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Inpatient bed needs Beyer Memorial Hospital, Ypsilanti, Michigan submitted ... in partial fulfillment ... Master of Hospital Administration /Briscoe, Richard J. January 1975 (has links)
Thesis (M.H.A.)--University of Michigan, 1975.
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Design lůžka pro anesteziologicko-resustitační oddělení (ARO) / Design of Bed for Anesthesiology and Resuscitation Hospital DepartmentAndrášová, Lenka January 2013 (has links)
The thesis focuses on analysis and design of a special hospital bed designed for the department of anesthesiology and resuscitation. The design was based on the rules set by the ČSN EN 60601-2-52 norm. The bed is adjusted for the use at the department of anesthesiology and resuscitation not only with its look but also with its functions. The design emphasizes the ergonomics of the bed, safety and the needs of the patient as well as of the staff and also an easy maintenance of the bed. Some of the main innovative elements are: basal stimulation system placed directly in the bed, used colors, more infusion-rack holders or a headboard fixed to the construction of the bed if not needed. The bed was designed especially to provide more comfort to the patient.
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Development of a Downscaled Hovering Device for a Hospital Bed to Reduce Rolling Resistance / Utveckling av en nedskalad svävningsanordning för en sjukhussäng för att minska rullmotståndNamrood, Kristian January 2021 (has links)
Fall-related injuries are common problems in elderly care in particular. These can cause brain damage and hip fractures, which in many cases can be serious. To reduce or mitigate the damage, various safety measures have been developed. One of them concerns a change in the surroundings, more specifically, the floor. At KTH within the Division of Neuronic Engineering, research has been done on how the impact of the case can be minimized and a shock absorbing floor (SAF) was developed. Diving problems with this type of flooring are that heavy medical beds sink into the floor, which means increased rolling resistance and thus long-term damage to both the floor and the medical staff. The aim of this thesis was to investigate how much rolling resistance can be minimized by building a downscaled hovering device based on hovercraft technology. The purpose was to enable the device to possibly be mounted under hospital beds and create a lifting force. To evaluate the performance, force measurements were performed on KTH SAF with different weights and with the use of a dynamometer. The results showed that the device reduced rolling resistance by up to 57.4% with additional weight. Four axial fans were used together with manual control of the speed of each fan. The selected components were made taking into account, in particular, cost, weight and dimensions and can thus also be limiting factors for this thesis. For future work, effective soundproofing is needed for this solution to be possible to be implemented in a hospital environment. Furthermore, studies needs to be carried out for a full-scale prototype to confirm that an equally large reduction in rolling resistance can be achieved.
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Ocorrência de fungos patogênicos em leito hospitalar e interferência química de agentes desinfetantes.Fernando, Francine da Silva e Lima de 30 December 2015 (has links)
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Previous issue date: 2015-12-30 / Introduction: Fungal diseases have increased recently these years in many
parts of the world and in different health care settings, being attributed to
several factors, inherent or not to the patient, such as increased aggressive
therapeutic practices, previous exposure to antifungals, and diseases or
immunosuppressive drugs. These morbidities arise in the hospital as
nosocomial infections, being the main cause of morbidity and mortality in
hospitalized patients. The high rates of hospital or nosocomial infection may be
associated with limitated physical and therapeutic resources, or insufficient
investment in training programs, implementation and control of CCIHs, and
limited number of health workers. Such factors corroborate greater demands on
health services, associated to the lack of qualified professionals and the
deficiency in the cleaning and disinfection of environments. Studies has shown
that busy environment by infected or colonized patients by resistant
microorganisms, constitutes a risk factor for maintaining this colonization or
infection of these patients, subsequent and team. Objective: Analyze the
occurrence of pathogenic fungi in a hospital bed and the chemical interference
of disinfectants.Results: in 74 mattresses reviews of a public hospital, there
was growth of yeasts in 28 (38.2%), 19 (67.9%) before and 9 (32.1%) after
cleaning and disinfection. In particular hospital, in 25 mattresses reviewed,
there was growth of Candida spp.in 15 (60.0%), being 10 (66.7%) of them
before and 5 (33.3%) after cleaning / disinfection. Both hospitals showed
occurrence of Candida spp. before and after terminal cleaning, the prevalented
species was C. parapsilos. Conclusion: The persistence of Candida spp. in
both hospital mattresses, after disinfection, demonstrates that the process is
flawed, and that mattresses can serve as reservoirs or fungal vectors potentially
pathogenic, representing a cross risk of acquiring infection for the patient to
professionals and as contamination of surfaces in hospitals. It is necessary to
reassess the techniques used for disinfection of mattresses, adoption of new
measures, such as the pre-cleaning or the use of a detergent / disinfectant to
carry out the process of cleaning and disinfection in one step, definition of roles,
investments in training, supplies and supervision, in both of the team responsible for the procedure, and the nursing staff, in an attempt to reduce the
prevalence of these findings, thus ensuring a microbiologically safe to the
patient and to all involved in the care environment. / Introdução: Doenças provocadas por fungos aumentaram nos últimos anos,
em várias partes do mundo, e em diferentes ambientes de assistência à saúde,
fato este atribuído a inúmeros fatores, inerentes ou não ao paciente, tais como
aumento de práticas terapêuticas agressivas, exposição prévia a antifúngicos,
doenças e ou medicamentos imunossupressores. Estas morbidades surgem no
ambiente hospitalar como infecções nosocomiais, e encontram-se como
principal causa de morbimortalidade em pacientes internados. As altas taxas de
infecção hospitalar ou nosocomial podem estar associadas a limitação de
recursos físicos e terapêuticos, bem como investimentos insuficientes em
programas de treinamento, implementação e controle das CCIHs, além de
número limitado de trabalhadores da saúde. Tais fatores corroboram com
grandes demandas nos serviços de saúde, associados à carência de
profissionais qualificados e adeficiencia nos processos de limpeza e
desinfecção dos ambientes. Estudos demonstram que ambiente ocupado, por
pacientes infectados ou colonizados, por microrganismos resistentes, constituise
em fator de risco para manutenção desta colonização ou infecção destes
pacientes, dos subsequentes e da equipe. Objetivo: Analisar a ocorrência de
fungos patogênicos em leito hospitalar e a interferência química de agentes
desinfetantes. Resultados: dos 74 colchões avaliados de um hospital público,
houve crescimento de leveduras em 28 (38,2%), sendo 19 (67,9%) antes e 9
(32,1%) depois da limpeza e desinfecção. No hospital particular, dos 25
colchões avaliados, houve crescimento de espécies de Candida spp. em 15
(60,0%), sendo 10 (66,7%) antes e cinco (33,3%) depois da
limpeza/desinfecção. Nos dois hospitais houve a ocorrência de Candida spp.
antes e após limpeza terminal e a espécie prevalente foi a C.
parapsilos.Conclusão: A persistência de Candida spp. nos colchões de ambos
os hospitais, após a desinfecção, demonstra que o processo é falho e, que os
colchões podem servir de reservatórios ou vetores de fungos, potencialmente
patogênicos, representando um risco de aquisição de infecção cruzada para os
pacientes, para profissionais, assim como contaminação das superfícies no
ambiente hospitalar. Faz-se necessário reavaliar as técnicas empregadas para desinfecção dos colchões, adoção de novas medidas, tais como a limpeza
prévia ou a utilização de um detergente/desinfetante que realize o processo de
limpeza e desinfecção em uma única etapa, definição de papéis, investimentos
em treinamentos, insumos e supervisão, tanto da equipe responsável pelo
procedimento, quanto da equipe de Enfermagem, na tentativa de diminuir a
prevalência destes achados, garantindo assim um ambiente
microbiologicamente seguro ao paciente e a todos os envolvidos na
assistência.
