehospital akutsjukvård pågår just nu ett paradigmskifte. Spinal rörelsebegränsning (SRB) är ett sätt att vårda patienter som varit utsatta för trauma och som uppvisar symtom på spinal skada. Det benämndes till en början som ’rutinmässig SRB’ och inkluderade användning av spineboard och nackkrage. Under 2000-talet visade det sig finnas en avsaknad av vetenskapliga bevis som talade för fördelarna med ’rutinmässig SRB’, vilket ledde till att nackkrage och spineboard exkluderades. Det här föranledde en expertgrupp att ta fram nya nationella riktlinjer som publicerades 2019. De nationella riktlinjerna kan beskrivas som ’selektiv SRB’, vilket handlar om att SRB ska anpassas utifrån patientens tillstånd och inte efter utrustningen. Patienten ska även involveras så mycket som möjligt i omhändertagandet. Det här examensarbetet har utförts vid Luleå Tekniska Universitet (LTU), tillsammans med AB Germa. Syftet var att underlätta för ambulanssjukvårdare (användarna i det här projektet) att utföra säker och effektiv SRB på traumapatienter, genom att förbättra användbarheten hos befintliga eller framtida produkter för SRB. Målet var därför att leverera ett konceptuellt förslag med feedback från användarna. Utöver detta skulle en kartläggning av dagens utrustning och problem med dessa undersökas, med rekommendationer om hur den framtida utvecklingen kan gå mot en mer användarcentrerad riktning. För att få med de fysiska såväl som de kognitiva aspekterna av en god användbarhet så inkluderades både ergonomi, inkluderande antropometri och anatomi, samt semiotik i den teoretiska referensramen. Det här användes som ett komplement till den kontextuella undersökningen för att försäkra sig om att det framtagna konceptet var väl genomtänkt. Den kontextuella undersökningen inkluderade kontakt med Sveriges 21 regioner och 16 ambulanssjukvårdare. Genom besök, intervjuer och observationer samlades information om dagens utrustning för SRB, som utgjorde underlag för en kartläggning av de upplevda problemen. Allt sammanställdes som användarbehov i en lista. Det här kom att ligga till grund för den kommande idégenereingen, som resulterade i över 200 idéer. Iterativa feedbacksessioner tillsammans med användarna resulterade i fem koncept, som genom ännu mer feedback och iterativt arbete resulterade i ett slutgiltigt koncept. Projektet levererar en väst med vakuumteknologi som möjliggör för användarna att utföra säker och effektiv SRB på traumapatienter med varierande anatomi. Konceptet har smidigheten av en KED och följsamheten av en vakuummadrass. Den möjliggör ’selektiv SRB’ i trånga utrymmen och underlättar för patienten att vara deltagande i omhändertagandet. Projektet har också levererat insikter om vad ’selektiv SRB’ kan innebära för framtida produktutveckling. Det har visat sig att trenden går mot att utrustningen inte ska rörelsebegränsa lika mycket som den gjort tidigare. Många produkter inom ambulansen har inte uppdaterats på länge och det finns inga tvivel om att det finns ett behov för detta.

As closed-loop controllers become increasingly prevalent in medical technology, increasing emphasis is being placed on ensuring that such systems operate in a safe manner. In our approach to guaranteeing the safe operation of a physiologic closed-loop control system, we wish to provide a mathematical guarantee that, despite limited control authority, the system’s state can be confined to a region designated as safe. The largest subset of the safe region for which there exists an admissible control input that keeps the state within the safe region is known as the viability kernel, or maximal controlled invariant set. Many methods are known for computing viability kernels in low-dimensional systems, but these existing methods rely on gridding the state space and hence their time complexity increases exponentially with the state dimension. In this thesis we describe a new connection between reachability and viability theory that enables us to approximate the viability kernel using Lagrangian methods which scale well with the state dimension. We present four new viability kernel approximation algorithms using polytope-, ellipsoid- and support vector-based set representations and we compare their performances in terms of accuracy and scalability with the state dimension. Using the support vector and ellipsoidal techniques, we are able to accurately approximate the viability kernel for systems of much larger state dimension than was previously feasible using existing Eulerian methods. We also present a viability theoretic solution to the problem of determining when a physiologic closed-loop control system should initiate a fallback mode of operation. The viability-based method allows impending safety violations to be detected in advance, allowing the fallback mode to be initiated earlier than using a naive approach. Our new approach to fallback mode initiation is examined in two sample contexts: the closed-loop control of carbon dioxide partial pressure under mechanical ventilation, and the control of the concentration of the anaesthetic drug Propofol using a paediatric model of Propofol pharmacokinetics.

