硬式内镜清洗方法的改进及评价指标的研究

发布时间：2018-05-14 10:14

本文选题：硬式内镜 + 清洗方法　；参考：《郑州大学》2017年硕士论文

【摘要】：目的随着微创技术的发展,内镜器械在各级医疗机构中应用广泛,内镜相关感染引起的危害严重。清洗是消毒灭菌的必要步骤,内镜器械的彻底清洗可以防止生物膜的产生,是控制医院感染的关键性环节。现临床上硬式内镜相关器械清洗方法仍遵循2004版《内镜清洗消毒技术操作规范》。本研究采用不同的硬式内镜清洗方法,采用三种检测方法对清洗效果进行评价,从而优化硬式内镜清洗流程,提高内镜清洗质量。方法清洗方法实验分为两部分:硬式内镜内窥镜清洗实验和硬式内镜其他相关器械清洗实验,按照2004版《内镜清洗消毒技术操作规范》清洗的硬式内镜器械为规范清洗组。硬式内镜内窥镜清洗实验:自2015年9月-2016年1月,随机抽取某三甲医院腹腔镜手术后硬式内镜内窥镜132个·次,分为规范清洗组和预处理组,每组各进行66个内窥镜实验。内窥镜清洗方法:规范清洗组:初洗—多酶浸泡5min—漂洗—终末漂洗—干燥,预处理组的处理措施是:初洗前使用多酶原液进行预处理,多酶浸泡5min后使用一次性清洁纱布擦拭3min(清洗流程为:预处理—多酶浸泡5min—多酶清洗液中擦拭3min—漂洗—终末漂洗—干燥)。硬式内镜其他器械清洗实验:自2016年2月-2016年10月,随机抽取硬式内镜相关器械(腹腔镜手术器械)330套·次,分为五组,每组66套。选取每套器械中的五件器械:分离剪、分离钳、持针器、双极钳、自动结扎钳(Hem-o-lok钳以下均简称Hem-o-lok钳)进行实验。硬式内镜相关器械(除内窥镜)清洗方法:规范清洗组:器械回收后拆卸至最小单位,初洗—多酶清洗5min—超声清洗5min—漂洗—终末漂洗—干燥;超声喷淋清洗组(改进后的清洗流程:初洗—多酶清洗5min—超声喷淋清洗器清洗5min—漂洗—终末漂洗—干燥);超声喷淋+浸油煮沸组(改进后的清洗流程:初洗—多酶清洗5min—超声喷淋清洗器清洗5min—浸油煮沸槽进行处理10min—漂洗—终末漂洗—干燥);全自动清洗消毒机组(改进后的清洗流程:初洗—多酶清洗5min—超声清洗5min—漂洗—全自动清洗消毒机清洗—干燥);超声喷淋+全自动清洗消毒机组(改进后的清洗流程:初洗—超声喷淋清洗器清洗5min—漂洗—全自动清洗消毒机清洗—干燥)。器械充分干燥后进行清洗效果的检测,分别采用十倍带光源放大镜检测法、蛋白残留检测法、ATP生物荧光检测法,依次对每一件硬式内镜器械的清洗效果进行评价。统计学方法采用Microsoft office excel 2007表格进行数据收集和录入,IBM SPSS statistics 23.0统计软件进行统计处理,两独立样本采用t检验、Mann-Whitney U检验,相关样本比较采用Friedman秩和检验,两组二分类资料采用卡方检验,独立多组资料比较采用Kruskal-Wallis H检验,P0.05,差异有统计学意义。结果1.硬式内镜内窥镜采用两种不同的清洗方法,结果进行比较,采用十倍带光源放大镜进行检测,两组内窥镜清洗合格率差异无统计学意义(P0.05);采用蛋白残留检测,规范清洗组合格率为69.70%(46/66),预处理组合格率为84.85%(56/66),χ2=4.314,P0.05,差异有统计学意义;采用ATP生物荧光检测,规范清洗组合格率为80.30%(53/66),预处理组合格率为92.42%(61/66),χ2=4.117,P0.05,差异有统计学意义。2.硬式内镜相关器械(除内窥镜)采用不同方法清洗结果:采用十倍带光源放大镜进行检测,规范清洗组合格率91.52%(302/330),超声喷淋清洗组合格率93.94%(310/330),超声喷淋+浸油煮沸组合格率96.06%(317/330);全自动清洗消毒机组合格率97.58%(322/330),超声喷淋+全自动清洗消毒机组合格率98.18%(324/330);采用蛋白残留检测,规范清洗组合格率77.88%(257/330),超声喷淋清洗组合格率85.76%(283/330),超声喷淋+浸油煮沸组合格率87.27%(288/330),全自动清洗消毒机组合格率93.03%(307/330),超声喷淋+全自动清洗消毒机组合格率94.24%(311/330);采用ATP生物荧光检测仪进行检测,规范清洗组合格率83.33%(275/330),超声喷淋清洗组合格率86.97%(287/330),超声喷淋+浸油煮沸组合格率87.58%(289/330),全自动清洗消毒机组合格率94.55%(312/330),超声喷淋+全自动清洗消毒机组合格率95.45%(315/330)。3.硬式内镜(除内窥镜)相关器械清洗结果:采用三种检测方法检测,各组清洗合格率进行比较,H值分别为22.894、52.234、38.505,P0.05,5种清洗方法合格率差异有统计学意义。采用十倍带光源放大镜检测,全自动清洗消毒机组、超声喷淋+全自动清洗消毒机组清洗合格率分别与规范清洗组比较,H值分别为3.736、4.110,P0.05,差异有统计学意义;采用蛋白残留检测结果显示:超声喷淋清洗组、超声喷淋+浸油煮沸组、全自动清洗消毒机组、超声喷淋+全自动清洗消毒机组清洗合格率分别与规范清洗组比较,H值分别为3.074、3.665、5.911、6.384,P0.05,差异有统计学意义,全自动清洗消毒机组、超声喷淋+全自动清洗消毒机组清洗合格率分别与超声喷淋清洗组比较,H值分别为2.837、3.310,P0.05,差异有统计学意义;采用ATP生物荧光检测,结果示:全自动清洗消毒机组清洗合格率分别与规范清洗组、超声喷淋清洗组、超声喷淋+浸油煮沸组比较,H值分别为4.712、3.184、2.929,P0.05,差异有统计学意义,超声喷淋+全自动清洗消毒机组清洗合格率分别与规范清洗组、超声喷淋清洗组、超声喷淋+浸油煮沸组比较,H值分别为5.094、3.566、3.311,P0.05,差异有统计学意义。全自动清洗消毒机组清洗合格率与超声喷淋+全自动清洗消毒机组比较差异无统计学意义(P0.05)。4.三种检测方法阳性检出率进行比较,十倍带光源放大镜阳性检出率4.26%(76/1782),蛋白残留检测阳性检出率13.13%(234/1782),ATP生物荧光检测阳性检出率10.66%(190/1782),十倍带光源放大镜检测阳性检出率分别与蛋白残留检测、ATP生物荧光检测阳性检出率比较,H值分别为:3.970、2.864,P0.05,差异有统计学意义,蛋白残留检测阳性检出率和ATP生物荧光检测阳性检出率差异无统计学意义,kappa值为0.572,吻合程度一般。5.硬式内镜不同器械采用三种检测方法进行检测,清洗合格率均存在明显差异,采用十倍带光源放大镜检测,分离剪的清洗合格率98.18%(324/330)与双极钳清洗合格率93.03%(307/330)比较,H=-3.176,P0.05,差异有统计学意义;采用蛋白残留检测,分离剪的清洗合格率93.03%(307/330)、双极钳的清洗合格率83.63%(276/330)、分离钳的清洗合格率85.45%(282/330),分离剪的清洗合格率分别与分离钳、双极钳的清洗合格率比较,H值分别为:-2.955、-3.665,P0.05,差异有统计学意义;采用ATP生物荧光检测仪检测,分离剪的清洗合格率95.76%(316/330)、分离钳的清洗合格率86.36%(285/330)、双极钳的清洗合格率86.97%(287/330)、Hem-o-lok钳的清洗合格率87.58%(289/330),分离剪的清洗合格率分别与分离钳、双极钳、Hem-o-lok钳的清洗合格率比较,H值分别为:-3.948、-3.693、-3.438,P0.05,差异有统计学意义。6.