Europeiska unionen röstade igenom nya regelverk för medicintekniska produkter och för medicintekniska produkter för in vitrodiagnostik 2017. Regelverken implementerades 2021. De nya regelverken innebär striktare krav på tillsyn, klinisk prövning och spårbarhet, för att stärka patientsäkerheten. Målet med projektet var att undersöka om vårdcentralerna inom Stockholm läns sjukvårdsområde (SLSO) uppfyller de nya regelverken och sedan ta fram en analysmodell och analysera hur väl de anpassar sig till regelverken. För att säkerställa att SLSO:s vårdcentralerna uppfyller de nya regelverken utfördes i detta projekt fysiska inventeringar på tio slumpmässigt utvalda enheter som inte har befintliga serviceavtal med leverantörer eller servicegivare. Det visade sig att på samtliga enheter nyttjas konsumentprodukter till patienter, som inte är avsedda för medicinskt bruk. Flertalet enheter saknade även produkter som bör finnas tillgängliga. Överlag var enhetscheferna på vårdcentralerna inte insatta i de nya regelverken och visste inte att produkterna de använde inte är avsedda för sjukvård. De hade även flera produkter som var gamla och/eller trasiga som användes på daglig basis vilket inte uppfyller kraven på patientsäkerheten. Slutsatsen blev därför att SLSO:s vårdcentraler inte uppfyller de nya regelverken. / The European Union voted through new regulations regarding medical devices and medical devices for in vitro diagnostics in 2017. These new regulations were implemented in 2021. The new regulations entailed stricter supervision, clinical testing, and traceability requirements to strengthen patient safety. To ensure that care centers within Region Stockholm comply with the new regulations, physical inventories were carried out at ten randomly selected units that do not have existing service agreements with suppliers or service providers. To compare different units’ individual adaptations to the regulations, an analysis model was created in which the proportion of products that were not approved for medical use and the lack of certain necessary equipment were factors. In all units, consumer products are used for patients, which are not intended for medical use, and several units lack products that should be available. Overall, the unit managers at the care centers were unfamiliar with the new regulations and were unaware that the products they used were not intended for healthcare. The care centers also had several old and/or broken products that were used daily, which does not meet the requirements for patient safety. The conclusion was therefore that the care centers in Region Stockholm do not comply with the new regulations.

This thesis examines how the pressure sensors can be used in rehabilitation for patients with weakened hand strength. The rehabilitation process usually contains everyday tasks to evaluate the patient’s capability and the tools for this part of the rehabilitation process are few. The challenges will be to find a suitable sensor for the application and how to implement the sensor in a versatile prototype with direct feedback for the user. To solve this problem, research will be conducted on different pressure sensor types to determine the most suitable one for this implementation. The resulting prototype is utilizing a force sensing resistor (FSR) mounted on a glove together with a module that presents direct feedback to the patient and caretaker. The glove has pressure sensors in each fingertip to detect the applied force for each individual finger when the patient grips an object. To present the feedback, a visual interface is created in the form of a hand with a LED for each finger, which provides direct visual feedback and a display to present numerical data. / Denna avhandling undersöker hur trycksensorer kan användas vid rehabilitering av patienter med försvagad handstyrka. Rehabiliteringsprocessen innehåller vanligtvis vardagliga uppgifter för att utvärdera patientens förmåga och nuvarande hjälpmedel är få. Utmaningarna är att hitta en lämplig sensor för applikationen och hur man kan implementera sensorn i en mångsidig prototyp med en direkt återkoppling för användaren. För att lösa detta problem kommer forskning att genomföras på olika typer av trycksensorer. Detta görs för att kunna bestämma den mest lämpade sensortypen för denna implementering. Den resulterande prototypen består av en handske med kraft känsliga resistorer (FSR) och en separat modul som ger direkt återkoppling till patienten och vårdtagaren. Handsken har en sensor i varje fingertopp för att detektera applicerad kraft för varje enskilt finger när patienten greppar ett föremål. För att presentera data från sensorerna skapas ett visuellt gränssnitt. Gränssnittet är i form av en hand med lysdioder i varje finger för direkt återkoppling och en bildskärm för att presentera numeriska data.

