降低使用硬质容器装载的骨科器械包灭菌后湿包发生率的临床研究

Clinical research on reducing incidence rate of wet package with rigid containers for packaging orthopedics instruments

目的降低使用硬质容器装载的骨科器械包灭菌后湿包的发生率。方法选择100套装载5 kg骨科手术器械包灭菌后的硬质容器,随机分为A组、B组,每组50套。采用高温灭菌后, A组采用隔层冷却保护,B组采用自然冷却法。应用冷凝水称质量及临床使用时肉眼观测,综合评价两种冷却方法湿包的发生情况,监测指标包括灭菌前1 min内所称质量(W1)、灭菌过程冷凝水(SPW)、冷却过程冷凝水(CPW)、最终冷凝水(TW)、可允许冷凝水最大值(Wmax)及肉眼观察到的湿包数量等。结果 A组W_1为(7 992.2±26.0) g,SPW为(4.8±1.1) g,W_(max)为(16.0±0.1) g;B组W_1为(7 998.9±28.0) g,SPW为(4.7±1.2) g,W_(max)为(16.0±0.1) g;两组W_1、SPW、W_(max)指标比较,差异无统计学意义(P> 0.05)。A组CPW为(1.6±0.7) g,TW为(6.5±1.4) g;B组CPW为(5.2±0.9) g,TW为(9.9±1.6) g;A组CPW、TW指标明显小于B组,差异有统计学意义(P <0.05)。两组灭菌过程中SPW超标0套,灭菌后TW超标0套。A组湿包发生率为2.0%,B组为18.0%;A组明显低于B组,差异有显著统计学意义(χ~2=7.111,P <0.01)。结论在使用硬质容器装载骨科器械包灭菌后冷却时,使用预热的低尘纯棉包布对硬质容器进行隔层冷却保护,可有效避免湿包的产生。

Objective To reduce the incidence rate of wet package when using rigid containers for packaging sterilized orthopedics instruments.Methods A total of 100 sets of rigid containers of 5 kg sterilized orthopedics surgical instruments were divided into group A(n=50,interlayer cooling protection)and group B(n=50,natural cooling).The incidence of wet package was comprehensively evaluated by weighing condensate water and observed by naked eye in clinical use.The monitoring indicators included mass within 1-minute before sterilization(W1),sterile process water(SPW),cold process water(CPW),total water(TW),maximum allowable condensate water(Wmax),and the number of wet package observed by naked eye.Results In group A,W1 was(7 992.2±26.0)g,SPW was(4.8±1.1)g and Wmaxwas(16.0±0.1)g.In group B,W1 was(7 998.9±28.0)g,SPW was(4.7±1.2)g and Wmaxwas(16.0±0.1)g.There were no significant differences in W1,SPW,Wmaxbetween 2 groups(P>0.05).In group A,CPW was(1.6±0.7)g and TW was(6.5±1.4)g.In group B,CPW was(5.2±0.9)g and TW was(9.9±1.6)g.CPW and TW in group A were significantly less than those in group B,and the difference was statistically significant(P<0.05).SPW of both groups met the standard during sterilization,while TW of both groups met the standard after sterilization.The incidence of wet package was 2.0%in group A and 18.0%in group B,the incidence in group A was significantly lower than that of group B,and difference was statistically significant(χ2=7.111,P<0.01).Conclusion It is demonstrated that using preheated low-dust cotton cloth in interlayer cooling protection for hard container after sterilizing orthopedic instrument package could effectively avoid the occurrence wet package.