3D Printing of PPE and Other Medical Devices
During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.
For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.
Recognizing that the healthcare industry is turning to 3D printing to address PPE needs, FDA released a frequently asked questions page addressing the issue. Although FDA recognizes the possibility of such manufacturing, it makes it clear that 3D-printed PPE has its limitations, especially when compared to traditionally manufactured PPE.
As the FDA FAQ states:
"While it is possible to use 3D printing to make certain PPE, there are technical challenges that have to be overcome to be effective enough. For example, 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators."
Similarly, FDA also acknowledged that certain medical devices and equipment, such as ventilators, ventilator tubing connectors, and ventilator accessories, could be 3D printed in part or in whole. FDA recently gave Emergency Use Authorization for these products, and the FAQ makes clear that it expressly includes 3D-printed devices, which could include items such as 3D-printed tubing connectors for multiplexing ventilator use.
Given the concerns and cautions raised by FDA, manufacturers of PPE or other medical devices currently in shortage should consider adopting certain best practices. For example, manufacturers should consider including warnings with 3D-printed PPE regarding potential limitations with the fluid barrier compared with that of traditionally manufactured equipment. Further, manufacturers looking to 3D print all or part of certain devices, such as tubes and ventilators, are invited to consult with FDA before engaging in such production. Traditionally, initial consultation with FDA, such as a presubmission meeting, is a helpful tool for manufacturers to identify and address FDA concerns before investing resources. Finally, FDA advised manufacturers, especially those involved in the 3D production of certain parts for equipment such as tubes for a ventilator, to the consult the original design plans to verify fit and compatibility.
Consistent with the FDA’s concerns, many in the healthcare industry view 3D printing as a stopgap, in hopes that it will address current needs while traditional manufacturers are able to catchup with the demand. As Dr. Beth Ripley, director of the VA 3D Printing Network, recently told 3DPrint.com, “3D printing allows us to bump up that production curve… . I think it’s totally worth it for face shields and medical supplies, getting the medical supplies into the community… with a strong caveat that we should not rest on that as the final solution. It really is a stopgap, a temporary measure while we shore up more robust solutions.”
Even if 3D printing is not the “solution,” this emerging technology has proven its potential in playing a significant role in providing relief to the healthcare industry during this critical period.