Bakgrund: Hjärtat är en stark symbol för människor. Den medicintekniska utvecklingen har förändrat människors livsvillkor och sjuksköterskans arbete. Den tekniska utvecklingen speglar ett behov personcentrerad vård. Detta har väckt ett intresse för hjärttransplantationspatienters upplevelser. Syfte: Att beskriva patienters upplevelser efter en hjärttransplantation. Metod: En litteraturöversikt genomfördes med åtta artiklar. Datainsamlingen genomfördes på databaserna CINAHL och Pubmed. Resultatet analyserade med Fribergs analysmetod. Resultat: Utifrån resultatet framträdde fyra teman: Medicinsk påverkan,sociala relationer, känslomässiga prövningar och en andra chans. Sammanfattning: Litteraturöversikten gav en inblick i hjärttransplantationspatienternas upplevelser efter transplantationen. Dessa handlade om upplevelser av medicinbiverkningar, förändringar i sociala relationer, utmaningar i känsloliv och deras upplevelser efter att ha fått en andra chans på livet. / Background: The heart is a powerful symbol for humans. The technological advancements in medicine have changed people's living conditions and the work of nurses. The technological development reflects a need for person-centered care. This has generated an interest in the experiences of heart transplantation patients. Aim: To describe patients experiences after a heart transplantation. Method: A literature review was conducted utilizing eight articles. Data collection was performed on the CINAHL and PubMed databases. The results were analyzed using Friberg's analysis method. Results: Based on the results, four themes emerged: Medical impact, social relationships, emotional trials, and a second chance. Summary: The literature review provided insight into the experiences of hearttransplant patients post-transplantation. These experiences included encountering medication side effects, changes in social relationships, emotional challenges, and reflections on their experiences after being given a second chance at life.

Att leva med diabetes typ-1 innebär att sprutstick och kanyler blir en del av vardagen som idagsläget inte kan väljas bort. Insulintekniken är inte anpassad efter en varierad livsstil ochdärför kan få många drabbade att känna sig begränsad i sin vardag.I mitt examensprojekt har jag försökt skapa en designlösning som kan ge diabetiker en friareanvändning av diabetesteknik, utan att hindras av receptutskrivningar och läkarbesök.Duo skapar en modern mer hållbar lösning för diabetestekniken, både ur en hälso- ochmiljösynpunkt. Projektet har gjorts i samarbete med Medtronic samt Ung Diabetes i Umeå. / Living with diabetes type-1 means that needles and cannulas become a part of the daily life,that today cannot be excluded. The insulin technology is not fitted for a versatile lifestyle andcan therefore make the person living with the disease feel limited in their daily life.In my degree project I have aimed to create a design solution that can give people living withdiabetes a more free use of diabetes equipment, without being kept back by prescriptionsand doctor appointments. Duo creates a modern, more sustainable solution for diabetesequipment, both from a health and environmental point of view. The project was made incollaboration with Medtronic and Ung Diabetes (Young Diabetes) in Umeå.

