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 appli

SUBMITTER: Rindelaub JD 

PROVIDER: S-EPMC6530847 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature