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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.
41

Intenzivní domácí péče - Domácí péče s prvky intenzivního ošetřovatelství / Intensive home care - Home care with elements of intensive nursing

Králová, Eva January 2013 (has links)
The master thesis deals with an intensive home care - home care of intensive nursing and maps the situation concerning the home mechanical ventilation. The theoretical part draws from the researchers' reviews. It clarifies the basic concepts, intensive home care and trends in providing the home mechanical ventilation. Furthermore, this part of the thesis explains the term mechanical ventilation. To facilitate long-term ventilation of a chronic patients it is necessary to ensure an adequate airway. Therefore, it is included a chapter dealing with a tracheostomy and its treatment.The first part of the survey summarizes a statistical overview of the home mechanical ventilation used in the Czech Republic till 31th March 2013. Next section includes a qualitative form research, which is observing the whole indicating and transferring process of a patient from a hospital to the home environment where the home mechanical ventilation is assured. I have concluded that men are more ill and women, mothers or wives are taking part in the healing process according to the investigation results. We have 81 ventilated patients in home care in total. Mechanical ventilation is mostly indicated for children with spinal muscular atrophy disease. Men compared to women are more often affected by traumatic conditions,...
42

Long-term tracheostomy : outcome, cannula care and material wear /

Björling, Gunilla, January 2007 (has links)
Diss. (sammanfattning) Stockholm : Karolinska institutet, 2007. / Härtill 4 uppsatser.
43

Avaliação da sobrevida e fatores associados em pacientes críticos crônicos comparando duas definições em uma coorte histórica

Nunes, Diego Silva Leite January 2014 (has links)
Base teórica: O avanço no conhecimento e a introdução de tecnologias mais sofisticadas para o cuidado do paciente crítico trouxeram importante incremento na sobrevida deste grande grupo de pacientes. Por outro lado, existe um estrato de pacientes que sobrevivem à condição crítica aguda, porém permanecem dependentes de algum tipo de suporte de manutenção da vida por longos períodos. A doença crítica crônica (DCC) como é conhecida, apesar de descrita desde a década de 80, ainda não possui um critério de definição claro, levando a divergências nos resultados de estudos e prejudicando o avanço em pesquisas que investigam estratégias de tratamento. Objetivo: Avaliar a sobrevida e fatores associados à DCC em uma população de pacientes críticos comparando dois critérios de diagnóstico desta condição. Metodologia: Coorte histórica com avaliação de variáveis clínicas e desfechos durante a internação hospitalar em uma população de doentes críticos de uma única unidade de tratamento intensivo (UTI). Os pacientes foram alocados em três grupos, dois com critérios de DCC definidos por ≥14 ou ≥21 dias de ventilação mecânica (VM) e um terceiro grupo de pacientes críticos agudos (< 14 dias de VM). Recrutamento e alocação foram feitos através de um banco de dados institucional e dos registros hospitalares das internações ocorridas de janeiro de 2007 a dezembro de 2010. Resultados: No período analisado ocorreram 3.023 internações na UTI, 2.783 apresentavam os critérios de inclusão e compuseram a análise final. Em relação ao tempo de VM, 163 pacientes apresentaram ≥14 dias e 89 ≥21 dias. A mortalidade hospitalar e na UTI foi inferior no grupo de pacientes críticos agudos quando comparado com os dois grupos de DCC (≥14 e ≥21 dias de VM) (16.3% versus 55.8% e 58.4% p<0.001; 10.6% versus 47.3% e 53.9% p<0.001 respectivamente). Quando comparados os dois grupos de DCC (≥14 e ≥21 dias de VM), não houve diferença estatisticamente significativa para mortalidade hospitalar e na UTI (57.2% versus 58.4% p=0.5; 39.2% versus 53.9% p=0.18 respectivamente). O pequeno número de pacientes em cada grupo pode ter limitado o poder das análises. Ambos os grupos de DCC tiveram escores de gravidade mais altos, desenvolveram mais complicações na UTI, apresentaram maior tempo de internação hospitalar e mortalidade quando comparados aos críticos agudos. Conclusão: O estudo não mostrou diferença estatisticamente significativa quanto às características e desfechos clínicos entre as duas definições de DCC. Por outro lado, mostrou que os dois grupos de DCC apresentaram desfechos piores quando comparados com os pacientes críticos agudos. Estes resultados justificam o uso do critério de ≥14 dias de VM para a identificação mais precoce dos doentes críticos crônicos. / Theoretical basis: Progress in knowledge and the introduction of more advanced technologies for critical patient care brought about an important increase in the survival of this large group of patients. On the other side, there exists a subset of patients who survive their acute critical illness, but they remain dependent on some kind of life support for long periods. Despite being described since the 1980s, the chronic critical illness (CCI) has still not been clearly defined. This situation led to divergent studies’ results and jeopardized the progress in research focused on treatment strategies for CCI. Objective: To assess the survival and CCI-associated factors in a population of critically ill patients comparing two diagnostic criteria of this condition. Methodology: Historical cohort study assessing clinical variables and outcomes during hospital stay, in a population of critically ill patients of a single intensive care unit (ICU). The patients were divided into three groups, two of these with different criteria of CCI, defined by ≥14 or ≥21 days of mechanical ventilation (MV), and a third group with acutely critically ill patients (less than 14 days of MV). The recruitment and allocation were carried out through an institutional database and medical records of admissions occurred from January 1, 2007 to December 31, 2010. Results: In the study period 3,023 ICU admissions occurred, 2,783 met the inclusion criteria and made part of the final analysis. As far as MV days are concerned, 163 patients had ≥14 days and 89 ≥21 days. Hospital and ICU mortality were lower in the group of acutely critically ill patients compared with the two CCI groups (≥14 days and ≥21 MV days) (16.3% versus 55.8% and 58.4% p<0.001; 10.6% versus 47.3% and 53.9% p<0.001 respectively). The comparative analysis between the two CCI groups (≥14 days and ≥21 MV days, respectively) was not statistically significant for hospital and ICU mortality (57.2% versus 58.4% p=0.5; 39.2% versus 53.9% p=0.18, respectively). The small number of patients in the two groups may have limited the power of analyzes. Both CCI groups had higher severity scores, developed more ICU complications, showed higher hospital length of stay and mortality when compared with the acutely critically ill patients. Conclusion: This study did not show significant difference between the two CCI definitions regarding characteristics and clinical outcomes. However, it showed that both groups had worse outcomes when compared with the acutely critically ill patients. This result justifies the use of the CCI criteria of ≥14 days of MV for earlier identification of this subset of patients.
44

