1st Sterilization System for 3D-Printed Medical Devices Given OK by the FDA
The FDA has recently granted approval for the inaugural device designed to sterilize 3D-printed medical products, encompassing items such as personalized surgical guides and anatomical models utilized in healthcare settings.
The approved product in question is the Steris' V-PRO maX 2 Low Temperature Sterilization System, a sterilization apparatus distinguished by its specialized cycle.
This sterilization system demonstrates the capability to proficiently sterilize surgical instruments, specifically catering to patient-specific surgical guides, as well as anatomical models. These objects are typically manufactured using 3D printing techniques and are intended for one-time use during operative procedures. The FDA has affirmed the device's efficacy in this regard.