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Vårda patienter vid vårdplatsbrist : Sjuksköterskors upplevelser på en akutmottagning / Caring for patients when there is a lack of hospitalbeds : Nurses' experiences in an emergency departmentSiirilä Gustafsson, Amanda, Ullisgård, Adam January 2023 (has links)
Bakgrund: En akutmottagning har som mål att bedöma, vårda och stabilisera akut sjuka patienter. De patienter som behöver fortsatt vård kommer att läggas in på en vårdavdelning. Vårdplatsbristen leder till att patienter blir kvar på akutmottagningen. Detta leder till en hög arbetsbelastning och en ansträngd situation för sjuksköterskorna som arbetar på akutmottagningen. Syfte: Syftet är att undersöka sjuksköterskors upplevelser av att vårda inläggningsklara patienter som blir kvar på akutmottagningen vid vårdplatsbrist. Metod: Studien genomfördes med en kvalitativ metod med fenomenologisk ansats, där 10 sjuksköterskor intervjuades med öppna frågor. Datan analyserades med en innebördsanalys. Resultat: Resultatet av sjuksköterskors upplevelser av att vårda inläggningsklara patienter vid vårdplatsbrist kunde sammanställas i fem innebördsteman: Inläggningsklara patienter prioriteras bort, Brister i den praktiska omvårdnaden, Avsaknad av resurser till att bedriva avdelningsarbete på akutmottagningen, Att aldrig få ett avslut och En känsla av att inte ge god vård. Konklusion: Sjuksköterskorna upplever att de inläggningsklara patienterna oftast blir nedprioriterade. Vilket leder till att sjuksköterskorna inte möter de inläggningsklara patienternas vårdbehov som de hade önskat. De beskriver känslor som ångest, ilska, stress, irritation och ett dåligt samvete. / Background: An emergency department aims to care for, treat and stabilize acute ill patients. The patients who need continued care will be admitted to the hospital ward. The shortage of hospital beds leads to patients remaining in the emergency department. This leads to a high workload and a stressful situation for the nurses working in the emergency department. Aim: The purpose is to explore nurses' experiences of caring for patients awaiting admission who remain in the emergency department when there is a shortage of hospital beds. Method: The study was conducted using a qualitative method with a phenomenological approach. 10 nurses were interviewed with open-ended questions. The data were analyzed using a meaning analysis. Findings: The results of nurses’ experiencesof caring for patients awaiting admission who remain in the emergency department when there is a shortage of hospital beds could be compiled into five meaning themes: Patients awaiting admission are not prioritized, Shortcomings in practical nursing, Lack of resources to provide ward care in the emergency department, Never getting a closure and A feeling of not provide for good care. Conclusion: Nurses experience of the patients that are ready for hospital ward regularly getting down prioritized. Which leads to the nurses not meeting the standards for the patients and their need of care as the nurses would have wanted. They are describing feelings like anxiety, anger, stress, irritation and a guilty conscience.
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Informační systémy ve zdravotnických zařízeních / Healthcare information systemsPotančok, Martin January 2011 (has links)
This diploma thesis is focused on information systems in the field of hospital and nursing-care bed management and contactless vital signals monitoring. The aim of this thesis is to provide the basic overview of information systems used in health care facilities, to introduce both the LINis and Vitalmonitor systems, to analyse the effectiveness of their implementation as well as to prepare their financing models. The introductory section defines the area of health information systems. It covers the whole system spectrum from the strategic to the less important ones. This definition determines the environment for the new systems. The analysis of the largest suppliers within the Czech Republic is also included in this section. The second part deals with the LINis system and Vitalmonitor system, their basic functionality, structure and integration. The most important is the third section which contains the analysis of the effects resulting from the standard information system extension. The Effects of the LINis system and Vitalmonitor system are assessed according to the level of patient care, staff performance, value added for different types of medical facilities and financing models.
