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  1. FDA STEM Outreach, Education and Engagement

Sterilization Methods and Their Effects on the Dimensional Stability of Additively Manufactured Medical Devices

Authors:
Poster Author(s)
Capadona, Charisse, FDA/CDRH; David Kaplan and Irada Isayeva (Mentors), Tanmay Jain, and Joyce Kitzmiller
Center:
Contributing Office
Center for Devices and Radiological Health

Abstract

Poster Abstract

Additive manufacturing (AM), also known as 3D printing, is a process that utilizes digital design to build a physical object generally through successive addition of layers of one or more materials. In recent years, AM technologies have become increasingly used for medical devices for their versatility and high degree of customizability, in order to create patient-matched products. 3d printed medical devices include surgical tools, implants, anatomical guides for surgical planning, as well as endoscopes and suction tubes, among many others. Medical devices, particularly ones in contact with tissue and body fluids, may require repeated sterilization to prevent risk for infections. The AM Working Group at the US FDA has identified gaps on (1) whether the dimensional stability of AM polymer medical devices is affected by sterilization, and (2) whether this will affect the performance of the medical device. In our study, we surveyed the current, published literature in the PubMed/MEDLINE, Web of Science, ProQuest, and EMBASE databases in order to address the impact of sterilization methods on the dimensional stability as well as mechanical and surface properties of 3D printed constructs.

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