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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
341

Improving Type 1 DiabetesPatients’ Quality of LifeThrough Data Collection / Förbättring av livskvalitet för typ 1-diabetespatienter genom datainsamling

Ilja, Leiko January 2021 (has links)
Type 1 diabetes (T1D) is a complex chronic disease without treatment. When anindividual is diagnosed with T1D they are taught how to monitor blood glucoselevel as well as external insulin administration. While this management strategyhelps prolong the individual’s life, there are other lifestyle factors not consideredthat negatively impact the patients’ life. This thesis aims to investigate the types of data that can be gathered to benefit T1D patients and healthcare specialists by improving life quality. To do so, the work employs a literature review and its qualitative analysis, aninterviewing process and its qualitative analysis as well as overall findings analysiswhere data is interpreted in order to identify areas of interest, common topics andtrends. 43 literature publications, 3 healthcare professionals and 3 T1D patientsparticipated in this study. Results show initial education is limited leaving patients to initiate their ownresearch which could be a cause for stress. Technological integration does not seemchallenging provided the right training of more complex solutions. Education asa means to reduce stress seems effective both for patients but also for their socialnetworks. Finally, there are currently useful data markers not being used that couldprovide a wider range of information to healthcare specialists aiding in better patientcare and improved T1D patients’ Quality of Life (QOL). To conclude, T1D is a complex chronic disease that requires both clinical andnon-clinical interventions. It is not sufficient to only address its clinical implicationsbut is important to investigate factors that impact the lifestyle and quality of life. Byextracting proper data markers, collecting and analyzing them, it is believed thattechnology can assist healthcare and ultimately improve T1D patient’s quality oflife. / Diabetes typ 1 är en komplex kronisk sjukdom som inte har en behandling. När enindivid blir diagnostiserad med Diabetes typ 1 lär dem att mäta blodsocker nivåernasamt externa insulin administering. Medan denna strategi hjälps förlänga individensliv, finns där andra livsstilsfaktorer som inte är övervägd. Denna avhandling syfta mot att kunna undersöka datatyper som kan insamlas tillfördel för Diabetes typ 1 patienter och värdpersonal genom att förbättra livskvalitet. För att kunna utföra detta genomfördes en litteratursammanställning med en kvalitativ analys, intervjuer med en kvalitativ analys samt ett övergripande rön där datantolkas för att kunna identifiera områden som kan vara intressanta, allmänna temanoch trender. 43 litteratur publikationer, 3 vårdpersonal och 3 diabetes typ 1 patienterdeltog i undersökningen. Resultatet visar inledande utbildning är begränsad vilket leder till att patienterinitiera egen fördjupning. Detta kan bidra till stressnivåerna. Teknologisk integrering verka inte vara en utmaning för patienter om dem få rätt utbildning för komplexa lösningar. Utbildning som metod för att bekämpa och minska stressnivåernaverka effektivt både för patienterna och vårdpersonal men även för deras sociala nätverk. Slutligen, finns där användbara data markörer som inte används men kan förse bredare information till vårdpersonal vilket kan förbättra vården samt patientenslivskvalitet. Slutligen är diabetes typ 1 en komplex sjukdom som kräver både klinisk menäven icke-kliniska ingripande. Det är inte tillräcklig att enbart ta itu med dem kliniska ingripande men det är även viktigt att undersöka faktorer som påverkar livsstiloch livskvalitet. Genom att excerpera lämplig data markörer samt samla och analysera dem, är det tänkt att teknologi kan assistera vårdpersonal och till slut förbättralivskvaliteten av diabetes typ 1 patienter
342

”Inte ens preventivmedel handlar om sex" : En fenomenologisk studie om sexologisk stöttning efter en vaginal förlossning. / “Not even contraceptives are about sex" : A phenomenological study of sexological support after vaginal childbirth

