Rapid Convergence: The Outcomes of Making PPE during a Healthcare Crisis

TL;DR

This study analyzes 3D-printed PPE submissions during COVID-19, revealing rapid design convergence, limited safety review, and insights into community-driven medical device manufacturing.

Contribution

It provides a systematic evaluation of PPE designs during a healthcare crisis, highlighting design trends, safety review challenges, and community engagement insights.

Findings

Designs rapidly converged to derivatives of few initial templates

Majority of submissions were never reviewed for safety

A small percentage of designs were deemed safe for use

Abstract

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).