硬式内镜内窥镜规范清洗组与预处理组所需时间、成本的比较:规范清洗组每个内窥镜的清洗时间7.517±0.149min,预处理组每个内窥镜的清洗时间11.333±0.220min,Z=-9.960,P0.05,差异有统计学意义,费用多支出1.5元;硬式内镜相关器械不同清洗方法所需时间、成本(除购置清洗设备所需费用)同规范清洗组的比较:规范清洗组每套硬式内镜相关器械(分离剪、分离钳、持针器、双极钳、Hem-o-lok钳)清洗时间21.85±1.417min;超声喷淋清洗组每套硬式内镜相关器械清洗时间21.80±1.449min,成本较规范清洗组约多支出5元/套;超声喷淋+浸油煮沸组每套硬式内镜相关器械清洗时间为31.94±1.424min,成本较规范清洗组约多10元/套;全自动清洗消毒机组每套硬式内镜相关器械清洗时间为33.73±1.431min,成本较规范清洗组约多42.5元/套;超声喷淋+全自动清洗消毒机组每套硬式内镜相关器械清洗时间为27.82±1.122min,成本较规范清洗组约多支出42.5元/套。各组清洗时间进行比较,χ2=291.665,P0.05,差异有统计学意义,超声喷淋+浸油煮沸组、全自动清洗消毒机组、超声喷淋+全自动清洗消毒机组所用时间分别与规范清洗组比较,H值分别为:-10.717、-13.110、-5.935,P0.05,差异有统计学意义,分别与超声喷淋清洗组比较,H值分别为:-10.803、-13.197、-6.022,P0.05,差异有统计学意义,超声喷淋+全自动清洗消毒机组所用时间分别与超声喷淋+浸油煮沸组、全自动清洗消毒机组比较,H值分别为:4.782、7.175,P0.05,差异有统计学意义。结论1.硬式内镜内窥镜采用预处理及酶液下擦拭3分钟同时进行规范清洗,能够提高内窥镜的清洗效果;硬式内镜相关器械(除内窥镜)清洗使用超声喷淋清洗器清洗代替多酶清洗和超声清洗,配合使用全自动清洗消毒机,可提高清洗效果。2.评价指标的研究:ATP生物荧光检测与十倍带光源放大镜检测、蛋白残留检测综合比较,其结果较客观,检测速度快,临床条件允许的情况下推荐使用。
[Abstract]:Objective with the development of minimally invasive technology, endoscopic instruments are widely used in medical institutions at all levels, and endoscopy related infections are serious. Cleaning is a necessary step for disinfection and sterilization. The thorough cleaning of endoscopic instruments can prevent the production of biofilm. It is a key link to control hospital infection. The washing method still follows the 2004 edition < endoscopic cleaning and disinfection technology operation specification >. This study uses different hard endoscopic cleaning methods and uses three methods to evaluate the cleaning effect, so as to optimize the process of hard endoscopic cleaning and improve the quality of endoscopic cleaning. The method of cleaning method is divided into two parts: hard endoscopy endoscope cleaning reality The experimental and hard endoscopy related instrument cleaning experiments were conducted in accordance with the 2004 edition of the 2004 edition of the endoscopic cleaning and disinfection technique, the cleaning of the hard endoscopic instruments. The hard endoscopic endoscopy cleaning experiment: the 132 times of a hard endoscopic endoscopy after laparoscopy in a three a hospital were randomly selected from January -2016 September 2015. Cleaning group and pre treatment group, each group carried out 66 endoscopy experiments. Endoscopic cleaning method: standard cleaning group: initial washing - Multi enzyme soaking 5min - rinsing - end rinsing - drying. Pretreatment group was treated with multi enzyme original solution before initial washing, and after 5min was soaked with disposable clean gauze to wipe 3min (cleaning flow) The process is: preprocessing - Multi enzyme soaking in 5min - Multi enzyme cleaning solution, wiping 3min - rinsing end rinse - drying). Hard endoscopy other instruments cleaning experiments: from October -2016 February 2016, 330 sets of hard endoscopy related instruments (laparoscopic surgical instruments) were randomly selected and divided into five groups, 66 sets of each set. Separation shear, separation forceps, needle holder, bipolar forceps, automatic ligature forceps (Hem-o-lok forceps below Hem-o-lok forceps) for experiment. Hard endoscopy related instruments (except endoscope) cleaning methods: standard cleaning group: removal of equipment after recovery to the minimum unit, initial washing - Multi enzyme cleaning 5min - ultrasonic cleaning 5min - rinsing finish bleaching drying; ultrasonic drying; ultrasonic Spray cleaning group (improved cleaning process: first washing - Multi enzyme cleaning 5min - ultrasonic spray cleaner cleaning 5min - Rinse - end rinsing - drying); ultrasonic spray + soaked boiling - group (improved