Bäckström, Sara January 2023 (has links)
Since 2015, the Swedish government has invested more money in the post-partum care to make it more accessible. The number of Swedish qualitative studies, which highlight women's experiences of sexological support after childbirth since 2015, is limited. This means that we do not know how adequate the government's investments have been in terms of patients' access to sexological support after childbirth. The purpose of the study is to gain an increased understanding of what sexological support, from healthcare, people feel they need after childbirth. The author has conducted ten qualitative semi-structured interviews with respondents who had a vaginal birth in the last two years. Analyzed through Merleau-Ponty's (1945/2006) and Ahmed's (2014) phenomenological theories the results show that the respondents' sexual health was affected by the interaction of the changes in their physical body and life situation. These aspects were also influenced by their partner and the post-partum care. During the follow-up, several respondents felt that their midwife focused too much on their physical body instead of changes related to their sexual health. Participants expressed a need for more information and confirmation regarding the physical, psychological, and social changes that affected their sexual health. The participants also wished to have more sexological support for their partner. This result indicates that the government's investment in the post-partum care has not been sufficient in terms of sexual health after childbirth, which means that parts of this care remain unavailable. Key words: childbirth, partner, post-partum, postnatal care, sexual health, sexual function, sexual satisfaction, sexological support.
343

Chefers och medarbetares erfarenheter av anpassning till digital transformation i äldreomsorgen - en kvalitativ fallstudie med deduktiv ansats / Managers' and employees' experiences of adapting to digital transformation in elderly care - a qualitative case study with a deductive approach

Andersson, Marie January 2023 (has links)
Bakgrund: Det råder en obalans i den svenska välfärdssektorn på grund av den demo­grafiska utvecklingen. Äldreomsorgen är ett välfärdsområde där digitaliseringen kan skapa stora möjligheter genom att tänka och arbeta på nya sätt i kombination med att använda digital teknik och e-hälsa men för att nyttja digitaliserings möjligheter behö­ver anpassningar göras inom äldreomsorgen. Syfte: Syftet med studien är att beskriva chefers och medarbetares erfarenheter av hur anpassning till förutsättningar vision, kompetens, belöning, resurser och handlings­plan kan främja förändring vid en digital transformation av en kommuns äldreomsorg. Metod: Genom en kvalitativ fallstudie genomfördes tre fokusgrupps­intervjuer med chefer och medarbetare inom äldreomsorgen i en mindre kommun. Urvalet av informanter baserades på ett generiskt ändamålsstyrt urval och fokus­gruppsintervjuerna utgick från en semistrukturerad intervjuguide. Resultatet analyse­rades genom kvalitativ riktad innehållsanalys med deduktiv ansats utifrån byggsten­arna i Thylefors förändringsmodell. Resultat: Chefers och medarbetares erfarenheter av hur anpassningar till förutsätt­ningar kan främja digital transformation inom äldreomsorgen i en kommun beskrivs samt chefers och medarbetares behov av stöd i förändringen. Totalt tio subkategorier identifierades till Thylefors byggstenar vision, kompetens, belöning, resurser och handlingsplan. Slutsats: Chefers och medarbetares erfarenheter av hur anpassningar kan främja för­ändring inom äldreomsorgen vid en digital transformation, i den kommun där studien genomfördes, visar att vision, förändringsledning och digital kompetens spelar en central roll. Chefers och medarbetares erfarenheter av stöd i förändringsprocessen vi­sar på behov av tid för utbildning och innovation samt en handlingsplan som bör in­kluderas i det systematiska kvalitetsarbetet. Chefer och medarbetare erfar liknande behov av anpassningar och stöd vilket skulle kunna indikera att resultatet kan beaktas vid digital transformation inom äldreomsorgen i en liknande kontext. Förslag till framtida forskning är bland annat att undersöka hur digital transformation inom äl­dreomsorgen kan främja ett hållbart ledarskap och utvecklande medarbetarskap. / Background: There is an imbalance in the Swedish welfare sector due to demogra­phic changes. Elderly care is an area of welfare where digitization can create great opportunities by thinking and working in new ways in combination with using digital technology and e-health. However, to take advantage of the opportunities, adaptations need to be made within the elderly care.  Aim: The purpose of the study is to describe managers' and employees' experiences of how adaptation to conditions such as vision, competence, incentives, resources, and action plan can promote change in a digital transformation of a municipality's elderly care.  Method: A qualitative case study was conducted, including three fo­cus group interviews with managers and employees in elderly care in a small muni­cipality. The selection of informants was based on a generic purpose-driven selection and the focus group interviews were based on a semi-structured interview guide. The data were analyzed through qualitative directed content analysis with a deductive ap­proach based on the building blocks in Thylefors' change model. Results: Managers' and employees' experiences of how adaptations to conditions can promote digital transformation in elderly care in a municipality are described, as well as managers' and employees' needs for support in the change. A total of ten subcate­gories were identified related to Thylefors' building blocks: vision, competence, in­centives, resources, and action plan.  Conclusion: Managers' and employees' experiences of how adaptations can promote change in elderly care during digital transformation, in the municipality where the case study was conducted, show that vision, change management and digital compe­tence play a central role. Managers' and employees' experiences of support in the change process show the need for time regarding training, innovation and an action plan which should be included in systematic quality management. Managers’ and em­ployees’ experience similar needs for adaptations and support, which could indicate that the findings can be considered in a similar context of digital transformation in elderly care. Suggestions for future research include for example investigating how digital transformation in elderly care can promote sustainable leadership and emplo­yee empowerment skills.
344

