The ongoing coronavirus disease 2019 (COVID-19) crisis has uncovered numerous deficiencies in the health care system and its capability to respond to a global pandemic. Although as of press time the spread of the disease appears to have slowed in select countries, parts of the U.S. continue to experience growth in the number of cases. The influx of critically ill patients had overwhelmed the capacity of an already taxed health care system in many regions, and providers had rapidly exhausted critical supplies needed to protect themselves and provide optimal care for their patients. Notably, critical shortages in essential personal protective equipment (PPE), along with a previous reliance on foreign supply chains, had left health care personnel, as well as patients, in a particularly vulnerable state. As a result, providers were understandably frustrated and often resorted to bringing their own supplies, as well as cleaning and reusing items normally recommended for single use.1
This critical shortage, however, spurred innovation and brought forth novel approaches to overcoming the supply gaps. Of these, additive manufacturing and three-dimensional (3-D) printing emerged as promising solutions to this and future medical supply dilemmas.
How it works
The techniques associated with 3-D printing use a multitude of materials to create on-demand, user-defined objects that can be produced on site and are rapidly adaptable to the current needs. Additive manufacturing techniques have been used in the medical field for years; however, they have been confined largely to anatomic modeling, custom-fit surgical implants, and tissue engineering.
In response to the COVID-19 pandemic, numerous grassroots movements surfaced to help combat the ongoing logistical shortages facing the health care community. To date, items such as ventilator parts, respirator masks, face shields, and nasopharyngeal swabs have all been designed by numerous multidisciplinary members of the 3-D-printing community, ranging from physicians and engineers to high school students. 3-D printing offers the ability to create customized, reusable parts that can be produced at a rate that is scalable to fill supply gaps in resource-stressed health care systems.
Early adoption of these techniques has not been widely accepted in the medical community. Concerns surrounding the safety, performance, and efficacy of 3-D-printed PPE, medical devices, and equipment have been raised because of the untested nature of these products.
Despite these concerns, numerous Italian hospitals incorporated these techniques to create 3-D-printed mechanical ventilator valves following the depletion of their supply and cite their use as a critical component of patient care during the peak of their crisis.2 Although the demand for mechanical ventilators continues to rise in the U.S., the use of these 3-D-printed mechanical ventilator parts has not been reported.
Nevertheless, some U.S. hospitals have turned to 3-D printing to address the critical shortages of nasopharyngeal swabs for patient testing, as well as PPE for both health care personnel and patients. Northwell Health, the largest health care system in New York State, recently announced it was able to produce thousands of nasopharyngeal swabs per day using 3-D printing to help avoid supply shortages as widespread testing is implemented.3
In March, physicians at Billings Clinic, MT, announced production of 3-D-printed personal respirator masks, which led to significant demand for a 3-D-printed reusable personal mask.4 The “Montana Mask” has the capability to change filter materials based on supply availability and situational risk profile. Numerous private and academic entities have also recently described similar successes, ranging from small- to large-scale production of 3-D-printed face shields for health care workers. One example of institutional production of 3-D face shields is the University of California-San Francisco clinical technologies program.5
Pros and cons
Hesitancy and skepticism regarding these new manufacturing techniques, however, continue to surround the multiple PPE prototypes recently developed, resulting in mixed feelings within the health care community. With recent Centers for Disease Control and Prevention (CDC) recommendations supporting the nationwide use of masks in public places, at press time the critical shortage of PPE was projected to worsen. Researchers at the National Institutes of Health (NIH), Veterans Affairs, and Food and Drug Administration (FDA) recognized these issues and implemented programs, such as the NIH 3D Print Exchange—an open-sourced, online file-sharing community dedicated to the safe development of 3-D-printed medical devices, to help overcome the critical supply deficiencies.6 The Joint Commission issued a statement authorizing the use of PPE brought from home, but consensus statements from the U.S. medical associations supporting the use of 3-D-printed materials are lacking.7
Despite being an exciting and promising solution for the critical supply shortage the health care system is facing, the rapid creation of 3-D-printed materials remains an ongoing source of debate. Proponents argue that Internet-based, open-source file-sharing networks, along with the global armamentarium of 3-D printers, act as a major strength and force multiplier for this movement, contending that decentralization improves overall access to these resources.
Opponents and skeptics fear that the lack of a centralized repository places end users at risk of using potentially inferior products. Many questions regarding the safety of the materials used in these approaches, as well as their efficacy, have yet to be answered within the scientific community. Many of these designs have yet to meet or be subjected to the rigorous quality assurance testing processes that define industry standards. Programs such as the NIH 3D Print Exchange should help to address these concerns; however, objective data within the literature surrounding these products is sparse. Recognizing these concerns, supporters of this movement argue that 3-D-printed products should not replace standard equipment, but rather serve as an alternative option should the need arise.
COVID-19 reveals deficiencies
The ongoing COVID-19 crisis has uncovered a multitude of limitations within our health care system. At press time, social distancing efforts suggested promising confinement of disease spread, but these efforts had fallen short in terms of addressing the needs of the thousands of afflicted patients and the health care personnel striving to care for them. Prospective planning and the development of novel solutions need to be actively pursued to ensure the U.S. health care system is designed to proactively respond to such enormous challenges now and in the future.
As technology-based fields continue to become more prominent components of our society, adaptations of their state-of-the-art processes, specifically additive manufacturing and 3-D printing, within the health care system may prove to be the missing link in overcoming the logistical and supply gap shortages. Nonetheless, the concerns regarding the safety and efficacy of these innovative solutions is valid and more research should be rapidly sought before widespread adoption can be recommended.
The views addressed in this article represent the opinions of the authors and do not reflect the views of the U.S. Army, the Department of Defense, or the U.S. government.
- Thielking M. Frustrated and afraid about protective gear shortages, health workers are scouring for masks on their own. Stat News. March 18, 2020. Available at: www.statnews.com/2020/03/18/ppe-shortages-health-workers-afraid-scouring/. Accessed April 4, 2020.
- Feldman A. Meet the Italian engineers 3-D printing respirator parts for free to help keep coronavirus patients alive. Forbes. March 19, 2020. Available at: www.forbes.com/sites/amyfeldman/2020/03/19/talking-with-the-italian-engineers-who-3d-printed-respirator-parts-for-hospitals-with-coronavirus-patients-for-free/#5bdb5b1778f1. Accessed April 3, 2020.
- Carroll L. New York’s Northwell Health begins 3-D printing nasal swabs for coronavirus testing. Reuters. March 31, 2020. Available at: www.reuters.com/article/us-health-coronavirus-usa-swabs/new-yorks-northwell-health-begins-3d-printing-nasal-swabs-for-coronavirus-testing-idUSKBN21I2Y2. Accessed April 3, 2020.
- Make the Masks. The Montana Mask. Available at: www.makethemasks.com/. Accessed April 3, 2020.
- University of California-San Francisco. Face Shield Project. Available at: www.library.ucsf.edu/news/ucsf-3d-printed-face-shield-project/. Accessed April 3, 2020.
- National Institutes of Health. COVID-19 supply chain response. National Institutes of Health 3D Print Exchange. Available at: https://3dprint.nih.gov/collections/covid-19-response. Accessed April 1, 2020.
- The Joint Commission. Statement on Use of Face Masks Brought From Home. March 31, 2020. Available at: www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/infection-prevention-and-hai/covid19/public_statement_on_masks_from_home.pdf. Accessed April 4, 2020.