Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.
Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.
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DOI：
10.3389/fmedt.2022.952767
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发表时间：
2022
影响因子：
--
通讯作者：
Ssekitoleko, Robert T.
中科院分区：
文献类型：
--
作者：
Matovu, Brian;Takuwa, Mercy;Mpaata, Charles Norman;Denison, Fiona;Kiwanuka, Noah;Lewis, Steff;Norrie, John;Ononge, Sam;Muhimbise, Owen;Tuck, Sharon;Etuket, Maureen Dimitri;Ssekitoleko, Robert T.
关键词：
医疗技术在改善全球健康方面具有巨大潜力，在实现2030年可持续发展目标3方面发挥着关键作用。许多临床医生、创新者、商业实体和生物医学工程师等开发了许多创新的医疗设备和技术，以应对医疗保健挑战，特别是在非洲。在全球范围内，医疗器械临床试验是确定医疗器械创新风险和受益的最可接受的方法，目的是确定其与既定医疗实践相比的有效性和安全性。然而，与美国、英国和欧洲等其他地区相比，非洲报告的医疗器械临床试验很少。非洲报告的大多数医疗器械临床试验都是为了应对艾滋病毒/艾滋病、孕产妇保健和非传染性疾病方面的挑战。在这篇小型综述中，我们报告了非洲PubMed和Google Scholar上发表的一些医疗器械临床试验及其相关挑战。
Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.
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