In December 2017, The Food and Drug Administration (FDA) released a guidance document for 3D printing of medical devices, titled “Technical Considerations for Additive Manufactured Medical Devices.” The guidance covers technical considerations specific to devices using “additive manufacturing,” a phrase often used synonymously with “3D printing.” To shape its recommendations, the FDA reviewed 100 currently-marketed medical devices made with additive manufacturing and consulted stakeholders in the 3D printing industry.
What is 3D Printing and How Does It Affect Medical Device Development?
3D printing creates a three-dimensional object out of layers of the building material. The “pattern” used to make the object exists in the form of a computer file. Tools like computer-aided design (CAD) and magnetic resonance imaging (MRI) are often used to create or develop the file.
Because a 3D printer reads from a standard computer file, it offers greater flexibility than many other types of manufacturing tools. Designers can make a wide variety of changes without using additional equipment or tools. 3D printing’s ability to capture very fine detail also makes it useful for creating patient-specific medical devices, such as tooth crowns, or devices with very complex internal structures.
Medical devices may be entirely 3D printed or may contain one or more parts that are 3D printed. In both cases, the FDA’s guidance recommends extensive device testing, internal checks that prevent users from exceeding the device’s specifications, and archiving of both device files and materials documentation.
Like their predecessors, these devices are subject to both premarket and postmarket FDA regulation. The FDA’s recent guidance is not regulation, rather, it “describe[s] the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”
Potential Product Liability Pitfalls for 3D Printed Medical Devices
The FDA guidance on 3D printed medical devices positions 3D printing as an emerging technology whose implications in medical use have yet to be fully explored or understood. As 3D printing of medical devices becomes commonplace, additional laws and regulations are likely to emerge.
The FDA’s guidance indicates that the agency is focusing on maintaining patient safety as the number of wholly or partly 3D-printed medical devices continues to increase. Although the FDA’s current guidance functions largely as a recommendation, product liability laws in various states may still provide an avenue for compensating patients who suffer injuries as the result of defective medical devices that are wholly or partly 3D printed.
Like other devices, a 3D printed medical device may have dangerous defects of manufacturing or design, or negligently fail to warn doctors and patients of potential risks. The FDA recommends several concrete steps manufacturers and designers can take to reduce the risk of unreasonably dangerous hidden defects, including:
- Collaborating with clinicians on custom devices to ensure that the device operates safely within the necessary parameters
- Documenting every aspect of design since even minute changes to CAD files can introduce potential defects
- Providing extensive documentation and warnings about software use in applications like 3D printing of dental devices in office settings – including warnings about ensuring that design file formats are compatible with the office’s software
- Standardizing or specifying which 3D printers are compatible with the device’s design so that the device can be accurately printed
While following each of these steps cannot guarantee a product free from defects, failing to follow them may expose manufacturers and/or designers to a higher risk of liability if a defect arises. Attorneys pursuing compensation for injured clients may use the FDA’s guidance to better inform their approach to the case, the evidence they seek, and the choice of expert witnesses if needed.