Maintaining safety and efficacy for 3D printing in medicine.
Maintaining safety and efficacy for 3D printing in medicine.
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DOI：
10.1186/s41205-016-0009-5
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发表时间：
2017
影响因子：
3.7
通讯作者：
Rybicki FJ
中科院分区：
文献类型：
--
作者：
Christensen A;Rybicki FJ
3D打印在医学中的应用越来越多，越来越快，这引发了有关使用医学模型的安全性和有效性的问题。作者认识到，在医院环境中，医疗模型的制造向床旁生产的重要转变。这一变化，以及放射科医生作为这些服务的中心促进者的作用，开启了关于从临床用途到患者安全到监管影响等主题的讨论。该项目首先定义了3D打印对患者护理产生积极影响的三组患者。描述了每个组所需的步骤。我们就我们认为最合适的监管角色提供我们的意见，平衡安全性和有效性与该领域个人的自主权，以对医疗保健产生最大的积极影响。
The increased and accelerating utilization of 3D printing in medicine opens up questions regarding safety and efficacy in the use of medical models. The authors recognize an important shift towards point-of-care manufacturing for medical models in a hospital environment. This change, and the role of the radiologist as a central facilitator of these services, opens discussion about topics ranging from clinical uses to patient safety to regulatory implications. This project first defines three groups of patients for whom 3D printing positively impacts patient care. The steps needed for each group are described. We provide our opinions regarding the regulatory role that we feel is most appropriate, balancing safety and efficacy with the autonomy of individuals in the field to make the greatest positive impact on healthcare.