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非洲研究性医疗器械临床试验与法规综述:作为新创新的基准

Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.

作者信息

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

机构信息

Biomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences College of Health Sciences, Makerere University, Kampala, Uganda.

Department of Epidemiology and Biostatistics, The Queen's Medical Research Institute, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, United Kingdom.

出版信息

Front Med Technol. 2022 Jul 28;4:952767. doi: 10.3389/fmedt.2022.952767. eCollection 2022.

DOI:10.3389/fmedt.2022.952767
PMID:35968546
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9368574/
Abstract

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.

摘要

医疗技术在改善全球健康方面具有巨大潜力,对实现2030年可持续发展目标3起着关键作用。许多临床医生、创新者、商业实体和生物医学工程师等已经开发出了一些创新的医疗设备和技术,以应对尤其是非洲地区的医疗挑战。在全球范围内,医疗器械临床试验是确定医疗器械创新的风险和益处的最可接受的方法,目的是与既定的医疗实践相比,确定其有效性和安全性。然而,与美国、英国和欧洲等其他地区相比,非洲报道的医疗器械临床试验非常少。非洲报道的大多数医疗器械临床试验都在应对围绕艾滋病毒/艾滋病、孕产妇健康和非传染性疾病的挑战。在这篇小型综述中,我们报告了非洲PubMed和谷歌学术上一些已发表的医疗器械临床试验及其相关挑战。

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Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study.埃塞俄比亚医疗器械监管审批流程评估:混合顺序解释性研究。
Ther Innov Regul Sci. 2023 Sep;57(5):987-996. doi: 10.1007/s43441-023-00534-0. Epub 2023 May 21.
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Systems and processes for regulation of investigational medical devices in Uganda.乌干达用于监管试验性医疗器械的系统和流程。
Front Med Technol. 2023 Jan 23;4:1054120. doi: 10.3389/fmedt.2022.1054120. eCollection 2022.

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Multilevel determinants of community health workers for an effective maternal and child health programme in sub-Saharan Africa: a systematic review.多层面因素对撒哈拉以南非洲地区有效母婴健康项目中社区卫生工作者的影响:系统评价。
BMJ Glob Health. 2022 Apr;7(4). doi: 10.1136/bmjgh-2021-008162.
2
Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial.CRADLE 生命体征警报装置干预对中低收入国家产科出血转介的影响:一项 stepped-wedge 集群随机对照试验的二次分析。
BMC Pregnancy Childbirth. 2021 Apr 21;21(1):317. doi: 10.1186/s12884-021-03796-4.
3
Politics of disease control in Africa and the critical role of global health diplomacy: A systematic review.非洲疾病控制的政治与全球卫生外交的关键作用:一项系统综述。
Health Promot Perspect. 2021 Feb 7;11(1):20-31. doi: 10.34172/hpp.2021.04. eCollection 2021.
4
A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency.支持南非卫生产品监管局提高效率和效能的监管审查模式建议。
Int J Health Policy Manag. 2022 Jun 1;11(6):795-809. doi: 10.34172/ijhpm.2020.213.
5
Accuracy of fluid delivery devices for the neonate: Are the measures assured?新生儿输液装置的准确性:这些测量有保障吗?
Niger J Clin Pract. 2020 Aug;23(8):1044-1047. doi: 10.4103/njcp.njcp_502_19.
6
Safety and continued use of the levonorgestrel intrauterine system as compared with the copper intrauterine device among women living with HIV in South Africa: A randomized controlled trial.安全性和继续使用左炔诺孕酮宫内节育系统与南非艾滋病毒感染者中铜宫内节育器相比:一项随机对照试验。
PLoS Med. 2020 May 22;17(5):e1003110. doi: 10.1371/journal.pmed.1003110. eCollection 2020 May.
7
Medical Devices: Definition, Classification, and Regulatory Implications.医疗器械:定义、分类和监管影响。
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8
The rising burden of non-communicable diseases in sub-Saharan Africa.撒哈拉以南非洲地区非传染性疾病负担日益加重。
Lancet Glob Health. 2019 Oct;7(10):e1295-e1296. doi: 10.1016/S2214-109X(19)30370-5.
9
Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial.一种新型生命体征监测设备对资源匮乏环境下产妇死亡率和发病率的影响:一项实用的、阶梯式、群组随机对照试验。
Lancet Glob Health. 2019 Mar;7(3):e347-e356. doi: 10.1016/S2214-109X(18)30526-6.
10
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BMC Pregnancy Childbirth. 2018 May 4;18(1):134. doi: 10.1186/s12884-018-1746-9.