美国。Food and Drug Administration（FDA）发布了公开呼吁对其设计的未来防止监管框架的评论，以确保3D打印的医疗设备的质量。
以一种形式出版discussion paper，FDA文档不仅概述了如何管理3D打印的方法，还确定了其最终用途的挑战，并提供了修订的潜在规则集。FDA并没有担任指导，而是说这些建议是为了“提出问题”，因此现在要求医疗3D印刷行业的反馈，以帮助未来的法规。
“The 3D printing of medical devices is at the forefront of innovation and health care,” said William Maisel and Ed Margerrison of the FDA’sOSELandCDRHdivisions. “The discussion paper we’re sharing today provides insight into our perspective of the benefits and challenges of 3D printing at hospitals and other points of care, and presents a potential approach for regulatory oversight.”
A medtech call to action
根据FDA的说法，在医院和手术中采用3D打印允许快速生产患者特定的设备，例如解剖模型以及其他护理医疗工具。该人体的论文还强调了该技术在帮助解决供应链问题方面的作用，例如在大流行的早期阶段，全球在世界各地看到的Covid-19齿轮的短缺。
目前，这样的3D打印的医疗设备由FD&C Act, with the FDA’s paper focused on those where the Center for Devices and Radiological Health (CDRH) holds jurisdiction over their regulation. In the past, the legislation has been used to clear everything fromOnkos手术’s3D打印的生物环项圈to桌面金属Flexcera Base resins, paving the way for their clinical adoption.
However, the FDA’s paper also accepts the existence of challenges to the wider roll-out of such devices at scale, including the fact that providers are unlikely to have the same level of production knowledge as traditional manufacturers. Therefore, to ensure instruments remain safe and fit for purpose, it’s now seeking the feedback of the latter on what it calls an “initial outline for a regulatory approach.”
触发医学辩论
Within its discussion paper, the FDA underlines how differences between a 3D printer manufacturer’s and point of care device producer’s technologies and training can lead to varying end-product quality. These mismatches range from aspects like internal processes and clinical practise guidelines, right through to the availability of post-processing equipment, which can be safety-critical in certain cases.
To get around these potential pitfalls, the body has outlined a five-step basis on which a revised approach to regulating point of care 3D printed devices can be built. Overall, the FDA has emphasized that it intends to “employ a risk-based approach” to the process, taking into account that some healthcare providers may not be capable of managing these dangers alongside their daily duties.
The organization also says that changes in the location of a device’s manufacture shouldn’t affect its ability to meet specifications, while training should be in place by the time clinicians adopt any advanced technology. Interestingly, the FDA has called for the “least burdensome approach” to achieving this as well, and suggests that “relying on existing standards and processes” could be key in this respect.
To further stimulate debate about what future regulation could look like, the FDA has added three hypotheticals to its paper, which it’s now encouraging a public response to. In the first of these, a healthcare provider installs a 3D printer on-site, in the second, the hospital or surgery adopts related processes too, and in the last, a nearby service bureau is contracted to produce medical devices and deliver them.
Each situation, in the eyes of the FDA, raises questions surrounding the reporting of adverse effects, how changes in design can be accommodated for in regulatory terms and which devices can be categorized ‘low-risk.’ In addition to these twelve related questions, the paper also poses additional discussion points, including room for feedback on the future use of 3D printing to produce COVID-19 equipment.
最终，FDA表示，“所有利益相关者之间的沟通”是“创造技术增长和发展环境”的关键。尽管该机构同意目前正在进行这项工作，但它补充说，3D打印正在迅速发展，以至于当前的法规在未来几年中可能不合适，因此它旨在创建修订后的规则集，“平衡创新与监管监督”。
“重要的是,这个讨论论文的发布is intended to foster discussion and solicit feedback from the public,” conclude Maisel and Margerrison. “This feedback will help build the foundation for an appropriate regulatory approach for 3D printing at the point of care, personalized care for patients and new innovations in this area.”
那些有兴趣阅读FDA讨论paper in full and contributing to its call for feedback, can do sohere. The initiative is set to run for 60 days until February 7, 2022, and while the organization hasn’t provided a publication date for the results, it says it “expects to publish draft and final guidance on this topic in the future.”
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Featured image shows a sign outside FDA headquarters. Photo via the University of Oxford.
