三种包装材料对超大超重骨科器械包灭菌湿包的影响

Influence of three packaging materials on wet packaging of super large overweight orthopedic equipment package

目的对比医用无纺布、普通棉布、新型纺织品三种不同包装材料应用于超大超重骨科器械灭菌的湿包情况,评价不同包装材料对灭菌效果的影响,寻找既能符合YY/T 0698《最终灭菌医疗器械包装材料》相关要求,又能改善超大超重器械包灭菌后易湿包的包装材料。方法将大于7 kg的不同重量8、9、10、11、12、13 kg的骨科手术器械分别用三种包装材料进行包装,通过预真空压力蒸汽灭菌后,每包器械至少连续三次进行灭菌效果监测。根据《外来医疗器械清洗消毒及灭菌技术操作指南》相关要求,每次灭菌后冷却>30 min,分别用目测法观察三种包装材料包外包内是否存在潮湿、水珠等湿包现象,并进行灭菌前后称重法对比,对比金属器械包重量是否>0.2%,同时,每个灭菌包均进行物理参数检测、化学监测及生物监测。结果每个器械包的灭菌物理参数检测、化学监测及生物监测均合格;用普通棉布包装8 kg器械时,即出现湿包现象,湿包率为83.33%,用医用无纺布包装11 kg器械时,出现湿包现象,湿包率为50.00%,而新型纺织品包装的器械13 kg均未出现湿包现象。结论三种包装材料应用于超大超重骨科器械包装中,普通棉布较易引起湿包,医用无纺布次之,新型纺织品包装材料预防湿包效果最好。

OBJECTIVE To compare the application of medical non-woven fabrics,ordinary cotton fabrics and new textiles in the wet package sterilization of super overweight orthopedic instruments,and to evaluate the influence of different packaging materials on the sterilization effect,in order to find the packaging materials that can not only meet the relevant requirements of YY/T 0698"Final Sterilization Medical Device Packaging Materials",but also improve the packaging materials that are easy to wet after sterilization of super large and overweight device kits.METHODS The orthopaedic surgical instruments larger than 7 kg with different weights of 8,9,10,11,12 and 13 kg were packed with three kinds of packaging materials,respectively.After sterilization by pre-vacuum autoclaved steam,sterilization effect of each package of instruments should be monitored at least three times consecutively.According to the relevant requirements of the"Technical Operation Guide for Cleaning,Disinfection and Sterilization of Foreign Medical Devices",after cooling>30 minutes,the outer layer of the three packaging materials were observed by naked eyes to find whether package was wet or had any water drops.The packages’weight was compared before and after sterilization by using weighing method to find out whether the weight of the metal instrument sets was>0.2%.At the same time,each sterilization package was tested for physical parameters,chemical monitoring,and biological monitoring.RESULTS The sterilization physical parameters,chemical monitoring and biological monitoring of each instrument package were qualified.When instruments weighed 8 kg were packaged with ordinary cotton cloth,the wet package phenomenon appeared,with the wet package rate of 83.33%.When 11 kg instruments were packaged with medical non-woven cloth,the wet package phenomenon appeared,with the wet package rate of 50.00%.However,13 kg instruments packaged with new textiles did not appear wet package phenomenon.CONCLUSION When three packaging materials are used in super-overweight orthopedic equipment packaging,ordinary cotton cloth easily causes wet packaging,followed by medical non-textile textile packaging material,and new textile has the best effect on preventing wet packaging.