In the past decade, there has been an increasing attention for the development of personal and rehabilitation robots to assist, enhance, and quantify the rehabilitation therapy. This interest is expected to continue due to the improvements in health care that will allow people to live longer. A promising approach is the use of virtual reality in combination with haptic devices, i.e. manipulators that are capable of providing realistic force stimuli and accurate measurements of user’s movements, to treat the disability induced by stroke or chronic musculo-skeletal pathologies. The use of this technology not only helps to recover lost motor skills, but allows to obtain objective information on the rehabilitation process. In this research we have investigated the application of this approach in hand/finger rehabilitation of stroke patients. The first objective has been the development of a software framework that could support the flexibility and adaptability required by the addressed applications. Indeed, rehabilitation exercises have to be adapted to the patient disability, different devices must be integrated depending on the target of the rehabilitation, and different quantitative inforamtion should be recorded according to the objective of the trainign session. Based on the available tools, a software framework was developed using the Model/View/Controller software pattern that allows to decouple the different modules composing the application. Three main components were developed, namely: device management, virtual environment state evolution, and user interface. To reduce the cost, the framework was implemented only through the use of freely available libraries. The software framework was then used to develop a prototype application based on a five-bar linkage haptic device. During its development we paid special attention to the medial device regulations. Two main areas were identified as the most critical ones: the mechanical and physiological safety. A mechanical protection barrier for the hand/finger device was developed to ensure safe use by the user. At the same time, we investigated how to pursue physiological safey, i.e. how to monitor patients fatigue through the analysis of their physiological signals. When the patient enters a state of fatigue, it is necessary to change the intensity of the exercise according to the rehabilitation needs of the patient. The recognition of such state is a further element to be monitored during the control loop of the device, and that should be integrated in the analysis in real time. A first attempt to recognize the satte of fatigue was the observation of changes in the frequency band of electromyographic signals (EMG) of the patient. A framework for the acquisition of electromyographic signals, interfacing the rehabilitation system with an EMG amplifier, was developed. In the last part of the research, we investigated a different strategy for acquiring physiological signals of patient fatigue using the analysis of electroencephalographic signals (EEG). From an in-depth analysis of related literature, a software framework to integrate the analysis of EEG signals within the rehabilitation device conrol was identified. Additionally, a set of indexes for the definition of the level of mental fatigue of the patient was also designed.
Negli ultimi dieci anni, si è assistito a una sempre crescente attenzione verso lo sviluppo di robot personali e per la riabilitazione al fine di assistere e migliorare la terapia riabilitativa, oltre che a meglio quantificarne l’efficacia. Ci si aspetta che questo interesse cresca sempre di più grazie all'allungamento delle aspettative di vita. In questo ambito, un approccio che appare promettente per il recupero di disabilità legate a ictus e patologie neuromuscoloscheletriche croniche è l’uso della realtà virtuale in combinazione con dispositivi aptici (manipolatori robotici in grado di generare forze che vanno a stimolare il sistema tattile e/o propriocettivo dell’utente). L’uso di queste tecnologie non solo aiutano a recuperare le disabilità ma permette di ottenere una obiettiva valutazione sul processo di riabilitazione. Questa ricerca si è occupata di investigare l’applicabilità di questo approccio alla riabilitazione dei movimenti della mano e delle dita in pazienti post-ictus. Il primo obiettivo è stato sviluppare un framework software che potesse supportare la flessibilità e l’adattabilità richieste dalla applicazione studiata. Infatti, deve essere possibile adattare gli esercizi di riabilitazione al livello di disabilità del paziente, supportare diversi dispositivi secondo l’obiettivo della terapia riabilitativa e raccogliere differenti informazioni in funzione dell’obiettivo della sessione stessa. Per offrire una risposta adeguata a queste esigenze, si è sviluppato un framework software basato sul software pattern Model/View/Controller che permette di disaccoppiare i diversi moduli che compongono l’applicazione. Tre sono stati i componenti principali che sono stati sviluppati, ovvero: la gestione del dispositivo, la predizione dell’evoluzione dello stato dell’ambiente virtuale e l’interfaccia utente. Per ridurre il costo, il framework si basa solo su librerie disponibili gratuitamente. Il framework software è stato poi utilizzato per sviluppare una applicazione prototipo basata su un dispositivo aptico. Durante il suo sviluppo si è prestata particolare attenzione all'analisi delle normative sui dispositivi medici. Due aree principali sono state identificate come le più carenti del dispositivo, ovvero: la sicurezza meccanica e quella fisiologica. Si è pertanto sviluppato una barriera meccanica di protezione del dispositivo, garantendo agli utenti un utilizzo sicuro dello stesso. Contemporaneamente ci è occupati degli aspetti fisiologici relativi alla sicurezza, come ad esempio lo studio dell’affaticamento del paziente attraverso l’analisi di segnali fisiologici dello stesso. Nel momento in cui il paziente entra in uno stato di affaticamento, è infatti necessario modificare l’intensità dell’esercizio secondo le esigenze riabilitative del paziente. Il riconoscimento di tale stato costituisce un ulteriore elemento da monitorare all'interno della catena di controllo del dispositivo, che dovrà anche essere integrato nell'analisi in real-time. Un primo tentativo è stato fatto per cercare di riconoscere lo stato di fatica attraverso l’osservazione dei cambiamenti nella banda di frequenza dei segnali elettromiografici (EMG) del paziente, e il riconoscimento, da questi, dello stato di affaticamento secondo le indicazioni della letteratura. Si è sviluppato quindi un framework per l’acquisizione dei segnali elettromiografici, interfacciando il sistema riabilitativo con un amplificatore di segnali EMG. I dati ottenuti con questo approccio non hanno portato a risultati conclusivi, a causa dell’assenza di un protocollo di posizionamento dei sensori sull'avambraccio definito a livello internazionale, l’elevato cross-talk tra i segnali e l'ipotono muscolare dei pazienti anziani. Nell'ultima parte della ricerca, si è elaborato una diversa strategia per identificare la fatica mentale del paziente durante l’esercizio di riabilitazione, concentrandosi sull'uso dei segnali elettroencefalografici (EEG). Da una dettagliata analisi della letteratura correlata, si è definito una struttura software per integrare l’analisi dei segnali EEG con il controllo del dispositivo di riabilitazione e si è inoltre individuato degli indici per il riconoscimento del livello di affaticamento mentale del paziente.