Bakgrund: Operationssjukvården utvecklas ständigt med nya medicintekniska produkter. Operationssjuksköterskan ansvarar för att ta fram rätt medicintekniska produkter till operationen och för att de medicintekniska produkterna ska fungera. Fungerar inte medicintekniska produkter under operationen hotar det patientsäkerheten. Syfte: Att undersöka hur operationssjuksköterskan arbetar med medicintekniska produkter på operationssalen. Metod: En strukturerad, icke-deltagande observationsstudie med kvantitativ ansats har genomförts på två olika sjukhus i västra Sverige. Totalt genomfördes 21 observationer som analyserades med beskrivande statistik. Resultat: Medelvärdet på antal medicintekniska produkter i operationssalen var nio. Operationssjuksköterskan utförde funktionstest av medicintekniska produkter innan operationens start i 76 % av observationerna. Problem med medicintekniska produkter uppstod i 71 % av observationerna, vilket ledde till att vid en tredjedel av observationerna fick någon i operationsteamet gå ut från operationssalen för att hämta nya medicintekniska produkter. Medelvärdet för tiden att hämta ny medicintekniska produkter var två minuter och 29 sekunder. Konklusion: Studien har bidragit med en överblick över hur operationssjuksköterskans arbetar med medicintekniska produkter på operationssalen, både hur operationssjuksköterskan förbereder medicintekniska produkter innan operationens start och hur många problem som uppstår med medicintekniska produkter under operationen som operationsteamet måste lösa. Att förebygga problem med medicintekniska produkter är viktigt för patientsäkerheten, operationspersonalens arbetsmiljö och produktiviteten för operationsenheten. / Background: Surgical care is constantly evolving with new medical devices. The operating room nurse is responsible for providing correct medical devices and making sure the medical devices function correctly. If the medical devices are not functioning correctly the patient safety is endangered. Aim: Examine how the operating room nurse works with medical devices in the operating room. Method: A structured, non-participating observation study with a quantitative design was conducted at two hospitals in western Sweden. A total of 21 observations were analyzed using descriptive statistics. Result: The mean number of medical devices in the operation room was nine. The operating room nurse performed function tests of the medical devices prior to operation in 76 % of observations. Problems with medical devices occurred in 71 % of observations, resulting in someone from the operating team having to leave the operating room and fetch new medical devices in one third of observations. The mean time required for fetching new medical devices was two minutes and 29 seconds. Conclusion: The study offers an overview of how the operating room nurse utilizes medical devices in the operating room, both how the operating room nurse prepare the medical devices before the start of the operation and how many problems occur with the medical devices during the operation which the operating team must resolve. Preventing problems with medical devices are important due to patient safety, work environment and productivity in the operating ward.

Thesis (M.Tech.: Biomedical Technology)-Dept. of Biomedical Technology, Durban University of Technology, 2007 xxiii, 244 leaves / In 2004, it was reported that KwaZulu-Natal had the greatest number of HIV infected people, approximately 1.8 million people, of whom an estimated 450 000 were in need of antiretroviral drug therapy based on their Cluster of Differentiation 4 (CD4) counts and clinical status. Studies on the success of antiretroviral drugs in improving the quality of life in HIV infected individuals have been extensively performed and published. However, there are no published data on the effect that immune boosters have in improving the quality of life in such persons. Considering the side effects, toxicity, multi-drug regimens and drug resistance problems associated with antiretroviral therapy, alternative or supplementary therapies may play an important role in improving the quality of life in HIV infected people. Such therapy might help in situations where some patients who qualify for antiretroviral treatment are unable to access them because of several reasons such as long waiting lists, travelling costs, unwilling to take antiretroviral drugs, etc. Some patients have reservations in taking antiretroviral drugs. The stigma associated with the disease may be a major factor. The aim of this study was to investigate the change in the immune status of HIV infected patients that were on the Inochi New Medicine immune booster, as well as, to assess the safety and efficacy of this immune booster in improving the patients’ quality of life.

