Longevity Expectations for Polymers in Medical Devices Demand New Approaches to Evaluating Their Biostability,ACS Macro Letters

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Longevity Expectations for Polymers in Medical Devices Demand New Approaches to Evaluating Their Biostability
ACS Macro Letters ( IF 5.1 ) Pub Date : 2020-11-23 , DOI: 10.1021/acsmacrolett.0c00685
K. A. Chaffin ₁

Affiliation

Ten years after a new poly(dimethylsiloxane)urethane material was introduced as part of a long-term medical device implant, an unexpectedly high rate of in-service degradation was observed. The chemical signatures of molecular degradation in the materials were not identified during the comparatively short preclinical assessment of biostability. This outcome highlights the need to transform the assessment of biostability for new materials used in long-term implanted medical devices to protocols that rely more heavily on accelerated in vitro testing. The industry has over-relied on in vivo exposure to assess the stability of a material due to the perceived complexities associated with the accurate simulation of the biological environment. Strategically designed accelerated in vitro testing can provide important insights into the long-term biostability of materials: insights that cannot be readily gleaned through the in vivo studies that dominate current regulatory guidelines. Real-time validation of previously published accelerated data combined with clinical observations substantiates the accelerated approach and creates a compelling case for shifting the emphases in biostability assessment, especially for devices that have anticipated lifespans that exceed a decade.

中文翻译：

对医疗器械中聚合物寿命的期望要求评估其生物稳定性的新方法

在将新的聚二甲基硅氧烷氨基甲酸乙酯材料作为长期医疗设备植入物的一部分引入十年后，发现使用中的降解率出乎意料地高。在相对较短的生物稳定性临床前评估中，未鉴定出材料中分子降解的化学特征。这一结果突出表明，有必要将长期植入医疗设备中使用的新材料的生物稳定性评估转换为更依赖于加速体外测试的方案。由于与生物环境的精确模拟相关的感知复杂性，该行业过度依赖于体内暴露来评估材料的稳定性。通过战略性设计的加速体外测试可以为材料的长期生物稳定性提供重要的见识：无法通过在当前监管指南中占主导地位的体内研究容易地获得见识。先前发布的加速数据的实时验证与临床观察相结合，证实了加速方法的成功，并为改变生物稳定性评估的重点创造了令人信服的案例，尤其是对于那些预期寿命超过十年的设备而言。

更新日期：2020-12-15

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