Discussion on the scheme of removing residual o-phthalaldehyde in endoscopy
Release time:
2022-09-05
邻苯二甲醛( Orthophthalaldehyde，OPA) 由于其 刺激性气味小、消毒时间短的优点作为第二代内镜 清洗消毒剂近年来逐渐被广泛应用，现阶段日本邻 苯二甲醛的使用率为 45% ，美国为 41%〔1〕。但由于 其易致敏反应被禁用于膀胱镜消毒，且残留 OPA 会 对患者胃肠黏膜产生损害〔2〕，导致异丙醇休克反 应〔3〕。虽然现有的国内外内镜指南均强调了清洗 步骤对残留消毒剂的清除作用〔4〕，但对于实际内镜 的 OPA 残留量及有效清除方法暂无相关研究报道。 因此，本研究从多水平处理方案验证 OPA 经不同清 洗时间和方法后的残留量，以期为临床规范制定和 应用提供理论依据
材料与方法
1． 1 试验材料 高效液相色谱仪，1200 HPLC( Agilent technologies 公司) ; 漩涡振荡器: SL － A256( Scientific Industries 公司) ; 2，4 － 二硝基苯肼: 含量 99% ( 广州化学 · 2611 · Chinese Journal of Disinfection 2016; 33( 12)试剂厂) ; 乙腈: 色谱纯( MEＲK 公司) ; 邻苯二甲醛: 含量 99% ( SIGMA － ALDＲICH 公司) 。 本研究采用的内镜为 GIF － Q260J( Olympus 公 司) ，0． 55% CIDEX OPA 消毒液( 强生公司) ，一体 化内镜清洗消毒水槽 1 套( 深圳柯丽尔) ，自动喷淋 式内窥镜清洗消毒槽 1 套( 国家实用新型专利: ZL 2013 2 0185558． 2) ，内镜自动清洗消毒机 1 台( 强 生公司) 。
1． 2 试验方法
1． 2． 1 分组方法 试验分为 4 组: 第 1 组为空白对照组，直接使用过滤水清洗后采样; 第 2 组为单股水 流组，采用传统水龙头进行清洗; 第 3 组为喷淋式清 洗组，以流量水泵为依托，在清洗槽槽体各壁均安装 旋转喷淋头，清洗水可从喷淋头集中射出，均匀覆盖冲洗内镜所有外表面; 第 4 组为自动清洗消毒机组， 使用自动清洗消毒机进行清洗。除空白对照组内镜 不浸泡 OPA 外，实验组内镜均先浸泡 OPA 5 min。 每组各 12 条内镜，清洗时间分为 1、2、3、4 min 共 4 个水平。控制进水管压力，每组方法清洗水量均为 10 L /min。
1． 2． 2 采样方法 清洗后的内镜用高压气枪吹干， 将纯化水浸泡插入部外表面 5 min 后收集; 使用高 效液相色谱仪分析残留 OPA 浓度。分别作用 1、2、 3、4 min。
1． 2． 3 高效液相色谱法 色谱分析 C18色谱柱( 可 选用 Lunna － C18 柱，150mm × 4． 6mm，5 ( m) ，流动 相: 乙 腈: 水 = 50: 50 ( v /v ) ，柱 温: 25℃，流 速: 1 ml /min，检测波长: 220 nm，进样体积: 20 μl。
1． 3
统计方法
数据以 x珋± s 表示，采用 SPSS 13． 0 统计软件对 数据进行分析，用多因素析因设计方差分析对处理 方法和处理时间作统计分析，对同一组间不同水平 的 OPA 残留量采用 LSD 法进行比较，P ＜ 0． 05 表示 差异有统计学意义。 2 结果 应用析因设计资料方差分析不同清洗方法及处 理时间后 OPA 残留量间差异，均存在统计学差异， 需采用 LSD 进行多重比较。 2． 1 不同清洗方法 OPA 残留量的 LSD 多重比较 自动清洗消毒机组 OPA 残留量最低，与空白对 照组间无统计学差异，清除效果最佳。单股水流组 的 OPA 残留量最高，与各组间均存在显著性差异。 喷淋式清洗组与自动清洗消毒机组间戊二醛残留量 虽无统计学差异，但均值比较喷淋式清洗组较自动 清洗消毒机组和空白对照组均高( 表 1) 。 表 1 不同清洗方法对内镜外表面 OPA 残留量影响的比较 处理方法 ( I) 处理方法 ( J) MD ( I － J) SE P 95% 置信区间 下限 上限 空白对照 单股水流 -0． 597* 0． 085 0． 000 -0． 770 -0． 423 喷淋 -0． 265* 0． 085 0． 004 -0． 438 -0． 092 自动洗消机 -0． 127 0． 085 0．144 -0． 301 0． 046