cleaning process: initial washing - Multi enzyme cleaning 5min - ultrasonic spray cleaner 5min - soaked and boiling tank for treatment of 10min - rinse - end Final rinsing - drying); automatic cleaning and disinfection unit (improved cleaning process: initial washing - Multi enzyme cleaning 5min - ultrasonic cleaning 5min - Rinse - fully automatic cleaning and disinfecting machine cleaning - drying); ultrasonic spray + fully automatic cleaning and disinfection unit (improved cleaning process: initial washing - ultrasonic spray cleaner cleaning 5min rinse - fully automatic The cleaning effect was detected by ten times light source magnifying mirror, protein residue detection and ATP biological fluorescence detection, respectively. The cleaning effect of each hard endoscope instrument was evaluated in turn. The statistical method was carried out by the Microsoft Office Excel 2007 form. Data collection and input, IBM SPSS statistics 23 statistical software for statistical processing, two independent samples using t test, Mann-Whitney U test, the relative samples were compared to the Friedman rank and test, two groups of two classified data using chi square test, independent multiple groups of data compared with Kruskal-Wallis H test, P0.05, the difference was statistically significant. Two different cleaning methods were used in 1. hard endoscopy endoscopy. The results were compared with ten times the light source magnifying glass. There was no significant difference between the two groups of endoscopy (P0.05). The rate of standard cleaning combined lattice was 69.70% (46/66), the pre treatment combination lattice rate was 84.85% (56/66), X 2=4.314, P. 0.05, the difference was statistically significant; using ATP bioluminescence detection, the standard cleaning combination lattice rate was 80.30% (53/66), the pretreated combined lattice rate was 92.42% (61/66), X 2=4.117, P0.05, the difference was statistically significant, and the difference between.2. hard endoscopy related instruments (except endoscope) was used in different method cleaning results: ten times with light source magnifying mirror was used for testing. The combination lattice rate of 91.52% (302/330), ultrasonic spray cleaning combined lattice rate 93.94% (310/330), ultrasonic spray + oil boiling group qualified rate 96.06% (317/330), full automatic cleaning and disinfection unit 97.58% (322/330), ultrasonic spray + fully automatic cleaning unit 98.18% (324/330), the use of protein residue detection, standardized cleaning combination lattice rate 77.88% (257/330), ultrasonic spray cleaning combined rate of 85.76% (283/330), ultrasonic spray + oil boiling group qualified rate of 87.27% (288/330), full automatic cleaning and disinfection unit 93.03% (307/330), ultrasonic spray + full automatic cleaning and disinfection unit 94.24% (311/ 330); use ATP bio fluorescence detector to test, standardize the cleaning combination rate 83.33% (275/330), 86.97% (287/330), 87.58% (289/330), 94.55% (312/330), 87.58% (312/330), 95.45% (315/ 330).3. hard endoscopy (except for endoscopy): three kinds of cleaning results The test method was used to compare the qualified rate of each group. The H value was 22.894,52.234,38.505, and the difference of the qualified rate of the P0.05,5 cleaning method was statistically significant. The ten times of the light source magnifying mirror was used for the automatic cleaning and disinfection unit, and the standard cleaning