3D printing can strengthen America’s medical supply chain

In the first year of the COVID-19 pandemic, at least 3,607 healthcare workers in the United States died from the disease. One major reason: many did not have access to personal protective equipment (PPE). Indeed, desperate doctors and nurses have resorted to reusing disposable masks, using disinfectant gloves on multiple patients, and wearing trash bags instead of gowns. From swabs to ventilators, shortages of other medical devices have further exacerbated the crisis.

However, very early on, 3D printing appeared as a workaround. Between February 15 and July 15, 2020, companies with 3D printing capability, hospitals and even 3D printing enthusiasts printed around 38 million pieces of face shields, 12 million nasal swabs used in the tests, 2.5 million mask earmuffs, 241,000 mask parts, and 116,000 ventilator parts.

To understand how 3D printing has succeeded and failed during the pandemic, The Pew Charitable Trusts interviewed 19 stakeholders from the 3D printing industry, academic medical centers and healthcare systems, and agencies. government about their experiences. The most common theme expressed by interviewees was gratitude: for the direction that regulatory agencies such as the Food and Drug Administration have provided to stakeholders; for the flexibility to meet urgent patient needs, particularly through Emergency Use Authorization (EUA), which temporarily allows manufacturers of FDA-regulated products to market their items without undergoing the review process standard ; for the infrastructure that public and private institutions have built to facilitate communication; and, overall, for the hard work and sacrifice people made to deliver lifesaving equipment when and where it was most needed.

When asked to anticipate the next pandemic, respondents identified several common issues that regulators, designers, manufacturers, and healthcare providers should consider to ensure 3D printing can perform better. meet patient needs.

Centralized communication

At the start of the pandemic, when equipment shortages first emerged, manufacturers relied on various sources of information, such as news media and word of mouth, to determine what workers needed. health needed most. However, this ad hoc approach proved ineffective. In some cases, manufacturers have focused too much on high-demand devices such as N95 masks, even though these products may not offer the same level of protection when 3D printed. Other times, there was not enough emphasis on determining the best product design, leading to a plethora of different constructions for face shields and other accessories, most of which have not been checked to ensure that the design and materials were safe or effective.

To foster real-time communication between hospitals and healthcare systems, designers and manufacturers, and to provide more consistent oversight of 3D printed devices, the FDA, National Institutes of Health, Department of Veterans Affairs, and America Makes have established an information sharing system. collaboration in March 2020, now called COVID 3D TRUST. FDA consulted on best practices and answered questions; VA used its printing capability to develop and evaluate designs; NIH adapted its 3D Print Exchange to serve as a repository for approved design files; and America Makes connects healthcare providers to manufacturers with 3D printing capability. Respondents said that in the event of a new pandemic, a federally-supervised communications platform should already be in place or needs to be established much more quickly.

Opening

Some healthcare systems and manufacturers could take advantage of open standards to quickly print equipment. Licensing requirements, however, created bureaucratic hurdles that prevented manufacturers, including those in hospitals, from printing the necessary equipment. While some companies have restricted the use of their designs, others have made their print files available as open source. Experts have advised manufacturers, designers, healthcare providers and policy makers to explore how to balance intellectual property rights during a pandemic with ways that maximize innovation and access for patient needs . They also recommended creating a digital repository where verified design files, printing instructions, and quality assurance protocols are freely available to manufacturers.

Quality assurance

Even for low-risk devices that don’t require FDA approval, hospitals and healthcare systems were still wary of using 3D printed products from non-traditional sources. By providing clear guidance on materials and designs, COVID 3D TRUST ultimately built end-user confidence in equipment, such as face shields and nasal swabs, that were printed using materials and designs validated.

Still, interviewees said hospitals need to put processes in place to procure 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 the FDA on roles, responsibilities and requirements. regulations of each agency, the types of devices that should and should not be 3D-printed, the most appropriate materials for different devices, and design and printing standards. Questions also remain about whether and how devices with an EUA will eventually be required to gain more formal FDA approval.

Larger print capacity

Respondents said health systems should develop or improve their 3D printing expertise internally so that in the event of future shortages, they can meet the needs of their communities as quickly as possible. Beyond acquiring the right equipment, it also requires hospitals to hire and train staff who know how to use it properly. Some have also advised the federal government to establish and maintain 3D printing facilities — a strategic stockpile of printing capacity — to ensure agencies can fill supply gaps if they reappear. Federal legislation, including the National Manufacturing Guard Act, would build and train a dedicated manufacturing workforce as well as a reserve corps to fill gaps and ease 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 its limitations. It works well for developing prototypes or creating certain specialty products, such as those that are personalized for an individual patient. But more complex devices or those that require higher and faster throughput (the amount of product that can be made in a certain amount of time) might be better suited to other manufacturing technologies.

COVID-19 has exposed many weaknesses in American society and economy, including the healthcare system’s overreliance on foreign-made medical equipment and an undersupplied strategic national stockpile. Although 3D printed devices have served as an essential stopgap solution amid the crisis, they may become a permanent part of the medical supply chain for some products. By applying lessons learned during the pandemic and continuing to examine critical issues related to the design, manufacturing, testing, regulation and supply of these products, policy makers, healthcare providers, academics and other stakeholders can help ensure the US healthcare system is ready for the next public health emergency.

Zahra Younoszai works on The Pew Charitable Trusts Healthcare Products Project.

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