Ensuring the Sterility of 3-D Printed Objects
January 15, 2020 | Evaluations & Guidance
The swift growth of 3-D printing has brought about an unprecedented level of flexibility in the rapid manufacturing of objects with highly complicated designs. The broad array of 3-D printing methods and materials available enables the creation of objects with complex shapes and specialized features such as convoluted channels, internal voids, and customized surface finishes and porosities—features that may be difficult or impossible to create with other manufacturing methods.
Medical devices such as anatomic models, instrumentation, implants, prostheses, and accessories to procedures are being made using 3-D printing. (For further discussion, see our Guidance Article 3-D Printing in Medicine: An Introduction. ) Although it has been demonstrated that 3-D printing can produce sterile objects, it should be recognized that properly manufacturing a 3-D printed object is by no means simple, and adding the requirement that the final product must be sterile further complicates this already complex process. Each change of design or materials can affect the sterilizability of a 3-D printed object. Consequently, every step of the process must be carefully examined to ensure that nothing in the design or manufacture of the object is likely to make sterilization difficult or impossible, and that the object's physical integrity or function will not be impaired by the sterilization process.
Not all 3-D printing processes have been shown to result in sterile finished objects. However, certain materials and methods have demonstrated success in producing safe, effective, and sterile finished devices. Whether you're using a 3-D printing manufacturing process that produces sterile objects, or printing an object that...