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Simulation of 48-Hour Queue Dynamics for A Semi-Private Hospital Ward Considering Blocked BedsChen, Wei 23 March 2016 (has links)
This thesis study evaluates access to care at an internal medicine unit with solely semi-private rooms at Baystate Medical Center (BMC). Patients are divided into two types: Type I patient consumes one bed; Type II patient occupies two beds or an entire semi-private room as a private space for clinical reasons, resulting in one empty but unavailable (blocked) bed per Type II patient. Because little data is available on blocked beds and Type II patients, unit-level hospital bed planning studies that consider blocked beds have been lacking. This thesis study bridges that gap by building a single-stream and a two-stream discrete micro-simulation model in Excel VBA to describe unit-level bed queue dynamics at hourly granularity in the next 48-hour time horizon, using historical arrival rates and census-dependent discharge rates, supplemented with qualitative results on complexity of patient-level discharge prediction. Results showed that while we increase additional semiprivate beds, there was notable difference between the traditional single-stream model and the two-stream model concerning improvement in bed queue size. Possible directions for future research include patient-level discharge prediction considering both clinical and nonclinical milestones, and strategic redesign of hospital unit(s) considering overflows and internal transfers.
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O registro dos prontuários hospitalares como subsídio para a gestão em saúde / The hospital medical records as support for health managementNascimento, Alexandra Bulgarelli do 12 November 2010 (has links)
Este trabalho teve o objetivo de analisar o registro dos prontuários hospitalares como subsídio para a gestão em saúde. Foram analisados 430 prontuários de egressos de 2 hospitais públicos municipais de São Paulo internados em abril de 2010. Os resultados mostraram que os registros dos hospitais foram diferentes na maioria das variáveis estudadas, motivo pelo qual foram tratados separadamente. Observou-se que as variáveis sexo, idade, número de diagnósticos, motivo da saída, tempo de permanência e número de cuidados foram totalmente registradas. Enquanto que as variáveis pressão arterial, freqüência cardíaca, freqüência respiratória, temperatura, dor, alimentação, banho e locomoção foram parcialmente registradas. Analisando as variáveis totalmente registradas verificou-se que no Hospital A e B, respectivamente, adultos de 30 a 59 anos (35.9%, 42.3%), idosos com 60 anos ou mais (22.8%, 16.3%) e crianças menores de 4 anos (20.1%, 17.2%) foram os que mais demandaram internações. Da mesma forma, crianças (4 a 5 dias, 4 a 6 dias) e idosos (2 a 6 dias, 4 a 6 dias) necessitaram de maior tempo de permanência. No Hospital A, as doenças do aparelho respiratório (20.5%) foram as principais responsáveis pelas internações, seguidas pelos transtornos mentais e comportamentais (14.4%). Enquanto que, no Hospital B, as doenças do aparelho respiratório (15.4%) foram as principais responsáveis pelas internações, seguidas pelas doenças do aparelho circulatório (13.5%). No Hospital A e B, respectivamente, os cuidados básicos foram mais freqüentemente registrados na saída (n=278, n=315) em comparação à admissão (n=271, n=234), enquanto que os cuidados invasivos foram mais freqüentemente registrados na admissão (n=505, n=618), em comparação à saída (n=201, n=208). Analisando a presença do registro parcial das variáveis, houve ocorrência no Hospital A na admissão e saída, respectivamente, em: pressão arterial (73.5%, 73.5%), freqüência cardíaca (72.1%, 71.6%), freqüência respiratória (39.1%, 29.3%), temperatura (89.3%, 80.5%), dor (12.6%, 11.2%), alimentação (92.6%, 95.3%), banho (91.6%, 94.4%) e locomoção (94.9%, 95.8%). Enquanto que, no Hospital B, houve presença de registro parcial na admissão e saída, respectivamente, em: pressão arterial (80%, 73.5%), freqüência cardíaca (80.5%, 73%), freqüência respiratória (21.4%, 12.1%), temperatura (96.7%, 89.8%), dor (1.4%, 0.5%), alimentação (100%, 99.5%), banho (99.1%, 99.1%) e locomoção (99.5%, 99.1%). A associação entre as variáveis indicativas: tempo de permanência e número de cuidados na admissão