FDA OKs 1st sterilization system for 3D-printed medical devices

The FDA recently greenlit the first device to sterilize 3D-printed products used in healthcare, including personalized surgical guides and anatomical models.

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The product is Steris’ V-PRO maX 2 Low Temperature Sterilization System, which is a sterilization system with a specialty cycle. 

It “can effectively sterilize surgical instruments such as patient-specific surgical guides … and anatomical models that are fabricated via 3D printing processes and that are intended for single-use during operative procedures,” the FDA said.

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