Security of 3D-printed polylactide acid piece sterilization in the operating room: a sterility test

Ferràs-Tarragó, Joan; Sabalza-Baztán, Oihana; Sahuquillo-Arce, José Miguel; Angulo-Sánchez, Manuel Ángel; Amaya-Valero, Jose Vicente; Ceinos, Carolina De-La-Calva; Baixauli-García, Francisco

doi:10.1007/s00068-020-01564-1

Cited by 11 publications

(8 citation statements)

References 33 publications

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“…The literature mainly refers to the evaluation of sterilization in terms of the sterility of medical devices, e.g., an evaluation of the sterilization process [23,24]. We are aware that all the sterilization methods we used should ensure the sterility of the designed implants; however, the results of our research show that some of them cause unacceptable structural changes to the implants based on PLA.…”

Section: Change In the Shape Of The Implantsmentioning

confidence: 98%

“…Due to the widespread availability and low implementation costs, steam sterilization was planned, despite various assessments of its impact on PLA-based implants [21,23,24].…”

Section: Preparation Implants For Studymentioning

confidence: 99%

“…That is why the final stage of manufacturing an implantable medical device is its sterilization. It should be taken into account that the sterilization process may affect on the properties of the biodegradable implant [21,23,24]. That is why the main goal of this work was to investigate the influence of sterilization methods on the structural and thermal properties of implants made by 3D printing from biodegradable polylactide and hydroxyapatite in a proportion of 9/1 by weight.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Sterilization on Bone Implants Based on Biodegradable Polylactide and Hydroxyapatite

Kucharska-Jastrząbek,

Chmal-Fudali,

Rudnicka

et al. 2023

Materials

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Medical devices intended for implantation must be, in accordance with the legal provisions in force in the European Union, sterile. The effect of sterilization on the structural and thermal properties of implants, made by 3D printing from biodegradable polylactide and hydroxyapatite in a proportion of 9/1 by weight, was evaluated. The implants were sterilized using three different methods, i.e., steam sterilization, ethylene oxide sterilization, and electron beam radiation sterilization. As a result of the assessment of the structural properties of the implants after sterilization, a change in the molecular weight of the raw material of the designed implants was found after each of the performed sterilization methods, while maintaining similar characteristics of the thermal properties and functional groups present.

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Section: Change In the Shape Of The Implantsmentioning

confidence: 98%

“…Due to the widespread availability and low implementation costs, steam sterilization was planned, despite various assessments of its impact on PLA-based implants [21,23,24].…”

Section: Preparation Implants For Studymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effect of Sterilization on Bone Implants Based on Biodegradable Polylactide and Hydroxyapatite

Kucharska-Jastrząbek,

Chmal-Fudali,

Rudnicka

et al. 2023

Materials

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“…First, fused deposition modeling (FDM) utilizes thermoplastic filaments introduced to heated extrusion heads via mechanical pressure 7 . A major medical benefit of FDM printers is that most materials can be sterilized for surgical applications 8–10 . Second, polyjet photopolymerization (PJP) involves the expulsion of liquid resin through several print nozzles.…”

Section: Introductionmentioning

confidence: 99%

“…7 A major medical benefit of FDM printers is that most materials can be sterilized for surgical applications. [8][9][10] Second, polyjet photopolymerization (PJP) involves the expulsion of liquid resin through several print nozzles. The resin is immediately cured with UV light.…”

mentioning

confidence: 99%

Accuracy of anatomic 3‐dimensionally printed canine humeral models

et al. 2022

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Objective: To evaluate the accuracy of various three-dimensional print (3DP) technologies using morphometric measurements.Study design: Experimental. Sample population: Cadaveric canine humeri and size-matched 3DP models.Methods: Fiduciary radiopaque markers were affixed to canine humeri of three different sizes (4, 13, 29 kg) at predetermined anatomical landmarks. 3DP models were created using one of three printers; desktop printers Form 3L and Ultimaker 5S, and industrial printer Objet Connex (n = 5/group/ printer). Marker based morphometric dimensions between cadavers and 3DP models were statistically compared using 2-factor repeated measures ANOVA followed by Tukey's post-hoc test (p < .05).Results: Bone size and printer type both significantly affected 3DP accuracy, with size having the larger effect (p < .0001 and p < .02, respectively). Regardless of printing technology, model size was smaller than native bone in most cases. At the humeral condylar level, the best accuracy was seen in the medium-sized humerus with the Ultimaker printer ([0.09 mm], p < .03).Accuracy was reduced in the proximal humerus in all groups. Conclusion: Desktop printers were overall more accurate than the industrial printer. Although significant differences were identified between models of different sizes, the submillimetric magnitude of these differences is unlikely to be clinically relevant.Clinical significance: While preoperative planning using 3DP models is becoming mainstream, accurate representation of the actual bone is critical. This study demonstrates that common desktop printers are suitable for this purpose.

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Circularity of Polymers Used in Hospitals: Current Status, Challenges, and Future Solutions

Zechel,

Schubert

et al. 2024

Advanced Sustainable Systems

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Polymers are applied extensively in the healthcare sector and enable a variety of different applications. In addition to packaging and personal protective equipment, a large number of medical devices are also coated with or consist of polymers. Today's medicine is therefore inconceivable without these materials. However, the huge challenge is to design these polymers more sustainable and to find new possibilities for the future of medicine with polymers. This study therefore highlights potential ways, in how polymers applied in the healthcare sector and in particular in hospitals can be utilized in a circular manner, but also indicates what risks and challenges this entails.

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Security of 3D-printed polylactide acid piece sterilization in the operating room: a sterility test

Cited by 11 publications

References 33 publications

Effect of Sterilization on Bone Implants Based on Biodegradable Polylactide and Hydroxyapatite

Effect of Sterilization on Bone Implants Based on Biodegradable Polylactide and Hydroxyapatite

Accuracy of anatomic 3‐dimensionally printed canine humeral models

Circularity of Polymers Used in Hospitals: Current Status, Challenges, and Future Solutions

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