An unprecedented demand for critical medical products in recent weeks has triggered an urgent interest in the potential of 3D printing to create personal protective equipment (PPE) and other medical devices during the COVID-19 pandemic. But despite the undeniable need for increased production of certain medical supplies, regulators are urging caution. As further addressed below, businesses and individuals need to be aware of the regulatory issues and potential liability risks associated with producing 3D printed products, both in response to the COVID-19 crisis[1] and in all aspects of the manufacture and sale of consumer products.

Relevant authorities, including the U.S. Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC), have issued updated guidance on the 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic. While recognizing that 3D printing may occur to provide wider availability of medical devices during the current public health emergency, the FDA notes that some devices are more amenable to 3D printing than others and urges caution to health care providers using 3D printed protective equipment, which might not be as safe as equipment made by traditional methods.[2]

While recent medical supply shortages have brought new public attention to the application of 3D printing technologies to product manufacturing, the CPSC has been paying increased attention to product safety and compliance issues in 3D printing for several years, with an amplified emphasis on these issues since at least 2019. In fact, the CPSC’s Risk Management Group identified 3D printing and 3D printed products as an “Emerging Hazards Focus” for 2020 and addressed 3D printing as one of the primary topics in its presentation at the 2020 Annual Meeting and Symposium of the International Consumer Product Health and Safety Organization (ICPHSO) in January.

Below we answer some common questions about product safety and compliance issues related to 3D printing and 3D printed parts and products.

What is 3D printing?

The term “3D printing” refers generally to a variety of processes in which material is joined under computer control to create a three-dimensional object. Also known as “additive manufacturing,” 3D printing processes create three-dimensional objects by depositing materials layer by layer in accordance to the object’s digital model. A key advantage of 3D printing is the ability to produce complex shapes and geometries, usually without the lead time of a mass production product development cycle. 3D printing also enables manufacturers to create new shapes and lighter parts that use less raw material and require fewer manufacturing steps.

Of course, the use of 3D printing is not limited to medical products, and 3D printing technologies are being utilized across a variety of manufacturing industries. Currently, 3D printing is mostly used to build small, relatively costly components using plastics and metal powders. However, as the price of 3D printing equipment continues to drop, users are experimenting with different materials, including wax, ceramics, concrete, glass, biomaterials, and even food products.[3]

Why are federal agencies concerned about the 3D printing of consumer parts and products?

The CPSC characterizes 3D printing as a rapidly growing technology and credits that growth to the increased affordability of 3D printing equipment, decreased print times (and increased production limits), and a growing range of materials and capabilities. The CPSC reports that manufacturers and small businesses are quickly adopting 3D printing technologies, with the likely result that more consumer products may contain 3D printed parts. The CPSC also anticipates the increased used of 3D printers in home, library, and school environments.

In its Fiscal Year 2019 Annual Performance Report, the CPSC stated:

Technical improvements and cost reductions of 3-D printing have made the technology become more widely available, allowing for consumers to print products for children and the home. However, printing filaments used in certain 3-D printers contain nanomaterials. The CPSC has been collaborating successfully with the Environmental Protection Agency (EPA) and NIOSH to study potential health hazards associated with nanomaterials in 3-D printing filaments.

As entities increasingly utilize 3D printing technologies to manufacture parts and products, the CPSC notes that issues are likely to arise from users’ lack of training on 3D printing equipment use and safety, lack of science and engineering expertise in “good manufacturing practices,” and unsafe storage of printing equipment and materials. To that end, the CPSC has identified two primary areas of concern related to 3D printing - safety of the printing equipment itself and safety of the printed parts and products.

The FDA is also working with the National Institutes of Health, the U.S. Department of Veterans Affairs, and 3D manufacturers to help create designs for needed medical supplies that can be quickly approved. Entities engaged in 3D printing are encouraged to work with relevant medical device manufacturers.

What potential hazards are associated with 3D printing equipment?

The potential hazards associated with 3D printing include fire and electrical hazards, chemical hazards, children’s hazards, and mechanical hazards. These hazards exist separately for the 3D printing equipment itself and for 3D printed products and components.

              Hazards for 3D Printing Equipment:

• Fire and electrical hazards: thermal runaway, temperature check failures, cooling fan failures, lack of fire suppression and detection at the printer location, improper flame retardants, improper UV inhibitors, unsupervised printing, combustible and explosive dust generation;
• Chemical hazards: toxicity of materials and exposure (e.g., metals, nanomaterials, thermoplastics), safe storage and packaging of materials, emissions during product manufacturing, accumulation of released chemicals in the indoor environment;
• Children’s hazards: burns, electric shocks, exposures to additives or chemicals;
• Mechanical hazards: physical injuries from interaction with printing equipment (e.g., cuts, burns).

              Hazards for 3D Printed Products and Components

• Fire and electrical hazards: noncompliance with flammability standards, material compatibility concerns, product durability and performance degradation;
• Chemical hazards: product durability and chemical stability, product degradation and release of chemicals;
• Children’s hazards: mandatory regulation compliance uncertainty – choking hazards, small parts, exposure to phthalates, replica toy guns (proper marking);
• Mechanical hazards: untested designs impossible to produce using traditional manufacturing methods, redefining of material and mechanical engineering roles in product development, raw materials with different mechanical properties, limited postproduction product treatment (e.g., heat treating of metals), difficulties in quality assessment and quality control.

What are the potential regulatory compliance issues and legal liabilities associated with 3D printing?

As 3D printing continues to become more prevalent, businesses and individuals need to be aware of the regulatory issues and potential liability risks.

Regarding regulatory compliance, manufacturers and retailers who produce or sale 3D printed products and components need to be aware that these goods are still subject to mandatory and voluntary standards, and they are subject to the same regulatory requirements as other goods. UL, ASTM, and ANSI have all played a role in the development of voluntary standards. Most consumer products are under the jurisdiction of the CPSC, and medical devices are under the jurisdiction of the FDA. Certain other products are overseen by other federal agencies such as the National Highway Traffic Safety Administration. Each of these agencies enforces its own product safety, notice, and recall requirements. For example, the reporting requirements under Section 15(b) of the Consumer Product Safety Act, which require a manufacturer, distributor, or retailer to notify the CPSC immediately if it obtains information that reasonably supports the conclusion that a product (1) fails to comply with an applicable consumer product safety rule enforced by the CPSC; (2) contains a defect that could create a substantial product hazard; or (3) creates an unreasonable risk of serious injury or death to consumers. Manufacturers and sellers need to be mindful of this another regulatory requirements and treat 3D printed products with the same degree of scrutiny and diligence as other products.

The potential liability issues associated with 3D printing also apply equally to 3D printed products as to any other product. Product liability laws are designed to provide accountability for injuries or loss caused by defective and unreasonably dangerous products. Most states allow an injured person to bring a lawsuit for monetary recovery based on an alleged defect in a product’s design, manufacture, or warnings. Under any of these legal theories, the plaintiff must generally prove that the injury occurred because the product was defective and unreasonably dangerous. The risk of harm from and associate liability from product defects is heightened if the product and the manufacturing processes have not undergone rigorous testing for reliability, which is among the risks the CPSC has identified with untested designs impossible to produce using traditional manufacturing methods. In the event a consumer is injured using a 3D printed product and can meet her burden of proof on these elements, a manufacturer or seller could be held to the same standards of liability as any other product.

Where I can learn more about these issues?

The CPSC and FDA are willing to discuss these and other issues with manufacturers and facilities during the COVID-19 emergency. Interested persons can email COVIDManufacturing@fda.hhs.gov for more information about 3D printing to meet product demand.