Os dispositivos médicos assumem uma grande importância na medicina actual. No entanto, muitos dos materiais destes dispositivos não podem ser submetidos a processos de esterilização que utilizem temperaturas elevadas, pois deformam-se ou degradam-se, impedindo assim a sua posterior utilização. A esterilização por óxido de etileno é um tipo de esterilização química baseada na utilização deste composto como agente esterilizante, sendo o método recomendado para os dispositivos que não podem ser esterilizados através das técnicas tradicionais de calor e/ou vapor, incluindo artigos termossensíveis e em embalagem final. Tendo em vista a implementação de uma central de esterilização de dispositivos médicos por óxido de etileno, desenvolveu-se este estudo com o objectivo de estudar os factores que contribuem para a contaminação dos dispositivos médicos, nomeadamente: manipuladores, ar, superfícies, matéria-prima, e avaliar as condições microbiológicas em que se encontram após a sua embalagem, bem como a actividade biocida do óxido de etileno em diversos dispositivos médicos contaminados com carga microbiana conhecida. Os resultados obtidos mostraram uma variação da carga contaminante influenciada por diversos factores, nomeadamente durante a produção, em períodos de calor e em superfícies em que mais difícil efectuar a sua higienização, o que obriga à imposição de regras de higiene adequadas de modo a reduzir os valores. Foi avaliada a carga microbiana de diversos dispositivos médicos a qual mostrou que os dispositivos em gaze e não tecido apresentam uma maior carga microbiana que os materiais de plástico e metal. A proliferação ao longo de um período de tempo de armazenamento foi também avaliada. No estudo efectuado comprovou-se que o óxido de etileno é eficaz na esterilização dos diversos dispositivos embalados até uma carga microbiana de 106 ufc/g. Verificou-se também que o método enzimático é sensível a valores de carga microbiana de 107 ufc/g; ABSTRACT:Medical devices have great importance in modern medicine. However many of these medical devices materials cannot be submitted to sterilization processes that use high temperatures, because they can be deformed or degraded, thus preventing there further use. Sterilization by ethylene oxide is a type of chemistry sterilization process based on the use of this reagent, whith is the recommended method for devices that cannot be sterilized by traditional techniques of heat and / or steam, including thermo sensitive medical devices and articles in the final package. In order to implement a central sterilization unit of medical devices by ethylene oxide, this study was carried out to study the factors that contribute to the contamination of medical devices, including: handlers, air, surfaces, raw materials and the microbiological conditions in which they are after packaging. Additionally the biocidal activity of ethylene oxide was evaluated in various medical devices contaminated with known microbial load. The results showed a variation of the microbial load, influenced by several factors, namely during the production, in warmer weather, and in areas where was more difficult to carry out their cleaning, which requires the imposition of rules of proper hygiene to reduce these values. It was also evaluated the microbial load of several medical devices, which showed that the devices in gauze and nonwoven have a higher microbial load than the plastic materials and metal. The proliferation over a period storage time was also evaluated. In the study it was shown that ethylene oxide is effective in sterilization of various devices packed into a microbial load of 106 ufc/g. It was also found that the enzymatic method is sensitive to values of microbial load of 107 ufc/g.

