The first part of the thesis focuses on the Health care system in India and the medical device regulations. The health care system in India provided by the government lacks manpower and funds for the operation. This situation led to the bloom of hospitals in private sector. The multispecialty private facilities in India provides most advance health care services delivered to the citizens. The public end up spending out of their pocket for addressing their health-related problems in private hospitals for getting high end treatment options thus increasing the health expenditure of the general population. The organization of the Health care providing hospitals, primary health care centers and the governing body in the sector has been discussed. Medical device market has reached its peak in the recent years of 21st centaury. India being a country with lenient regulation policies turns itself into a global hub for the medical device industries leads to the availability of numerous devices to be installed in the hospitals at wide range of budgets. As of 2020, a new amendment has been passed which will be effective from 2021, which considers “all medical devices as drugs” aimed for more crucial regulatory approach towards the medical devices. The government laid set of law to be followed by the medical device manufacturers for their device to obtain legal license for marketing and distribution rights. The law includes various aspects, listing out the principles essential for design and manufacture a medical device. After such screening procedures, if a device after entering market faces difficulties in its operation and couldn’t succeed in providing it’s intended use for the patients then such devices are discarded by the regulatory body. Individuals are banned from production, sale and purchase of such devices or drugs that has been eliminated by the Government authority. The second part of the thesis discusses in detail about the clinical internship training program done in the biomedical department of the multispecialty hospital in India. Six months of maintenance of biomedical instruments in Sudha Institute of Medical Sciences, assisted me in gaining profound knowledge on the practical application of the theoretical parts studied in various courses in the University. The role of the biomedical department in the hospital is very essential for the optimal functioning of any hospital. The major work carried out by the department can be divided as planning, management and maintenance of biomedical instruments in the hospital. The team also manages the purchase and stock maintenance of devices that are required to perform service in the clinical equipment. The routine day to day checkup of all the instruments present in the hospital premises has to be done and recorded in the register. The department manages registers for all the entries regarding an instrument. The entry on the registers is mainly on purchase, costs, service charges, service date, calibration expiry date, monthly or yearly checkup routine dates, breakdown and replacement of the instruments. Any query regarding the working of the device has to be clarified with the biomedical department chief before noting down the device in the breakdown register. The department abide by certain rules and regulations listed out by the Government of India such as Biomedical waste management and handling, local authority registration, Radiation dosage limits and some other laws also. The department divides the work on the daily routine, machine checkup, parts verification, soldering on loose wire connections among the staff and the final working condition of the device in any of the above case is recorded on the register along with the timestamp and signature of the personnel. The department focuses on providing education for the nurses and staff of the hospital on safety policies, device handling, reporting the breakdown and checking the device’s general working state to handle the device in situations of emergency.
La prima parte della tesi si concentra sul sistema sanitario in India e sulle normative sui dispositivi medici. Il sistema sanitario indiano fornito dal governo manca di personale e fondi per l'operazione. Questa situazione ha portato alla fioritura degli ospedali nel settore privato. Le strutture private multi-specialistiche in India forniscono i servizi sanitari più avanzati forniti ai cittadini. Il pubblico finisce per spendere di tasca propria per affrontare i problemi di salute negli ospedali privati per ottenere opzioni di trattamento di fascia alta, aumentando così la spesa sanitaria della popolazione generale. È stata discussa l'organizzazione della Sanità che fornisce ospedali, centri di assistenza sanitaria di base e l'organo di governo del settore. Il mercato dei dispositivi medici ha raggiunto il suo picco negli ultimi anni del 21 ° secolo. Essendo l'India un paese con politiche di regolamentazione indulgenti, si trasforma in un hub globale per le industrie dei dispositivi medici porta alla disponibilità di numerosi dispositivi da installare negli ospedali con un'ampia gamma di budget. A partire dal 2020 è stato approvato un nuovo emendamento che entrerà in vigore dal 2021, che considera "tutti i dispositivi medici come farmaci" finalizzato a un approccio normativo più cruciale nei confronti dei dispositivi medici. Il governo ha stabilito una serie di leggi che devono essere seguite dai produttori di dispositivi medici per il loro dispositivo per ottenere la licenza legale per i diritti di commercializzazione e distribuzione. La legge include vari aspetti, elencando i principi essenziali per la progettazione e la produzione di un dispositivo medico. Dopo tali procedure di screening, se un dispositivo dopo essere entrato nel mercato incontra difficoltà nel suo funzionamento e non riesce a fornire l'uso previsto per i pazienti, tali dispositivi vengono scartati dall'organismo di regolamentazione. Agli individui è vietata la produzione, la vendita e l'acquisto di tali dispositivi o farmaci che sono stati eliminati dall'autorità governativa. La seconda parte della tesi discute in dettaglio sul programma di tirocinio clinico svolto nel dipartimento di biomedicina dell'ospedale multi-specialistico in India. Sei mesi di manutenzione degli strumenti biomedici presso il Sudha Institute of Medical Sciences, mi hanno aiutato ad acquisire una profonda conoscenza sull'applicazione pratica delle parti teoriche studiate nei vari corsi dell'Università. Il ruolo del reparto biomedico in ospedale è molto essenziale per il