Avaliação da sobrevida e fatores associados em pacientes críticos crônicos comparando duas definições em uma coorte histórica

Nunes, Diego Silva Leite January 2014 (has links)
Base teórica: O avanço no conhecimento e a introdução de tecnologias mais sofisticadas para o cuidado do paciente crítico trouxeram importante incremento na sobrevida deste grande grupo de pacientes. Por outro lado, existe um estrato de pacientes que sobrevivem à condição crítica aguda, porém permanecem dependentes de algum tipo de suporte de manutenção da vida por longos períodos. A doença crítica crônica (DCC) como é conhecida, apesar de descrita desde a década de 80, ainda não possui um critério de definição claro, levando a divergências nos resultados de estudos e prejudicando o avanço em pesquisas que investigam estratégias de tratamento. Objetivo: Avaliar a sobrevida e fatores associados à DCC em uma população de pacientes críticos comparando dois critérios de diagnóstico desta condição. Metodologia: Coorte histórica com avaliação de variáveis clínicas e desfechos durante a internação hospitalar em uma população de doentes críticos de uma única unidade de tratamento intensivo (UTI). Os pacientes foram alocados em três grupos, dois com critérios de DCC definidos por ≥14 ou ≥21 dias de ventilação mecânica (VM) e um terceiro grupo de pacientes críticos agudos (< 14 dias de VM). Recrutamento e alocação foram feitos através de um banco de dados institucional e dos registros hospitalares das internações ocorridas de janeiro de 2007 a dezembro de 2010. Resultados: No período analisado ocorreram 3.023 internações na UTI, 2.783 apresentavam os critérios de inclusão e compuseram a análise final. Em relação ao tempo de VM, 163 pacientes apresentaram ≥14 dias e 89 ≥21 dias. A mortalidade hospitalar e na UTI foi inferior no grupo de pacientes críticos agudos quando comparado com os dois grupos de DCC (≥14 e ≥21 dias de VM) (16.3% versus 55.8% e 58.4% p<0.001; 10.6% versus 47.3% e 53.9% p<0.001 respectivamente). Quando comparados os dois grupos de DCC (≥14 e ≥21 dias de VM), não houve diferença estatisticamente significativa para mortalidade hospitalar e na UTI (57.2% versus 58.4% p=0.5; 39.2% versus 53.9% p=0.18 respectivamente). O pequeno número de pacientes em cada grupo pode ter limitado o poder das análises. Ambos os grupos de DCC tiveram escores de gravidade mais altos, desenvolveram mais complicações na UTI, apresentaram maior tempo de internação hospitalar e mortalidade quando comparados aos críticos agudos. Conclusão: O estudo não mostrou diferença estatisticamente significativa quanto às características e desfechos clínicos entre as duas definições de DCC. Por outro lado, mostrou que os dois grupos de DCC apresentaram desfechos piores quando comparados com os pacientes críticos agudos. Estes resultados justificam o uso do critério de ≥14 dias de VM para a identificação mais precoce dos doentes críticos crônicos. / Theoretical basis: Progress in knowledge and the introduction of more advanced technologies for critical patient care brought about an important increase in the survival of this large group of patients. On the other side, there exists a subset of patients who survive their acute critical illness, but they remain dependent on some kind of life support for long periods. Despite being described since the 1980s, the chronic critical illness (CCI) has still not been clearly defined. This situation led to divergent studies’ results and jeopardized the progress in research focused on treatment strategies for CCI. Objective: To assess the survival and CCI-associated factors in a population of critically ill patients comparing two diagnostic criteria of this condition. Methodology: Historical cohort study assessing clinical variables and outcomes during hospital stay, in a population of critically ill patients of a single intensive care unit (ICU). The patients were divided into three groups, two of these with different criteria of CCI, defined by ≥14 or ≥21 days of mechanical ventilation (MV), and a third group with acutely critically ill patients (less than 14 days of MV). The recruitment and allocation were carried out through an institutional database and medical records of admissions occurred from January 1, 2007 to December 31, 2010. Results: In the study period 3,023 ICU admissions occurred, 2,783 met the inclusion criteria and made part of the final analysis. As far as MV days are concerned, 163 patients had ≥14 days and 89 ≥21 days. Hospital and ICU mortality were lower in the group of acutely critically ill patients compared with the two CCI groups (≥14 days and ≥21 MV days) (16.3% versus 55.8% and 58.4% p<0.001; 10.6% versus 47.3% and 53.9% p<0.001 respectively). The comparative analysis between the two CCI groups (≥14 days and ≥21 MV days, respectively) was not statistically significant for hospital and ICU mortality (57.2% versus 58.4% p=0.5; 39.2% versus 53.9% p=0.18, respectively). The small number of patients in the two groups may have limited the power of analyzes. Both CCI groups had higher severity scores, developed more ICU complications, showed higher hospital length of stay and mortality when compared with the acutely critically ill patients. Conclusion: This study did not show significant difference between the two CCI definitions regarding characteristics and clinical outcomes. However, it showed that both groups had worse outcomes when compared with the acutely critically ill patients. This result justifies the use of the CCI criteria of ≥14 days of MV for earlier identification of this subset of patients.
45

Avaliação da sobrevida e fatores associados em pacientes críticos crônicos comparando duas definições em uma coorte histórica

