中低收入国家脊柱植入物的监管、批准和使用:叙述性综述和案例研究。

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI:10.1080/17434440.2023.2264767
Chibuikem A Ikwuegbuenyi, Laura-Nanna Lohkamp, Joel Maruthanal, Kassim O Kassim, Hamisi Shabani, Roger Härtl
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引用次数: 0

摘要

简介:脊柱植入物在医疗保健中发挥着至关重要的作用,有必要制定法规以确保其质量、批准、使用和使用。在这篇文章中,我们考察了中低收入国家医疗器械监管和审批程序的现状,强调了坦桑尼亚的情况。涵盖领域:我们进行了系统的文献检索,并采访了当地脊椎植入物代表,以调查LMIC,特别是非洲的外科和脊椎植入物的批准、可用性和使用情况。在纳入的18篇文章中,有6篇提到了非洲的法规,没有提到脊椎植入物。我们的分析表明,LMIC在获得植入物方面面临挑战,原因是可负担性、供应链差以及缺乏应用专业知识。然而,外科医生已经找到了替代方案,例如使用土耳其制造商的低成本植入物。坦桑尼亚医疗器械和药品管理局负责监督当地植入物的监管和审批程序。专家意见:LMIC中脊柱植入物的监管和可及性,特别是在非洲,是有限的,并对患者护理和最佳医疗实践产生负面影响。潜在的解决方案包括监管组织内部的能力建设和合作,以改进监管流程,并将财政资源分配给定性和定量的植入物获取。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study.

Introduction: Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania.

Areas covered: We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spinal implants in LMICs, particularly in Africa. Out of the 18 included articles, six referred to African regulations, with no mention of spinal implants. Our analysis revealed that LMICs face challenges in accessing implants due to affordability, poor supply chain, and lack of expertise for their application. However, surgeons have found alternative solutions, such as using lower-cost implants from Turkish manufacturers. The Tanzania Medical Devices and Drugs Authority oversees the local regulatory and approval process for implants.

Expert opinion: Regulation and accessibility of spinal implants in LMICs, particularly in Africa, are limited and negatively impact patient care and best medical practice. Potential solutions include capacity building within and collaboration among regulatory organizations to improve regulatory processes and allocating financial resources to qualitative and quantitative implant access.

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