Frazer John Scott, Shard Amelia, Herdman James
Somerville College, University of Oxford, Oxford, UK.
Buckinghamshire Healthcare, NHS Trust, Aylesbury, UK.
J Med Eng Technol. 2020 May;44(4):169-176. doi: 10.1080/03091902.2020.1757772. Epub 2020 May 13.
The ongoing COVID-19 pandemic is unprecedented in the modern age both due to its scale and its disruption to daily life throughout the world. Widespread social isolation and restrictions in the age of modern communicative technology, coupled with some early successes for makers, have united the open-source community towards a common goal in a way not previously seen. Local hospitals and care facilities are turning to makers to print essential consumable parts, such as simple visors, while in the hardest hit areas, critical pieces of medical technology are being fabricated. While important and effective innovations are appearing almost daily, there are also some worrying trends towards hobbyists attempting manufacture of complex medical devices with little understanding of the clinical or scientific rationale behind their design. The nature of the open-source community, an area of intensive innovation, fluidity, and experimentation, jars with the exacting standards of medical device regulation. Here, we review the involvement of rapid prototyping and the open-source community in the key areas of personal protective equipment (PPE), diagnostics, critical care technology, and information acquisition and sharing, highlighting where makers and hackers have clashed with medical device regulations, and areas where the system has worked well to facilitate change.
持续的新冠疫情在现代社会是前所未有的，这既归因于其规模，也归因于它对全球日常生活的扰乱。在现代通信技术时代，广泛的社会隔离和限制措施，再加上制造商取得的一些早期成果，使得开源社区以前所未有的方式朝着一个共同目标团结起来。当地医院和护理机构正在求助于制造商打印诸如简易面罩之类的必需耗材部件，而在受影响最严重的地区，关键的医疗技术部件也正在被制造出来。虽然几乎每天都有重要且有效的创新出现，但也存在一些令人担忧的趋势，即业余爱好者在对复杂医疗设备设计背后的临床或科学原理知之甚少的情况下就试图进行制造。开源社区具有密集创新、流动性和实验性的特点，这与医疗器械监管的严格标准存在冲突。在此，我们回顾快速成型和开源社区在个人防护装备（PPE）、诊断、重症护理技术以及信息获取与共享等关键领域的参与情况，突出制造商和黑客与医疗器械法规发生冲突的地方，以及该体系在促进变革方面运作良好的领域。
