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

Aguado-Maestro, I.; Frutos-Serna, M. De; González-Nava, A.; Santos, Arsénio; García-Alonso, Manuel

doi:10.1016/j.injury.2020.09.014

Cited by 32 publications

(41 citation statements)

References 21 publications

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“…There are also specific studies on the effect of autoclave sterilization on PLA models, scaffolds or devices made with 3D printing. Aguado-Maestro confirms that autoclaving completely deformed their PLA cylinders in size or shape, not being an exact replica of the original STL file created by computer [ 15 ]. Boursier et al also studied the effect of the autoclave sterilization on 3D-printed bone models by measuring changes in size.…”

Section: Heat-based Sterilization Methodsmentioning

confidence: 99%

“…As shown in Figure 2 , sterilization by ethylene oxide causes a total loss of orientation of the fibres and a change in shape from cylindrical to ribbon-like structures, combined with a 28% higher polymer crystallinity, that could have a negative effect on cell adhesion and proliferation. In contrast to these studies, and focussed on 3D manufacturing, Aguado-Maestro recommends EtO to sterilize non-solid surgical guides and biomodels made with PLA because, compared with steam heat and gas plasma, the EtO treatment was the only one without any Colony Forming Unit (CFU) or visual deformations [ 15 ]. Nevertheless, a more detailed analysis of physical-chemical properties and toxicity is required.…”

Section: Chemical and Plasma-based Sterilization Methodsmentioning

confidence: 99%

“…Aguado-Maestro did not recommend gas plasma (without specifying which gas they used) for sterilising non-solid surgical guides and biomodels made of PLA as they detected Colony Forming Units (CFU), probably due to the lower penetrability of this technique compared to EtO. Gas Plasma could be used in solid models or in devices printed under sterile atmospheric conditions, such as under a laminar flow hood [ 15 ].…”

Section: Chemical and Plasma-based Sterilization Methodsmentioning

confidence: 99%

“…In the reviewed literature ( Table 3 ), several publications can be found that demonstrate the intrinsic sterility of 3D-printed devices using fused deposition modelling manufacturing (FDM) [ 15 , 38 , 55 ]. The pieces could be manufactured and simultaneously sterilized to be used in biomedical applications, lowering costs and without damaging them by other sterilization methods [ 15 ].…”

Section: New Approaches and Alternativesmentioning

confidence: 99%

“…One of the most widely used techniques is the fused deposition modelling (FDM) technique, that allows the rapid manufacture of customised structures with complex geometries and excellent reproducibility, allowing a personalised medicine. It is already applied in numerous domains both in research and in surgical practices, such as patient-specific implants, surgical guides (cranial and maxillofacial surgery) and surgical tools, improving medical outcomes and decreasing radiation exposure for patients [ 15 , 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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How to Sterilize Polylactic Acid Based Medical Devices?

et al. 2021

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How sterilization techniques accurately affect the properties of biopolymers continues to be an issue of discussion in the field of biomedical engineering, particularly now with the development of 3D-printed devices. One of the most widely used biopolymers in the manufacture of biomedical devices is the polylactic acid (PLA). Despite the large number of studies found in the literature on PLA devices, relatively few papers focus on the effects of sterilization treatments on its properties. It is well documented in the literature that conventional sterilization techniques, such as heat, gamma irradiation and ethylene oxide, can induced damages, alterations or toxic products release, due to the thermal and hydrolytical sensitivity of PLA. The purposes of this paper are, therefore, to review the published data on the most common techniques used to sterilize PLA medical devices and to analyse how they are affecting their physicochemical and biocompatible properties. Emerging and alternative sterilization methods for sensitive biomaterials are also presented.

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Section: Heat-based Sterilization Methodsmentioning

confidence: 99%

Section: Chemical and Plasma-based Sterilization Methodsmentioning

confidence: 99%

Section: Chemical and Plasma-based Sterilization Methodsmentioning

confidence: 99%

Section: New Approaches and Alternativesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

How to Sterilize Polylactic Acid Based Medical Devices?

et al. 2021

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Invitro biocompatibility evaluation of a heat‐resistant 3D printing material for use in customized cell culture devices

Winkler

Meyer

Heuer

et al. 2022

Engineering in Life Sciences

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Additive manufacturing (3D printing) enables the fabrication of highly customized and complex devices and is therefore increasingly used in the field of life sciences and biotechnology. However, the application of 3D-printed parts in these fields requires not only their biocompatibility but also their sterility. The most common method for sterilizing 3D-printed parts is heat steam sterilizationbut most commercially available 3D printing materials cannot withstand high temperatures. In this study, a novel heat-resistant polyacrylate material for highresolution 3D Multijet printing was evaluated for the first time for its resistance to heat steam sterilization and in vitro biocompatibility with mouse fibroblasts (L929), human embryonic kidney cells (HEK 293E), and yeast (Saccharomyces cerevisiae (S. cerevisiae)). Analysis of the growth and viability of L929 cells and the growth of S. cerevisiae confirmed that the extraction media obtained from 3D-printed parts had no negative effect on the aforementioned cell types, while, in contrast, viability and growth of HEK 293E cells were affected. No different effects of the material on the cells were found when comparing heat steam sterilization and disinfection with ethanol (70%, v/v). In principle, the investigated material shows great potential for high-resolution 3D printing of novel cell culture systems that are highly complex in design, customized and easily sterilizable-however, the biocompatibility of the material for other cell types needs to be re-evaluated.

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The effect of 3‐D printed polylactic acid scaffold with and without hyaluronic acid on bone regeneration

Yun

Lee

et al. 2022

Journal of Periodontology

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Background: Three-dimensional (3D) technology has been suggested to overcome several limitations in guided bone regeneration (GBR) procedures because 3D-printed scaffolds can be easily molded to patient-specific bone defect site. This study aimed to investigate the effect of 3-D printed polylactic acid (PLA) scaffolds with or without hyaluronic acid (HA) in a rabbit calvaria model. Methods:A calvaria defect with a diameter of 15 mm was created in 30 New Zealand white rabbits. The rabbits were randomly allocated into three groups including no graft group (control, n = 10), 3D printed PLA graft group (3D-PLA, n = 10), and 3D printed PLA with hyaluronic acid graft group (3D-PLA/HA, n = 10). Five animals in each group were sacrificed at 4 and 12 weeks after surgery. Microcomputed tomography and histologic and histomorphometric analyses were performed. Results: Over the whole examination period, no significant adverse reactions were observed. There were no statistically significant differences in bone volume (BV) /tissue volume (TV) among the three groups at 4 weeks. However, the highest BV/TV was observed in the 3D-PLA/HA group at 12 weeks. The new bone area for control, 3D-PLA, and 3D-PLA/HA showed no statistical differences at 4 weeks. However, the value was significantly higher in the 3D-PLA and 3D-PLA/HA groups compared to the control group at 12 weeks. Conclusion:The 3D printed PLA scaffolds was biocompatible and integrated well with bone defect margin. They were also provided the proper space for new bone formation. Therefore, 3D printed PLA/HA might be a potential tool to enhance bone augmentation.

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

Cited by 32 publications

References 21 publications

How to Sterilize Polylactic Acid Based Medical Devices?

How to Sterilize Polylactic Acid Based Medical Devices?

Invitro biocompatibility evaluation of a heat‐resistant 3D printing material for use in customized cell culture devices

The effect of 3‐D printed polylactic acid scaffold with and without hyaluronic acid on bone regeneration

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