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Title: Registration process for medical devices used in hospital
Authors: Vella, Julian
Keywords: Medical instruments and apparatus -- Malta
Medical instruments and apparatus -- Standards -- Malta
Medical instruments and apparatus -- Safety regulations -- Malta
Issue Date: 2019
Citation: Vella, J. (2019). Registration process for medical devices used in hospital (Bachelor's dissertation).
Abstract: The aim of this study was to improve the regulatory process to ensure the quality of medical devices, related accessories and consumables reaching the hospitals, enhances the patient’s and health care professional’s health and safety. The current regulatory system was based on the responsibility of the importer to follow the legislation and the Malta Competition and Consumer Affairs Authority to guide them through their technical regulatory unit. However, though the legislation stipulates safeguards there are still incidents within the hospital not related to practice, but to low quality devices that are entering the market leaving the health care professionals and patients at a risk to device failure. The shadowing of registration professionals at the Medicines Authority was carried out and medical products registration processes were reviewed to see what can be applied to the medical devices regulatory system. A strength, weakness, opportunity and threats analysis were developed and interviews with professionals affiliated with the procurement of medical devices for the Maltese National Health System (NHS) was carried out. The data collected through the interviews allowed the identification of gaps within the current regulatory system for medical devices, related accessories and consumables and the relevant suggestions on methods which can resolve such flaws in the system. A flow chart illustrating an improved procedure was compiled and a table detailing each step of the process was collated. The process involves three phases: i) Phase one: verification of the medical devices documentation by registering personnel. ii) Phase two: physical testing of medical device samples by qualified testing facilities. iii) Phase three: confirmation of registration by the licensing director. The current certification process of medical devices does not inspect the devices registered; process involves the inspection of documentation only when requested. The physical inspection will ensure that the medical device is of a high standard, will function effectively and will not be of harm to patients and healthcare professionals.
Description: B.PHARM.(HONS)
Appears in Collections:Dissertations - FacM&S - 2019
Dissertations - FacM&SPha - 2019

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