By: Christopher Sirota, CPCU
There have been reports that 3D Printing technology is being used to develop components that are vital for the production of crucial medical equipment, such as Personal Protective Equipment (PPE), during the COVID-19 outbreak. Such 3D-printed equipment reportedly includes face shields, valves for reanimation devices, and test kit swabs.
Are 3D-Printed Components as Effective?
The Food and Drug Administration (FDA) has issued FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic, which addresses some common concerns.
Notably, the FDA highlights a concern regarding the effectiveness of 3D printed components to physically block droplets and other bodily fluids that may contain a virus. Specifically, the FDA states the following:
PPE includes protective clothing, gowns, gloves, face shields, goggles, face masks, and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. 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.
The FDA also explains that some medical devices are complex and may require electronics or pumps that have dimensions or specifications not easily replicated with 3D printing; thus the FDA encourages 3D printing manufacturers to seek guidance from the original equipment manufacturer.
Regarding 3D-printed masks, the FDA offers the following guidance to healthcare workers:
- "Check the 3D-printed mask's seal for leaks.
- Confirm that they can breathe through any makeshift filter materials.
- Exercise caution in surgical environments where the need for liquid barrier protection and flammability is a concern.
- Recognize that the mask may not provide air filtration enough to prevent transmission of infectious agents.
- Safely dispose of infectious materials and disinfect any part they intend to reuse."
Is there Liability Immunity for 3D-Printing Manufacturers of Medical Supplies During the Crisis?
According to a blog post by Shook, Hardy & Bacon L.L.P., one company has distributed 1,000 3D printed parts to hospitals in the U.S. and in Europe. Additionally, other companies have provided free downloads of blueprints to 3D print medical components, and some universities are providing their 3D printers to help manufacture parts for ventilators and PPE.
The blog then discusses, in part, some considerations regarding potential personal injury liability risk for manufacturers in general during the COVID-19 crisis.
The blog explains, for example, that under the Defense Production Act (DPA), the "government may encourage and in some instances compel private industry to manufacture certain products, [but] those manufacturers are by no means automatically shielded from subsequent tort claims". The blog further notes that the DPA may have some relevance regarding strict liability, but most likely does not provide "blanket tort immunity […] for liability to injured third parties."
The blog also looks at the Public Readiness and Emergency Preparedness Act (PREP). According to the blog:
Companies that produce medical and protective products pursuant to an FDA Emergency Use Authorization (EUA) may benefit from some level of tort immunity under the PREP Act, which was enacted in 2005 and amended the Public Health Service Act (PHS Act). The amendments “added new legal authorities to the [PHS Act] to provide liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against […] epidemics and pandemics.” The amendments also authorized the Secretary of Health and Human Services to issue a declaration “that provides immunity from liability for any loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases […] determined in the Declaration to constitute a present or credible risk of a future public health emergency.”