Rapid Convergence: The Outcomes of Making PPE during a Healthcare Crisis
This research addresses the problem of managing distributed medical making in crises for healthcare platforms and regulators, highlighting inefficiencies in safety review processes.
The study analyzed 623 submissions to the NIH 3D Print Exchange during the COVID-19 pandemic to understand community-based PPE production, finding that 81.3% were never reviewed and only 10.4% of reviewed designs were deemed safe for use.
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).