Nunes, Diego Silva Leite January 2014 (has links)
Base teórica: O avanço no conhecimento e a introdução de tecnologias mais sofisticadas para o cuidado do paciente crítico trouxeram importante incremento na sobrevida deste grande grupo de pacientes. Por outro lado, existe um estrato de pacientes que sobrevivem à condição crítica aguda, porém permanecem dependentes de algum tipo de suporte de manutenção da vida por longos períodos. A doença crítica crônica (DCC) como é conhecida, apesar de descrita desde a década de 80, ainda não possui um critério de definição claro, levando a divergências nos resultados de estudos e prejudicando o avanço em pesquisas que investigam estratégias de tratamento. Objetivo: Avaliar a sobrevida e fatores associados à DCC em uma população de pacientes críticos comparando dois critérios de diagnóstico desta condição. Metodologia: Coorte histórica com avaliação de variáveis clínicas e desfechos durante a internação hospitalar em uma população de doentes críticos de uma única unidade de tratamento intensivo (UTI). Os pacientes foram alocados em três grupos, dois com critérios de DCC definidos por ≥14 ou ≥21 dias de ventilação mecânica (VM) e um terceiro grupo de pacientes críticos agudos (< 14 dias de VM). Recrutamento e alocação foram feitos através de um banco de dados institucional e dos registros hospitalares das internações ocorridas de janeiro de 2007 a dezembro de 2010. Resultados: No período analisado ocorreram 3.023 internações na UTI, 2.783 apresentavam os critérios de inclusão e compuseram a análise final. Em relação ao tempo de VM, 163 pacientes apresentaram ≥14 dias e 89 ≥21 dias. A mortalidade hospitalar e na UTI foi inferior no grupo de pacientes críticos agudos quando comparado com os dois grupos de DCC (≥14 e ≥21 dias de VM) (16.3% versus 55.8% e 58.4% p<0.001; 10.6% versus 47.3% e 53.9% p<0.001 respectivamente). Quando comparados os dois grupos de DCC (≥14 e ≥21 dias de VM), não houve diferença estatisticamente significativa para mortalidade hospitalar e na UTI (57.2% versus 58.4% p=0.5; 39.2% versus 53.9% p=0.18 respectivamente). O pequeno número de pacientes em cada grupo pode ter limitado o poder das análises. Ambos os grupos de DCC tiveram escores de gravidade mais altos, desenvolveram mais complicações na UTI, apresentaram maior tempo de internação hospitalar e mortalidade quando comparados aos críticos agudos. Conclusão: O estudo não mostrou diferença estatisticamente significativa quanto às características e desfechos clínicos entre as duas definições de DCC. Por outro lado, mostrou que os dois grupos de DCC apresentaram desfechos piores quando comparados com os pacientes críticos agudos. Estes resultados justificam o uso do critério de ≥14 dias de VM para a identificação mais precoce dos doentes críticos crônicos. / Theoretical basis: Progress in knowledge and the introduction of more advanced technologies for critical patient care brought about an important increase in the survival of this large group of patients. On the other side, there exists a subset of patients who survive their acute critical illness, but they remain dependent on some kind of life support for long periods. Despite being described since the 1980s, the chronic critical illness (CCI) has still not been clearly defined. This situation led to divergent studies’ results and jeopardized the progress in research focused on treatment strategies for CCI. Objective: To assess the survival and CCI-associated factors in a population of critically ill patients comparing two diagnostic criteria of this condition. Methodology: Historical cohort study assessing clinical variables and outcomes during hospital stay, in a population of critically ill patients of a single intensive care unit (ICU). The patients were divided into three groups, two of these with different criteria of CCI, defined by ≥14 or ≥21 days of mechanical ventilation (MV), and a third group with acutely critically ill patients (less than 14 days of MV). The recruitment and allocation were carried out through an institutional database and medical records of admissions occurred from January 1, 2007 to December 31, 2010. Results: In the study period 3,023 ICU admissions occurred, 2,783 met the inclusion criteria and made part of the final analysis. As far as MV days are concerned, 163 patients had ≥14 days and 89 ≥21 days. Hospital and ICU mortality were lower in the group of acutely critically ill patients compared with the two CCI groups (≥14 days and ≥21 MV days) (16.3% versus 55.8% and 58.4% p<0.001; 10.6% versus 47.3% and 53.9% p<0.001 respectively). The comparative analysis between the two CCI groups (≥14 days and ≥21 MV days, respectively) was not statistically significant for hospital and ICU mortality (57.2% versus 58.4% p=0.5; 39.2% versus 53.9% p=0.18, respectively). The small number of patients in the two groups may have limited the power of analyzes. Both CCI groups had higher severity scores, developed more ICU complications, showed higher hospital length of stay and mortality when compared with the acutely critically ill patients. Conclusion: This study did not show significant difference between the two CCI definitions regarding characteristics and clinical outcomes. However, it showed that both groups had worse outcomes when compared with the acutely critically ill patients. This result justifies the use of the CCI criteria of ≥14 days of MV for earlier identification of this subset of patients.
46

Lived Experiences of Individuals Quality of Life on Prolonged Home Mechanical Ventilation

Rwakonda, Munyaradzi Ephie 01 January 2017 (has links)
Improvements in technology have allowed people with tracheostomies to live at home on mechanical ventilation (HMV). Quality of life (QOL) for HMV users has been studied quantitatively, but few qualitative studies have been published. The purpose of this phenomenological study was to explore QOL for individuals with tracheostomies on prolonged HMV focusing on activities of daily living (ADLs) and the role of decision- making. The Roper, Logan, and Tierney activities of living theory were used to categorize activities. Ten participants, 18 years and older, with a tracheostomy and on HMV for at least 6 months were enrolled using purposive sampling. Data were collected through structured, in-depth, face-to-face interviews. Themes that emerged were (a) autonomy, (b) significance of ventilator for well-being, (c) feeling tied up, (d) creating meaning, (e) tipping point, (f) reminiscence, (g) building trust and confidence, (h) adjusting to technology, (i) family support and relationships, and (g) meaning of life. The participants were relatively healthy and their QOL was improved when they were on HMV compared to the hospital. The participants felt empowered that they had control in their daily lives at home when they had competent caregivers and family members for continuity of care. Recommendations for future research would include exploring improved methods of collaboration among health care workers and families in providing holistic care and reducing role strain and isolation in young HMV users. The study may promote positive social change through education for family, health care workers, and the public about strategies to promote independence and subsequent improvement in QOL for individuals on HMV.
47

