医学计量的挑战和机遇

    Challenges and Opportunities for Medical Metrology

    • 摘要: 人类健康工程已被各国政府提高到国家战略高度,关系人身健康与生命安全的医疗卫生计量器具被列入强制检定目录,人类健康工程的研究需求为医学计量发展带来了全面挑战。为了应对挑战,国际计量委员会(CIPM)组织制定了下一阶段战略文件:《CIPM战略2022》,旨在加强计量基础科研与跨学科合作,提升计量科研支撑能力与政策影响力。来自人口统计学和经济方面的大量统计信息预示了全球健康和生命科学方面的重要趋势,计量不仅要继续支撑现有的诊疗技术,还要应对新的医疗技术挑战。目前,我国已成为全球第二大医疗器械市场,市场增速高于全球市场规模增速,医疗健康相关支出已成为继食品、教育之后的第三大消费支出。传统医疗器械行业国产高端设备占有率有待提升,新兴医学与健康行业标准体系有待建立,医学人工智能和大数据的安全有效有待保障,以及医用材料行业期待高质量发展,这些挑战都需要加快医学计量能力建设,提升医学计量研究深度,紧密支撑监管科学,瞄准对接医疗临床。基于国际计量委员会(CIPM)战略2022,分析国际计量发展最新趋势,关注健康与生命科学领域,开展国内医学计量态势研究,根据需求明确行业与计量挑战,对未来工作提出建议与展望,期待引领并推动医学计量领域发展。

       

      Abstract: Human health engineering has been raised to the height of national strategy by governments, medical and healthcare measuring instruments related to personal health and life safety are included in the compulsory verification catalog, and the research needs of human health engineering have brought comprehensive challenges to the development of medical metrology. In order to meet the challenges, the International Committee for Weights and Measures (CIPM) organization has developed a document for the next phase of its strategy: “CIPM Strategy 2022”, which aims to strengthen basic metrological scientific research and interdisciplinary cooperation, and to enhance metrological scientific research support capacity and policy impact. The large amount of statistical information from demographics and economics illustrates important trends in global health and life sciences, where measurement must not only continue to support existing diagnostic and treatment technologies, but also respond to the challenges of new medical technologies. At present, China has become the world's second largest medical device market, and the market growth rate is higher than the growth rate of the global market size. Medical and health-related expenditures have become the third largest consumer spending after food, education. Domestic high-end medical equipment share needs to be improved, emerging medical and health industry standard system needs to be established, medical artificial intelligence and big data safety and effectiveness needs to be guaranteed, as well as the medical materials industry is looking forward to high-quality development, all these challenges need to accelerate the construction of medical metrology capacity, enhance the depth of medical metrology research, closely support regulatory science, aiming to connect with medical clinical practice. Based on the CIPM Strategy 2022, this paper analyzes the latest trends in international metrology development, focuses on the field of health and life sciences, and carries out a study of domestic medical metrology posture. It clarifies the industry and metrology challenges according to the needs, proposes suggestions and prospects for future work, and looks forward to leading and promoting the development of the medical metrology field.

       

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