医疗器械清洗质量监测方法与影响因素研究

Medical Instrument Cleaning Quality:Surveillance Methods and Impact Factors

目的比较两种器械清洗质量监测方法,探索影响清洗质量的因素。方法选择16所医院共228件清洗消毒灭菌后待用的医疗器械(结构对称),每件器械左侧采用隐血试纸法、右侧采用蛋白质残留法进行清洗质量监测。结果 228件器械中残留血阳性7件,蛋白质残留阳性58件,阳性率分别为3.1%和25.4%(χ2=46.668,P=0.000);手工清洗和机器清洗残留血阳性率分别为3.7%和2.2%(χ2=0.446,P=0.504),蛋白质残留阳性率分别为30.4%和18.3%(χ2=4.244,P=0.039);采用消毒剂浸泡的70件器械,残留血无阳性,蛋白质残留阳性率为24.3%(Fisher精确测验,P=0.000);消毒剂使用与否,对清除蛋白质残留差异无统计学意义;采用国产酶与进口酶清洗,其蛋白质残留阳性率分别为25.0%和28.1%(2χ=0.210,P=0.647)。结论残留血试纸法和蛋白质残留法可用于医疗器械清洗质量监测,但前者敏感度和检出率低于后者;机器清洗效果明显优于手工清洗。

OBJECTIVE To compare two methods for their cleaning efficacy of medical instrument and determine the factors of cleaning.METHODS A total of 228 instruments which had been sterilized and ready for patient use were collected from 16 hospitals.These were examined using OB test for occult blood（left side） and tested for residual protein using biuret test（right side）.RESULTS Of all 228 observations,7 instruments（3.1%） tested positive for occult blood and 58 instruments（25.4%） tested positive for residual protein（χ2=46.668,P=0.000）.There were 3.7% and 2.2% instruments presented occult blood after manual cleaning and automated washer-disinfectors respectively（χ2=0.446,P=0.504）,while 30.4% and 18.3% presented residual protein（χ2=4.244,P=0.039）.Of the 70 instruments which were pretreated with disinfectors,none had occult blood,but 24.3% tested positive for residual protein（Fisher′s exact test,P=0.000）.There was no difference in removing protein using disinfector or not（χ2=0.071,P=0.790）.The positive rates of residual protein were 25.0% and 28.1% when using domestic-made and import enzyme（χ2=0.210,P=0.647）.CONCLUSIONS The occult blood test and biuret test can be both used in surveilling the cleaning quality of medical instrument,but the sensitivity and positive rate of the former is lower than the latter.Compared with manual cleaning,mechanical cleaning is more effective.