The COVID-19 disease, caused by the new coronavirus SARS-CoV-2, started to spread at the beginning of December 2019 in the city of Wuhan, China, and then it spread to the rest of the world. In severe cases of the disease, patients who are not able to breathe on their own should be assisted by mechanical ventilation. This implies the need for admission to semi-intensive care or intensive care. Due to the high contagiousness of the virus and the severity of the disease, the number of infections and consequently of the hospital admissions started to increase. It was therefore necessary to set up numerous wards of ordinary hospitalization, semi-intensive care and intensive care adapted to accommodate patients with COVID-19. In particular, biocontainment measures have been integrated into traditional intensive care to make the hospital environment safe. The purpose of this thesis work is to describe the work carried out by the Clinical Engineering Service of the IRCCS Ca' Granda Fondazione Ospedale Maggiore Policlinico in the realization of the intensive care modules of the emergency healthcare facility Ospedale Fiera Milano. Furthermore, the testing procedures for electromedical equipment designed and followed during the emergency situation are described. In Italy, the virus began to spread towards the end of February 2020, mainly affecting the Lombardy Region. To try to contain the spread of the virus, restrictive measures were implemented by the government until a state of general lockdown was reached. At the health care level, the Lombardy Region immediately set up an emergency task force to guide the response of intensive care to the emergency. In order to increase the availability of IC beds, a temporary emergency hospital called Ospedale Fiera Milano was conceived and designed by the Lombardy Region, in collaboration with the Fiera Milano Foundation. The hospital, equipped with all the necessary facilities and services, is composed of two independent departments, arranged on two levels, with a modular structure in order to separate contaminated environments from clean ones. The various intensive care modules were set up with the appropriate equipment for the management of COVID-19 patients. Moreover, radiology areas and analysis laboratories were created for each floor, to support the IC patient care activity. Because of the pandemic, there was a lack of medical devices in the EU market. It was therefore necessary to import from foreign markets or to reconvert the production of non-specialized companies. So, emergency testing procedures were devised to assess the operation and safety of medical devices supplied to the emergency hospital facility. The first phase of the testing procedure is dedicated to ascertaining the CE marking, while the second phase was dedicated to functional tests and assessments. In particular, a visual inspection, electrical safety checks and particular safety checks and functional checks were carried out. At the end of this phase, any non-conformities found were resolved, if possible, and the equipment was put into service. These emergency testing protocols are correlated by a risk analysis and are aimed at obtaining an overall view of the equipment. Despite the criticalities related to the construction of the Ospedale Fiera Milano, such as the scarce use, the non-integration of the structure in a complex hospital context and the lack of staff, the temporary hospital structure was designed, built and equipped in an adequate and functional way, in the face of the management of the health emergency due to the COVID-19 disease. In addition, the structure will be used by the Lombardy Region as a "bridge structure" during the planned reorganization period of intensive care.
La malattia COVID-19, causata dal nuovo coronavirus SARS-CoV-2, ha cominciato a diffondersi all’inizio del mese di dicembre 2019 nella città di Wuhan, Cina, per poi propagarsi nel resto del mondo. Nei casi più gravi della malattia, i pazienti che non sono più in grado di respirare autonomamente, devono essere assistiti mediante ventilazione meccanica. Ciò comporta la necessità di ricovero in terapia semi-intensiva o in terapia intensiva. A causa dell’elevata contagiosità del virus e della gravità della malattia, il numero di contagi e di conseguenza dei ricoveri in ospedale ha cominciato ad aumentare. Si è quindi reso necessario l’allestimento di numerosi reparti di degenza ordinaria, di terapia semi-intensiva e di terapia intensiva adeguati ad accogliere i pazienti malati di COVID-19. In particolare, alle tradizionali terapie intensive sono state integrate delle misure di Biocontenimento per rendere sicuro l’ambiente ospedaliero. Lo scopo del presente lavoro di tesi è descrivere il lavoro svolto dal Servizio di Ingegneria Clinica della Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico nella realizzazione dei moduli di terapia intensiva della struttura sanitaria di emergenza Ospedale Fiera Milano, e descrivere le procedure di collaudo di apparecchiature elettromedicali ideate e seguite durante la situazione di emergenza. In Italia, il virus ha cominciato a diffondersi verso la fine del mese di febbraio 2020 colpendo principalmente la Regione Lombardia. Per tentare di contenere la diffusione del virus, sono state attuate dal Governo delle misure restrittive fino al raggiungimento di uno stato di lockdown generale. A livello sanitario, Regione Lombardia ha subito istituito una task-force di emergenza per guidare la risposta delle terapie intensive all’emergenza. Allo scopo aumentare la disponibilità di posti letto di TI, è stata ideata e progettata da Regione Lombardia, in collaborazione con la Fondazione Fiera Milano, una struttura ospedaliera temporanea di emergenza denominata Ospedale Fiera Milano. L’ospedale, dotato di tutti gli impianti e i servizi necessari, è composto da due reparti indipendenti tra loro disposti su due livelli e di struttura modulare, in modo tale da separare gli ambienti contaminati da quelli puliti. I vari moduli di terapia intensiva sono stati