Part of Pandemic proofFuture Perfect’s series on improvements we can make to prepare for the next pandemic.
Some of the most indelible images from the start of the pandemic concerned the personal protective equipment (PPE) crisis in our hospitals – photos of doctors and nurses carrying garbage bags, swimming goggles and reused diving masks as PPE supplies dwindled in the face of the onslaught of Covid-19.
These images underscored how unprepared we were to deal with a rapidly evolving pandemic. American hospitals relied heavily on foreign suppliers, particularly in China, for PPE, and there are no regulations requiring hospitals or states to keep a certain level of inventory in the event of a crisis. Most did not; Healthcare in the United States is under severe financial pressure and just-in-time supply is – in normal times – more cost effective. The result was a supply shortage that hampered our pandemic response.
As the country waited for American manufacturers to ramp up production of PPE and for supply chains to stabilize, an intriguing workaround emerged: 3D printing. Faced with a shortage of masks, a coalition of private, public and voluntary groups came together to fill a void, their efforts focused on the production and distribution of 3D printed masks.
Their work, of course, was far from enough to make up the shortfall. But as a palliative they undoubtedly helped, especially at the local level where such operations were concentrated – and all this suggests a limited but promising role for 3D printing in the fight against future pandemics.
“The Wild West of PPE”
It’s hard to overstate how terrible the PPE crisis of the early days of the pandemic was, especially for healthcare workers on the front lines of the crisis.
The shortage has led to a fierce search for masks and other equipment that has pitted hospitals and states against each other. John Hick, medical director of emergency preparedness at Hennepin Healthcare in Minnesota, recalls his hospital’s efforts to secure shipments from increasingly insufficient inventory. “We knew the supply chain was not going to be able to keep pace with the pandemic. And it didn’t work,” he told me.
Meanwhile, sourcing companies in China tried to circumvent export restrictions put in place by the Chinese government at the start of the pandemic. “When we received samples of masks and gowns from China,” Hick told me, “a lot of times they would come in a box wrapped in clothes, so from an export perspective it would look like they were sending them and not PPE.
Premier Inc, a health care supplies company, told me that orders surged 17-fold at the start of Covid-19 and that hospitals across the country were sending representatives overseas in a frantic attempt to buy all the remaining supplies they could. Sometimes they got lucky, but staff unfamiliar with the process and without pre-existing supplier relationships often came back with counterfeit products – or sometimes nothing at all.
It was the “Wild West of PPE”, recalls Hick.
This is where 3D printing came in.
The promise to print PPE in a pandemic crisis
3D printers can create solid three-dimensional objects from digital designs. According to a digital plan, materials like plastics or metal powders are deposited in successive layers, one after the other – one of the reasons why 3D printing is also known as additive manufacturing.
With enough raw material and a digital design to work from, 3D printers can make physical objects like face shields and masks in minutes or hours. It’s far from perfect – additive manufacturing has generally been used more for prototype designs than large-scale manufacturing – but the desperate need for PPE at the start of the pandemic has provided an opportunity to push back the limitations of 3D printing technology.
This is exactly what the COVID 3D Trust project attempted to facilitate, once PPE shortages became evident at the start of the pandemic. The group was founded under the National Institutes of Health (NIH) 3D Print Exchange, a program the agency launched in 2014 to support bioscience research; they mainly printed 3D models of molecules studied in biology research laboratories.
They already had the necessary infrastructure and could work closely with the Food and Drug Administration (FDA) and the Department of Veterans Affairs (VA) to support cutting-edge biomedical work, print masks and face shields for healthcare workers. In just 10 days in March 2020, they were able to deliver a platform that would host a crowdsourced repository of 3D printed designs for masks, face shields and other supplies such as nasal swabs for testing – all tested by the VA to meet FDA emergency use authorization standards for PPE.
Meanwhile, the Advanced Manufacturing Crisis Production Response, (AMCPR) Exchange, a website platform operated by America Makes (a public-private partnership promoting innovative work like 3D printing), provided a separate platform to connect small manufacturers to buyers. According to Meghan McCarthy, program manager at the NIH 3D Print Exchange, the demand was clear: Traffic to the COVID 3D Trust site jumped rapidly, from 15,000 users per month before the pandemic to 30,000 users per day. in March 2020.
The success of the AMCPR has relied on individuals, volunteer groups, academic organizations, and commercial entities stepping up to contribute their local 3D printing capability to the supply of PPE needed for disaster response efforts. Covid-19.
Among them was the Illinois PPE Project, a volunteer-led effort that came together when the urgent need for PPE at nearby hospitals became dire and the response from established institutions proved lackluster. The project was able to get veterans to make product deliveries, use loading dock space donated by local businesses, and rely on volunteer efforts to call hospitals and find out who had the most needs. urgent.
A report by America Makes estimated that its efforts produced and delivered 38 million face shields and face shield parts, over 12 million Covid-19 diagnostic nasal swabs, over 2 million savers ear pieces and hundreds of thousands of mask components and ventilator parts. (The earmuff is an accessory that can be used to make masks more comfortable by taking pressure off the ears. This may not matter to the average person temporarily wearing a mask while diving in a store, but this is highly relevant to healthcare providers, who often have to wear a mask for the duration of a 12-hour shift.)
Nation of Makers, a nonprofit organization founded to support the “maker” community — a subculture focused on engineering new materials and tinkering, often through the use of 3D printing — believes that nearly of 50 million total units of PPE and other medical supplies have been produced for the Covid-19 response by local additive manufacturing groups by January 2021. That’s a staggering number – although still low in the context of domestic mass manufacturing and total demand within the health system; in March 2020, the US Department of Health and Human Services contracted companies to deliver 600 million N95 masks over an 18-month period.
A palliative, not a solution
As these figures suggest, 3D printing is inherently small scale. It’s not a long-term solution to meeting the demand for PPE in the healthcare system and will never be as cost effective at scale as traditional mass manufacturing. Its main value is that it can be done locally, with minimal lead time, and can temporarily fill the gap to save time for larger scale manufacturing and shipping.
3D printing also has value as a way to prototype new PPE designs. Digital designs can be quickly revised during the additive manufacturing process to test new approaches. A notable success during this pandemic has been the Provisional Surgical Mask, a sterilizable mask with a replaceable filter that meets FDA standards and is currently going through the CDC’s NIOSH approval process for N95 masks.
Other promising projects have reached the prototype stage; in particular, the Bellus3D application (which is unfortunately in the process of closing) hoped to offer a service for scanning an individual’s face to be associated with 3D printing to create a custom-made reusable and sterilizable mask, or a customizable plastic frame. to improve the seal of a surgical mask.
But additive manufacturing is just that: additive. Preparing for the next pandemic will also require reforming supply chains and improving emergency stocks for conventionally produced PPE.
The upgrade wish list is long: moving away from just-in-time shipping when it comes to PPE; tax incentives or hospital regulations to encourage year-round production of PPE; and new mechanisms to improve the visibility of PPE supplies and chains in hospitals and states, among others.
But we have now understood the limits of 3D printing in an emergency and how much further we can push them. It almost certainly saved lives this time around, and it may well have even more consequences in the next pandemic.