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.

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

碩士
長庚大學
醫務管理學研究所
93
Patient safety has become a global hot issue. Although leading researchers try to fully discover causes of medical errors from different perspectives, such as legal liability and risk management, and have accumulated valuable information, but for the modern healthcare system that relies increasingly on medical devices in treatment procedures, there are very limited study on medical devices-related patient safety issues. This study, through systematic literature review, aims to understand medical devices safety regulations, clarify causes of medical devices-related errors and critical factors in building the medical device reporting system. The findings include: (1) Approval of medical devices safety through regulations does not guarantee safety in use. Due to design errors, manufacturing errors and user errors, medical devices may induce patient safety issues. However, such devices-related errors can be detected through medical devices reporting system, and through appropriate analyses and researches, provide evidence to manufacturers in removing unsafe factors. (2) The medical devices industry in the U.S. or European countries, have well-established regulations for design control, validation, premarket approval and postmarket surveillance phases to closely monitor medical devices quality and safety. That is probably the reason why medical device-related patient safety issues rarely got notices in the patient movement wave. (3) Taiwan has limited its medical devices safety monitoring through GMP regulations, leaving medical devices postmarket surveillance at large. (4) The medical devices reporting in Taiwan is voluntary and obviously face under reporting issues. The recommendations and suggestions are as follows: (1) policy maker should modify medical device regulations to include postmarket surveillance and medical device reporting. To promote reporting, it may enhance education to hospitals and issue medical device alert letter on regular and timely basis. (2) The medical device manufactures shall implement risk management for each medical device product cycle. (3) The medical device distributors bear the responsibility to conduct device user operation training, and file all device maintenance and service records. (4) The user shall receive proper operation training. Users are strongly advised to adopt reference manuals or check list techniques in properly operating the devises, less patients endure unnecessary harms. Keywords: Medical device; Safety regulations; Patient safety; Reporting system.

碩士
國立聯合大學
環境與安全衛生工程學系碩士班
99
The purpose of this study was to discuss the safety culture difference of native laborer and foreign worker in a medical device manufacturing company in Taiwan. The concept of safety culture evaluation sheet used in this study was based on the safety culture mode developed by the International Atomic Energy Authority ( IAEA ) and constructed the evaluation questionnaires. Several statistic methods were used to analyze the collected date sets, including descriptive statistics, reliability analysis and t-test. This study was interested in determining whether personal background and nationality affect recognition in safety culture level within the company. The safety culture evaluation sheet and the suggestions of this study could be use to promote the safety culture level within the company. Major findings of this study were concluded as below: 一.The differences of the nationality showed some significant differences in the safety culture recognition. 二.The differences of the background of native laborer and foreign worker showed some significant differences in the safety culture recognition. 三.The differences of the job position showed significant differences in the safety culture recognition.