Os temas pertinentes à introdução e à difusão do Método de Ponseti para o Tratamento do pé torto congênito no Brasil são discutidos. O Método Ponseti é baseado na confecção de gessos seriados de forma específica, tenotomia do Achillis, e manutenção da correção com órtese de abdução. Este tratamento era diferente do tratamento então vigente no país, baseado em maior tempo de confecção de gessos e realização de uma cirurgia extensa do pé. A difusão do Método Ponseti é analisada de forma cronológica, com ênfase na história de sua difusão no Brasil e no mundo a partir da Universidade de Iowa, na influência da Internet, e no Programa de treinamento de ortopedistas denominado Ponseti Brasil. Dados populacionais foram utilizados como avaliação da difusão do Método Ponseti antes do Programa de Treinamento. Quatro formas de avaliação direta do impacto do Programa de Treinamento são propostas: a reação dos participantes, o questionamento dos participantes sobre sua prática clínica após um ano do Programa, a avaliação dos participantes com relação ao tratamento do pé torto em duas cidades do Programa, São Luis e Teresina, e apresentações de casuísticas de nove serviços de ortopedia brasileira em um Painel Nacional no Curso Ponseti Avançado realizado dois anos após o Programa Ponseti Brasil. Para corroborar as informações sobre difusão, as publicações em países em desenvolvimento são discutidas, como ampliações da indicação do Método Ponseti. A tendência da literatura médica sobre pé torto congênito é analisada, por bases de dados em língua inglesa e bases de dados latino-americanas, e também são revisados os anais dos congressos nacionais da Sociedade Brasileira de Ortopedia e Traumatologia (CBOT Congresso Brasileiro de Ortopedia e Traumatologia) e Congresso Brasileiro de Ortopedia Pediátrica para observar a apresentação de trabalhos sobre tratamento pelo Método Ponseti e tratamento cirúrgico do pé torto. A difusão também é discutida em outros países, organizações não governamentais, com relação à visão dos pais e com relação aos custos do tratamento. A difusão do Método no Brasil é considerada na fase de expansão, e sua discussão pode trazer elementos que auxiliem a incorporação dessa tecnologia no Sistema Único de Saúde / Introduction and diifusion of Ponseti Method for congenital clubfoot treatment in Brazil are discussed. Ponseti Method is based on specific serial casting, Achillis tenotomy and use of abduction brace to maintain correction. This was different from standard treatment in Brazil at that time, based in many more months of serial casting and an extensive foot surgery. The Ponseti Method difusion is analized in a cronologic manner, with focus in the history of its difusion in Brazil and in the world, beginning in University of Iowa. Internet influence is discussed, as well as the Program Ponseti Brasil for training orthopaedic surgeons in Ponseti clubfoot treatment. Populational data were used to evaluate Ponseti Method difusion, before the Training Program. Four manners of direct evaluation of the impact of the Training Program are presented: the participants´reaction, enquiries about clinical practice with Ponseti Method after one year, evaluation of the impact of the Training Program in two cities, São Luis and Tesesina, and case series presentations of nine Brazilian Orthopaedic Clinics in a national panel in the Advanced Ponseti Course, two years after the Training ProgramPonseti Brasil. To reinforce information about difusion, publications in developing countries are discussed, extending indications for use of the Ponseti Method. Tendencies of medical literature about clubfoot treatment were analized, through written english and latinoamerican databases, and proceedings of two national meetings Brazilian Orthopaedic Meeting and Brazilian Pediatric Orthopaedic Meeting were revised to evaluate presentations about clubfoot treatment (Ponseti and surgical). Difusion is also discussed in other countries, non governamental organizations, related to parents perspective, and related to costs of treatment. Difusion of Ponseti Method is considered in expansion phase, and its discussion can help in the incorporation of this tecnology into the SUS (Sistema Único de Saúde Brazilian Health System)

In spite of electrogustometry having been in existence since the 1930s, there is no state of the art instrument to assess the electrogustometric threshold. A state of the art electrogustometer has been designed and constructed and tested for reliability and repeatability. This is based on embedded digital technology and is a semi-automatic, battery-powered portable instrument. Physical factors such as electrode area and stimulus duration affect the taste threshold but there are no recommended standards for these factors. Studies have been conducted to ascertain a recommended standard – a circular stainless steel electrode area of 28.5 mm2 and a stimulus duration of 2 seconds. While performing the test-retest assessment of the Sussex Electrogustometer, the new instrument, an anomaly was observed. Upon further investigation it was concluded that it was caused by alcohol consumed by a subject prior to the retest. Elaborate experiments were designed with the help of a neurologist and psychologist to understand the immediate effect of alcohol on taste for non-alcoholics. The results indicated an immediate improvement of taste for lower concentrations of alcohol and a delayed improvement for higher concentration. The studies were extended to understand the immediate effect of anaesthetics and smoking on taste which showed that taste deteriorated as expected. The new machine was used successfully in the clinical environment by local doctors and a report on their findings has also been included within this thesis.

