Are the common sterilization methods completely effective for our in-house 3D printed biomodels and surgical guides?

In-hospital 3D printing is being implemented in orthopaedic departments worldwide, being used for additive manufacturing of fracture models (or even surgical guides) which are sterilized and used in the operating room. However, to save time and material, prints are nearly hollow, while 3D printers are placed in non-sterile rooms. The aim of our study is to evaluate whether common sterilization methods can sterilize the inside of the pieces, which would be of utmost importance in case a model breaks during a surgical intervention.

A total of 24 cylinders were designed and printed with a 3D printer in Polylactic Acid (PLA) with an infill density of 12%. Manufacturing was paused when 60% of the print was reached and 20 of the cylinders were inoculated with 0.4 mL of a suspension of S epidermidis ATTCC 1228 in saline solution at turbidity 1 McFarland. Printing was resumed, being all the pieces completely sealed with the inoculum inside. Posteriorly, 4 groups were made according to the chosen sterilization method: Ethylene Oxide (EtO), Gas Plasma, Steam Heat or non-sterilized (positive control). Each group included 5 contaminated cylinders and 1 non-contaminated cylinder as a negative control. After sterilization, the inside of the cylinders was cultured during 7 days.

We observed bacterial growth of just a few Forming Colony Units (FCU) in 4 out of 5 positive controls and in 2 out of 5 contaminated cylinders sterilized with Gas Plasma. We could not assess any bacterial growth in any of the EtO or Steam Heat samples or in any of the negative controls. Pieces sterilized under Steam Heat resulted completely deformed.

High temperatures reached during the procedure of additive manufacturing can decrease the bacterial load of the biomodels. However, there is a potential risk of contamination during the procedure. We recommend sterilization with EtO for in-hospital 3D-printed PLA hollow biomodels or guides. Otherwise, in case of using Gas Plasma, an infill of 100% should be applied.