White Paper

Sterilization Of 3D Printed Medical Devices

Source: Stratasys, Inc.

By David Espalin, Francisco Medina, Mireya Perez, and Ryan Wicker, The University of Texas at El Paso; and Terry Hoppe and Rob Winker, Stratasys

Fused Deposition Modeling™ (FDM® ) can be used to produce an array of medical devices; however, for such devices to be practical, they must be manufactured using sterilizable materials. Nine FDM materials were tested using four methods of sterilization: autoclave, ethylene oxide, hydrogen peroxide, and gamma radiation. Sterility testing was performed by incubating the samples in Tryptic Soy Broth for 14 days. The majority of the materials were sterilizable by all four methods while deformations were caused by autoclaving. Results from this research will allow medical staff to sterilize an FDM-manufactured device using a suitable method.

Fused Deposition Modeling (FDM) is an additive manufacturing technology that is used in industry for development of three-dimensional models. The automotive industry, for example, uses FDM to produce functional prototypes to make design and testing more efficient processes. Because of its ability to provide highly accurate models, FDM may offer many benefits to those wishing to use it for a range of medical applications. FDM can be used to build models that aid physicians in the surgical planning process or in the production of a surgical implant. It can be used to achieve a patient’s agreement prior to surgery by providing a preoperative simulation device. During surgery, an FDM model can act as an orienting aid or a template for resection. FDM can also be used to directly manufacture medical implants out of bioimplantable materials. However, such surgical devices and implants will come into direct contact with sterile body tissues and fluids, and therefore, must be manufactured of sterilizable materials.

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