The child and family living with complex health needs in the community: lived experiences and patterns of coping and relationship

Duff, Miriam Anne 05 September 2012 (has links)
This study explored the perspectives of children whose complex health needs included respiratory technology dependence, and that of their parents, regarding community life and helpful patterns of coping and relationship. In-depth interviews were conducted with 7 children (3-18 yrs. old) and 8 parents. Survey data collected from 31 parents contributed to a convergent mixed methods design. Findings showed that children viewed themselves as normal, but experienced "a constricted life". Parents' active engagement in their child's life, as system navigators and advocates, was necessary to ensure their child's wellbeing. Key relational components included "authentic engaged presence", caring, competence, communication and collaboration. Effective coping patterns included reliable social support and both emotion-focused and problem-focused strategies. Contextual factors significantly affecting parental coping and relationships included family structure and child’s dependence on invasive respiratory technology (tracheostomy). Respite reported inadequate. Findings have practice and policy implications for health, respite and education systems, professionals and parents.
48

The child and family living with complex health needs in the community: lived experiences and patterns of coping and relationship

Duff, Miriam Anne 05 September 2012 (has links)
This study explored the perspectives of children whose complex health needs included respiratory technology dependence, and that of their parents, regarding community life and helpful patterns of coping and relationship. In-depth interviews were conducted with 7 children (3-18 yrs. old) and 8 parents. Survey data collected from 31 parents contributed to a convergent mixed methods design. Findings showed that children viewed themselves as normal, but experienced "a constricted life". Parents' active engagement in their child's life, as system navigators and advocates, was necessary to ensure their child's wellbeing. Key relational components included "authentic engaged presence", caring, competence, communication and collaboration. Effective coping patterns included reliable social support and both emotion-focused and problem-focused strategies. Contextual factors significantly affecting parental coping and relationships included family structure and child’s dependence on invasive respiratory technology (tracheostomy). Respite reported inadequate. Findings have practice and policy implications for health, respite and education systems, professionals and parents.
49

Tyst kunskap och produktdatasystem vid medicinteknisk tillverkning : Pilotstudie av system för produktdatahantering och kartläggning av den tysta kunskapen vid Nationellt respirationscetrum, NRC / Tacit knowledge and product data management system in medical technology production : Pilot study of a PDM system and survey of the tacit knowledge at National respiratory centre, NRC

Hedlund, Niclas January 2009 (has links)
<p>This thesis looks at two sides of the same coin: how to support the production and future development at a specialist medical technology department at Danderyd Hospital. The two sides are; a pilot study of a product management system (PDM) and an interview based study on the characteristics of the silent knowledge of the technicians. The department (National respiratory centre, NRC) is facing retirement of several key employees.</p><p>The technical study shows that the success of an implementation is largely dependent on the users’ prior knowledge and use of a 3D Computer aided design system (CAD).The system itself is shown to fulfill the Lifecycle requirement of tracking the products (mostly tracheostomy tubes) but without a CAD centered workflow, some substantial education and preferably some new recruits, an implementation of the PDM system will fail. The author recommends development of the current “low-tech” system of MS Excel and Access rather than redistribute the dependency from technician towards a complex, commercial software and its vendor.</p><p>The analysis of the technicians’ silent knowledge with the newly developed method, epithet for silent knowledge (ETK), shows that the longer employment time:</p><ul><li>the more differentiated technicians become in describing their work,</li><li>practical knowledge are regarded higher and</li><li>the social and collective problem solving factors of the work becomes more important.</li></ul><p>Typically, it is shown that a new employee should preferably enjoy problem solving, being pragmatic and social as well as having some prior education or work experience in a CAD and/or a PDM system.</p>
50

Mobilt operationsbord för trakeotomi - Från prototyp till egentillverkning av MT-utrustning på Karolinska Universitetssjukhuset / Mobile Operating Table for Tracheotomy – A Prototype of an In-house Manufacture Medical Device at Karolinska University Hospital

