The NIH 3D Print Exchange is a public and open source repository for primarily 3D printable medical device designs with contributions from expert-amateur makers, engineers from industry and academia, and clinicians. In response to the COVID-19 pandemic, a collection was formed to foster submissions of low-cost, local manufacture of personal protective equipment (Personal Protective Equipment (PPE)). We systematically evaluated the 623 submissions in this collection to understand: what makers contributed, how they were made, who made them, and key characteristics of their designs. Our analysis reveals an immediate design convergence to derivatives of a few initial designs affiliated with NIH partners (e.g., universities, the Veteran's Health Administration, America Makes) and major for-profit groups (e.g., Prusa). The NIH worked to review safe and effective designs but was quickly overloaded by derivative works. We found that the vast majority were never reviewed (81.3%) while 10.4% of those reviewed were deemed safe for clinical (5.6%) or community use (4.8%). Our work contributes insights into: the outcomes of distributed, community-based, medical making; features the community accepted as "safe" making; and how platforms can support regulated maker activities in high-risk domains (e.g., healthcare).
翻译:NIH 3D印刷交换所是一个公开的公开源码储存库,主要用于3D印刷型医疗设备设计。为了应对COVID-19大流行,成立了一个集,以促进低成本、当地制造个人防护设备(个人防护设备)的提交。我们系统地评估了该集中的623份呈件,以了解:哪些制造商、他们是如何做的、他们是谁做的、他们设计的主要特点。我们的分析显示,在设计上,与与与NIH伙伴(例如大学、Veteran卫生管理局、美国制片公司)和主要盈利团体(例如Prusa公司)的一些初始设计衍生物直接相融合。NIH致力于审查安全有效的设计,但很快被衍生作品超负荷。我们发现,绝大多数被审查的623份呈件从未经过审查(81.3%),而10.4%的被审查者被认为对临床(5.6%)或社区使用安全(4.8%)或社区使用安全。我们的工作有助于深入了解:分布的、基于社区的医疗支持、医疗管理、社区管理平台的特征(可以安全地进行)。