Identifying extractable profiles from 3D printed medical devices.

Abstract

With the ability to create customizable products tailored to individual patients, the use of 3D printed medical devices has rapidly increased in recent years. Despite such interest in these materials, a risk assessment based on the material characterization of final device extracts-as per regulatory guidance-has not yet been completed, even though the printing process may potentially impact the leachability of polymer components. To further our understanding of the chemical impact of 3D printed medical devices, this study investigated the extractable profiles of four different materials, including a PLA polymer advertised as "FDA-approved". The fusion deposition modeling (FDM) printing process created distinct chemical and physical signatures in the extracts of certain materials. The application of an annealing procedure to printed devices led to a substantial decrease in extractable components by as much as a factor of 50. In addition, the use of a brass printing nozzle led to an increase in the amount of Pb detected in 3D printed device extracts. The data generated provides valuable information that can be used to help assess extractable risks of 3D printed medical devices, assist with future 3D printing designs, and may provide insight for agencies tasked with governing 3D printed medical device regulations.