For the past several months, the COVID-19 pandemic has placed unique pressure on the U.S. health care system and led to significant spikes in demand for hospital beds, personal protective equipment (PPE) for health care workers, and other essential medical products. At the same time, the public health emergency has had a significant impact on the global supply chain as social distancing rules, export limits, and a lack of raw materials have constrained access to these products. This has caused global shortages of medical devices that are critical to the health care system’s response to COVID-19.
Using 3D printing to manufacture a range of medical products could help address these shortages. However, although this emerging technology can be an important stopgap in meeting pressing needs, policymakers will need to consider the potential risks and benefits associated with its use and carefully assess how it can be deployed in future emergencies.
Since the start of the pandemic, 3D printing has been used to manufacture several types of medical devices, including PPE such as face shields and masks; ventilator splitters; and the nasopharyngeal (NP) swabs that are essential for testing. This technology has helped fill the production void for a variety of reasons. First, unlike most medical device manufacturing—which takes place at centralized facilities that are, in many cases, located abroad—3D printers are relatively portable and can be used at different sites, including the hospital itself. This means that supplies will not be tied up because a manufacturing plant has shut down due to coronavirus or because other countries have imposed export controls. There has been a shortage of NP swabs, for example, in part because the market is dominated by just two manufacturers: one based in Maine and the other located in Italy, which was a COVID-19 hot spot in the spring. In response to the enormous demand, some hospitals used 3D printing to produce their own swabs, or looked to purchase them from other U.S. companies. In addition to allowing for more local manufacturing, 3D printing has a supply chain distinct from that of traditionally manufactured devices, meaning that raw materials may be easier to acquire.
Recognizing the important role that 3D printing could play in addressing constraints on the global supply chain for medical devices, the Food and Drug Administration has taken several steps to support this technology’s use during the pandemic. In March, the agency announced a memorandum of understanding with the National Institutes of Health and the Veterans Health Administration, allowing for an interagency partnership to support nontraditional manufacturing methods such as 3D printing. Through the collaboration, individuals can upload digital design files—which provide the specifications that 3D printers follow—to NIH’s 3D Print Exchange for evaluation by the VHA and others. To date, NIH has published nearly 600 designs for PPE and other products, of which more than 30 have been clinically reviewed for use in a health care setting.
In addition to consulting closely on evaluation of these designs, FDA released an FAQ on using 3D printing during the current public health emergency, providing guidance to those interested in making 3D-printed versions of devices in short supply. The agency has also issued numerous emergency use authorizations for specific 3D-printed products, including ventilator components, face shields, and swabs. At the same time, legions of do-it-yourself volunteers throughout the country have stepped up to meet shortages, using their own consumer-grade 3D printers from their homes or offices to manufacture PPE.
Although these are important and necessary developments given the urgency of the current situation, experts consider the use of 3D printing to manufacture these products to be a stopgap. Many 3D printers—chiefly those being used in this emergency—have a limited daily output. Particularly for disposable products that must be manufactured at large scale, 3D printing is relatively inefficient in terms of both time and cost. And although 3D printers rely on a separate supply chain, shortages can still occur if demand outstrips supply. Traditional manufacturing techniques that have higher throughput and standardized quality controls are vastly preferable.
3D printing of medical products that haven’t been printed before also presents risks—even for relatively simple items such as face shields or swabs. For example, FDA has cautioned that 3D-printed PPE is unlikely to provide the same level of air filtration and protection against fluids as FDA-reviewed surgical masks and N95 respirators. In some cases, 3D-printed materials can be porous, making them more difficult to sterilize. The raw materials that go into the printers also may not have been evaluated to ensure that they are safe for medical use.
Many of these risks stem from the technology’s relative novelty and from the outstanding scientific, regulatory, and operational questions about how it can be deployed safely, effectively, and with an appropriate level of oversight. These issues can be addressed through additional scientific research—for example, through studies to evaluate the biocompatibility of raw materials when used in different medical scenarios—and with adequate federal guidance on how to effectively deploy the technology in future emergencies. Going forward, policymakers must consider this emerging technology’s overall risks and benefits and can do so by drawing from the lessons learned during this pandemic.
Liz Richardson directs The Pew Charitable Trusts’ health care products project.