e na saída com as demais variáveis, mostrou que, quanto maior o tempo de permanência e o número de cuidados na admissão e saída, maior a idade, o número de diagnósticos e o comprometimento clínico e funcional. / This work aims to set the basis for a health management by analyzing the key informations of 430 medical records, which were taken from two public hospitals in the city of São Paulo, in April 2010.The research showed that the records were different in both hospitals in most of the variables studied. Consequently, they had to be analysed distinctively. It was observed that, while the variables: gender, age, diagnosis, hospital discharge reasons, lengh of stay and medical cares were entirely recorded, variables like blood pressure, cardiac and breathing frequency, body temperature, pain, food, bath and locomotion were partially recorded. Considering the variables entirely recorded, it was verified that in the hospitals A and B, respectively, the most medical admission requirements were for adults between 30-59 years of age (35.9%, 42.3%), elderly aged 60 or older (22.8%, 16.3%) and children under 4 years old (20.1%, 17.2%). On the same way, children (4 a 5 days, 4 a 6 days) and elderly (2 a 6 days, 4 a 6 days) had longer lenght of stay. In hospital A respiratory system diseases (20.5%) were the leading cause of medical admissions followed by mental and behavioral disorders (14.4%), compared to hospital B, respiratory system diseases (15.4%) followed by circulatory system illnesses(13.5%). In both cases A and B, respectively, the basic care were more frequent on the hospital discharge (n=278, n=315) if compaired to admissions (n=271, n=234), while invasive care were more frequent in the admissions (n=505, n=618) if compaired to hospital discharge (n=201, n=208). Upong analyzing the presence of the variables partial record, it has occurred in hospital A at the time of admissions and medical discharges, respectively,: blood pressure (73.5%, 73.5%), cardiac frequency (72.1%, 71.6%), breathing frequency(39.1%, 29.3%), body temperature (89.3%, 80.5%), pain (12.6%, 11.2%), food (92.6%, 95.3%), bath (91.6%, 94.4%) and locomotion (94.9%, 95.8%), while in the the hospital B, it has occurred respectively;: blood pressure (80%, 73.5%), cardiac frequency (80.5%, 73%), breathing frequency (21.4%, 12.1%), body temperature (96.7%, 89.8%), pain (1.4%, 0.5%), food (100%, 99.5%), bath (99.1%, 99.1%) and locomotion (99.5%, 99.1%). The association between the variables: lenght of stay and number of cares at the time of hospital admissions and discharges with the other parameters, showed that the longer the length of stay and the greater the number of cares in admissions and discharges, the older are the inpatients and the greater are the number of diagnosis and the clinical and functional impairements.
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O registro dos prontuários hospitalares como subsídio para a gestão em saúde / The hospital medical records as support for health managementAlexandra Bulgarelli do Nascimento 12 November 2010 (has links)
Este trabalho teve o objetivo de analisar o registro dos prontuários hospitalares como subsídio para a gestão em saúde. Foram analisados 430 prontuários de egressos de 2 hospitais públicos municipais de São Paulo internados em abril de 2010. Os resultados mostraram que os registros dos hospitais foram diferentes na maioria das variáveis estudadas, motivo pelo qual foram tratados separadamente. Observou-se que as variáveis sexo, idade, número de diagnósticos, motivo da saída, tempo de permanência e número de cuidados foram totalmente registradas. Enquanto que as variáveis pressão arterial, freqüência cardíaca, freqüência respiratória, temperatura, dor, alimentação, banho e locomoção foram parcialmente registradas. Analisando as variáveis totalmente registradas verificou-se que no Hospital A e B, respectivamente, adultos de 30 a 59 anos (35.9%, 42.3%), idosos com 60 anos ou mais (22.8%, 16.3%) e crianças menores de 4 anos (20.1%, 17.2%) foram os que mais demandaram internações. Da mesma forma, crianças (4 a 5 dias, 4 a 6 dias) e idosos (2 a 6 dias, 4 a 6 dias) necessitaram de maior tempo de permanência. No Hospital A, as doenças do aparelho respiratório (20.5%) foram as principais responsáveis pelas internações, seguidas pelos transtornos mentais e