Health Data Exchange during Transfer of Multi-morbid Elderly / Hälsodatautbyte vid transport av multisjuka äldre

Hadi, Hanan January 2023 (has links)
This project aimed to enhance communication and collaboration among care providers in Stockholm Region and Stockholm Municipality by analyzing health data in various medical record systems and identifying the data that needs to be shared to support elderly individuals with multi-morbidity. Interviews with health experts, caregivers, and policymakers, as well as a literature review, were conducted to gather data. The findings indicated that caring for multi-morbid elderly individuals poses many challenges, including managing multiple chronic conditions, the risk of adverse drug interactions, physical and emotional burden, reduced functional ability, social isolation, and economic consequences. A holistic approach to care is needed, including coordinating care across multiple specialities, addressing social and psychological factors, and providing support for caregivers. Additionally, health data sharing could help with the challenges of ageing and multi-morbidity, but barriers to accessing relevant health data exist. The barriers include a lack of measurement values, different systems used in different healthcare facilities, outdated systems and a large amount of health data existing as free-text notes which make it difficult to extract useful information. Therefore, new HIE solutions are needed to improve patient safety and better integrate existing systems. Future work should focus on improving the accessibility and usability of health data, addressing security and privacy issues, and promoting standardization and interoperability. / Målet med detta projekt var att förbättra kommunikationen och samarbetet mellan vårdgivare i Stockholmsregionen och Stockholm kommun genom att analysera hälsodata i olika medicinska journalsystem och identifiera de data som behöver delas för att stödja multi-sjuka äldre. Intervjuer med hälsoexperter, vårdgivare och beslutsfattare samt en litteraturstudie genomfördes för att samla in data. Resultaten visade att vården för äldre personer med flera sjukdomar innebär många utmaningar, inklusive hantering av flera kroniska tillstånd, risken för biverkningar från läkemedel, fysisk och emotionell belastning, minskad funktionell förmåga, social isolering och ekonomiska konsekvenser. En helhetssyn på vården krävs, inklusive samordning av vården över olika specialiteter, beaktande av sociala och psykologiska faktorer och stöd till vårdgivare. Dessutom kan delning av hälsodata hjälpa till med utmaningarna med åldrande och flera sjukdomar, men det finns hinder för att få tillgång till relevant hälsodata. Hindren inkluderar brist på mätvärden, olika system som används i olika vårdinrättningar, föråldrade system och en stor mängd hälsodata som finns som anteckningar, vilket gör det svårt att extrahera användbar information. Därav, behövs nya lösningar för hälsodata-utbyte för att förbättra patientens säkerhet och bättre integrera befintliga system. Framtida arbete bör fokusera på att förbättra tillgängligheten och användbarheten hos hälsodata, hantera säkerhets- och integritetsfrågor och främja standardisering och interoperabilitet.
345

