Sustainable procurement of medical devices in an international context - Part 3

Valerio Di Virgilio, Francisco Becerra Posada, Alexia Bouchard Saindon
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Abstract

Background and Objectives This article is the third in a series of three manuscripts published in this journal. It aims to describe how sustainable procurement of medical devices (MDs) can be implemented in operational projects in the context of developing countries. It also further details how the biomedical/clinical engineer lead (BCEL) in charge of technical support during the MD procurement process can apply sustainability principles and concepts of value-based procurement. Material and Methods Based on the authors’ experience of more than 20 years in procurement projects and implementation of MDs, the role of the BCEL will be developed from a theoretical point of view with the description of the second and third pillars of a sustainable purchase following the needs assessment: the assessment of existing conditions along with local capacities and the evaluation of the use conditions during the lifetime of the medical equipment. The application of these principles in operational projects will be further discussed by analyzing literature and lessons learned from projects implemented in developing countries. Results/Proposal The BCEL has a key role in the sustainable procurement of MDs to design the technical specifications of the goods, related services, and post-sales conditions to maximize the benefit of the investment. As the specialist can analyze the local existing conditions and capacities while ensuring efficient use of the MDs during their lifespan, they can contribute to a sustainable implementation of MDs in developing countries.   The BCEL shall also be able to analyze the local and international markets to find all possible technological solutions that meet the needs, local conditions, and capacities and ensure quality use during the lifespan of the purchased MD. The BCEL shall have competencies in identifying all the risks related to the use of the MD from the safety risks linked to its installation, use, and maintenance to the sustainability risks linked to obtaining the conditions that guarantee the use of the device and maintaining them as long as possible. Examples of these conditions include the presence of qualified and trained users, availability of maintenance and consumable budgets, availability and maintenance of infrastructure conditions (access, electrical power, water, drainage, medical gasses, etc.), and last but not least, presence of patients requiring a diagnosis or treatment using the purchased MD who were identified during the evaluation of the first pillar: a sound needs assessment. Conclusion As an evolution of the BCEL’s traditional biomedical and clinical engineering work, he/she shall assume the responsibility to guarantee the sustainability of the MD purchase. This quality assurance and control role is achieved by a sound theoretical background knowledge based on the three sustainable procurement pillars: the needs, existing and lifetime use conditions assessments, the analysis of the local and international markets, and a broad understanding of sustainability risks.
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国际范围内医疗器械的可持续采购 - 第 3 部分
背景与目的 本文是本期刊发表的三篇系列稿件中的第三篇。文章旨在介绍如何在发展中国家的运营项目中实施医疗设备(MD)的可持续采购。文章还进一步详细介绍了在医疗设备采购过程中负责技术支持的生物医学/临床工程师领导(BCEL)如何应用可持续发展原则和以价值为基础的采购概念。材料和方法根据作者在医疗设备采购项目和实施方面 20 多年的经验,将从理论角度阐述生物医学/临床工程师领导的作用,并介绍需求评估后可持续采购的第二和第三大支柱:评估现有条件和当地能力,以及评估医疗设备使用寿命期间的使用条件。通过分析文献和从发展中国家实施的项目中吸取的经验教训,将进一步讨论这些原则在业务项目中的应用。结果/建议巴塞尔公约专家小组在可持续采购 MD 方面发挥关键作用,设计货物的技术规格、相关服务和售后条件,以实现投资效益最大化。由于该专家能够分析当地的现有条件和能力,同时确保在 MD 的使用期限内有效利用 MD,因此他们能够为发展中国家可持续地实施 MD 做出贡献。BCEL 还应能够分析当地和国际市场,找到所有可能的技术解决方案,以满足需求、当地 条件和能力,并确保所购 MD 在使用期限内的高质量使用。BCEL 应具备识别与 MD 使用有关的所有风险的能力,包括与 MD 的安装、使用和维护有关的安全风险,以及与获得保证设备使用的条件和尽可能长时间的维护有关的可持续性风险。这些条件的例子包括:有合格的和经过培训的用户、有维护和消耗品预算、有基础设施条件(通道、电力、水、排水、医用气体等)并加以维护,最后但并非最不重要的是,有需要使用所购买的 MD 进行诊断或治疗的病人,这些病人是在第一个支柱的评估过程中确定的:合理的需求评估。这种质量保证和控制作用是通过基于三大可持续采购支柱的可靠理论背景知识来实现的:需求、现有和终生使用条件评估,本地和国际市场分析,以及对可持续发展风险的广泛了解。
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