rate of the ultrasonic spray + full automatic cleaning machine group was compared with the standard cleaning group, and the H value was compared with the standard cleaning group. The difference was statistically significant in 3.736,4.110 and P0.05, and the results of the detection of protein residue showed: ultrasonic spray cleaning group, ultrasonic spray + soaked boiling group, automatic cleaning and disinfection unit, ultrasonic spray + fully automatic cleaning unit cleaning rate compared with the standard cleaning group respectively, H value was 3.074,3.665,5.911,6.384, P0.05, respectively. The difference has statistical significance, the total automatic cleaning and disinfection unit, ultrasonic spray + full automatic cleaning unit cleaning rate are compared with the ultrasonic spray cleaning group respectively, H value is 2.837,3.310, P0.05, the difference is statistically significant; ATP bio fluorescence detection, the results show that the full automatic cleaning and disinfection unit cleaning rate and the standard clear, respectively. Washing group, ultrasonic spray cleaning group, ultrasonic spray + soaked boiling group, H value was 4.712,3.184,2.929, P0.05 respectively, the difference was statistically significant, ultrasonic spray + full automatic cleaning unit cleaning rate was compared with the standard cleaning group, ultrasonic spray cleaning group, ultrasonic spray + soaked oil boiling group, H value was 5.094,3.566,3.311, P0.05 respectively. The difference was statistically significant. There was no significant difference between the cleaning rate of the automatic cleaning and disinfection unit and the ultrasonic spray + full automatic cleaning unit (P0.05), the positive detection rate of the three.4. detection methods was compared, the positive rate of the ten times with the light source magnifier was 4.26% (76/ 1782), and the positive detection rate of protein residue was 13.13% (234/1782 The positive detection rate of ATP bioluminescence detection was 10.66% (190/1782), the positive detection rate of the ten times with the light source magnifying mirror was compared with the protein residue detection, and the positive detection rate of ATP bioluminescence detection was compared. The H values were respectively 3.970,2.864 and P0.05, the difference was statistically significant, the positive detection rate of egg white residue detection and the positive detection of ATP bioluminescence detection were positive. There was no statistically significant difference in rate of rate, kappa value was 0.572, the degree of anastomosis of.5. hard endoscopy was generally detected by three methods, and there were obvious differences in the rate of qualified cleaning. Ten times the ten times with light source magnifying mirror, 98.18% (324/330) and 93.03% (307/330) of the bipolar forceps cleaning rate (307/330), H=-3.17 6, P0.05, the difference is statistically significant; using protein residue detection, separation scissors cleaning rate 93.03% (307/330), the cleaning rate of bipolar forceps 83.63% (276/330), separation forceps cleaning rate of 85.45% (282/330), separation scissors cleaning rate and separation forceps and bipolar forceps cleaning rate respectively compared, H values are: -2.955, -3.665, P0.0, respectively. 