U-Med : A Mobile Application and a Reverse Vending Machine for Individuals to Reduce Unused Medication Waste

Bacaksizlar, Ecenur January 2022 (has links)
Medication waste, both packaging and actual drug waste, has been having a tremendous impact on the environment and healthcare budget. However, this is even more concerning after Covid-19 affects the drug purchasing behaviours and causes potentially more unused medications while many people are not able to access healthcare. Some of the main challenges of lack of contribution to the life after the purchase of unused medicine are the patient’s lack of knowledge of how to dispose of them, the medication distribution, the legislation and not having an encouraging sustainable system to reduce medication waste on a bigger scale. This project focused on understanding medicine usage behaviours in Turkish society and developing a circular model called U-Med (Unused Medications). The model has a mobile application and reverse vending machines which are linked with e-Nabız (e-Heartbeat, an application that Turkish citizens and health professionals access to health data collected from health institutions) to reduce medication waste by providing individuals to dispose of or share their unused medicines with the healthcare system or the other industries that can reuse. The concept also aims to show a sustainable approach which can influence decision-making in legislation on medication distribution. This project includes face-to-face, semi-structured interviews in a neighbourhood in Sarıyer, Istanbul Turkey with 5 patients, 3 doctors, 3 nurses and 5 pharmacists along with the health director in the municipality of Sarıyer. Additionally, remote interviews were organised with a non-profit organisation in Greece called GIVMED which has similar concerns. Apart from these, a Turkish survey among 88 Turkish citizens about medication usage behaviour was conducted.
346

Färre vårdskador genom förbättrad följsamhet till checklista för säker kirurgi : Operationsteamets erfarenheter om vilka faktorer som påverkar följsamheten – En kvalitativ studie / Decreased healthcare injuries through improved compliance to safe surgery checklist : The surgery team's experiences of the factors that affect compliance - A qualitative study