Neck braces and head supports used today do not allow wearers to rotate their head while maintaining the support they need. For people with chronic muscle diseases, such as ALS, DHS, Myasthenia Gravis, and Muscular Dystrophy, this inconvenience greatly affects their quality of life in that it hinders their abilities to perform activities of daily living, such as nonverbal communication and knowing their surroundings outside without having to move their entire body. There is a need for a head support device that allows individuals with chronic muscle diseases to rotate their heads, so they may better perform daily activities of living and thus live a more fulfilling life.

The purpose of this study was to assess the basic stance of safety of a dynamic head support device that allows individuals with chronic muscle diseases to rotate their heads left and right. The assessment includes an experimental procedure that will conclude whether this device can withstand the load equivalent to an average adult’s head in a stationary position and a dynamic movement.

This research proposed a procedure that has a testing apparatus that will place a predetermined load onto the dynamic head support device to stabilize it and then continuously add weight that was checked incrementally. This load was placed on the device while it was centered and static first. The next step in this procedure is to assess whether or not the load on the device can be carried while dynamically moving on the race of the radial sliding track of the device. The data recorded from this experiment will provide the necessary information to determine whether the basic safety requirement of load capacity for a medical device such as the one in this proposed research is met.

INTRODUCTION: While mobile device use by physicians increases, there is an increased risk that errors committed while using mobile devices can lead to harm. This mixed-method study evaluates the effects of screen size on clinical users’ perceptions of medical application usability and safety when interfacing to critical patient information. In this research, two mobile devices are examined: iPhone® and the iPad®. METHOD: Eleven physicians and one nurse practitioner participated in a chart-review simulation using an app that was an end-point to an electronic health record. Screen-recording, video-recording and a think-aloud protocol were used to gather data during the simulation. Additionally, participants completed Likert-based questionnaires and engaged in semi-structured interviews. RESULTS: A total of 105 usability, usefulness and safety problems were recorded and analysed. A strong preference was found for the larger screen when reviewing patient data due to the large quantity of data and the increased display size. The smaller device was preferred due to the devices portability when participants needed to remain informed when they were away from the point of care. CONCLUSION: There is an association between screen size and the perceived safety of the handheld device. The iPad was perceived to be safer to use in clinical practice. Participants preferred the iPad® because of the larger size, not because they thought it was safer or easier to use. The iPhone® was preferred for its portability and its usefulness was perceived to increase with greater distance from the point of care.
Graduate

Orientação: Luís Monteiro Rodrigues ; co-orientação: Isabel Abreu
A utilização de dispositivos médicos enquanto instrumentos de diagnóstico, de prevenção, de monitorização e tratamento de doenças e de atenuação ou compensação de deficiências deve garantir ao doente os mais elevados padrões de segurança. A rastreabilidade dos dispositivos, feita através da criação de um sistema de identificação única (UDI), introduzido nos novos Regulamentos dos Dispositivos Médicos veio possibilitar uma dinamização na vigilância do mercado. O mercado global possui um elevado número de dispositivos médicos, sendo necessário criar meios que possibilitem um controlo mais restrito. Tendo em vista, estas necessidades está a ser desenvolvido em vários países sistemas de codificação, UDI, que permitem conter toda a informação relativa ao dispositivo, em base de dados centralizadas, assim como a consulta das várias entidades associadas à utilização de dispositivos. O presente trabalho aborda as diferentes visões que estão a ser aplicadas no sistema UDI quer a nível Europeu quer a nível dos Estados Unidos que é referido como exemplo, por ser pioneiro nesta área. Todas estas normas que estão a ser implementadas têm como principal objetivo a harmonização global sobre a rastreabilidade dos dispositivos, sendo deste modo possível aumentar segurança da utilização destes, e criar uma partilha dinâmica de informação sobre os dispositivos médicos.
The use of medical devices with the purpose of diagnostic, prevention, monitoring and treatment for disease and for mitigating or compensating for disabilities should guarantee the patient the highest safety standards. The traceability of devices through the creation of a unique identification system (UDI) introduced in the new Medical Device Regulations has made it possible to streamline market surveillance. The global market has a large number of medical devices and it is necessary to create means for more stringent control. In view of these needs, coding systems (UDIs) are being developed in several countries to contain all device-related information in a centralized database as well as the consultation of the various entities associated with the use of devices. This paper addresses the different visions that are being applied in the UDI system at both European and United States level which is cited as an example as a pioneer in this area. All of these standards that are being implemented have as their main objective the overall harmonization of device traceability, thereby increasing the safety of their use and creating a dynamic sharing of information about medical devices.