Le travail de cette thèse s’interroge sur les réponses à apporter en terme d’organisation de l’offre médico-technique et de sa juste répartition sur les territoires en particulier pour les patients âgés poly-pathologiques. Il part de l’hypothèse qu’il existe un espace pour des concepts de petits établissements de santé ambulatoires pluridisciplinaires, dotés d’un petit plateau médico-technique, qui permettraient de participer à fluidifier et optimiser les parcours de soins. La méthode a consisté d’une part à étudier des structures plus petites de proximité en Allemagne, les MVZ, avec une expérience plus ancienne que celle dont nous disposons en France avec les MSP ou les Centres de Santé, et d’autre part à analyser les données PMSI pour faire émerger à la fois l’existence de groupes homogènes de co-morbidités et de groupes homogènes de parcours de soins. Les résultats sont constructifs, à la fois dans l’analyse par les sciences des réseaux et par l’automatisation de représentations de parcours de soins complexes. Ils ont permis de faire émerger des patterns représentatifs de groupes, d’en caractériser la consommation de soins, en matière de dispositifs médicaux et de ressources humaines, de quantifier les distances parcourues cumulées et les coûts cumulés par les patients selon leur lieu d’habitation et les institutions de santé auxquelles elles sont adressées. Nous en tirons des éléments pour la définition et la labellisation de nouvelles structures de santé de proximité satellites d’hôpitaux plus importants. Ce travail représente une avancée particulièrement utile, à la fois conceptuelle et pratique, pour les études de données de santé complexes des personnes âgées. / This work questions the answer to be given in terms of organization of the health technical offer and its fair distribution in the territories especially for the elderly patients with multimorbidities. It is based on the assumption that there is space for a concept of small multi-disciplinary outpatient health facilities, with a small health-technical platform, which would help to streamline and optimize care pathways. The method consisted on the one hand to study in Germany smaller community interdisciplinary health care center (the MVZ) in operation for a longer time than the the French multidisciplinary médical care centers. And on the other hand it analyzed the national heath data to reveal both the existence of comorbidités related groups and homogeneous care pathways related groups. The results are positive, both in network science analysis and in the automation of representations of complex care pathways. They made it possible to create representative patterns of groups, to characterize the consumption of care, in terms of medical devices and human resources, to quantify the cumulative distances traveled and the costs accumulated by patients according to their place of residence and the health institutions to which they are sent. We get addition elements for the definition and labeling of small community health centers, satellite of larger hospitals. This work represents a particularly useful step, both conceptual and practical, for complex health data studies of elderly.

Information and communication technologies hope to revolutionize the healthcare industry with innovative and affordable solutions with a focus on pervasive care. Wearable sensors products can provide monitoring in a natural environment with a constant stream of information, enriching healthcare practices and enabling better pervasive care. Wearable sensor technologies could monitor patients' mobility, gait, tremor, daily activity and other health indicators in real time that could allow for simple, non-invasive, tracking of spine care that may lead to increased patient engagement, integration, feedback, post-surgery analysis, monitoring of patient's condition, patient's data extraction and analysis and possibly aiding in better diagnosis, intervention, adherence to treatment for the betterment of quality of care. This research focuses on the assessment of technology adoption potential of medical devices particular to tracking the mobility of patients of neurosurgery and orthopedics. Wearable medical devices that track the mobility of patients after spinal procedures could help surgeons in providing post-operative care, analysis of treatment outcomes and patient mobility. The assessment of those devices by physicians is a complex process associated with various perspectives and criteria. Therefore, the objective of this research is to assess the potential for technology adoption of those wearable medical devices through development of a hierarchical decision-making model (HDM) that incorporates the relevant perspectives and criteria encompassing the needs of hospital neurological surgery and orthopedics departments. The proposed research builds on an existing body of knowledge researched through literature review and background of the field and expands the health technology assessment field by implementation of a holistic, comprehensive and multi-perspective approach to technology assessment in wearable sensor products adoption for pervasive care in neurosurgery and orthopedics. The Hierarchical Decision Model (HDM) approach is used to break the problem down into hierarchical levels and then calculate the alternatives using pairwise comparison scales and a judgment quantification technique. Inconsistencies, disagreement, sensitivity and scenario analysis are performed as well. HDM research software is created with Ruby and R to facilitate the computation of some of these important model parameters to higher precision than is available in current statistical analysis software packages or extensions targeted for decision making. Patient perspective dominates as the main perspective for the technology adoption potential of wearable devices for pervasive care in neurosurgery and orthopedics, followed by technical and financial perspectives. Valedo, a wearable device aimed to relieve back pain through exercises, motivation and mobility tracking, received the highest ranking for adoption potential, while other devices also received high relative scores. The framework could serve as a supplementary technology assessment tool and could be tested in other settings: private, small clinic etc. with the experts and special needs of physicians in particular healthcare departments.