Widén, Sara January 2022 (has links)
WHO tog 2009 fram en checklista för att öka patientsäkerheten i samband med operationer, SafeSurgery Checklist [SSC] eller på svenska: Checklista för säker kirurgi. Syftet med checklistan är attförebygga de risker som kan leda till vårdskador vid operationer och att förbättra operationsteametskommunikation. Detta via ett antal säkerhetsfrågor samt att alla på operationssalen presenterar sig mednamn och profession.En rad studier visar på att checklistan om den är rätt använd reducerar operationskomplikationerna.Dessvärre finns det också studier som menar att följsamheten till checklista för säker kirurgi brister.I en kartläggning på författarens arbetsplats så identifierades flera förbättringsgap. Det framkom blandannat att det i operationsteamen brister i följsamhet på flera punkter i checklistan och att det var storaskillnader i hur den genomfördes. Det visade sig också att flera professioner i mikrosystemet inte kändesig delaktiga och inkluderade när checklistan genomfördes.Författaren valde därför att genomföra ett förbättringsarbete för att få bättre följsamhet till checklistaför säker kirurgi. Förbättringsarbetet genomfördes i samband med att den ursprungliga checklistanskulle ersättas med en uppdaterad version, Checklista 2.0 framtagen av Landstingens ömsesidigaförsäkringsbolag.Med Nolans förbättringsmodell som stöd så genomfördes utbildningsdagar, workshops och dialogerunder 2020–2021. Därefter infördes Checklista 2.0 på en operationssal som ett pilottest.En majoritet av medarbetarna upplevde att de nya rutinerna förbättrat delaktigheten. Sedan november2021 så är de nya rutinerna implementerade på hela avdelningen.Under 2022 genomfördes en kvalitativ intervjustudie som undersökte operationsteamets uppfattningav vilka faktorer som påverkat följsamheten under tiden förbättringsarbetet pågick. Resultatet mynnadeut i tre teman; motivation, ledarskapets betydelse och känsla av tillhörighet.Resultatet kan användas som vägledning för framtida förbättringsarbeten och förändringar i rutiner.Det kan ge en ökad förståelse för att operationsteamets professioner har olika utgångslägen. Därförbehöver förändringar som berör flera professioner ta hänsyn till dessa utgångslägen för att bliframgångsrika.Mer forskning kring vad som påverkar patientsäkerhetskulturen inom hälso- och sjukvården behövs ochden behöver ta hänsyn till samtliga professioner som verkar inom kontexten. / In 2009, WHO introduced a checklist to increase patient safety during surgery, Safe Surgery Checklist[SSC]. The purpose of the checklist is to prevent risks that can lead to medical injuries during surgeryand to improve team communication.A number of studies show that the checklist, if used correctly, reduces surgical complications.Unfortunately, there are also studies that suggest that compliance with the checklist for safe surgery isinaccurate.In a survey at the author's workplace, several improvement gaps were identified. It emerged, amongother things, that there was a lack of compliance in surgery teams and there were major differences inhow the checklist was carried out. It also turned out that several professionals in the microsystem didnot feel involved and included when the checklists were conducted.The author therefore chose to carry out an improvement work to get better compliance to the SSC. Theimprovement work was carried out in connection with the original checklist being replaced with anupdated version, Checklist 2.0, developed by the County Council's mutual insurance company.With Nolan's improvement model as support, training days, workshops and dialogues were heldbetween 2020–2021. Then Checklist 2.0 was introduced in one theatre as a pilot test.A majority of the employees felt that the new routines improved participation. Since November 2021,the new routine have been implemented throughout the department.In 2022, a qualitative interview study was conducted that examined the surgical team's perception ofthe factors that affected compliance during the improvement work. The result resulted in three themes.Motivation, the importance of leadership and sense of belonging. The perception differed somewhatdepending on one's professional affiliation.The results can be used as a guide for future implementations and changes in routines. It can provide anincreased understanding that the surgical team's professions have different starting points and thereforechanges that affect several professions need to take these starting points into account in order to besuccessful.More research on what affects the patient safety culture in health care is needed and it needs to take intoaccount all professions that operate in the context.
347

Vårdpersonals upplevelser inför omställning till digifysisk vård inom öppenvårdspsykiatri : En studie med kvalitativ ansats som undersöker möjligheter och hinder. / Healthcare professionals' perceptions toward Digi-physical healthcare in outpatient psychiatry : A study with a qualitative approach that explores enablers and barriers

