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.As frontline health care workers began to express desperate needs for personal protective equipment (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.
3DP/AM enabled manufacturers to distribute and make products outside of their traditional offerings with little start-up time. Additionally, 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. Numerous designs for needed medical devices were quickly distributed through social media and file-sharing sites. For instance, in Italy, the use of 3DP/AM for the creation of reverse-engineered ventilator parts showed that this technology could play a life-saving role,but these new products lacked the evidence of effectiveness, safety, and quality.
In March 2020, America Makes, a nonprofit organization and a Department of Defense Manufacturing Innovation Institute managed by the National Center for Defense Manufacturing and Machining, sent a letter to the U.S. Food and Drug Administration (FDA) Commissioner and U.S. members of Congress on behalf of the 3DP/AM industry, calling on the U.S. government to consider using 3DP/AM to fill emerging supply chain gaps.Concurrently, 3DP/AM subject matter experts at the FDA, U.S. National Institutes of Health, National Institute of Allergy and Infectious Disease (NIAID), and U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA) formalized a federal government partnership with similar goals.
This team collaborated with America Makes to establish the Covid-19 Supply Chain Response collection on the NIH 3D Print Exchange, later renamed the Covid 3D Trusted Repository for Users and Suppliers through Testing (Covid 3D TRUST), an initiative to gather and test open-source designs for 3D-printable PPE and devices. The present report describes the conception, implementation, and effectiveness of the initiative and highlights two keys to its successful rapid response: (1) trust among our respective groups and the diverse community of stakeholders and contributors and (2) value added for designers, manufacturers, and end-users of 3D-printed PPE and medical supplies.
Establishing Covid 3D TRUST
We established Covid 3D TRUST to address pandemic needs, several of which had been outlined by America Makes, including (1) information on product shortages, (2) a repository for 3D-printable designs that had undergone some testing and evaluation, (3) direction from responsible entities such as government agencies on the use of 3DP/AM to address the pandemic, and (4) connection between manufacturers and hospitals. Working relationships that empowered Covid 3D TRUST included the FDA’s long-standing membership in America Makes and a Memorandum of Understanding (MOA) between the FDA, NIAID, and VHA. The document was drafted on March 22 and was signed on March 25, 2020 — by all accounts, a rapid turnaround for federal agencies.
Covid 3D TRUST identified several gaps in communications from nationally recognized authorities on medical device and clinical safety. In the pandemic situation, the FDA granted Emergency Use Authorization and enforcement discretion to mitigate critical shortages for certain types of PPE and medical devices. However, standards and performance benchmarks were not available for the production of any of these products outside of a traditional manufacturing environment. As a result, the group created a framework for collecting, evaluating, and categorizing user-submitted designs. Evaluation included tests that could be performed by an end-user or printer user to give a measure of quality control to the process. The VHA printed and tested many of these designs to ensure that sufficient objective data existed to support their use.
The NIAID and America Makes became the interface points with the public through the NIH 3D Print Exchange (3DPX), primarily for designers and community producers, and the America Makes Covid-19 Response site, which connected traditional manufacturers with health care providers. 3D-printable design files that were shared haphazardly across the Internet often had little documentation and no validation. 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.
Within 3 days after the announcement of the Memorandum of Understanding on the FDA website, visits to the NIH 3DPX increased by 709%, and, within 1 month, 488 designs were uploaded to the site ( ). The overwhelming response from the community underscored the dire need for PPE and devices and for designs with scientific and manufacturing information ( ). Later during the pandemic, nasal swabs were in shortage and the Covid 3D TRUST developed a set of testing protocols for 3DP swabs. The VHA then tested seven 3DP swab designs for safety and to compare them to the standard of care. All protocols and testing data were made available on the NIH 3DPX.
