国际范围内医疗器械的可持续采购 - 第 2 部分

Valerio Di Virgilio, Alexia Bouchard Saindon, Francisco Becerra Posada
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引用次数: 0

摘要

背景和目的:本文描述了如何在发展中国家的运营项目中实施可持续的医疗器械采购。它还进一步详细说明了负责医学博士采购过程的技术和质量方面的生物医学/临床工程师领导(BCEL)如何应用可持续性原则和需求评估。它还强调了在发展中国家开展药物管理采购项目时,BCEL必须考虑到国家或区域的具体卫生保健情况。材料和方法:本文描述了如何在发展中国家的运营项目中实施医疗器械(MDs)的可持续采购。它还进一步详细说明了负责医学博士采购过程的技术和质量方面的生物医学/临床工程师领导(BCEL)如何应用可持续性原则和需求评估。它还强调了在发展中国家开展药物管理采购项目时,BCEL必须考虑到国家或区域的具体卫生保健情况。结果:BCEL在医学博士的可持续采购中发挥着关键作用,作为一个整合者,能够理解临床需求并将其转化为要求,同时意识到在资源有限的发展中国家脆弱环境中实施的技术的可持续性和安全风险。如果BCEL意识到国家的卫生支出、地缘政治、医疗保健、护理模式、监管、基础设施和后勤条件,这种情况也会带来额外的挑战,这些挑战是可以应对的。如果技术实施不符合受益者的需要,许多设备可能仍未使用。因此,由BCEL进行全面的需求评估,以获得MDs的详细清单、它们的技术水平和估计预算,对于提高项目的可持续性和降低未使用MDs的风险至关重要。结论:除了生物医学和临床工程等传统学科外,BCEL还应至少学习公共卫生、医疗保健规划、项目管理、卫生基础设施和发展援助方面的基本原则,以促进基于知识、灵活性和预测和解决实际问题的能力与利益相关者的对话。在这个程度上,对发展中国家环境不熟悉的BCEL建议逐步接触更复杂的项目,并广泛使用同行审查机制,以确保项目实施期间的可持续性和质量。以可持续采购原则为基础的理论背景、对地方和国家卫生情况和条例的分析以及对从过去项目中吸取的经验教训的了解,应指导咨询中心在执行新项目时进行需求评估的方法。
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Sustainable procurement of medical devices in an international context - Part 2
Background and Objectives: This article describes how sustainable procurement of medical devices (MDs) can be implemented in operational projects in developing countries. It also further details how sustainability principles and the needs assessment can be applied by the biomedical/clinical engineer lead (BCEL) responsible for the technical and quality aspects of the procurement process of MDs. It also emphasizes the importance of the BCEL considering the country’s or region’s specific healthcare context when working on MD procurement projects in developing countries.Material and Methods: This article describes how sustainable procurement of medical devices (MDs) can be implemented in operational projects in developing countries. It also further details how sustainability principles and the needs assessment can be applied by the biomedical/clinical engineer lead (BCEL) responsible for the technical and quality aspects of the procurement process of MDs. It also emphasizes the importance of the BCEL considering the country’s or region’s specific healthcare context when working on MD procurement projects in developing countries.Results: The BCEL has a key role in the sustainable procurement of MDs as an integrator able to understand clinical needs and translate them into requirements while being aware of the sustainability and safety risks linked to technology implemented in the fragile environment of a developing country with limited resources. This context also creates additional challenges that can be managed if the BCEL is conscious of the country’s health expenditure, geopolitical, healthcare, model of care, regulatory, infrastructure, and logistical conditions in which the MDs will be installed. Many equipment may remain unused if the technology implementation is not in line with the needs of the beneficiaries. Therefore, a thorough needs assessment performed by the BCEL to obtain the detailed list of MDs, their technological level and estimated budget is of utmost importance to increase the project’s sustainability and mitigate the risk of unused MDs.Conclusion: Besides traditional disciplines in biomedical and clinical engineering, the BCEL shall also learn at least basic principles in public health, healthcare planning, project management, health infrastructure, and development aid to facilitate the dialogue with stakeholders based on knowledge, flexibility, and capacity to anticipate and solve practical issues on the ground. To this extent, it is advisable for a BCEL new to the environment of developing countries to have progressive exposure to more complex projects and to extensively use the peer review mechanism to assure sustainability and quality during project implementation. A theoretical background based on sustainable procurement principles, analysis of the local and national health context and regulations, and knowledge of lessons learned from past projects should guide the BCEL’s approach to performing the needs assessment while implementing a new project.
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