Orthopaedic medical device manufacturing often utilizes manufacturing materials or processing aids that can remain on device surfaces as residues and result in leachable chemicals to which patients can be exposed upon contact with the device. Manufacturing steps that modify a device surface through electrochemical means such as electropolishing can remove manufacturing material residues and be considered as surface “reset” in the manufacturing process. In this report, a retrospective analysis of chemical characterization data gathered for medical devices subjected to electropolishing steps during the manufacturing process is summarized. Review of the extractables data from metallic medical devices demonstrated that electropolishing operations effectively remove the residues originating from manufacturing materials utilized upstream of electropolishing. Based on this retrospective review, electropolishing can serve as a surface “reset” point in the manufacturing process in biological safety evaluations, thereby reducing the overall testing requirements, including animal testing, in alignment with the ISO 10993 framework.
Godlewska et al. (Thu,) studied this question.