Implementation of a digital chain for the design and manufacture of implant-based surgical guides in a hospital setting

Pajot, T.; Bénichou, L.; Moreau, E.; Tallon, V.; Méningaud, Jean-Paul; Khonsari, R.H.; Ketoff, Serge

doi:10.1016/j.jormas.2019.09.009

Cited by 4 publications

(7 citation statements)

References 11 publications

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“…Such advents, when integrated with medical additive manufacturing (AM) or 3D printing, facilitates the transfer of virtual planning to the surgical site through patient-specific surgical/cutting guides [3][4][5][6]. Lately, several hospitals across the globe have integrated in-house 3D printing into their daily clinical practices to achieve personalized patient treatments [7,8].…”

Section: Introductionmentioning

confidence: 99%

Effects of Steam Sterilization on 3D Printed Biocompatible Resin Materials for Surgical Guides—An Accuracy Assessment Study

Sharma

Cao

Msallem

et al. 2020

JCM

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Computer-assisted surgery with three-dimensional (3D) printed surgical guides provides more accurate results than free-hand surgery. Steam sterilization could be one of the factors that affect the dimensions of surgical guide resin materials, leading to inaccuracies during surgeries. The purpose of this study was to evaluate the effects of steam sterilization on the dimensional accuracy of indication-specific hollow cube test bodies, manufactured in-house using Class IIa biocompatible resin materials (proprietary and third-party). To evaluate the pre- and post-sterilization dimensional accuracy, root mean square (RMS) values were calculated. The results indicate that, in all the groups, steam sterilization resulted in an overall linear expansion of the photopolymeric resin material, with an increase in outer dimensions and a decrease in inner dimensions. The effects on the dimensional accuracy of test bodies were not statistically significant in all the groups, except PolyJet Glossy (p > 0.05). The overall pre- and post-sterilization RMS values were below 100 and 200 µm, respectively. The highest accuracies were seen in proprietary resin materials, i.e., PolyJet Glossy and SLA-LT, in pre- and post-sterilization measurements, respectively. The dimensional accuracy of third-party resin materials, i.e., SLA-Luxa and SLA-NextDent, were within a comparable range as proprietary materials and can serve as an economical alternative.

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Section: Introductionmentioning

confidence: 99%

Effects of Steam Sterilization on 3D Printed Biocompatible Resin Materials for Surgical Guides—An Accuracy Assessment Study

Sharma

Cao

Msallem

et al. 2020

JCM

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“…Confusion about the concept of the "manufacturer" of the "product"-even without the issue of CAD files-was mentioned in several papers (Colleen et al, 2015;Knight, 2016;Nissan, 2016;Beck and Jacobson, 2017;Pajot et al, 2019;Dagne, 2020;Manero et al, 2020).…”

Section: Resultsmentioning

confidence: 99%

Legal issues and underexplored data protection in medical 3D printing: A scoping review

Pettersson

Ballardini²,

Mimler³

et al. 2023

Front. Bioeng. Biotechnol.

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Introduction: 3D printing has quickly found many applications in medicine. However, as with any new technology the regulatory landscape is struggling to stay abreast. Unclear legislation or lack of legislation has been suggested as being one hindrance for wide-scale adoption.Methods: A scoping review was performed in PubMed, Web of Science, SCOPUS and Westlaw International to identify articles dealing with legal issues in medical 3D printing.Results: Thirty-four articles fulfilling inclusion criteria were identified in medical/technical databases and fifteen in the legal database. The majority of articles dealt with the USA, while the EU was also prominently represented. Some common unresolved legal issues were identified, among them terminological confusion between custom-made and patient-matched devices, lack of specific legislation for patient-matched products, and the undefined legal role of CAD files both from a liability and from an intellectual property standpoint. Data protection was mentioned only in two papers and seems an underexplored topic.Conclusion: In this scoping review, several relevant articles and several common unresolved legal issues were identified including a need for terminological uniformity in medical 3D printing. The results of this work are planned to inform our own deeper legal analysis of these issues in the future.

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“…To rule out the possibility that the RNA could be degraded in contact with the PLA when the samples were not processed immediately. We did the extraction after 1, 24, and 48 h after collection, 23 according to the guidelines from WHO. The amplification of the gene RNAse P was carried out by the qRT-PCR and the results (Fig.…”

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…20,22 Before the clinical use of the 3D swab prototypes, medical requirements were met, such as a sterilization process with ethylene oxide and tests for the absence of skin reactivity. 2,23 It is important to mention that in this study we considered as controls, the swabs used in the HGM for sampling patients with suspected COVID-19, these swabs are manufactured with rayon on the collecting head and are commonly used in public hospitals in the country. 3D-printed swabs are products that can be positioned in the market because they are easy to produce and can improve costs by being competitive and functional for OP and NP sampling, considering they are a good option to meet this need worldwide.…”

Section: Discussionmentioning

confidence: 99%

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Validation of 3D-Printed Swabs for Sampling in SARS-CoV-2 Detection: A Pilot Study

et al. 2022

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In this pilot study, we characterize and evaluate 3D-printed swabs for the collection of nasopharyngeal and oropharyngeal secretion samples for the SARS-CoV-2 detection. Swabs are made with the fused deposition modeling technique using the biopolymer polylactic acid (PLA) which is a medical-grade, biodegradable and low-cost material. We evaluated six swabs with mechanical tests in a laboratory and in an Adult Human Simulator performed by healthcare professionals. We proved the adequacy of the PLA swab to be used in the gold standard reverse transcriptase-polymerase chain reaction (qRT-PCR) for viral RNA detection. Then, we did in vitro validation for cell collection using the 3D-printed swabs and RNA extraction for samples from 10 healthy volunteers. The 3D-printed swabs showed good flexibility and maneuverability for sampling and at the same time robustness to pass into the posterior nasopharynx. The PLA did not interfere with the RNA extraction process and qRT-PCR test. When we evaluated the expression of the reference gene (RNase P) used in the SARS-CoV-2 detection, the 3D-printed swabs showed good reproducibility in the threshold cycle values (Ct = 23.5, range 19–26) that is comparable to control swabs (Ct = 24.7, range 20.8–32.6) with p value = 0.47. The 3D-printed swabs demonstrated to be a reliable, and an economical alternative for mass use in the detection of SARS-CoV-2.

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Implementation of a digital chain for the design and manufacture of implant-based surgical guides in a hospital setting

Cited by 4 publications

References 11 publications

Effects of Steam Sterilization on 3D Printed Biocompatible Resin Materials for Surgical Guides—An Accuracy Assessment Study

Effects of Steam Sterilization on 3D Printed Biocompatible Resin Materials for Surgical Guides—An Accuracy Assessment Study

Legal issues and underexplored data protection in medical 3D printing: A scoping review

Validation of 3D-Printed Swabs for Sampling in SARS-CoV-2 Detection: A Pilot Study

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