  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).