碩士
國立中央大學
工業管理研究所
105
The scope and the development directions of medical devices industry are varied among the countries. Owing to the ageing society and the high-quality healthcare requirements, rapid medical devices industry growth is occurring. The medical devices industry is mostly of hospital consumer products in Western countries. Comparing to Western, the main market in Taiwan is medical consumer products, like Electric Handicapped Scooter (EHS), and electric wheelchair, etc. It can be expected, Taiwan becomes the main supplier in the world. Safety of medical devices directly impacts on the patients. Therefore, the government attaches importance among the medical devices, products control, and verification. For the electric handicapped scooter suppliers in Taiwan, how to ensure the safety during the entire product life cycle becomes a major issue. We describe an information system to support the Product Lifecycle Management (PLM) concept holds the product details of supervising, integrating, and the omnigenous processing. Including research, manufacturing, marketing, customer service, financial, etc. Every step aims to enhance quality and safety assurance. This research illustrates three circumstances. First, we focus electric vehicle wheelchair industry on constructing the PLM system. Furthermore, applying Corrective Action and Preventive Action (CAPA) to inspect the manufacturing procedures. Using Failure Mode and Effect Analysis (FMEA) to find out the potential failure modes and calculate Risk Priority Number (RPN). Using before and after RPN number to know the improving approaches are worth. Finally, strengthen the approaches in CAPA to intensify both the quality and safety of medical devices. It can be applied to any sector, but special attention must be given to each industry particularities in the future.

A lot of laser medical devices have been developed over the past half-century. Particularly these days, low-level near-infrared laser devices that illuminate epidermal tissue have been rapidly innovated. Especially. it has been reported that less than 5 W/cm2 infrared light stimulates our immune system and is expected to be applied in clinical usage. In terms of the safety and efficacy of the therapies or the treatments, an accurate heat damage criterion is required. We showed the damage threshold of heat generated by infrared laser irradiation with cultivated human epidermal keratinocytes. These results define the safe combinations of temperature and laser duration.

Orientação: Isabel Portugal Abreu
Actualmente, encontramos à nossa disposição uma panóplia de produtos que já não conseguimos abdicar do seu uso, que nos proporcionam um bem-estar e conforto no nosso quotidiano e alguns até acabam por ser imprescindíveis para a nossa saúde. A tendência da Comunidade tem sido a de agrupar os produtos por classes, o que por vezes se torna uma tarefa complicada, sendo possível incluir um produto em duas ou mais classes, supostamente, distintas. São denominados “Produtos Fronteira” aos quais se poderão aplicar diferentes classificações, havendo por isso necessidade de definir um Estatuto legal para cada produto que, em caso de dúvida, possa determinar a classificação correcta e mais adequada. Ao longo desta monografia foram apresentados todos os aspectos relacionados com a definição/Estatuto legal dos “Produtos Fronteira”, o risco associado a cada produto, os critérios de avaliação e as entidades intervenientes na avaliação e na supervisão do mercado. Foram identificadas as questões relevantes que determinam a importância de uma correta demarcação da fronteira entre diferentes tipos de produtos e os dispositivos médicos, demonstrando a especificidade dos controlos que são efectuados em todo o ciclo de vida, de forma a garantir a qualidade, a segurança e a eficácia/desempenho de acordo o fim a que os mesmos se destinam.
Currently we find at our disposal a range of products that we can no longer abdicate its use, that give us a comfort in our daily life and some even turn out to be essential to our health. The trend of the Community has been to group the products into classes, which sometimes becomes a tricky task, but it could include a product in two or more classes supposedly distinct. "Borderline Produts" which may apply different classifications, which therefore need to define a legal statute for every product, if in doubt, to determine the correct and most appropriate classification are named. Throughout this monograph all aspects related to the definition/Legal Status of "Borderline Produts" were presented, the risk associated with each product, the evaluation criteria and stakeholders in the assessment and market surveillance authorities. Relevant issues that determine the importance of proper demarcation of the boundary between different types of products and medical devices, demonstrating the specificity of the checks that are carried out throughout the life cycle, to ensure the quality, safety, and were identified effectiveness /performance according to the order which they are intended .

