Opioid overdose is a growing epidemic plaguing the United States. Overdose related death has risen from 16,849 in 1999 to 69,029 in 2018. Almost 7 out of 10 of these deaths were due to opioids with 47% being caused by fentanyl or other synthetic opioids. There is a strong need to reduce the amount of overdose-related deaths. Indirect methods should be a first priority, and include counseling and care. For some individuals, this treatment option is unavailable because the drug user may not have the desire or economic means to pursue it. In this case, a more direct preventative approach is needed. This paper presents a novel method of detecting poor peripheral oxygenation, a biomarker linked to opioid overdose. A wristwatch near-infrared spectroscopy device (NIRS) was developed. SPICE simulations were conducted to confirm proper operation of electrical systems. The device was fabricated on a printed circuit board and mounted to a 3D printed enclosure. Absorbance of green, red and infrared (IR) light were measured. Additionally, peripheral capillary oxygen saturation (SpO2) modulation index and changes in concentration of oxyhemoglobin and deoxyhemoglobin were calculated from raw data. A brachial occlusion test was performed to mimic the effects of opioid overdose on peripheral oxygenation. A statistically significant difference (p < 0.05) was observed between pre-occlusion and during-occlusion groups in two subjects for measurement of peak-to-peak values of green raw data, red raw data, IR raw data, oxyhemoglobin concentration change, and deoxyhemoglobin concentration change. Peak-to-peak was observed as a consistent indicator of poor peripheral oxygenation and could serve as a useful metric in the detection of opioid overdose.

醫療器材法律規章與監督管理制度的探討，能夠教育社會大眾遵守法律、保障醫療器材產品品質、維持市場公平競爭、保障人們使用安全和身體健康。進而對於整體醫療器材產業，可以在面對法律問題之前的法律責任、行為規則、違法情形以及類推適用作為憑據和參考。 本研究目的是(1)檢視中國大陸醫療器材法律規章之起源與形成由來。(2)瞭解中國大陸醫療器材監督管理制度的發展情況。(3)探討中國大陸醫療器材監督管理相對人違法責任與違法處罰行為。 本研究主要以「內容分析法」，從中英文參考書籍、學術論文以及相關市場報告、期刊文章等，蒐集具有醫療器材相關的法學理論、法規制度、監督管理等關聯性資料加以歸納整理並進行討論。其次，採用「比較分析法」，將歐盟、日本、中華民國以及美國之醫療器材法規和監督管理制度與中國大陸進行對比分析。本研究以中國大陸醫療器材法律體系、法規制度和監督管理三項研究構面進行觀察，期許呈現符合學術標準的信度與效度之研究結果。 研究結果發現，中國大陸《醫療器械監督管理條例》屬於「行政法規」層級。監督管理的方式主要為「產品上市前審查」與「產品上市後監督」。其中「產品上市前審查」需要遵循：(a)醫療器材檢測管理、(b)醫療器材註冊管理、(c)醫療器材生產管理、(d)醫療器材說明書、標籤和包裝管理與(e)醫療器材經營管理；「產品上市後監督」必須恪守：(f)醫療器材使用管理、(g)醫療器材廣告管理、(h)醫療器材進出口管理、(i)醫療器材不良事件監測管理、(j)醫療器材召回管理、(k)醫療器材監督檢查和(l)醫療器材行政處罰等各項法規與條例。 研究結論歸納，2014年最新修訂的中國大陸《醫療器械監督管理條例》主要是：(1)風險管理分級、(2)審查制度精簡、(3)產品流向追蹤、(4)監管功能強化以及(5)明確法律責任。 / This study aimes to determine the regulations for the supervision and administration of medical devices which is able to educate citizen to complying with the law, ensuring the quality of medical products, maintaining fair competition in the market, protecting the safety and health of people utilization. Furthermore, according to the breadth and complexity of the industry, this proposal can be directed rules as reference in case encountered juridic liability, legal issues or wrongful circumstances before acquired appreciable support from counsellor. The research topics of this article are (1) Examining the draft laws, regulations and rules and policy plots on the governance of medical devices in China. (2) Understanding the development of medical devices regulatory system in China. (3) Exploring the regulatory responsibility of medical devices and penalize illegal behavior in China. Content analysis methodology was conducted for this overview, this writings evaluated regulations of medical devices and administrative institution. Quality system regulations were also investigated by the comparative analysis along with China, European Union, Japan, Taiwan, R.O.C. and the United States. Results reveal that the regulations of medical devices are belong to administrative statute level, the supervision of meical devices is divided to pre-market review and post-market surveillance. Pre-market review contains (a) inspection management, (b) registered management, (c) production management, (d) manuals, labeling and packaging management and (e) advertisement management. Post-market surveillance embodies (f) the application of medical devices management, (g) medical devices advertising management, (h) medical devices import and export management, (i) medical devices monitoring and management of adverse events, (j) medical devices recall management, (k) supervision and inspection of medical dvices together with (l) medical devices regulations and administrative penalties, and other regulations. The findings were summarized as the following statements, the essentials on the latest revised regulations for the supervision and administration of medical devices in China in 2014 are (1) risk based classification, (2) market notification and approval, (3) products sales tracking, (4) supervisory functions strength and (5) distinct legislative liability.

