The Surveillance System of Medical Devices, in Which the Responsible Individuals Have an Active Role, is the Guarantee of Patient and Medical Device User Safety

Abstract

The surveillance of medical devices is defined as a system for collecting, storing, scientifically evaluating, and assessing incidents resulting from the use of medical devices, as well as reporting them to the competent authorities for the purpose of continuous monitoring of the risk-benefit ratio and the adoption of necessary measures to reduce occurrences. The medical devices used in medical procedures must be safe, of high quality, and efficient. This is the goal of states and their competent authorities, who have recognized and implemented the management of medical technologies at the healthcare system level, which includes reporting any malfunction or deterioration in the characteristics and performance of a device that may or has led to the death or severe deterioration of a patient's or user's health condition. Following the non-reporting of incidents involving medical devices and not taking corrective actions to prevent incidents, the medical devices that are used, does not guarantee security and performance parameters. Thus, it is very important that there are, at regulatory level, tools and methods to report incidents and to prevent their occurrence or reoccurrence. On the other hand, the best international practices, regulates the fact that for the successful functioning of the vigilance system, users are must have an active role in the surveillance system of medical devices. Safety cannot be guaranteed without a medical device surveillance system, as well as the proper involvement of responsible individuals who will ensure and guarantee the use of safe medical devices with an appropriate level of performance and security parameters.