Materiovigilance of 3D Printed Devices

Introduction: Medical devices have been around for particularly in the medical field, and have enabled medicine to make major advances in healthcare, thanks to the development of innovative new technologies such as robotized surgery and 3D printers. These innovations have the potential to reshape th...

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Veröffentlicht in:Drug safety 2023-11, Vol.46 (11), p.1287-1288
Hauptverfasser: Errajouani, FZ, Attjioui, H, Alami, M, Abdelhafid, B, Sbai, H, Tanani, D
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Sprache:eng
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Zusammenfassung:Introduction: Medical devices have been around for particularly in the medical field, and have enabled medicine to make major advances in healthcare, thanks to the development of innovative new technologies such as robotized surgery and 3D printers. These innovations have the potential to reshape the way we imagine the future of research, but they also have3 the capacity to upend the roles and practices of the various players, each in their own place the entire medical staff is concerned. Main: To explain better, this work will attempt to answer two main questions: - How is the materiovigilance system organized? - What are the tools available to reinforce, secure and optimize the current organization of this vigilance, after taking stock of the system's weak points and the current inadequacy of DM-related legislation? Materiels and Methods: For the methods adopted, our study is based on an analysis of the materiovigilance process and on comparative studies. We have also carried out theoretical research to bring together all the work in this field and to produce detailed summaries. Results: Among the results obtained are the following: - These innovative techniques, which are beginning to flood the market, are also a source of increased material safety incidents, as the learning curve for device use can be greater too. - Legislation on medical devices is currently inadequate. - the field of medical devices is evolving very rapidly, with the appearance of devices that are certainly more efficient and less invasive for the patient, but often more complex to use. Conclusion: There's no doubt that 3D DMs are highly advantageous, but to take full advantage of their merits you need to have a good grasp of them and comply with the relevant legislation!
ISSN:0114-5916
1179-1942