Tese de Doutoramento em Informática
The advent of Interactive Computing Systems (ICSs) has released the great potential that computers have for influencing everyday human activity. The establishment of Human Computer Interaction (HCI) as an academic discipline has helped develop a sense that serious consideration and understanding of how humans interact with computers is a pressing necessity for both the computer scientist and the developer. One of the traditional ways of using HCI research to foster the development of better technology is by resorting to the use of Interaction Models – or simplifications of the reality capable of being operationalized in such a way that provide valuable information in order to adapt a given system to its user. Two types of models, often respectively referred as Predictive Cognitive Models (PCMs) and Descriptive Cognitive Models (DCMs), have emerged from the HCI research in the last decades, and they have been used with the primary goal of formalizing empirical insights and foreseeing design and interaction problems. Throughout this thesis, we will review the prolific history of user-research in HCI while showing contributions of both interaction-modeling approaches for the development of innovative and safer user interface technology. As a way of proving the benefit these approaches can bring to the development of today’s ICSs, we will demonstrate their application to the evaluation and development of two types of ICSs that are at the forefront of current HCI challenges: Immersive Virtual Environments (IVEs), and Safety-critical Interactive Medical Devices. Although distinct in principle, these ICSs have some communalities that render them interesting use-cases in the scope of this thesis. Both systems are becoming increasingly widespread, and due to their particularities, both present new interaction challenges that are absent from more traditional HCI use-cases, such as the personal computer. The main outputs of this thesis are thus twofold: the outline of new PCMs and design guidelines that can help the development of increasingly immersive virtual environments; and the outline of a new DCM of use-error with safety-critical devices in addition to a set of design guidelines that can help mitigate these errors and foster the development of increasingly safer medical devices.
O surgimento de Sistemas Interativos de Computação (SIC) potenciou o impacto e a influência que os computadores exercem sobre a atividade quotidiana dos seres humanos. A consolidação da Interação Humano-Computador (IHC) como uma disciplina académica, ajudou a estabelecer a ideia de que a séria consideração e o estudo aprofundado da forma como os utilizadores interagem com os computadores, é uma necessidade premente tanto para o cientista da computação, como para o técnico que desenha e desenvolve novos SIC. Uma das formas tradicionais de utilizar os métodos de IHC para fomentar o desenvolvimento de melhor tecnologia, é recorrendo ao uso de Modelos de Interação – simplificações da realidade capaz de serem operacionalizadas de modo a fornecer informações valiosas para adaptar um sistema ao seu utilizador. Da investigação em IHC emergiram dois tipos de modelos, frequentemente referidos como Modelos Cognitivos Preditivos (MCP) e Modelos Cognitivos Descritivos (MCD), usados com o objetivo principal de formalizar resultados empíricos e prever problemas de design da interação. Ao longo desta tese, iremos rever a prolifica história da investigação com utilizadores em IHC e demonstrar como ambas as abordagens de modelação da interação apoiaram o desenvolvimento de tecnologia, segura e inovadora, de interface com o utilizador. De forma a demonstrar que estas abordagens podem trazer o mesmo benefício ao desenvolvimento dos SIC atuais, descreveremos a sua aplicação à avaliação e desenvolvimento de dois tipos de SIC, na vanguarda dos atuais desafios da IHC: Ambientes Imersivos e Virtuais (AIVs), e Dispositivos Médicos Interativos e de Segurança-Crítica. Embora distintos na sua gênese, estes SIC têm algumas semelhanças que os tornam casos de uso interessantes no âmbito desta tese. Ambos os sistemas estão cada vez mais difundidos e, devido às suas particularidades, apresentam novos desafios de interação que estão ausentes nos casos de uso tradicionais da IHC, como o computador pessoal. Desta forma, os resultados desta tese dividem-se em duas principais áreas: o desenvolvimento de novos MCPs e diretrizes de design para apoiar o desenvolvimento de ambientes virtuais cada vez mais imersivos; e o desenvolvimento de um novo MCD de erro de uso em dispositivos de segurança-crítica, além de um conjunto de diretrizes de design que podem ajudar a mitigar esses erros e promover o desenvolvimento de dispositivos médicos cada vez mais seguros.