allestiti con apparecchiature adeguate alla gestione dei pazienti COVID-19, e sono state realizzate delle aree di radiologia e dei laboratori di analisi per ogni piano, a supporto dell’attività di assistenza dei pazienti di TI. A causa della pandemia, si è venuta a creare una situazione di carenza nel mercato europeo di apparecchiature mediche, rendendone necessaria l’importazione da mercati esteri o la riconversione della produzione di aziende non specializzate. È stato quindi fondamentale ideare delle procedure di collaudo in emergenza per valutare il funzionamento e la sicurezza dei dispositivi medici in dotazione alla struttura ospedaliera di emergenza. Una prima fase della procedura di collaudo è dedicata all’accertamento della marcatura CE, mentre la seconda fase è dedicata alle prove e valutazioni funzionali. In particolare, vengono effettuati un esame visivo, delle verifiche di sicurezza elettrica e delle verifiche di sicurezza particolari e controlli funzionali. Al termine di questa fase si procede con la risoluzione di eventuali non conformità riscontrate, se possibile, e con la messa in servizio dell’apparecchiatura. Tali protocolli di collaudo in emergenza sono correlati da un’analisi del rischio e sono mirati all’ottenimento di una visione complessiva riferita all’apparecchiatura. Nonostante le criticità relative alla realizzazione dell’Ospedale Fiera Milano, quali lo scarso utilizzo, la non integrazione della struttura in un contesto ospedaliero complesso e la carenza di personale, di fatto la struttura ospedaliera temporanea è stata progettata, costruita e attrezzata in maniera adeguata e funzionale, a fronte della gestione dell’emergenza sanitaria dovuta alla malattia COVID-19. Inoltre, la struttura verrà utilizzata da Regione Lombardia come “struttura ponte” durante il periodo di riordino delle terapie intensive previsto.
Il ruolo dell'ingegnere clinico nella realizzazione di una struttura ospedaliera di emergenza e nei processi di collaudo delle apparecchiature medicali durante la pandemia di COVID-19
Sgarro, Valentina
2019/2020
Abstract
The COVID-19 disease, caused by the new coronavirus SARS-CoV-2, started to spread at the beginning of December 2019 in the city of Wuhan, China, and then it spread to the rest of the world. In severe cases of the disease, patients who are not able to breathe on their own should be assisted by mechanical ventilation. This implies the need for admission to semi-intensive care or intensive care. Due to the high contagiousness of the virus and the severity of the disease, the number of infections and consequently of the hospital admissions started to increase. It was therefore necessary to set up numerous wards of ordinary hospitalization, semi-intensive care and intensive care adapted to accommodate patients with COVID-19. In particular, biocontainment measures have been integrated into traditional intensive care to make the hospital environment safe. The purpose of this thesis work is to describe the work carried out by the Clinical Engineering Service of the IRCCS Ca' Granda Fondazione Ospedale Maggiore Policlinico in the realization of the intensive care modules of the emergency healthcare facility Ospedale Fiera Milano. Furthermore, the testing procedures for electromedical equipment designed and followed during the emergency situation are described. In Italy, the virus began to spread towards the end of February 2020, mainly affecting the Lombardy Region. To try to contain the spread of the virus, restrictive measures were implemented by the government until a state of general lockdown was reached. At the health care level, the Lombardy Region immediately set up an emergency task force to guide the response of intensive care to the emergency. In order to increase the availability of IC beds, a temporary emergency hospital called Ospedale Fiera Milano was conceived and designed by the Lombardy Region, in collaboration with the Fiera Milano Foundation. The hospital, equipped with all the necessary facilities and services, is composed of two independent departments, arranged on two levels, with a modular structure in order to separate contaminated environments from clean ones. The various intensive care modules were set up with the appropriate equipment for the management of COVID-19 patients. Moreover, radiology areas and analysis laboratories were created for each floor, to support the IC patient care activity. Because of the pandemic, there was a lack of medical devices in the EU market. It was therefore necessary to import from foreign markets or to reconvert the production of non-specialized companies. So, emergency testing procedures were devised to assess the operation and safety of medical devices supplied to the emergency hospital facility. The first phase of the testing procedure is dedicated to ascertaining the CE marking, while the second phase was dedicated to functional tests and assessments. In particular, a visual inspection, electrical safety checks and particular safety checks and functional checks were carried out. At the end of this phase, any non-conformities found were resolved, if possible, and the equipment was put into service. These emergency testing protocols are correlated by a risk analysis and are aimed at obtaining an overall view of the equipment. Despite the criticalities related to the construction of the Ospedale Fiera Milano, such as the scarce use, the non-integration of the structure in a complex hospital context and the lack of staff, the temporary hospital structure was designed, built and equipped in an adequate and functional way, in the face of the management of the health emergency due to the COVID-19 disease. In addition, the structure will be used by the Lombardy Region as a "bridge structure" during the planned reorganization period of intensive care.| File | Dimensione | Formato | |
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Tesi_Sgarro 905405.pdf
Open Access dal 10/09/2021
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https://hdl.handle.net/10589/166078