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As 3D printing becomes more accessible, it will present significant liability questions for those injured by these devices. If a traditional manufacturer creates a 3D-printed device, that manufacturer is subject to products liability claims. But, when a hospital or doctor prints the device at their own facility, who is responsible if that device causes a patient harm? This article will provide a very brief overview of the existing legal landscape for those injured by medical devices printed by doctors and hospitals, but will not address the liability issues that arise when the 3D printer itself is defective.

The Additive Process

The 3D-printing process involves building solid, three-dimensional objects from digital models, using an additive process in which successive layers of material are assembled on top of one another to build the desired device. The 3D printer can layer materials such as metal, plastic, medication and even human tissue, until that material matches the original digital model. Customized devices are printed for a variety of medical uses including surgery preparation, medical devices such as prosthetics, hearing aids, braces, casts and may one day create organs. Several companies specialize in 3D manufacturing and that number is growing. These companies use a conventional distribution process by receiving patient specifications, printing the 3D device in their own plant and shipping the device directly to the doctor or hospital.

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