3D Surgical Planning Lab. Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Par Taulí 1. Santa Fe Building 2nd floor, 08208, Sabadell, Spain.
Department of Orthopaedic Surgery and Traumatology. Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT), Universitat Autònoma de Barcelona, Sabadell, Spain.
BMC Health Serv Res. 2020 Nov 12;20(1):1035. doi: 10.1186/s12913-020-05891-2.
To cope with shortages of equipment during the COVID-19 pandemic, we established a nonprofit end-to-end system to identify, validate, regulate, manufacture, and distribute 3D-printed medical equipment. Here we describe the local and global impact of this system.
Together with critical care experts, we identified potentially lacking medical equipment and proposed solutions based on 3D printing. Validation was based on the ISO 13485 quality standard for the manufacturing of customized medical devices. We posted the design files for each device on our website together with their technical and printing specifications and created a supply chain so that hospitals from our region could request them. We analyzed the number/type of items, petitioners, manufacturers, and catalogue views.
Among 33 devices analyzed, 26 (78·8%) were validated. Of these, 23 (88·5%) were airway consumables and 3 (11·5%) were personal protective equipment. Orders came from 19 (76%) hospitals and 6 (24%) other healthcare institutions. Peak production was reached 10 days after the catalogue was published. A total of 22,135 items were manufactured by 59 companies in 18 sectors; 19,212 items were distributed to requesting sites during the busiest days of the pandemic. Our online catalogue was also viewed by 27,861 individuals from 113 countries.
3D printing helped mitigate shortages of medical devices due to problems in the global supply chain.
为应对新冠疫情期间设备短缺的问题，我们建立了一个非营利性的端到端系统，用于识别、验证、监管、制造和分发 3D 打印医疗设备。本文描述了该系统的本地和全球影响。
我们与重症监护专家合作，根据 3D 打印技术确定潜在短缺的医疗设备并提出解决方案。验证基于定制医疗器械 ISO 13485 质量标准。我们将每个设备的设计文件及其技术和打印规格发布在我们的网站上，并创建了一个供应链，以便我们所在地区的医院可以请求这些设备。我们分析了设备的数量/类型、请求者、制造商和目录视图。
在分析的 33 种设备中，有 26 种（78.8%）得到了验证。其中，23 种（88.5%）是气道消耗品，3 种（11.5%）是个人防护设备。订单来自 19 家（76%）医院和 6 家（24%）其他医疗机构。目录发布后 10 天达到生产高峰。总共有 59 家公司在 18 个领域生产了 22,135 件产品；在疫情最繁忙的日子里，向请求的站点分发了 19,212 件产品。我们的在线目录还被来自 113 个国家的 27,861 人浏览过。
3D 打印有助于缓解因全球供应链问题导致的医疗器械短缺。
