过氧化氢低温等离子体灭菌质量管理研究

Management of quality of sterilization with hydrogen peroxide low temperature plasma

目的研究过氧化氢低温等离子体灭菌失败的原因,探讨相应的改进措施,提高灭菌成功率保证无菌物品的质量。方法统计医院2011年10月-2013年12月使用低温等离子体灭菌的情况,对灭菌失败的可控因素及不可控原因进行综合分析。结果共灭菌2 930舱,灭菌成功2 815舱次,灭菌失败115舱次,灭菌失败率为3.9%;其中化学监测指示物变色不合格100次、屏幕显示过氧化氢量不足1次、真空Ⅰ期及真空Ⅱ期超时各4次、真空Ⅲ期超时及生物监测不合格各3次。结论多种因素均能影响过氧化氢低温等离子体灭菌的成功率,重视细节和环节质量管理,均能有效提高过氧化氢低温等离子体灭菌成功率,降低灭菌成本,节省灭菌时间。

OBJECTIVE To study the causes of failure of sterilization with the hydrogen peroxide low temperature plasma, explore the corresponding measures to improve the sterilization, raise the success rate of sterilization, and ensure the quality of sterile objects. METHODS From Oct 2011 to Dec 2013, the sterilization with the hydrogen peroxide low temperature plasma was statistically analyzed, and the controllable and uncontrollable factors for the failure of sterilization were comprehensively analyzed. RESULTS Totally 2930 cabins of objects were sterilized, 2815 cabin‐times of sterilization were successful, and 115 cabin‐times of sterilization failed, with the rate of failure of 3. 9%. Among the cases of failure, there were 100 cases of unqualified discoloration of the chemical monitoring indicator, 1 case with the screen indicating insufficient amount of hydrogen peroxide, 4 cases of phase Ⅰ vacuum timeout, 4cases of phase Ⅱ vacuum timeout, 3 cases of phase Ⅲ vacuum timeout, and 3 cases of unqualified bio‐logical monitoring. CONCLUSION There are a variety of influencing factors for the success rate of sterilization with the hydrogen peroxide low temperature plasma. It is an effective way to focus on the detail and link quality management so as to raise the success rate of sterilization, reduce the sterilization cost, and save the time of sterili‐zation.