Abstract
3D printing in the context of medical application can allow for visualization of patient-specific anatomy to facilitate surgical planning and execution. Intra-operative usage of models and guides allows for real time feedback but ensuring sterility is essential to prevent infection. The additive manufacturing process restricts options for sterilisation owing to temperature sensitivity of thermoplastics utilised for fabrication. Here, we review one of the largest single cohorts of 3D models and guides constructed from Acrylonitrile butadiene styrene (ABS) and utilized intra-operatively, following terminal sterilization with hydrogen peroxide plasma. We describe our work flow from initial software rendering to printing, sterilization, and on-table application with the objective of demonstrating that our process is safe and can be implemented elsewhere. Overall, 7% (8/114 patients) of patients developed a surgical site infection, which was not elevated in comparison to related studies utilizing traditional surgical methods. Prolonged operation time with an associated increase in surgical complexity was identified to be a risk factor for infection. Low temperature plasma-based sterilization depends upon sufficient permeation and contact with surfaces which are a particular challenge when our 3D-printouts contain diffusion-restricted luminal spaces as well as hollows. Application of printouts as guides for power tools may further expose these regions to sterile bodily tissues and result in generation of debris. With each printout being a bespoke medical device, it is important that the multidisciplinary team involved in production and application understand potential pitfalls to ensuring sterility as to minimize infection risk.
Highlights
Advances in 3D printing has allowed for this technology to become increasingly prevalent across medical disciplines
In detailing the design, printing, and sterilization of 3D printouts as well as infection-related outcomes amongst this sizable cohort, we demonstrate that our production process is safe for continuation and may be adopted elsewhere
Seven cases were excluded as printouts were not constructed from Acrylonitrile butadiene styrene (ABS), of which four cases utilized nylon, two case utilized polyetherimide (Ultem1010 CG), and one case utilized cobalt chrome
Summary
Advances in 3D printing has allowed for this technology to become increasingly prevalent across medical disciplines. In the context of facilitating surgical management, 3D-printed models can be an essential component of both pre-operative planning as well as intra-operative (2020) 6:7 whilst guides can be created to direct osteotomies as well as screw entry sites [1]. As 3D models/guides intended for intra-operative application can come into direct contact with patient tissues, it is critical that sterility is ensured [2]. Polymers with melting temperature below 132°C are not compatible with steam sterilization as this would result in deformation [2, 3]. Low temperature (65°C) sterilization methods suitable for 3D printouts include ethylene oxide (EtO) gas and hydrogen peroxide plasma, with the latter technique preferred due to its absence of toxic by-products [4]. Hydrogen peroxide plasma is generated following excitation beyond the gaseous phase and achieves sterility by inducing free-radical formation [5]
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