Bioengineering Department, Imperial College London, London, UK.
Methods Mol Biol. 2023;2575:195-237. doi: 10.1007/978-1-0716-2716-7_10.
Meeting medical challenges posed by global burdens is proven to be of primary interest. One example is the COVID-19 epidemic that humankind is currently experiencing, since around December 2019. Innovation is key to respond rapidly and effectively to sanitary and health emergencies, when human lives are severely threatened. In this scenery, medical devices that can be rapidly launched in the market and manufactured at scale are crucial for saving lives. One example is a lifesaving respiratory device launched in about 10 days (Mercedes F1 team's new device based on continuous positive airway pressure devices) and rapidly approved by international agencies responsible for assuring drug and medical devices safety, in response to the COVID-19 burden. Remarkably, it is the first time in history that mankind observes disease spread reaching such high proportions, globally, in such short time scale. However, while this epidemic had, in March 2020, reached the critical figures of about 38,000 deaths and c. 738,000 infected, organ donation and transplantation patients are suffering for years, accounting for an increasing number of affected, annually. These patients are invisible for the general public. Therefore, this chapter approaches the organ donation and transplantation burden, proposing effective solutions to leverage the suffering, improving life quality of patients enduring several underlying issues, from hemodialysis complications and critical organ failure to lacking compatible donors. This, on the basis of technology repurposing, to speed up approval processes followed by international agencies responsible for assuring drug and medical devices safety, while adding innovative methods to existing technology and reducing invasiveness.
应对全球疾病负担带来的医学挑战是当务之急。例如，自 2019 年 12 月以来，人类正在经历的 COVID-19 疫情。创新是快速有效应对公共卫生和健康紧急情况的关键，当人类生命受到严重威胁时。在这种情况下，能够快速推向市场并大规模生产的医疗器械对于拯救生命至关重要。例如，为应对 COVID-19 负担，梅赛德斯 F1 车队基于持续气道正压设备的新型救生呼吸设备在大约 10 天内推出，并迅速获得负责确保药物和医疗器械安全的国际机构批准。值得注意的是，这是人类历史上第一次观察到疾病在如此短的时间内以如此高的比例在全球范围内传播。然而，尽管 2020 年 3 月，这种流行病的死亡人数达到了约 3.8 万，感染人数达到了 73.8 万，但器官捐献和移植患者多年来一直在受苦，每年受影响的人数都在增加。这些患者不为公众所熟知。因此，本章探讨了器官捐献和移植的负担，提出了有效的解决方案，以减轻痛苦，提高因血液透析并发症和重要器官衰竭以及缺乏相容供体等多种潜在问题而受苦的患者的生活质量。这是基于技术再利用，以加快负责确保药物和医疗器械安全的国际机构的审批流程，同时为现有技术添加创新方法并减少侵入性。
