化学指示剂检测过氧化氢残留

Detection of hydrogen peroxide residue with chemical indicators

  • 摘要: 目的 探究使用过氧化氢化学指示物及化学灭菌过程验证装置(PCD)检测过氧化氢残留情况,为低温过氧化氢灭菌质量管控提供参考。方法 采用过氧化氢残留对抗试验,分别观察灭菌器第1锅、连续3锅、连续5锅灭菌程序后,不启动灭菌程序静置状态下,观察不同化学指示物及化学PCD的颜色变化情况,采用Fisher精确检验进行统计学分析。结果 试验结果显示运行第1锅后,未启动灭菌程序时3种过氧化氢化学指示物变色合格存在安全隐患,尤其是4类卡和PCD, 抗残留稳定性表现为C1优于C2、C3,PCD1优于PCD2、PCD3,PCD2稳定性高于PCD3。连续运行3锅后,舱内过氧化氢残留增多,3种品牌1类卡均出现合格变色,4类卡及PCD较运行第1锅后变色增加。连续5锅灭菌后,过氧化氢持续蓄积,稳定性最高、最难变色的PCD亦可完全变色达标。组间差异均具有统计学意义(P<0.05)。结论 低温过氧化氢灭菌后灭菌舱和PCD内部存在过氧化氢残留,且残留量随连续灭菌次数增加而增多,残留可导致化学指示物假性合格,存在医疗安全隐患。医疗机构应严格规范操作流程,杜绝单独依赖化学指示物变色放行灭菌物品,优选选用具备对抗过氧化氢残留设计的化学指示物和PCD,提高灭菌监测的准确性与安全性。

     

    Abstract: OBJECTIVE To explore the influence of hydrogen peroxide residue on the monitoring effects of three types of hydrogen peroxide chemical indicators and chemical process challenge devices (PCD) so as to provide guidance for quality control of low-temperature hydrogen peroxide sterilization. METHODS The hydrogen peroxide residue resistance test was performed. The color changes of the different chemical indicators and chemical PCDs were observed without initiating a new sterilization procedure after the completion of the first, three consecutive, and five consecutive sterilization cycles. The statistical analysis was performed by means of Fisher's exact test. RESULTS After the first sterilization cycle, the qualified color change of the three types of hydrogen peroxide chemical indicators occurred without starting the sterilization procedure, indicating that there were potential safety risks, especially for the class 4 indicators and PCDs. The residue resistance stability ranked as C1 superior to C2 and C3, and PCD1 superior to PCD2 and PCD3, with PCD2 more stable than PCD3. After three consecutive sterilization cycles, the hydrogen peroxide residue in the sterilization chamber increased, resulting in qualified color changes of the class 1 indicators of all the three brands; the discoloration degree of the class 4 indicators and PCDs was significantly increased compared with that after the first cycle. After five consecutive cycles, hydrogen peroxide accumulated continuously, and even the most stable PCD with the strongest discoloration resistance achieved fully qualified discoloration; the statistically significant differences were observed among the groups (P<0.05). CONCLUSIONS Hydrogen peroxide residues remain in the sterilization chamber and inside the PCDs after the low-temperature hydrogen peroxide sterilization, and the residual volume increases with the number of consecutive sterilization cycles. The residual hydrogen peroxide may cause false qualification of chemical indicators, leading to potential medical safety hazards. It is necessary for medical institutions to rigidly standardize operational procedures, avoid releasing sterilized items merely based on the color change of chemical indicators, and preferentially adopt chemical indicators and PCDs designed to resist hydrogen peroxide residues so as to improve the accuracy and safety of the sterilization monitoring.

     

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