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.
How to Cite
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Similar Articles
- Rossana Orabona, Ivan Lomangino, Giulia Bonera, Giorgio Nocivelli, Anna Fichera, Adriana Valcamonico, Sonia Zatti, Mauro R. Benvenuti, Enrico Sartori, Franco E. Odicino, A strange case of pleuritic pain in the third trimester of pregnancy , Monaldi Archives for Chest Disease: Early Access
- Matteo Vitacca, Anna Giardini, Lidia Gazzi, Michele Vitacca, Hidden biases in clinical decision-making: potential solutions, challenges, and perspectives , Monaldi Archives for Chest Disease: Vol. 93 No. 2 (2023)
- Josef Finsterer, Claudia Stöllberger, Comments on “Tako-Tsubo syndrome in patients with COVID-19: a single centre retrospective case series” , Monaldi Archives for Chest Disease: Early Access
- Vidushi Rathi, Comments on "Comparison of immediate withdrawal and stepwise reduction in duration of non-invasive ventilation in chronic obstructive pulmonary disease patients presenting with acute hypercapnic respiratory failure" , Monaldi Archives for Chest Disease: Early Access
- Anu Anna George, Kevin John John, Vijairam Selvaraj, Ajay Kumar Mishra, Endocrinological abnormalities and Takotsubo cardiomyopathy , Monaldi Archives for Chest Disease: Vol. 91 No. 2 (2021)
- Laura Pini, Laura Tiberio, Marianna Arici, Luciano Corda, Jordan Giordani, Elena Bargagli, Claudio Tantucci, Z-alpha1-antitrypsin polymers and small airways disease: a new paradigm in alfa-1 anti-trypsin deficiency-related COPD development? , Monaldi Archives for Chest Disease: Vol. 91 No. 4 (2021)
- Marco Ambrosetti, Patrick Doherty, Pompilio Faggiano, Ugo Corrà, Carlo Vigorito, Dominique Hansen, Patrizio Sarto, Ana Abreu, Roberto F.E. Pedretti, Characteristics of structured physical training currently provided in cardiac patients: insights from the Exercise Training in Cardiac Rehabilitation (ETCR) Italian survey , Monaldi Archives for Chest Disease: Vol. 87 No. 1 (2017)
- Rosangela Cocchia, Gianluca Guggino, Luigia Romano, Roberto Annunziata, Antonio Raucci, Mario Sorice, Brigida Ranieri, Giuseppe Russo, Ciro Mauro, Eduardo Bossone, A giant mediastinal teratoma: From diagnosis to complete resection and restitutio ad integrum , Monaldi Archives for Chest Disease: Vol. 92 No. 1 (2022)
- Renato De Vecchis, Andrea Paccone, Marco Di Maio, Atrial mechanical hypofunction after electrical cardioversion of persistent or long-lasting persistent atrial fibrillation: a retrospective cohort study , Monaldi Archives for Chest Disease: Vol. 89 No. 3 (2019)
- Mario Tamburrini, Dipesh Maskey, Nirupam Sharan, T.K. Jayalakshmi, Umberto Zuccon, Giuseppe Deda, Convex probe endobronchial ultrasound guided transbronchial/transoesophageal fine needle aspiration (C-EBUS-TBNA/EUS-B FNA) of pleural lesions: A single center experience and review of literature , Monaldi Archives for Chest Disease: Vol. 90 No. 3 (2020)
<< < 58 59 60 61 62 63 64 65 66 67 > >>
You may also start an advanced similarity search for this article.
