化学工学およびプロセス技術ジャーナル
オープンアクセス

概要

The Use of Medical Devices in Italy and Europe: Between Legal Obligations, Operational Obstacles and Possible Responsibilities

Giuseppe Vacchiano

The use of medical devices is in continuous expansion and constitutes a valid aid to ailing people, due to remarkable technological advances. The regulation on their circulation in Italy and Europe are inspired by the principle of free circulation. In fact it is sufficient for a device to have the CE logo for it to be freely commercialized in all of Europe. This way of operating that favors commerce, exposes the sick to the risk of harm from defective devices that have not been suitably checked prior to their commercialization. Having discussed a few episodes characterized by device malfunctioning, the author observes the need for a more rigorous control policy for devices, adequate care