Quality and safety in medical 3D printing

Georgantis, Georgios; Kostidi, Evanthia; Dagkinis, Ioannis; Papachristos, Dimitrios; Nikitakos, Nikitas

doi:10.1016/b978-0-323-66164-5.00005-2

Cited by 5 publications

(7 citation statements)

References 23 publications

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“…The complexity and unpredictability of the 3D organ printing process, including issues such as biomaterial degradation, tissue integration, biocompatibility, and continuous tissue synthesis during material degradation, pose significant challenges. The potential for irreversible risks, such as cancer and dislodgement and migrations of the implant, is a further complication that defies easy resolution [ 12 , 13 , 16 , 18 , 21 , 22 ]. The impossibility of testing the safety of the organ before implantation, due to the organ being custom-made for the person in whom it will be implanted and therefore unable to be tested on others, is a further obstacle.…”

Section: Discussionmentioning

confidence: 99%

“…Within the regulatory structure of the European Union, a product incorporating living cells or tissues is viewed as primarily exerting its effect through pharmacological, immunological, or metabolic actions. This perspective is held by a working group within the European Commission, which has classified bioprinted items as advanced therapy medicinal products, in accordance with Regulation (EC) 1394/2007 [ 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ]. Both the FDA and EMA have an existing framework for Advanced Therapy Medicinal Products (ATMPs), which could potentially include 3D bioprinted organs in the future.…”

Section: Discussionmentioning

confidence: 99%

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Three-Dimensional Bioprinting of Human Organs and Tissues: Bioethical and Medico-Legal Implications Examined through a Scoping Review

Ricci,

Gibelli,

Sirignano

2023

Bioengineering

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Three-dimensional bioprinting is a rapidly evolving technology that holds the promise of addressing the increasing demand for organs, tissues, and personalized medicine. By employing computer-aided design and manufacturing processes, 3D bioprinting allows for the precise deposition of living cells, biomaterials, and biochemicals to create functional human tissues and organs. The potential applications of this technology are vast, including drug testing and development, disease modeling, regenerative medicine, and ultimately, organ transplantation. However, as with any groundbreaking technology, 3D bioprinting presents several ethical, legal, and regulatory concerns that warrant careful consideration. As the technology progresses towards clinical applications, it is essential to address these challenges and establish appropriate frameworks to guide the responsible development of 3D bioprinting. This article, utilizing the Arksey and O’Malley scoping review model, is designed to scrutinize the bioethical implications, legal and regulatory challenges, and medico-legal issues that are intertwined with this rapidly evolving technology.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Three-Dimensional Bioprinting of Human Organs and Tissues: Bioethical and Medico-Legal Implications Examined through a Scoping Review

Ricci,

Gibelli,

Sirignano

2023

Bioengineering

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“…Many of the potential technical risks in the tool creation process may also affect medical 3D printing generally (for example, those related to medical imaging and 3D printing). These errors are qualitatively induced if they are due to human error, or quantitatively induced if they are the result of technical failures or limitations [55,56]. Errors by surgeons or radiologists in selecting the appropriate patient image are qualitatively induced errors, while imaging artefacts in patient scans are quantitatively induced errors.…”

Section: Ethical Risks In the Tool Creation Processmentioning

confidence: 99%

“…Qualitative and quantitively induced errors may be addressed by a clear distribution of role responsibilities throughout the process [56]. To address the technical risks introduced by the computational design system, there should be clearly assigned responsibilities for confirming that the input for the system is what it expects, and that the design it produces appears suitable for the tool's intended use.…”

Section: Ethical Risks In the Tool Creation Processmentioning

confidence: 99%

Ethical risks of AI-designed products: bespoke surgical tools as a case study

2022

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An emerging use of machine learning (ML) is creating products optimised using computational design for individual users and produced using 3D printing. One potential application is bespoke surgical tools optimised for specific patients. While optimised tool designs benefit patients and surgeons, there is the risk that computational design may also create unexpected designs that are unsuitable for use with potentially harmful consequences. We interviewed potential stakeholders to identify both established and unique technical risks associated with the use of computational design for surgical tool design and applied ethical risk analysis (eRA) to identify how stakeholders might be exposed to ethical risk within this process. The main findings of this research are twofold. First, distinguishing between unique and established risks for new medical technologies helps identify where existing methods of risk mitigation may be applicable to a surgical innovation, and where new means of mitigating risks may be needed. Second, the value of distinguishing between technical and ethical risks in such a system is that it identifies the key responsibilities for managing these risks and allows for any potential interdependencies between stakeholders in managing these risks to be made explicit. The approach demonstrated in this paper may be applied to understanding the implications of new AI and ML applications in healthcare and other high consequence domains.

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“…The increasing use of additive manufacturing in pharmaceutical, dentistry and medicinal sectors have pointed towards the need for various legal considerations. According to Kririkos [44], they can be grouped as:…”

Section: Legal Aspectmentioning

confidence: 99%

Transfiguring Healthcare: Three-Dimensional Printing in Pharmaceutical Sciences; Trends during COVID-19: A Review

Siree

Amulya

Kumar

et al. 2021

JPRI

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Three-dimensional (3D) printing is a unique technique that allows for a high degree of customisation in pharmacy, dentistry and in designing of medical devices. 3D printing satiates the increasing exigency for consumer personalisation in these fields as custom-made medicines catering to the patients’ requirements are novel advancements in drug therapy. Current research in 3D printing indicates towards reproducing an organ in the form of a chip; paving the way for more studies and opportunities to perfecting the existing technique. In addition, we will also attempt to shed light on the impact of 3D printing in the COVID-19 pandemic.

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Quality and safety in medical 3D printing

Cited by 5 publications

References 23 publications

Three-Dimensional Bioprinting of Human Organs and Tissues: Bioethical and Medico-Legal Implications Examined through a Scoping Review

Three-Dimensional Bioprinting of Human Organs and Tissues: Bioethical and Medico-Legal Implications Examined through a Scoping Review

Ethical risks of AI-designed products: bespoke surgical tools as a case study

Transfiguring Healthcare: Three-Dimensional Printing in Pharmaceutical Sciences; Trends during COVID-19: A Review

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