新型骨植入器械监管科学研究探讨:以增材制造聚醚醚酮产品为例

Research on Regulatory Science for New Orthopedic Implant Devices:Taking Additive Manufacturing PEEK Device as an Example

目的:以增材制造聚醚醚酮骨植入器械为例,介绍新型骨植入医疗器械监管科学研究进展,保证人民用械安全和可及。方法:分别详细阐述了增材制造聚醚醚酮生产质量体系控制,以及骨植入器械性能验证和确认的各项重点要求。结果与结论:生产质量体系中需要重点关注聚醚醚酮原材料理化性能、增材制造工艺中温度控制和打印路径。同时,需要针对终产品开展全面的非临床和临床研究,以确保骨植入器械的安全性和有效性。

Objective: Taking the additive manufacturing PEEK orthopedic implant device as an example, to introduce the research progress on the regulatory science for new orthopedic implant medical devices, so as to ensure the safety and accessibility of medical device. Methods: The production quality system of additive manufacturing PEEK device and the key requirements for the performance verification and validation of orthopedic implant devices were described in detail. Results and Conclusion: In the production quality system,the physical and chemical properties of PEEK raw materials, the temperature control and printing path in the additive manufacturing process need to be focused on. At the same time, comprehensive non-clinical and clinical research on fi nal products are required to ensure the safety and ef fectiveness of bone implant devices.