comportamentais (14.4%). Enquanto que, no Hospital B, as doenças do aparelho respiratório (15.4%) foram as principais responsáveis pelas internações, seguidas pelas doenças do aparelho circulatório (13.5%). No Hospital A e B, respectivamente, os cuidados básicos foram mais freqüentemente registrados na saída (n=278, n=315) em comparação à admissão (n=271, n=234), enquanto que os cuidados invasivos foram mais freqüentemente registrados na admissão (n=505, n=618), em comparação à saída (n=201, n=208). Analisando a presença do registro parcial das variáveis, houve ocorrência no Hospital A na admissão e saída, respectivamente, em: pressão arterial (73.5%, 73.5%), freqüência cardíaca (72.1%, 71.6%), freqüência respiratória (39.1%, 29.3%), temperatura (89.3%, 80.5%), dor (12.6%, 11.2%), alimentação (92.6%, 95.3%), banho (91.6%, 94.4%) e locomoção (94.9%, 95.8%). Enquanto que, no Hospital B, houve presença de registro parcial na admissão e saída, respectivamente, em: pressão arterial (80%, 73.5%), freqüência cardíaca (80.5%, 73%), freqüência respiratória (21.4%, 12.1%), temperatura (96.7%, 89.8%), dor (1.4%, 0.5%), alimentação (100%, 99.5%), banho (99.1%, 99.1%) e locomoção (99.5%, 99.1%). A associação entre as variáveis indicativas: tempo de permanência e número de cuidados na admissão e na saída com as demais variáveis, mostrou que, quanto maior o tempo de permanência e o número de cuidados na admissão e saída, maior a idade, o número de diagnósticos e o comprometimento clínico e funcional. / This work aims to set the basis for a health management by analyzing the key informations of 430 medical records, which were taken from two public hospitals in the city of São Paulo, in April 2010.The research showed that the records were different in both hospitals in most of the variables studied. Consequently, they had to be analysed distinctively. It was observed that, while the variables: gender, age, diagnosis, hospital discharge reasons, lengh of stay and medical cares were entirely recorded, variables like blood pressure, cardiac and breathing frequency, body temperature, pain, food, bath and locomotion were partially recorded. Considering the variables entirely recorded, it was verified that in the hospitals A and B, respectively, the most medical admission requirements were for adults between 30-59 years of age (35.9%, 42.3%), elderly aged 60 or older (22.8%, 16.3%) and children under 4 years old (20.1%, 17.2%). On the same way, children (4 a 5 days, 4 a 6 days) and elderly (2 a 6 days, 4 a 6 days) had longer lenght of stay. In hospital A respiratory system diseases (20.5%) were the leading cause of medical admissions followed by mental and behavioral disorders (14.4%), compared to hospital B, respiratory system diseases (15.4%) followed by circulatory system illnesses(13.5%). In both cases A and B, respectively, the basic care were more frequent on the hospital discharge (n=278, n=315) if compaired to admissions (n=271, n=234), while invasive care were more frequent in the admissions (n=505, n=618) if compaired to hospital discharge (n=201, n=208). Upong analyzing the presence of the variables partial record, it has occurred in hospital A at the time of admissions and medical discharges, respectively,: blood pressure (73.5%, 73.5%), cardiac frequency (72.1%, 71.6%), breathing frequency(39.1%, 29.3%), body temperature (89.3%, 80.5%), pain (12.6%, 11.2%), food (92.6%, 95.3%), bath (91.6%, 94.4%) and locomotion (94.9%, 95.8%), while in the the hospital B, it has occurred respectively;: blood pressure (80%, 73.5%), cardiac frequency (80.5%, 73%), breathing frequency (21.4%, 12.1%), body temperature (96.7%, 89.8%), pain (1.4%, 0.5%), food (100%, 99.5%), bath (99.1%, 99.1%) and locomotion (99.5%, 99.1%). The association between the variables: lenght of stay and number of cares at the time of hospital admissions and discharges with the other parameters, showed that the longer the length of stay and the greater the number of cares in admissions and discharges, the older are the inpatients and the greater are the number of diagnosis and the clinical and functional impairements.
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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 HospitalRazavi, 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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