IT is often seen as a solution to many problems concerning effectiveness in organizations. Information systems within the healthcare sector is often viewed as medical devices rather than just systems or services. These medical devices are thoroughly regulated by laws, standards and certifications. In this study I participated in an innovative project that aimed to bring new life and use to the old fashioned patient journal by giving it a visual representation through the use of an avatar. I aimed to study the effects of regulators connected with the patient journal as a source of information for the innovative project. I drew upon Actor-network theory as a theoretical lens to trace the patient journal and connect it with regulatory aspects important to innovative projects such as the studied scenario. I also aimed to research the possibilities and obstacles provided with today’s IT-climate in Swedish healthcare. I found that regulatory aspects according to Actor-network theory proved to be an actor that stabilizes the network that is the innovative project. Certain regulatory aspects such as quality management standards provided support for unifying the vision concerning the innovation. Further the regulatory aspects proved to be an actor that can shift power between project developers and external actors. The regulatory aspects did not show any significant effect on the innovation or its original vision. These aspects did however show proof of being a heavy provider of project complexity and experience concerning these aspects was shown to be hard to find. I also found that there are two distinct ways for an innovator to realize a vision within Swedish healthcare, the healthcare way and the patient way, these two ways are represented in a model framework for future research. Last but not least I presented a framework for future IT-architecture based on modern technology and the results found in this study.