Dahlén Ölander, Linn January 2022 (has links)
Bakgrund: Nationellt eftersträvas en digital omställning där digital och fysisk vård integreras inom hälso- och sjukvården. Incitament för denna omställning är att ge invånare ökad tillgänglighet till vård men också att nå en ökad delaktighet för invånare. Den digitala omställningen av vården och därmed integrering av digitala vårdkontakter är inom regionalt driven psykiatri ännu i sin linda. Detta trots växande evidens, framsteg i utveckling och tillgång till digitala verktyg, en pandemi som forcerat barriärer och ökad samhällelig acceptans för vård på distans. En förutsättning för att digitala vårdtjänster integreras som en legitim del av vård och behandling vid psykisk ohälsa är att vårdpersonal integrerar digitala arbetssätt och vårdkontakter i yrkesvardagen.  Idag är lite känt om hur vårdpersonal inom specialiserad öppenvårdspsykiatri i Sverige uppfattar en sådan omställning.   Syfte: Studiens huvudsyfte är att undersöka möjligheter och hinder som vårdpersonal inom regionalt driven öppenvårdspsykiatri upplever vid omställning där patienter erbjuds kombination av fysisk och digital vård.  Metod: Ett webbaserat frågeformulär med öppna och slutna frågor utformades. Insamlade data analyserades med kvalitativ innehållsanalys utifrån en deduktiv ansats utifrån Theoretical Domains Framework (TDF). Deltagare i studien var vårdpersonal verksamma i regionalt driven psykiatrisk öppenvård för vuxna i en region i Södra Sverige. Resultat: Baserat på TDF ramverket identifierades områden som påverkar vårdpersonalen genom att utgöra möjligheter eller hinder för att använda digitala vårdformer som arbetssätt.  Resultatets höga överensstämmelse med tidigare forskning antyder att identifierade TDF- domäner kan användas för att stärka acceptansen och implementeringen av digitala vårdformer inom ramen för psykiatrisk öppenvård. / Background:  In Sweden, a digital transition is sought where digital and physical care, Digi-physical healthcare, are integrated into public health care. A digital transition is one approach to meet the increasing need for health services that significantly challenges the health system but also aims to achieve increased patient participation. The digital transformation of care and the integration of e-mental health is still in its infancy in public psychiatry. This is despite growing evidence, progress in development, and access to digital tools, a pandemic that has pushed through barriers and increased acceptance of Digi-physical healthcare. A prerequisite for the integration of Digi-physical healthcare as a routine in public psychiatry depends on the acceptance of health care professionals. Aim: This study aims to investigate barriers and facilitators, as perceived by health care professionals, for implementing a combination of physical and digital care in Swedish public psychiatry.   Methods: Participants were health care professionals active in public outpatient psychiatry in a region in Southern Sweden. A web-based questionnaire with open and closed questions was designed. Collected data was analyzed with qualitative content analysis based on a deductive approach using the Theoretical Domains Framework (TDF). Results: Based on the TDF framework, barriers and enablers that influence mental health care professionals to apply the distance format as a way of working were identified. The result`s high agreement with previous research, suggests that identified TDF domains can be used to strengthen the acceptance and implementation of Digi-physical healthcare within psychiatric outpatient care.
348

Betydande attribut för att attrahera och behålla specialistsjuksköterskor : En kvalitativ studie om Region Dalarna / Significant attributes for attracting and retaining specialist nurses

Björk, Emelie, Johansson, Sandra January 2022 (has links)
Syftet med denna kandidatuppsats är att synliggöra vilka attribut som är betydande i Region Dalarnas arbete med att attrahera och behålla specialistsjuksköterskor inom verksamheterna. Den teoretiska referensramen utgör grundläggande för tidigare forskning inom områdena Employer Brand och Employer Value Proposition (EVP). Vidare har den teoretiska referensramen analyserat tidigare forskning kring studiens identifierade teman: ledarskap, lönepolitik och kompetensförsörjning/ kompetensutveckling. Studien har en kvalitativ ansats där åtta semistruktrerade intervjuer utförts med tidigare eller nuvarande anställda specialistsjuksköterskor inom Region Dalarna. Resultatet påvisar att Region Dalarnas främsta betydande attribut för att attrahera och behålla specialistsjuksköterskor är de tre teman ovan nämnda vilka identifierats av föreliggande studie. Som ett bidrag till praktikersamhället kan Region Dalarna förslagsvis uppmärksamma studiens resultat för att utveckla arbetet kring att attrahera och behålla specialistsjuksköterskor i sina verksamheter. Föreliggande studie kan även ses som ett bidrag och komplement till tidigare forskning. / The purpose of this Bachelor ́s thesis is to highlight which attributes who are significant in Region Dalarnas work to attract and retain specialist nurses within the operations. The theoretical frame of reference form the basic for previous research in the areas of Employer Brand and Employer Value Proposition (EVP). Furthermore, the theoretical frame has analyzed previous research for the study's identified themes: Leadership, Wage Policy and Skills supply/Skills development. The study has a qualitative approach where eight semistructured interviews were conducted with previously or currented employed specialist nurces within Region Dalarna. The results shows that Region Dalarna ́s main significant attributes for attracting and retaining specialist nurses are the three themes mentioned above which has been idenified by the present study. As a contribution to the practitioner community, Region Dalarna can suggest paying attention to the results of the study to delvelope the work for attracting and retaining specialist nurses in the operations. The present study can also be seen as a contribution to previous research.
349