Razavi, Arvin, Alkhatib, Najla January 2021 (has links)
Medicinteknisk utrustning (MT) har en stor och avgörande roll i dagens samhälle för att kunna utföra en patientsäker sjukvård. De senaste tekniska framstegen har försett sjukvården med otaliga skräddarsydda MT-produkter för olika behov som uppstår vid behandling av patienterna. Trots detta har vissa hälso- och sjukvårdssektorer särskilda behov som inte kan tillgodoses genom marknadens utbud. När en sådan situation uppstår, tillåter regelverket sjukvårdsverksamheter att utveckla egentillverkade produkter eller modifiera befintlig MT-utrustning för att lösa det specifika sjukvårdsproblemet. Egentillverkning av en MT-produkt är en reglerad process i enlighet med EU-förordning om MT-produkter MDR (EU 2017/745) artikel 5.5. Detta regelverk säkerställer en patientsäker och kvalitetssäkrad MT-utrustning för intern användning inom sjukvårdsverksamheten.  Karolinska Universitetssjukhuset (Karolinska) som är Nordens största sjukhus har, i enlighet med regelverket, tagit fram egna interna riktlinjer för egentillverkning av MT-produkter. Covid-19-pandemin har aktualiserat att tillämpa dessa rutiner i praktiken. Karolinska har vårdat ett stort antal Covid-19-patienter med svåra respiratoriska symptom som har krävt ett särskilt omhändertagande bland annat på intensivvårdsavdelningen (IVA).  Ett av de mest förekommande kirurgiska ingreppen på IVA-patienter under denna period har varit trakeotomi. På grund av de stora svårigheter som uppstår med att flytta patienten till vanlig operationssal har öron-näsa-halsenheten (ÖNH) på Karolinska, som ansvarar för alla kirurgiska trakeotomier på sjukhuset, behövt utföra operationen på patienten i IVA-sängen. För att utföra en mer patientsäker på-plats-operation och förbättra denna ohållbara arbetsmiljö har ÖNH-kirurger önskat och sökt ett mobilt operationsbord som kan dockas till de olika IVA-sängtyperna som finns på sjukhuset. Eftersom detta operationsbord inte fanns att köpa på marknaden har MT-mekaniska verkstaden på Karolinska utvecklat en prototyp av trakeotomibordet som uppfyller ÖNH-kirurgernas specifika behov.  I detta arbete undersöktes egentillverkning av MT-produkter inom Karolinska i samband med utveckling av trakeotomibordet. I detta avseende studerades hela processen som krävs av regelverket och Karolinskas interna föreskrifter, från behovsanalys och definition av MT-produkten till kvalitetssäkring och riskhanteringen som garanterar en godkänd MT-utrustning för intern användning inom Karolinska Universitetssjukhuset. / Medical devices have a crucial role in performing a high-quality healthcare with patient safety in focus. Recent technological advances have provided healthcare systems with countless customized medical products for the various needs that arise in the treatment of patients. Despite this, some health care sectors have special needs that cannot be met by the market supply. In such circumstances, the regulations allow healthcare providers to develop in-house production or modify existing medical equipment to solve the specific need of the medical staff. In-house production of a medical device is a detailed regulated process defined in accordance with MDR (EU 2017/745) Article 5 (5). This regulatory framework ensures a patient-safe and quality-assured medical equipment for internal use within the healthcare.  Karolinska University Hospital (Karolinska), which is the Nordic region's largest hospital, follows the regulatory praxis for in-house production of medical devices. These praxes were put into use during the Covid-19 pandemic. Karolinska had to take care of many Covid-19 patients with severe respiratory symptoms who required special care, including intensive care unit (ICU).  One of the most common surgical procedures on ICU patients during this period was tracheotomy. Due to the complications that occur in moving patients to regular operating theatre, the ear-nose-throat unit (ENT) at Karolinska, which is responsible for all surgical tracheotomies at the hospital, has had to perform operations directly on ICU beds.  To improve the quality of the operations and the surgeon's work condition, the Karolinska ENT have sought a mobile operating table with ability to be docked to various ICU beds, available at the hospital. Since this medical equipment was not available on the market, the medical engineering workshop at Karolinska has developed a prototype of the tracheotomy table that meets the specific needs of ENT surgeons. This project studies the in-house production of a medical device at Karolinska through examining the development of tracheostomy table’s prototype by medical engineering workshop. In this respect, the regulatory requirements that approve the tracheostomy table for internal use within Karolinska University Hospital, are studied.

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