定制式骨植入物及工具设计开发中的医工交互质量控制要点  

Quality control main point on medicine-engineering interaction during design and development of customized bone implant and instrument

作　　者：郭晓磊[1] 刘斌[1] GUO Xiaolei;LIU Bin(Center for Medical Device Evaluation(CMDE),China Food and Drug Administration(CFDA),Beijing 100081,China)

机构地区：[1]国家食品药品监督管理总局医疗器械技术审评中心,北京100081

出　　处：《中国医药导报》2018年第30期160-163,177,共5页China Medical Herald

基　　金：国家重点研发计划增材制造与激光制造重点专项项目(2017YFB1104105)

摘　　要：定制式骨植入物及其配套工具的设计开发过程中,医工交互工作贯穿始终,其设计开发的程序、策划、输入、输出、评审、验证、确认、转换、更改及相应文档的记录,均必须由临床医师根据诊断、手术、术后康复的需求进行深度主导。因此,需要对临床医师的行为有大量的系统化的控制,方能提高定制式假体及工具的研发质量。工程师(包括统计师)从生产企业研发体系的角度,将临床医师的需求转化为工程内容,对临床医师间的自由度进行限定和校正,确保产品性能稳定性。同时,定制式骨植入物及工具设计开发中的医工交互,影响着长期临床研究的特征,需要临床医师有更丰富的临床科研能力。Medicine-engineering interaction runs through the design and development(D&D)of customized bone implant and matching instrument.The procedure,planning,input,output,review,verification,validation,transfer,change and file documentation should be deeply mastered by clinician based on diagnosis,operation and postoperative rehabilitation.So that there should be considerable and systematic control on clinicians′action to enhance D&D quality of customized implant and instrument.Based on research and development system of manufacturing enterprise,engineers including statisticians transfer clinical need to engineering language,define and calibrate the inter-clinician degree of freedom,so as to ensure stability of product performance.At the same time,the medicine-engineering interaction has deep and further influence on characteristic of long-term clinical study,so that abundant capability of clinical research is necessary for the clinician.

关 键 词：定制 骨植入物 设计开发 医工交互 质量控制 

分 类 号：R678.34[医药卫生—外科学]