Analysis of Physiotherapists Perceptions for Improvement of Digital Innovation / Analys av fysioterapeuters uppfattningar för förbättring av digital innovation

Eriksson, Per Gustav January 2020 (has links)
With the current challenges for the healthcare such as increased demand for care, financial and resource constraints along with rapid changes and complexity there is high believe in digital innovation and digitalisation to efficacy resources and aid in delivering a safer, more accessible and patient centred valuable care. There is a digitalisation that is ongoing, being used and implemented over several different areas of healthcare. Since healthcare can be seen as a complex adaptive system, there is a need to understand several agents. The aim is to gather more knowledge about perceptions within the physiotherapy staff and give recommendations and directions for improvements regarding digital innovation. Opinions about digital innovation have been gathered with open interviews and a semisystematic literature review with focus on physiotherapy. Too find subjective data the mixed method Q methodology was applied. The open interviews resulted in eight categories: digital innovation, digital innovation being used, digital innovation not used, management, obstacles, education, wishful thinking, applications and systems and associated opinions. The semi-systematic literature review showed on a rapid scientifically development, 25 articles was found and thematically analysed. 140 cited viewpoints and facts was merged with the results from the open interviews. Ten physiotherapists performed the q-sort consisting of 25 statements. Three factors were found. Interpreted as digital innovation optimism & patient oriented, digital innovation scepticism & management oriented and digital innovation sceptical optimism. Video-call technique is strongly encouraged by factor one contrary to factor two. Integrity is the major conflicting viewpoint between the factors. The result shows that gender can affect if a physiotherapist is either optimistic or sceptical to digital innovation. Using existing models such as UTAUT could improve acceptance about digital innovation. Education is perceived as important among all factors. Nine participants responded on baseline questions showing low knowledge of the term mHealth and little communication with IT departments.
350

MDR 2017/745 - New EU Regulation for Medical Devices: A Process Description for EHR Manufacturers on How to Fulfill the Regulation / MDR 2017/745 - Ny EU-förordning för medicintekniska produkter: En processbeskrivning för tillverkare av journalsystem om hur man uppfyller förordningen

Germundsson, Frida, Kvist, Nicole January 2020 (has links)
On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. The main goal of MDR is to strengthen and improve the already existing legislation and thus will entail large changes for manufactures, one of them being manufacturers of Electronic Health Record (EHR) systems. For medical software, such as EHR systems, the new regulation will imply an upgrade in risk classification. This upgrade will bring additional requirements for EHR manufacturers. Furthermore, the released guidelines have been insufficient regarding the specific requirements for medical device software and thus EHR manufacturers are in need of tools and guidance to fulfill MDR. This thesis examines the new regulation for medical devices and thus identifies main requirements for EHR manufacturers. A qualitative approach was conducted comprising a literature study as well as a document study of the medical device regulation along with interviews with experts within the field of medtech regulatory affairs and quality assurance. The information gathered was analyzed to create a process description on how EHR manufacturers are to fulfill MDR. The process description is a general outline and presents the main steps on the route to be compliant with MDR in a recommended order of execution. The main steps are: divide the system into modules, qualify the modules, classify the modules, implement a quality management system, compile a technical documentation, compile the declaration of conformity, undergo a conformity assessment and finally, obtain the CE-mark. To each of the main steps additional documentation provides further information and clarification. The process description functions as a useful tool for EHR manufacturers towards regulatory fulfillment. Even though the process description is created for EHR manufacturers, it can be useful for other medical device software manufacturers. The process description provides an overview of the path to a CE mark and functions as a guidance. It can be used in educational purposes as well as to serve as a checklist for the experienced manufacturer to make sure everything is covered. However, it is not sufficient to rely solely on the process description in order to be in full compliance with MDR. Moreover, there is still a need for further clarifications from the European Commission regarding specific requirements on medical device software.

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