Sterilization of bedside 3D-printed devices for use in the operating room

Abstract

The desire to rapidly integrate 3D printing technology by the surgical community, using both commercially available 3D printed custom devices and the emerging trend toward benchtop solutions. Sterilization guidelines for commercially available medical devices, is defined by manufacturers following industrial testing of approved sterilization protocols, whereas benchtop or bedside manufacture of devices by surgical units wishing to adopt and use 3D printed materials represents a grey area where regulation, standards or guidelines do not currently exist. To address this question, we have reviewed the literature. A search of Pubmed for search terms relating to sterilization and 3D printing was subjected to abstract and bibliographic review to identify relevant articles discussing sterilization of 3D printed devices or materials. Only a handful of authors in the peer reviewed literature have addressed the issue of sterilization of 3D printed materials. Commercial “white papers” provide the remainder of available information on the subject. In the quest to adapt and evolve our surgical practice toward the use of “benchtop” 3D-printing, the issue of sterilization was readily identified. The anecdotal experience reported here, with failed attempts using heat dependent sterilization together with evaluation of the literature and review of the available options has directed us toward low-temperature sterilization techniques as standard for sterilization of “in house” 3D printed Models. VHP as a widely institutionally available and employed technology would seem the logical choice as it is readily available, commonly used technique in hospital sterilization departments and quick , simple process compatible with a variety of materials.