https://doi.org/10.4081/monaldi.2018.901
On a defective Mitraclip© system: Considerations on the medical device regulation in Europe
Accepted: August 21, 2018
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
The use of medical devices is constantly growing and constitutes a valid aid to ailing people because of remarkable technological advances. The regulations on their circulation in Italy and Europe are inspired by the principle of free circulation: it is sufficient for a device to have the CE logo for it to be freely commercialized in all European countries. These regulations that favors commerce also expose the sick to the risk of harm from defective devices that have not been suitably checked prior to commercial release. This paper reports a case of a defective MitraClip© Delivery System, discusses other episodes of similar device malfunctioning, and analyzes the European legislation on medical devices. In the author's opinion, a careful 'control' policy for devices, an adequate care in device manufacturing, an appropriate evaluation of pre- and post-marketing and suitable measures for the patient's safety are needed.
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