Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices

Abstract

there are more clinical scenarios where anatomic models are beneficial in the procedure or operating room and this use requires sterilization. Patient specific 3D printed surgical guides improve patient outcomes via shorter procedure times and better post-operative results, and they are a prerequisite for many procedures. Sterilization prevents contamination of an established sterile field, and it mitigates patient risk when the medical team uses the surgical guide intraoperatively or interacts with the model during a procedure. When a hospital produces a 3D printed medical device for patient use, [4, 5] the provider assumes the role as the medical device's manufacturer, including the design, Background The hospital production of 3D printed, or additive manufacturing (AM), devices is becoming more prevalent. Patient specific 3D printed anatomical models are of tremendous value to medical practitioners for patient education , pre-operative surgical planning, surgeon training as well as interoperative and surgical use [2, 3]. With the increase in the number of evidence-based use cases, Abstract Background Low temperature vaporized hydrogen peroxide sterilization (VH2O2) is used in hospitals today to sterilize reusable medical devices. VH2O2 sterilized 3D printed materials were evaluated for sterilization, biocompatibility and material compatibility. Materials & methods Test articles were printed at Formlabs with BioMed Clear™ and BioMed Amber™, and at Stratasys with MED610™, MED615™ and MED620™. Sterilization, biocompatibility and material compatibility studies with 3D printed materials were conducted after VH2O2 sterilization in V-PRO™ Sterilizers. The overkill method was used to evaluate sterilization in a ½ cycle. Biocompatibility testing evaluated the processed materials as limited contact (< 24-hours) surface or externally communicating devices. Material compatibility after VH2O2 sterilization (material strength and dimensionality) was evaluated via ASTM methods and dimensional analysis. Results 3D printed devices, within a specific design window, were sterile after VH2O2 ½ cycles. After multiple cycle exposure, the materials were not cytotoxic, not sensitizing, not an irritant, not a systemic toxin, not pyrogenic and were hemo-compatible. Material compatibility via ASTM testing and dimensionality evaluations did not indicate any significant changes to the 3D printed materials after VH2O2 sterilization. Conclusion Low temperature vaporized hydrogen peroxide sterilization is demonstrated as a suitable method to sterilize 3D printed devices. The results are a subset of the data used in a regulatory submission with the US FDA to support claims for sterilization of 3D printed devices with specified materials, printers, and device design 1 .