Biomed Instrum Technol. 2023;57(3):98-105. doi: 10.2345/0899-8205-57.3.98. Epub 2023 Aug 25.
The effect of sterilization on bacterial endotoxin is receiving greater attention within the medical device industry. Contributing factors to this increased attention include the growing popularity of transferring devices among sterilization modalities and the focus on aspects of microbiological quality other than sterilization. This systematic review examined the effects of sterilization on bacterial endotoxin, with attention drawn to industry standards and regulations to elucidate whether such documents are aligned with published data. In summary, numerous experiments have shown a reduction in pyrogenicity and/or limulus amebocyte lysate reactivity of endotoxin following sterilization, whereas a number of publications and industry standards have claimed (without data or references) that sterilization does not inactivate endotoxin. The results of this review would be useful for device manufacturers when selecting a sterilization modality or deciding whether to test for endotoxin pre- vs poststerilization, as well as for standards developers and regulators in aligning standards and regulations with peer-reviewed data.
医疗器械行业越来越关注灭菌对细菌内毒素的影响。导致人们对此关注度增加的因素包括：灭菌方式中器械转移的日益普及，以及除灭菌以外的微生物质量方面的关注。本系统综述检查了灭菌对细菌内毒素的影响，同时关注了行业标准和法规，以阐明这些文件是否与已发表的数据一致。总之，大量实验表明，灭菌后热原和（或）鲎试剂反应性内毒素减少，而许多出版物和行业标准声称（无数据或参考文献），灭菌不会使内毒素失活。当器械制造商选择灭菌方式或决定是否对灭菌前和灭菌后的内毒素进行检测时，本综述的结果将非常有用，同时对于标准制定者和监管机构将标准和法规与同行评审数据保持一致也非常有用。
