Medical Technology Lab, Rizzoli Orthopaedic Institute, Via di Barbiano 1/10, 40136, Bologna, Italy.
J Mater Sci Mater Med. 2011 May;22(5):1137-46. doi: 10.1007/s10856-011-4303-x. Epub 2011 Apr 2.
Evaluation of medical devices retrieved after in vivo service provides unique evidence related to the physiological environment in which the biomaterials performed. This study implements a training procedure for evaluating polyethylene bearings of joint prostheses obtained after pre-clinical tests or explanted after in vivo function. A total of 161 damage regions on 45 bearings were evaluated by four observers. An illustrated Damage Mode Atlas was developed as a reference guide, inclusive of both photographs and concise written descriptions of 16 specific damage modes that are typical for polyethylene bearings. Utilizing the Damage Mode Atlas to train new researchers improved the damage pattern analysis, including more accurate identification of damage modes and improved inter-rater reliability. This Damage Mode Atlas is a useful supplementary tool for conducting Stage II non-destructive analysis of explanted polyethylene bearings used for joint replacement, in accordance with international guidelines for evaluating explanted medical devices.
对体内使用后的医疗器械进行评估，可提供与生物材料在生理环境中表现相关的独特证据。本研究实施了一种评估关节假体聚乙烯衬垫的方法，这些衬垫是在临床前测试后取出或在体内功能丧失后取出的。4 名观察者评估了 45 个轴承上的 161 个损伤区域。制作了一个损伤模式图谱，作为参考指南，其中包含 16 种特定损伤模式的照片和简明文字描述，这些损伤模式是聚乙烯轴承的典型损伤模式。使用损伤模式图谱培训新研究人员，可以提高损伤模式分析的准确性，包括更准确地识别损伤模式和提高评分者间的可靠性。该损伤模式图谱是根据评估植入医疗器械的国际指南，对用于关节置换的已植入聚乙烯轴承进行第二阶段非破坏性分析的有用辅助工具。
