Not Enough PPE? Print Some Out

A public/private enterprise taps into the entrepreneurial urge that will hopefully help the United States avoid the disastrous shortages of personal protective equipment that deviled the health care system in the first months of the COVID-19 pandemic.

When we can finally move COVID-19 from the “pandemic” into the “endemic” column, the health care system and society in general in the United States might go right to work preparing for the next pandemic which—though most probably don’t want to hear this—is also not a matter of if, but when. They might do well to keep their 3D printers on alert.

Of all the nightmares that became reality over the last couple of years, one vying for most nightmarish for infection preventionists (IPs) and other health care professionals on the frontlines involved having to scramble to find personal protective equipment (PPE). Many of the rules of infection prevention—masks should be used only once, to name just one—had to be suspended during the early months of the coronavirus onslaught.

Next pandemic, though, IPs and others might only need to print out the PPE that they need, as explained in a commentary in the New England Journal of Medicine (NEJM).

“The ubiquity of consumer-level desktop 3D printers allowed small-scale manufacturers, hospitals, communities, and even individuals to produce PPE and accessories, supplementing the traditional supply chain,” the commentary states.

One is reminded of this classic exchange in the classic movie ET the Extra-Terrestrial in which too youngsters parry.

Elliot: He’s a man from outer space and we’re taking him to his spaceship.
Greg: Well, can’t he just beam up?
Elliot: This is REALITY, Greg.

Thanks to a public/private collaborative called the COVID 3D TRUST, the next deadly pathogen that threatens humanity might be met with the reality of PPE being, in a sense, beamed to locations facing a shortage. (COVID 3D TRUST stands for Covid 3D Trusted Repository for Users and Suppliers through Testing.)

Trust, however, is the operative word. It’s what needs to be developed between the collaborative effort and individual hospitals. The commentary states that “anecdotal evidence revealed that hospitals were reluctant to use PPE manufactured from open-source designs and small-scale manufacturers, either because of uncertainty regarding product quality or because of concerns regarding liability in the event of failure.”

The authors provide a vivid description of what fighting COVID-19 in the spring of 2020 entailed. “In the first weeks of the COVID-19 pandemic, case numbers in the United States grew from 245 per day to >30,000 per day,” the commentary states. “As frontline health care workers began to express desperate needs for [PPE], face masks, and medical accessories early in the pandemic, three-dimensional (3D) printing and additive manufacturing (3DP/AM) technologies emerged as a solution to quickly fill some of those gaps.”

The effort tapped into humanity’s entrepreneurial spirit, especially after the Food and Drug Administration, the Veterans Health Administration, and America Makes joined forces. Founded in 2012 under the auspices of the Department of Defense, America Makes nurtures relationships between industry, academia, government, and workforce and economic development organizations to increase America’s global competitiveness, according to the America Makes website.

The organizations drafted a Memorandum of Understanding (MOU) on March 22, 2022, and signed it on March 25, 2022. As the NEJM commentary notes, this was “by all accounts, a rapid turnaround for federal agencies.”

They used a repository for ideas called the NIH 3D Print Exchange (3DPX) (NIH 3DPX) in which designers, manufacturers and inventors could submit their ideas on how best to use 3D printers to help solved the PPE shortage. Within three days of the MOU, visits to the NIH 3DPX website increased 709%, and within one month, 488 designs were uploaded to the site.

“3D-printable design files that were shared haphazardly across the Internet often had little documentation and no validation,” the NEJM commentary states. “The NIH 3DPX allowed contributors to pick from several open-source licenses, and contributors were encouraged to attach any available supplementary information including parameters, processing instructions, and existing test results.”

COVID 3D TRUST created a framework for evaluating the submitted designs. And although individual hospitals may have been reluctant to use equipment that had been printed out, the VHA provided a real-world testing ground. “The VHA printed and tested many of these designs to ensure that sufficient objective data existed to support their use,” the NEJM commentary states.

The lesson, one which has been borne out since at least World War II—and recently reaffirmed in the record-breaking time it took to create COVID-19 vaccines—is that public/private collaboration might be the best way to meet the challenges of a national crisis.

“Our experience with COVID 3D TRUST and the widespread use of 3DP in response to COVID-19 demonstrated the viability of both distributed and on-demand manufacturing,” the commentary states. “The initiative was mustered early and quickly in the pandemic through a lean, bottom-up approach that was reliant on trust from agency leadership in our respective organizations. No single organization could have addressed the needs of the community by itself.”