5, the difference is statistically significant; using ATP bioluminescence detector, the qualified rate of the separation scissors is 95.76% (316/330), the qualified rate of the separation forceps is 86.36% (285/330), the qualified rate of the bipolar forceps is 86.97% (287/330), the qualified rate of the Hem-o-lok forceps is 87.58% (289/330), and the qualified rate of the separation shear is respectively with the separation clamp, the bipolar forceps, Hem-. The comparison of the qualified rate of o-lok forceps, the H values were -3.948, -3.693, -3.438, P0.05, the difference was statistically significant, the time required for the standard cleaning group and the pre treatment group of.6. hard endoscopic endoscopy, the comparison of the cost: the cleaning time of each endoscope in the standard cleaning group was 7.517 + 0.149min, and the cleaning time of each endoscope in the pretreated group was 11.333 + 0.220mi N, Z=-9.960, P0.05, the difference is statistically significant, the cost is 1.5 yuan; the time required for different cleaning methods for hard endoscopy related instruments, the cost (except for the purchase of the cleaning equipment) and the standard cleaning group: the cleaning time for each set of hard endoscopy related instruments (separation clips, separation forceps, needle holder, bipolar forceps, Hem-o-lok forceps) in the standard cleaning group 21.85 + 1.417min, the cleaning time of each set of hard endoscope related instruments in the ultrasonic spray cleaning group was 21.80 + 1.449min, the cost was 5 yuan more than the standard cleaning group, and the cleaning time of each set of hard endoscope related instruments was 31.94 + 1.424min, and the cost was 10 yuan more than that of the standard cleaning group. The cleaning time of the hard endoscope related instruments was 33.73 + 1.431min, the cost was 42.5 yuan more than that of the standard cleaning group, and the cleaning time of each set of hard endoscope related instruments was 27.82 + 1.122min, and the cost was 42.5 yuan more than the standard cleaning group. The cleaning time of each group was compared, X 2=291.665, P0.05, The difference has statistical significance, the ultrasonic spray + oil soaked boiling group, the fully automatic cleaning and disinfection unit, the ultrasonic spray + full automatic cleaning unit time compared with the standard cleaning group respectively, H values are -10.717, -13.110, -5.935, P0.05, the difference is statistically significant, respectively compared with the ultrasonic spray cleaning group, respectively, H values are -10.803, -13.197, respectively. -6.022, P0.05, the difference was statistically significant. The time used by ultrasonic spray + full automatic cleaning and disinfection unit was compared with the ultrasonic spray + soaked boiling group and the full automatic cleaning and disinfection unit. The H value was 4.782,7.175, P0.05, respectively. Conclusion the 1. hard endoscope endoscope was pretreated with the enzyme liquid wiping for 3 minutes at the same time. Standard cleaning can improve the cleaning effect of endoscope; hard endoscopic related instruments (except endoscope) cleaning use ultrasonic spray cleaner to replace multi enzyme cleaning and ultrasonic cleaning, and the use of automatic cleaning machine can improve the.2. evaluation index of cleaning effect: ATP bioluminescence detection and ten times band light magnifying mirror examination The results showed that the results of protein residue detection were more objective and fast, and recommended for clinical conditions.

【学位授予单位】：郑州大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R472.1

【参考文献】