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On a defective Mitraclip® system: Considerations on the medical device regulation in Europe

Arturo Giordano, Angela Silvestre, Maria Pieri, Giuseppe Vacchiano
  • Arturo Giordano
    Invasive Cardiology Unit, Pineta Grande Hospital, Italy
  • Angela Silvestre
    University of Naples Federico II, Department of Advanced Biomedical Science, Italy
  • Maria Pieri
    University of Naples Federico II, Department of Advanced Biomedical Science, Italy | maria.pieri@unina.it
  • Giuseppe Vacchiano
    University of Sannio, Department of Law, Economics and Mathematical Methods, Italy

Abstract

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.

 

Keywords

Mitraclip system; defective devices; medical device regulation.

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Submitted: 2017-12-18 15:47:24
Published: 2018-09-04 16:12:50
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Copyright (c) 2018 Arturo Giordano, Angela Silvestre, Maria Pieri, Giuseppe Vacchiano

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