Safe innovation: On medical device legislation in Europe and Africa
Safe innovation: On medical device legislation in Europe and Africa
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DOI：
10.1016/j.hlpt.2018.01.012
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发表时间：
2018-06-01
影响因子：
6
通讯作者：
Ahluwalia, Arti
中科院分区：
文献类型：
--
作者：
De Maria, Carmelo;Di Pietro, Licia;Ahluwalia, Arti
目的：监管医疗器械的主要动机是保护患者和使用者。遵守法规可能会导致医疗公司以及最终医疗保健提供者和患者的开发、制造和服务成本增加，从而限制了获得适当医疗设备的机会。另一方面，监管不力导致使用不合标准的设备。本研究的目的是在比较的认证路线，制造商必须尊重在一些非洲国家和欧洲联盟的医疗器械上市。方法：我们研究和比较了当前和未来的法规，在欧洲联盟和非洲的一些国家的医疗器械。上下文，我们提出了未来的方法，以开放的设计策略支持的新兴技术，作为一种手段，以提高经济上可持续的医疗保健系统驱动的innovation.Results：非洲的医疗器械法规有亲和力欧洲指令，尽管后者是特别严格的。几个州还实施或协调了医疗器械法规指令，或表示有兴趣在其立法中建立这些指令。开源医疗器械在降低成本方面有很大的潜力，但确实需要高水平的监管，以控制其质量并确保其遵守安全标准。结论：两大洲的协调可以优化设备制造和销售的成本。受监管的开放式设计战略可以促进经济上可持续的创新。(C)2018年医学研究生奖学金。由Elsevier Ltd.发布。这是CC BY-NC-ND许可下的开放获取文章。(http：//creativecommons.org/licensesiby-nc-nd/4.0/）
Objectives: The principal motivation for regulating medical devices is to protect patients and users. Complying with regulations may result in an increase in development, manufacturing and service costs for medical companies and ultimately for healthcare providers and patients, limiting the access to adequate medical equipment. On the other hand, poor regulatory control has resulted in the use of substandard devices. This study aims at comparing the certification route that manufactures have to respect for marketing a medical device in some African Countries and in European Union.Methods: We examined and compared the current and future regulations on medical devices in the European Union and in some countries in Africa. Contextually we proposed future approaches to open design strategies supported by emerging technologies as a means to enhance economically sustainable healthcare system driven by innovation.Results: African medical device regulations have an affinity to European directives, despite the fact that the latter are particularly strict. Several states have also implemented or harmonized directives to medical device regulation, or have expressed interest in establishing them in their legislation. Open Source Medical Devices hold a great promise to reduce costs but do need a high level of supervision, to control their quality and to guarantee their respect for safety standards.Conclusion: Harmonization across the two continents could be leveraged to optimize the costs of device manufacture and sale. Regulated open design strategies can enhance economically sustainable innovation. (C) 2018 Fellowship of Postgraduate Medicine. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license. (http://creativecommons.org/licensesiby-nc-nd/4.0/)