In the first year of the COVID-19 pandemic, at least 3,607 health care workers in the United States died from the disease. One major reason: Many lacked access to personal protective equipment (PPE). Indeed, desperate doctors and nurses resorted to reusing disposable masks, sanitizing gloves to use across multiple patients, and wearing garbage bags in lieu of gowns. From swabs to ventilators, shortages of other medical devices further exacerbated the crisis.
Early on, however, 3D printing emerged as a stopgap solution. Between Feb. 15 and July 15, 2020, companies with 3D printing capability, hospitals, and even 3D printing enthusiasts printed about 38 million face shield parts, 12 million nasal swabs used in tests, 2.5 million ear savers for masks, 241,000 mask parts, and 116,000 ventilator parts.
To understand how 3D printing succeeded and failed during the pandemic, The Pew Charitable Trusts interviewed 19 stakeholders from the 3D printing industry, academic medical centers and health care systems, and government agencies about their experiences. The most common theme that interviewees expressed was gratitude: for the direction that regulators such as the Food and Drug Administration provided stakeholders; for the flexibility to meet urgent patient needs, especially via emergency use authorization (EUA), which temporarily allows makers of FDA-regulated products to market their items without undergoing the standard review process; for the infrastructure that public and private institutions built to facilitate communication; and, overall, for the hard work and sacrifices that people made to deliver lifesaving equipment when and where it was needed most.
When asked to look ahead to the next pandemic, interviewees identified several common issues that regulators, designers, manufacturers, and health care providers should consider to ensure that 3D printing can better meet patients’ needs.
Early in the pandemic, when equipment shortages first emerged, manufacturers relied on a variety of information sources, such as news media and word of mouth, to determine what health care workers needed most. However, this ad hoc approach proved inefficient. In some instances, manufacturers focused too heavily on high-demand devices such as N95 masks, even though such products might not provide the same level of protection when 3D-printed. Other times, there was not enough focus on determining the best product design, leading to a plethora of different constructs for face shields and other accessories, most of which were not vetted to ensure that the design and materials were safe or effective.
To foster real-time communication between hospitals and health systems, designers, and manufacturers and to provide more consistent oversight of 3D-printed devices, FDA, the National Institutes of Health, the Department of Veterans Affairs, and America Makes established an information-sharing collaboration in March 2020, now called COVID 3D TRUST. FDA consulted on best practices and fielded questions; VA used its printing capacity to develop and assess designs; NIH adapted its 3D Print Exchange to serve as the repository for vetted design files; and America Makes connected health care providers to manufacturers with 3D printing capability. Interviewees said that, in the event of another pandemic, a communications platform with federal oversight should already be in place or needs to be established much more quickly.
Some health systems and manufacturers could leverage open standards to print equipment quickly. Licensing requirements, however, created bureaucratic hurdles that kept manufacturers—including those within hospitals—from printing needed equipment. While some companies restricted use of their designs, others made their print files available by open source. Experts advised that manufacturers, designers, health care providers, and policymakers should explore how to balance intellectual property rights during a pandemic with ways that maximize innovation and access for patients’ needs. They also recommended the creation of a digital stockpile in which vetted design files, printing instructions, and quality assurance protocols are freely available to manufacturers.
Even for low-risk devices that do not require FDA approval, hospitals and health care systems were still wary of using 3D-printed products from nontraditional sources. By providing clear guidance on materials and designs, COVID 3D TRUST ultimately boosted end users’ confidence in equipment, such as face shields and nasal swabs, that were printed using validated materials and designs.
Still, interviewees said that hospitals need to build processes for procuring equipment outside of normal supply chains. They also called for clearer guidance from regulators such as the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health and FDA on the roles, responsibilities, and regulatory requirements of each agency, the types of devices that should and should not be 3D-printed, the most appropriate materials for different devices, and the standards for designing and printing them. Questions also remain as to whether and how devices with an EUA will eventually be required to obtain more formal FDA approval.
Greater printing capacity
Interviewees said that health care systems should develop or enhance their 3D-printing expertise in-house so that, in the event of future shortages, they can meet their communities’ needs as quickly as possible. Beyond acquiring the right equipment, that also requires hospitals to hire and train staff who know how to use it properly. Some also advised the federal government to establish and maintain 3D-printing facilities—a strategic stockpile of printing capacity—to ensure that agencies can bridge gaps in supply should they emerge again. Federal legislation, including the National Manufacturing Guard Act, would build and train a workforce dedicated to manufacturing as well as a reserve corps to fill gaps and alleviate bottlenecks during crises. Federal policymakers will also need to develop guidelines for when 3D printing is most useful. Like any other manufacturing technology, 3D printing has limitations. It works well for developing prototypes or creating certain specialized products, such as those that are personalized to an individual patient. But more complex devices or those that require higher and faster throughput (the amount of product that can be manufactured within a certain time frame) might be better suited to other manufacturing technologies.
COVID-19 revealed many weaknesses in America’s society and economy, including the health care system’s overreliance on foreign-made medical equipment and an inadequately supplied Strategic National Stockpile. Although 3D-printed devices served as a critical stopgap solution amid the crisis, they can become a permanent part of the medical supply chain for certain products. By applying lessons learned during the pandemic and continuing to examine critical issues related to the design, manufacture, testing, regulation, and procurement of these products, policymakers, health care providers, academics, and other stakeholders can help ensure that the U.S. health care system is prepared for the next public health emergency.
Zahra Younoszai works on The Pew Charitable Trusts’ health care products project.