Les gliomes sont les tumeurs cérébrales primaires les plus communes chez l’adulte. Parmi eux, le glioblastome (GBM) représente la tumeur cérébrale la plus fréquente avec le pronostic le plus sombre. Son incidence annuelle est d'environ 3 à 5 cas pour 100 000 personnes (environ 3000 nouvelles chaque année en France). La survie médiane varie entre 11 et 13 mois selon la qualité de la résection tumorale.Le standard de soins inclue une résection chirurgicale et est suivie d'une radiothérapie et d'une chimiothérapie. Une résection maximale est souhaitée afin de diminuer les risques de récidive. Bien que l’utilisation de la technique de diagnostic photodynamique peropératoire, appelée résection fluoroguidée (FGR), améliore la qualité de résection, une récidive survient dans ces berges de la cavité opératoire dans 85% des cas.Des thérapies alternatives doivent être développées pour améliorer la survie globale des patients. Dans ce contexte, la thérapie photodynamique (PDT) semble pertinente. La PDT est basée sur la synergie de trois paramètres : une molécule, la photosensibilisateur (PS) qui se concentre préférentiellement dans les cellules tumorales, la lumière laser et l'oxygène. La lumière laser induit une réaction entre le PS et l’oxygène de la cellule. Cette réaction produit des molécules cytotoxiques (dont l'oxygène singulet) et conduit à la mort de cellules tumorales. Deux modalités de traitement sont étudiées : la PDT interstitielle (iPDT) ou la PDT peropératoire.L'objectif principal de cette thèse est de fournir des outils technologiques afin développer la PDT pour le traitement du GBM. Ainsi, les deux modalités de traitement ont été étudiées.Lorsque la résection n'est pas réalisable (environ 20% à 30% des cas), l'iPDT peut être privilégiée. Cette modalité vise à insérer des fibres optiques dans la cible thérapeutique pour éclairer les tissus tumoraux. Ainsi, la simulation de la propagation de la lumière dans les tissus est nécessaire pour planifier la localisation des fibres optiques. Considérée comme méthode de référence, un modèle Monte-Carlo accéléré par processeurs graphiques a été développé. Ce modèle calcule la propagation de la lumière émise par un diffuseur cylindrique dans des milieux hétérogènes. La précision du modèle a été évaluée avec des mesures expérimentales. L'accélération fournie par la parallélisation permet son utilisation dans la routine clinique.L'iPDT doit être planifiée à l'aide d'un système de planification de traitement (TPS). Une preuve de concept d'un TPS dédié au traitement stéréotaxique iPDT du GBM a été développée. Ce logiciel fournit des outils de base pour planifier l'insertion stéréotaxique de diffuseurs cylindriques et calculer la dosimétrie associée. Le recalage stéréotaxique et la précision du calcul dosimétrique ont été évalués avec des méthodologies spécifiques.Lorsque la résection est réalisable, la PDT peropératoire peut être appliquée au début de la FGR. Celle-ci profite de la présence du PS (la protoporphyrine IX) utilisé pour la FGR et qui s’est déjà concentrée dans les cellules tumorales. Ainsi, la stratégie de traitement proposée peut s’inclure facilement au standard de soin. Un dispositif médical a été conçu pour s'adapter à la cavité et éclairer de façon homogène les berges de la cavité opératoire. Le dispositif est constitué de deux parties : un trocart couplé à un ballon gonflable et un guide de fibre optique développé au sein du laboratoire ONCO-THAI permettant d'insérer la source lumineuse. Des méthodologies spécifiques ont été développées pour étalonner et évaluer l'appareil en termes de contrainte mécanique et de dosimétrie. L'étalonnage a permis la création d’une fonction de transfert permettant une prescription de durée de traitement rapide, robuste et facile. De plus, de nombreux tests ont été réalisés en amont de l'essai clinique qui évalue la sécurité de la procédure. / Gliomas are the most common primary brain tumors in adults. Among them, glioblastoma (GBM) represents the most frequent primary brain tumor and have the most dismal prognosis. Its annual incidence is about 3 to 5 cases for 100,000 persons (about 3000 news cases each year in France). Median survival varies between 11 to 13 months according the extent of tumor resection.The standard of care includes surgery and is followed by radiation therapy and chemotherapy. Maximal resection is expected to delay recurrence. Despite of using intraoperative photodynamic diagnosis, or fluorescence guided resection (FGR), which improves the extent of resection, relapse still occurs in these resection margins in 85% of cases.Alternatives therapies have to be developed to enhance patients’ overall survival. In this context, Photodynamic Therapy (PDT) seems relevant. PDT is based on the synergy of three parameters: a photosensitizing molecule, the photosensitizer (PS) that concentrates preferentially into the tumor cells, laser light and oxygen. Laser light induces a reaction between the PS and the oxygen of the cell. This reaction produces highly cytotoxic molecules (including singlet oxygen) and leads to death of tumor cells. Two treatment modalities are investigated: interstitial PDT (iPDT) or intraoperative PDT.The main goal of this thesis is to provide technological tools to develop the PDT for GBM treatment. Thus, the two treatment modalities have been investigated.When tumor resection is non-achievable (about 20% to 30% of cases), iPDT may be preferred. This modality aims to insert optical fibers directly into the target to illuminate tumor tissues. Thus, simulation of light propagation in brain tissues is required to plan the location of optical fibers. Considered as reference method, a Monte-Carlo model accelerated by graphics processing unit was developed. This model computes the light propagation emitted by a cylindrical diffusor inside heterogeneous media. Accuracy of the model was evaluated with experimental measurements. The acceleration provided by the parallelization allows its use in clinical routine.The iPDT has to be planned using a Treatment Planning System (TPS). A proof of concept of a TPS dedicated to the stereotactic iPDT treatment of GBM was developed. This software provides basic tools to plan the stereotactic insertion of cylindrical diffusors in patient’s brain and to compute the associated dosimetry. The stereotactic registration and the dosimetry computation’s accuracy were evaluated with specific methodologies.When tumor resection is achievable, the intraoperative PDT may be applied early after the FGR. It takes advantage of the presence of the PS (the protoporphyrin IX) used for FGR purpose and that is already concentrates into the tumor cells. Thus, the proposed treatment strategy fits into the current standard of care. A medical device was designed to fit to the resection cavity and illuminate homogeneously the cavity’s margins. The device is constituted of two parts: a trocar coupled to an inflatable balloon and a fiber guide developed in the ONCO-THAI laboratory allowing to insert the light source. Specific methodologies were developed to calibrate and assess the device in terms of mechanical properties and dosimetry. The calibration process leaded to a transfer function that provides fast, robust and easy treatment duration prescription to induce a PDT response in cavity margins. Furthermore, a comprehensive experimental design has been worked out prior to the clinical trial that evaluate the safety of the procedure.

No description available.

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.

No description available.

Die Zunahme von Meldungen über Zwischenfälle in Kliniken und deren Ursachen werden in Wissenschaft und Gesellschaft diskutiert. Aus der Literatur lässt sich ableiten, dass die Mensch-Maschine-Schnittstelle Einfluss auf die Fehlerentstehung hat. Daher wird eine qualitative, standardisierte Befragung bei Anwendern von Medizingeräten durchgeführt. Die Ergebnisse der Untersuchung zeigen, dass anthropometrische Gestaltungsregeln bisher wenig beachtet werden und dass ergonomische Vorgaben bei der Gestaltung von Menüstrukturen nach wie vor Verzögerungen im klinischen Arbeitsfluss hervorrufen, worunter die Effizienz und besonders die Zufriedenheit der Mitarbeiter leidet.