funzionamento ottimale di qualsiasi ospedale. Il lavoro principale svolto dal reparto può essere suddiviso in pianificazione, gestione e manutenzione degli strumenti biomedicali in ospedale. Il team gestisce anche l'acquisto e la manutenzione delle scorte dei dispositivi necessari per eseguire il servizio nelle apparecchiature cliniche. Il controllo quotidiano di routine di tutti gli strumenti presenti nei locali ospedalieri deve essere effettuato e registrato nel registro. Il dipartimento gestisce i registri di tutte le registrazioni riguardanti uno strumento. L'iscrizione nei registri riguarda principalmente l'acquisto, i costi, le spese di servizio, la data di servizio, la data di scadenza della calibrazione, le date di routine dei controlli mensili o annuali, i guasti e la sostituzione degli strumenti. Qualsiasi domanda riguardante il funzionamento del dispositivo deve essere chiarita con il capo del dipartimento biomedico prima di annotare il dispositivo nel registro dei guasti. Il dipartimento rispetta alcune regole e regolamenti elencati dal governo indiano come la gestione e la gestione dei rifiuti biomedici, la registrazione dell'autorità locale, i limiti di dosaggio delle radiazioni e alcune altre leggi. Il reparto suddivide il lavoro sulla routine quotidiana, il controllo della macchina, la verifica delle parti, la saldatura su collegamenti a filo sciolto tra il personale e la condizione finale di funzionamento del dispositivo in uno dei casi sopra indicati viene registrata sul registro insieme alla telestampa e alla firma del personale. Il dipartimento si concentra sulla formazione degli infermieri e del personale dell'ospedale sulle politiche di sicurezza, sulla gestione del dispositivo, sulla segnalazione del guasto e sul controllo dello stato di funzionamento generale del dispositivo per gestire il dispositivo in situazioni di emergenza.
Clinical maintenance of biomedical instruments, health care system and medical device regulations in India : an overview
RAVI, JAYASUBHA
2019/2020
Abstract
The first part of the thesis focuses on the Health care system in India and the medical device regulations. The health care system in India provided by the government lacks manpower and funds for the operation. This situation led to the bloom of hospitals in private sector. The multispecialty private facilities in India provides most advance health care services delivered to the citizens. The public end up spending out of their pocket for addressing their health-related problems in private hospitals for getting high end treatment options thus increasing the health expenditure of the general population. The organization of the Health care providing hospitals, primary health care centers and the governing body in the sector has been discussed. Medical device market has reached its peak in the recent years of 21st centaury. India being a country with lenient regulation policies turns itself into a global hub for the medical device industries leads to the availability of numerous devices to be installed in the hospitals at wide range of budgets. As of 2020, a new amendment has been passed which will be effective from 2021, which considers “all medical devices as drugs” aimed for more crucial regulatory approach towards the medical devices. The government laid set of law to be followed by the medical device manufacturers for their device to obtain legal license for marketing and distribution rights. The law includes various aspects, listing out the principles essential for design and manufacture a medical device. After such screening procedures, if a device after entering market faces difficulties in its operation and couldn’t succeed in providing it’s intended use for the patients then such devices are discarded by the regulatory body. Individuals are banned from production, sale and purchase of such devices or drugs that has been eliminated by the Government authority. The second part of the thesis discusses in detail about the clinical internship training program done in the biomedical department of the multispecialty hospital in India. Six months of maintenance of biomedical instruments in Sudha Institute of Medical Sciences, assisted me in gaining profound knowledge on the practical application of the theoretical parts studied in various courses in the University. The role of the biomedical department in the hospital is very essential for the optimal functioning of any hospital. The major work carried out by the department can be divided as planning, management and maintenance of biomedical instruments in the hospital. The team also manages the purchase and stock maintenance of devices that are required to perform service in the clinical equipment. The routine day to day checkup of all the instruments present in the hospital premises has to be done and recorded in the register. The department manages registers for all the entries regarding an instrument. The entry on the registers is mainly on purchase, costs, service charges, service date, calibration expiry date, monthly or yearly checkup routine dates, breakdown and replacement of the instruments. Any query regarding the working of the device has to be clarified with the biomedical department chief before noting down the device in the breakdown register. The department abide by certain rules and regulations listed out by the Government of India such as Biomedical waste management and handling, local authority registration, Radiation dosage limits and some other laws also. The department divides the work on the daily routine, machine checkup, parts verification, soldering on loose wire connections among the staff and the final working condition of the device in any of the above case is recorded on the register along with the timestamp and signature of the personnel. The department focuses on providing education for the nurses and staff of the hospital on safety policies, device handling, reporting the breakdown and checking the device’s general working state to handle the device in situations of emergency.| File | Dimensione | Formato | |
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2021_4_Ravi.pdf
solo utenti autorizzati dal 09/04/2022
Descrizione: The first part of the thesis focuses on the Health care system in India and the medical device regulations. The second part of the thesis discusses in detail about the clinical internship training program done in the biomedical department of the multispecialty hospital in India.
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https://hdl.handle.net/10589/174200