A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively

Journal Title: 3D Printing in Medicine - Year 2020, Vol 6, Issue

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.

Authors and Affiliations

Graham Ka-Hon Shea, Kenneth Lap-Kei Wu, Iris Wai-Sum Li, Man-Fai Leung, Ada Lai-Ping Ko, Lane Tse, Sherby Suet-Ying Pang, Kenny Yat-Hong Kwan, Tak-Man Wong, Frankie Ka-Li Leung, Christian Xinshuo Fang

Keywords

Related Articles

Preoperative planning and tracheal stent design in thoracic surgery: a primer for the 2017 Radiological Society of North America (RSNA) hands-on course in 3D printing

All data used within this Technical Note is included as Additional files 1, 2 and 3. Free trial versions of the Materialise software are available from Materialise website.

Patient-specific 3D printed and augmented reality kidney and prostate cancer models: impact on patient education

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Maintaining safety and efficacy for 3D printing in medicine

The increased and accelerating utilization of 3D printing in medicine opens up questions regarding safety and efficacy in the use of medical models. The authors recognize an important shift towards point-of-care manufact...

Simulation of semilunar valve function: computer-aided design, 3D printing and flow assessment with MR

The structure of the valve leaflets and sinuses are crucial in supporting the proper function of the semilunar valve and ensuring leaflet durability. Therefore, an enhanced understanding of the structural characteristics...

Download PDF file
  • EP ID EP680662
  • DOI  10.1186/s41205-020-00061-w
  • Views 46
  • Downloads 0

How To Cite

Graham Ka-Hon Shea, Kenneth Lap-Kei Wu, Iris Wai-Sum Li, Man-Fai Leung, Ada Lai-Ping Ko, Lane Tse, Sherby Suet-Ying Pang, Kenny Yat-Hong Kwan, Tak-Man Wong, Frankie Ka-Li Leung, Christian Xinshuo Fang (2020). A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively. 3D Printing in Medicine, 6(), -. https://europub.co.uk./articles/-A-680662