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
- Ravi Manglani, Moshe Fenster, Theresa Henson, Ananth Jain, Neil Schluger, Clinical characteristics, imaging, and lung function among patients with persistent dyspnea of COVID-19: a retrospective observational cohort study , Monaldi Archives for Chest Disease: Early Access
- Michele Vitacca, Luca Barbano, Daniele Colombo, Olivia Leoni, Enrico Guffanti, Prevalence and variability of use of home mechanical ventilators, positive airway pressure and oxygen devices in the Lombardy region, Italy , Monaldi Archives for Chest Disease: Vol. 88 No. 1 (2018)
- Amit Gupta, Aman Snehil, Sujeet Kumar, Roshan Chanchlani, Reyaz Ahmad, Keerti Swarnkar, Garima Goel, Bronchiectasis without lower respiratory symptoms in the presence of multisystem anomalies – a clinical clue to diagnose esophageal lung anomaly , Monaldi Archives for Chest Disease: Vol. 93 No. 1 (2023)
- Sunil Mahavar, Princy Tyagi, Abhishek Agrawal, Sudhir Bhandari, Subrata Banerjee, Raman Sharma, Prakash Keshwani, Clinical and epidemiological profile of Indian COVID-19 patients from Jaipur: a descriptive study , Monaldi Archives for Chest Disease: Vol. 91 No. 2 (2021)
- Tarun Krishna Boppana, Saurabh Mittal, Karan Madan, Anant Mohan, Vijay Hadda, Pawan Tiwari, Randeep Guleria, Steroid therapy for COVID-19: A systematic review and meta-analysis of randomized controlled trials , Monaldi Archives for Chest Disease: Vol. 91 No. 4 (2021)
- Pramod Chaudhari, Pawan Kumar Singh, Manjunath Govindagoudar, Vinod Sharma, Puneet Saxena, Aman Ahuja, Lokesh Lalwani, Dhruva Chaudhry, Utility and timing of the respiratory rate-oxygenation index in the prediction of high-flow oxygen therapy failure in acute hypoxemic respiratory failure of infective etiology: a prospective observational study , Monaldi Archives for Chest Disease: Vol. 94 No. 1 (2024)
- Prakhar Agarwal, Kranti Garg, Varinder Saini, Isha Singh, Pulmonary rehabilitation: A novel adjunct in management of obstructive sleep apnea , Monaldi Archives for Chest Disease: Vol. 93 No. 1 (2023)
- Angelica Cersosimo, Mauro Riccardi, Ludovica Amore, Giuliana Cimino, Gianmarco Arabia, Marco Metra, Enrico Vizzardi, Varicella zoster virus and cardiovascular diseases , Monaldi Archives for Chest Disease: Vol. 93 No. 2 (2023)
- Genki Inui, Katsuyuki Tomita, Masaharu Fukuki, Hirokazu Touge, Tomoyuki Ikeuchi, Ichiro Hisatome, Akira Yamasaki, Clinical characteristics for distinguishing between acute cardiogenic pulmonary edema and community-acquired pneumonia in elderly patients: a prospective observational study , Monaldi Archives for Chest Disease: Vol. 94 No. 2 (2024)
- Naoto Ishimaru, Yohei Kanzawa, Takahiro Nakajima, Kayoko Okamura, Eiichiro Sando, Isao Ito, Saori Kinami , Hisashi Ohnishi, Specific antibody deficiency to pneumococcal polysaccharide in a young adult with recurrent respiratory infections: a case report , Monaldi Archives for Chest Disease: Vol. 93 No. 3 (2023)
<< < 10 11 12 13 14 15 16 17 18 19 > >>
You may also start an advanced similarity search for this article.
