Companies, organizations and individuals continue to attempt to lend support to the COVID-19 pandemic supply effort. We will be providing regular updates about these initiatives where necessary in an attempt to ensure that the 3D printing community is aware of what is being done, what can be done and what shouldn’t be done to provide coronavirus aid.
The Emergency Use Authorization (EUA) process that the U.S. Food and Drug Administration (FDA) has instituted in response to supply shortages has allowed for 3D-printed solutions to be fast-tracked for rapid deployment. Prisma Health and Ethicon Inc., a Johnson & Johnson company, has received EUA from the FDA to 3D print and distribute a ventilator splitting tool called the VESper Ventilator Expansion Splitter. Similar to previous splitter designs we have seen, the VESper makes it possible to provide ventilator support two patients simultaneously.
Ethicon will 3D print the tool for use in the U.S. while the partner companies determine how to fulfill global orders. Prisma Health is working with state and local health authorities, healthcare providers and national COVID-19 teams to determine where the VESper is needed so that they can work with those doctors and monitor clinical outcomes. Healthcare providers can request VESpers from the Prisma Health website.
While the devices are being provided at no cost, it is interesting to note how South Carolina’s largest private employer, Prisma Health, and a company as large as Johnson & Johnson are able to trademark the name for a product that is so similar to many free and open source designs that have been released in the wake of the pandemic.
Obviously, Johnson & Johnson has the medical manufacturing expertise to produce these parts according to FDA standards (despite its own issues with FDA violations and history of dangerous consumer products). The partners claim that all products will be made and packaged according the Instructions for Use, which includes the clinical protocol as published online on March 31, 2020 by the U.S. Department of Health & Human Services Assistant Secretary and the U.S Surgeon General titled “Optimizing Ventilator Use During the COVID-19 Pandemic.”
3D Systems has published a materials recommendation chart for 3D printing medical supplies in response to the coronavirus outbreak. In the company’s words, the chart identifies “the best candidates for printer-material combinations for which either Class VI and/or ISO 10993 certifications are possible, including potential solutions to applications in emergency situations though the materials are not Class VI and/or ISO 10993 certified and customers should conduct their own testing to determine whether certification is possible.” These materials are limited to those for 3D Systems’ machines, so we are exploring the topic of material safety from a broader standpoint and will publish a separate post on the topic.
Meanwhile, the company is continuing to work with healthcare providers and device manufacturers on about 50 different projects, including the production of face shields for hospitals in the UK, Italy and U.S., as well as face masks, ventilator components, disposable door openers and valves to convert scuba masks into emergency ventilators.
Europe’s largest hospital system, the University Hospital Trust (AP-HP) has installed 60 Stratasys F123 Series 3D printers in Paris to manufacture personal protection equipment and other parts on demand. Located within a 150-square-meter facility at the Cochin Hospital, the machines are being used to 3D print parts for face shields and masks, electrical syringe pumps, intubation equipment and respirator valves. The equipment was obtained through Stratasys reseller CADvision and will be supported by engineers from 3D printing service bureau Bone3D. AP-HP has also launched a website, 3dcovid.org, to fast track part requests from healthcare workers in Paris and surrounding areas.
Mobility goes Additive e.V. (MGA), a European consortium made up of almost 120 member companies, is hosting a platform dedicated to use cases for 3D printing supplies for the COVID-19 pandemic: weboostam.com. MGA was approached by the European Commission in March to support production of medical supplies, resulting in the 3D Printing Fights Corona project. The new website acts as a hub for these efforts, where members can fill out profiles and list 3D printing use cases, such as emergency masks, face shields, venturi valves and other items.
Smaller businesses are also throwing in their production capabilities. 3D printing service bureau Avid Product Development is manufacturing face shields at a rate of 290 parts per build. Israeli startup Nanofabrica hosted a virtual round table to determine if its one-micron resolution 3D printing technology could be used for producing microfluidic applications, such as nozzles and filters, to aid in deploying COVID-19 blood tests.
As the pandemic continues to grip the world, we will continue to provide regular updates about what the 3D printing community is doing in response. As always, it is important to keep safety in mind, remain critical about the potential marketing and financial interests behind seemingly good humanitarian efforts from businesses, and to do no harm.
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