In assistive technology, there are mainly two different users that needs to be taken into account when developing products. The first, and most important, is the end-user who requires the product in order to function and live a normal life. The second is the support person who, for some products, needs to assist the end-user by preparing it to be used. This report presents the master thesis project conducted by Mattias Bygge and Sofie Strand at KTH Royal Institute of Technology in Stockholm. The client was Abilia, a company that research, develop, manufacture and sell assistive technology to people with impairments. This main goal of this project was to redesign a cognitive planning board. The product is used as a visual aid by people who has difficulties in planning daily activities and keeping track of time. In order to develop the product in a suitable way, a literature study and interviews with Abilia’s employees laid the foundation for the user studies that were conducted with end-users and support people. Several concepts were generated and five were evaluated against the original product and presented to the company. The two concepts that received the highest ranking, (1) Extra Hours and (2) Extra Hours Bistable, were further investigated and were eventually developed into one single hybrid concept. The final design proposal is Day Master, a flexible planning board intended for people with a cognitive impairment that impedes their ability to plan daily activities and keep track of time. The product visually displays time and weekdays by using coloured LED lights, which support people may program without difficulty to fit the end-user’s preference. The amount of hours is changeable with a range of 12-18 hours of daytime and with the remaining hours distributed to night-time. The accessories that have been developed for this products are a simple protective cover, and two holders, one for images and one for whiteboard markers. All accessories attaches to the planning board with magnets. / I hjälpmedelsteknologi är det fler än en användare som man måste ta hänsyn till när man utvecklar produkter. Den första och viktigaste är slutanvändaren som är den som behöver produkten i vardagen för att kunna leva ett någorlunda normalt liv. Den andra är stödpersonen som i många fall är den som förbereder produkten för användning av slutanvändaren. Denna rapport presenterar masterexamensarbetet utfört av Mattias Bygge och Sofie Strand på KTH Kungliga Tekniska Högskola i Stockholm. Kunden för projektet var Abilia, ett företag som utvecklar, tillverkar, och säljer hjälpmedel till personer med funktionsnedsättning. Målet med detta projekt var att omdesigna deras kognitiva planeringstavla. Produkten används som ett visuellt hjälpmedel av personer som har problem med tidsuppfattning och planering av aktiviteter. Projektet inleddes genom en literaturstudie och intervjuer med personal på Abilia. Detta lade grunden för användarstudierna där både slutanvändare och stödpersoner deltog. Utifrån användarstudierna så genererades ett flertal koncept varav fem stycken evaluerades mot original produkten och som presenterades för företaget under en delpresentation. De två koncept som erhöll högsta ranking i evalueringen var (1) Extra Hours och (2) Extra Hours Bistable. Koncepten undersöktes ytterligare och kom slutligen att kombineras till ett gemensamt koncept. Det slutgiltiga designförslaget är Day Master, en flexibel planeringstavla som riktar sig mot personer med en kognitiv funktionsnedsättning som försvårar för dem att hålla koll på tiden och planera aktiviteter. Produkten visar tid och veckodagar visuellt med hjälp av färgade LED lampor som stödpersonerna lätt och intuitivt kan programmera för att passa slutanvändarens individuella behov. Day Master ger möjligheten att själv bestämma antalet timmar som distribueras mellan dag och natt. Den har ett spann på 12-18 timmar för dagtid och återstående timmar läggs på natttid. Tillbehören som har utvecklats för denna produkt är ett enkelt magnetiskt plastskydd och två stycken olika ställ, ett för bilder och ett för whiteboardpennor. Alla tillbehör fästs på whiteboardtavlan med hjälp av magneter.

To ensure the safety for both patients and personnel using medical equipment there are several regulations. The regulations differ between countries and the largest markets are the US and Europe. There are regulations regarding both risk and requirement management and for a digitized signature process. This report shows a way of digitizing parts of the quality management system and workflows that fulfills these requirements, including both an approval process and a requirement hierarchy. For the development of a digitized system several workshops and interviews were performed to understand the workflow used. This to reduce the changes in the new system where the existing processes worked, but at the same time make changes possible where the users noticed problems in the workflow earlier used. The main advantage of a digitized quality management system is that the linking between the different objects are easier to follow which gives a perspicuous traceability. A digitized system can generate reports, e.g. for traceability and requirement without a test, automatically that will decrease the manual work and by that both increase efficiency and reduce the risk of human errors.