From the beginning of the coronavirus disease 2019 (COVID-19) pandemic, there has been a worldwide struggle to obtain adequate amounts of personal protective equipment (PPE), such as face masks, face shields, gowns, and gloves. These equipment are essential to protecting frontline workers and preventing the transmission of COVID-19, as inadequate access to PPE is associated with high rates of mortality and infection among health care workers. (1) As COVID-19 has spread globally, PPE supply shortages have been augmented by global supply chain disruptions. These disruptions are in part due to travel restrictions and factory shutdowns in China as part of an effort to contain COVID-19 in January and February. (2) The decrease in production in China is particularly disadvantageous as the country is estimated to produce 50%-90% of all masks globally. (2) As infection rates have fallen in China, mask production has increased nearly 12-fold. However, this increase in production was followed by export restrictions aimed at retaining the masks for internal use. (3) Similarly, over 38 countries, including Germany, Thailand, and India, have limited the export of masks and other key materials. (3,4)
The United States relies heavily on overseas production of PPE; 95% of surgical masks and 70% of respirators are imported. (2) As COVID-19 began to spread throughout the U.S., PPE shortages became increasingly obvious as just-in-time supply chains failed. As a result, hospitals have struggled to receive shipments of PPE. Health systems have responded by requiring frontline workers to ration and reuse their PPE. Stories have emerged of health care workers using the same N95 for multiple shifts, along with attempts to sanitize soiled N95 masks that are designed for a single use. (1) Other essential PPE such as face shields, gowns, and shoe covers became incredibly scarce; 36% of health care facilities across the United States reported no supply of face shields or shoe covers as of April 8th, 2020. (5) This nationwide shortage was especially pronounced across New York, the U.S. epicenter of the pandemic. Here, we illustrate how a collaboration between a student-led task force and a medical device innovation hub at Mount Sinai, Sinai BioDesign, helped to mitigate the effects of the PPE shortage within our own health system.
In response to the COVID-19 pandemic in NYC, medical and graduate students at the Icahn School of Medicine at Mount Sinai rapidly mobilized a student task force, volunteering to assist in various roles throughout the health system. As Mount Sinai and its affiliate hospitals constitute one of the largest non-profit hospital networks in the country, student support tasks were quickly identified in non-patient contact roles in the pharmacy, labs, administration, and telehealth practices. While efforts are still ongoing, as of May 17, 2020, the student task force was composed of more than 250 volunteers who had worked 25,164 hours over 8 weeks. One of the roles in the overarching task force of particular importance was to help mitigate the challenges faced by global PPE shortages. A dedicated PPE task force was therefore created to help source, assemble, and distribute PPE across the Mount Sinai Health System.
The work of the task force was focused on augmenting hospital system efforts where demand outpaced pre-existing capacity. For example, as new N95 models were introduced to address shortages, the need arose for every Mount Sinai employee to be “fit tested,” a process necessary to ensure a protective seal. Within days, more than 50 medical students were trained and deployed across the Mount Sinai Health System. While this facilitated the safe introduction of PPE from new sources, the conversion of hospital floors to COVID units caused PPE consumption to rise exponentially. To meet demand, students became “PPE runners,” receiving calls from units whose PPE stocks were dwindling and delivering the needed equipment within minutes. As students integrated into the health system, they learned about the individual units’ evolving needs firsthand from nurse managers, residents, and faculty. This motivated efforts to coordinate an influx of community, international, and research lab donations, yielding nearly 5,500 N95 and 61,000 surgical masks for frontline workers. Despite the well-publicized shortage of respirators, students quickly identified a rapidly growing need for face shields. While the system was working to source hundreds of thousands of face shields to meet long-term demand, the student task force engaged Sinai BioDesign to discuss how to address the immediate need.
As these efforts evolved, it became apparent that 3D printing was particularly well-suited to address the acute shortage of face shields. Designed as a barrier to protect the wearer’s eyes and face from fluids, an effective emergency face shield can rapidly be produced from a variety of transparent plastics mounted to a 3D printed visor, which ensures the protective window fully covers the face. As a Class I medical device providing only a physical barrier, the risks associated with community-produced face shield models are extremely low.
Since the onset of COVID-19, Sinai BioDesign has been involved in the design and evaluation of alternative PPE, drawing from designs released by the online community as well as from local and regional manufacturers. With in-house rapid prototyping resources, in addition to access to frontline healthcare workers, Sinai BioDesign was able to manufacture PPE designs of interest and have them evaluated directly by clinicians. Rapid cycles of design iterative, improvement, and clinical evaluation, provided critical insight into various designs, such as ease of use, comfort, and viable materials. These evaluations allowed Sinai BioDesign to endorse the production of several printed face shield designs, including the Prusa and 3DVerkstan models, which were produced for the student task force.
In addition to the direct fabrication support and clinical validation provided through Sinai BioDesign, the task force was able to make connections with Futureworks NYC, a city-wide coalition of manufacturers sponsored by the New York City Economic Development Corporation (NYCEDC). Through this network, several local manufacturers with large-scale rapid prototyping capacity were activated. These organizations were able to provide over 1,500 additional face shields under the design guidance of Sinai BioDesign and the student task force. In total, the efforts from Sinai BioDesign, plus the contributions from local manufacturers, successfully delivered over 2,100 face shields to four hospital sites experiencing acute shortages.
The pace at which the COVID-19 pandemic developed in New York resulted in an unprecedented strain on our hospital system, further exacerbated by limitations in the supply chain. The PPE task force was able to dynamically support the unmet needs of the hospital system. Direct communication between frontline workers across various hospital units and the task force made it possible to rapidly identify critical face shield shortages. Through collaborations with our in-house innovation hub, Sinai BioDesign, and activation of a local manufacturing network through Futureworks NYC, the task force was able to bridge the gap between acute face shield shortages and long-term system-wide solutions. As the country shifts its focus towards lifting shutdown orders and restarting the economy, there is a real possibility of a COVID-19 resurgence. In the event that hospital systems across the country continue to be strained by PPE supply chain shortages, student workforces and local innovation hubs can play critical roles to mitigate the challenges posed by COVID-19.
Acknowledgments
We thank all the students who volunteered their time to the student task force. We also thank all the individuals who donated their time and resources to 3D print face shields for us. Lastly, we thank all the frontline workers who worked tirelessly to combat COVID-19.
References
- Parshley L. The mask shortage is forcing health workers to disregard basic coronavirus infection control. Vox. April 3, 2020. Accessed May 14, 2020. https://www.vox.com/2020/4/3/21206726/coronavirus-masks-n95-hospitals-health-care-doctors-ppe-shortage
- Park C-Y, Kim K, Roth S, et al. Global Shortage of Personal Protective Equipment amid COVID-19: Supply Chains, Bottlenecks, and Policy Implications. Asian Development Bank. 2020;130. http://dx.doi.org/10.22617/BRF200128-2
- Bradsher K, Alderman L. The World Needs Masks. China Makes Them, but Has Been Hoarding Them. New York Times. March 13, 2020. Accessed May 14, 2020. https://www.nytimes.com/2020/03/13/business/masks-china-coronavirus.html
- World Customs Organization. Accessed May 14, 2020. http://www.wcoomd.org/en/topics/facilitation/activities-and-programmes/natural-disaster/list-of-countries-coronavirus.aspx
- Schlanger Z. Begging for Thermometers, Body Bags, and Gowns: U.S. Health Care Workers Are Dangerously Ill-Equipped to Fight COVID-19. Time. April 20, 2020. Accessed May 14, 2020. https://time.com/5823983/coronavirus-ppe-shortage/