At the time of writing, the NIH 3DPX Covid 3D TRUST collection included 625 designs with >2 million views from nearly every country (Table 1). Based on data collected by America Makes, an estimated 38 million face shield parts, 12 million nasal swabs, 2.5 million ear savers, 241,000 mask parts, and 116,000 ventilator parts were 3D printed in the U.S. between February 15 and July 15, 2020.). The most popular downloads were face masks, face shields, and ear savers, favorites of small groups with desktop 3D printers responding to the urgent needs of frontline workers (
|Device Type||Number of Tagged Designs|
|Ear savers and strap adapters||72|
Covid 3D TRUST Roles and Hurdles
Roles and responsibilities for Covid 3D TRUST were distributed across our organizations, with close collaboration on all sides (Code of Federal Regulations Title 21, Part 820) for quality control and supply chain needs. Emergency FDA Guidance and shortage strategies allowed production in other types of facilities, such as clinical and community sites. The FDA did not directly establish new requirements for those trying to make PPE and other medical devices during the pandemic due to concerns of lasting effects after the pandemic. Establishing credible clinical safety parameters for 3DP devices required the clinical capabilities of the VHA, the scientific expertise of the NIAID, and the manufacturing collaborations of America Makes. The NIAID modified the NIH 3DPX to manage design submissions then to communicate with designers and users. Subject matter experts at the FDA provided testing parameters and published informational websites and guidance.). The regulatory environment around 3DP devices often put them in a class that relied on current good manufacturing practices (
So many people wanted to help during the pandemic that designs flooded into the NIH 3DPX and other websites. Choosing safe and functional PPE, especially face masks, is of prime importance as ineffective designs can increase risks to the wearer. Engineers and health care providers at the VHA Innovation Ecosystem tested hundreds of designs (Table 2). This designation provided users with a smaller list of tested devices from which to choose. Other designs were labeled as “prototypes” or “warning” if there were greater safety implications or regulatory requirements. Ultimately, the informal designation applied by Covid 3D TRUST gave the user community additional confidence when using 3DP designs.), and new testing protocols, developed with extensive interaction and input from the FDA, established minimum viable product performance across several categories of devices. Use of common benchmarks served as the backbone of the Covid 3D TRUST collection. A selection of the best functioning designs were categorized as being suitable for clinical or community settings based on the functional and protective requirements met (
|Device Assessment||Number of Designs|
Many manufacturers outside of the medical manufacturing community wanted to contribute their capacity to make PPE or other accessories. However, identifying clinical facilities with shortages of PPE and devices was a challenge because they were often overwhelmed with patients. The America Makes Web portal matched manufacturing capacity with local health care provider needs, drawing from the NIH 3DPX for validated designs. America Makes also hosted challenges, such as the Fit to Face – Mask Design Challenge,to catalyze innovative designs for the purpose of improving the fit characteristics of additively manufactured face masks. Participants were tasked with delivering face mask designs in 6 days using digital head-form data that were made available by the National Institute for Occupational Safety and Health (NIOSH). Responses were evaluated according to various criteria, including fit, for a variety of face types and the conciseness of the manufacturing instruction set.
Fostering a Trusted Network of Contributors
We believe that the success of Covid 3D TRUST stemmed from the extensive personal and organizational collaborations and mutual confidence that have been built over the last 8 years. These factors enabled quick identification of each partner’s capabilities and needs, followed by the formulation and execution of action plans. Many stakeholders contributed, including the U.S. Department of Defense, National Aeronautics and Space Administration, National Institute for Occupational Safety and Health, American Society of Mechanical Engineers, and community organizations, such as Nation of Makers, Get Us PPE, Open-Source Medical Supplies, and others. This cross-disciplinary support was only possible because contacts and relationships among the organizations were developed well before they were needed.
It was also essential that the online repository was trusted by the user community, leveraging the existing credibility of the NIH, VA, and FDA. Publicly provided testing protocols and data helped users to meet their needs while maintaining quality and safety as top priorities. Manufacturers indicated the value of VHA’s design assessments by sourcing designs from the NIH 3DPX.In addition, other knowledge hubs increased awareness of best practices and use of trusted designs.
The severity of the Covid-19 pandemic is unprecedented; however, this is not the first time that a pandemic has resulted in gaps in supply chains.Despite the lessons learned from previous public health emergencies, more remains to be done to ensure preparedness for future events. ,
Feedback from industry, health care providers, and the community affirmed the value and trust established through device assessments and categorization in the NIH 3DPX. However, 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. In the future, health care organizations could incorporate criteria needed to accept products from nontraditional sources, including 3DP/AM industry manufacturers without a history of medical device production and community producers without formal manufacturing credentials.
America Makes has proposed a digital stockpile of vetted designs producible during emergencies, an approach endorsed in policy memos and media., The digital stockpile model is intended to help educate producers in current Good Manufacturing Practices and in the important considerations for producing and distributing PPE or other devices, especially under emergency circumstances such as the Covid-19 pandemic.
Covid 3D TRUST Modeled Public-Private Partnerships for Emergency Response
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 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.
The pandemic exposed a clear need to address supply chain limitations by tapping into unused and nontraditional domestic manufacturing capabilities. While we cannot predict the next public health emergency, continued engagement with designers, manufacturers, and end-users is paramount to improve readiness in the event of future crises. Covid 3D TRUST demonstrates the importance of communication and resource-sharing among collaborators, stakeholders, and a diverse end-user community. As a collective, the Covid 3D TRUST partners remain committed to building our network and sharing our expertise and organizational capabilities to advance the nation’s preparedness to quickly mobilize both industrial and community manufacturers with 3DP/AM capabilities. These principles should be considered highly important for adapting and expanding this operational model to other responses, capabilities, and partnerships.
Meghan C. McCarthy, Matthew A. Di Prima, Phillip Cruz, Brandon Ribic, John Wilczynski, Beth A. Ripley, and James C. Coburn have nothing to disclose. The NIH 3D Print Exchange is owned and operated by NIH/NIAID and funded in part through BCBB Support Services Contract HHSN316201300006W/HHSN27200002. The contents of this report are the responsibility of the authors and do not necessarily represent official positions of the National Institutes of Health, the U.S. Food and Drug Administration, the National Center for Defense Manufacturing and Machining, or the U.S. Department of Veterans Affairs.
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The authors wish the thank the hundreds of individuals who contributed to the Covid 3D TRUST design collection, especially those organizations referenced above, with special recognition to engineers and clinicians within the VHA Innovation Ecosystem; Todd Spurgeon, America Makes; Kelly Visconti, PM2; Dorothy Jones-Davis, Nation of Makers; Lauralyn McDaniel, ASME; the FDA Additive Manufacturing of Medical Products (AMMP) Lab; and the NIH 3D Print Exchange team at NIAID.