单股水流 空白对照 0． 597* 0． 085 0． 000 0． 423 0． 770 喷淋 0． 332* 0． 085 0． 000 0． 159 0． 505 自动洗消机 0． 469* 0． 085 0． 000 0． 296 0． 643
喷淋 空白对照 0． 265* 0． 085 0． 004 0． 092 0． 438
单股水流 -0． 332* 0． 085 0． 000 -0． 505 -0． 159
自动洗消机 0． 137 0． 085 0． 116 -0． 036 0． 311
自动洗消机 空白对照 0． 127 0． 085 0． 144 -0． 046 0． 301
单股水流 -0． 469* 0． 085 0． 000 -0． 643 -0． 296
喷淋 -0． 137 0． 085 0． 116 -0． 311 0． 036
注: 基于观测到的均值。* : 均值差值在 0． 05 级别上较显著。
2． 2
不同清洗时间 OPA 残留量的 LSD 多重比较 清洗时间为 1 min 时，OPA 的残留量与其他时 间点具有显著性差异，2 min 与 3 min、4 min 时间组 间无显著性差异。处理时间达 2 min 后对 OPA 的 残留量清除效果无变化( 表 2) 。 表 2 不同清洗时间对内镜外表面 OPA 残留量影响的比较 处理 时间( min) ( I) 处理 时间( min) ( J) MD ( I － J) SE P 95% 置信区间 下限 上限 1 2 0． 300* 0． 085 0． 001 0． 126 0． 473 3 0． 306* 0． 085 0． 001 0． 133 0． 479 4 0． 258* 0． 085 0． 005 0． 085 0． 431 2 1 － 0． 300* 0． 085 0． 001 － 0． 473 － 0． 126 3 0． 006 0． 085 0． 941 － 0． 167 0． 180 4 － 0． 042 0． 085 0． 628 － 0． 215 0． 132 3 1 － 0． 306* 0． 0850． 001 － 0． 479 － 0． 133 2 － 0． 006 0． 085 0． 941 － 0． 180 0． 167 4 － 0． 048 0． 085 0． 576 － 0． 221 0． 125 4 1 － 0． 258* 0． 085 0． 005 － 0．431 － 0． 085 2 0． 042 0． 085 0． 628 － 0． 132 0． 215 3 0． 048 0． 085 0． 576 － 0． 125 0． 221 注: 基于观测到的均值。* : 均值差值在 0． 05 级别上较显著。
3 讨论
我国现有的内镜机构多使用自动灌流器( 或压 力水枪) 对内镜管腔进行冲洗，以其产生的液体冲 刷力达到漂洗效果。但是内镜外表面的冲洗仍多使 用传统的水龙头冲洗方法，该方法存在水流分布不 均匀与压力限制问题，易导致消毒液在内镜外表面 残留量高。改进内镜清洗方法，减少 OPA 残留量是 临床工作中引起关注的问题。本研究结果显示，自 动清洗消毒机组 OPA 残留量最低，喷淋式清洗槽次 之，单股水流最高，说明喷淋式清洗槽和自动清洗消 毒机可更有效的清除 OPA 残留，原因可能与两者均 采用全方位压力喷洒原理进行冲洗，其冲刷力和水 流的均匀分布对 OPA 清除更为有效。其中喷淋式 清洗槽由于成本远低于自动清洗消毒机，符合我国 临床实际需求，值得推广应用。
· 3611 ·
中国消毒学杂志 2016 年第 33 卷第 12 期合理设置清洗时间，提高清洗效率内镜表面残留 OPA 与清洗流程时长呈负相关。本研究结果显示，当 清洗时间达 2 min( 量 = 20 L) 时，OPA 残留量趋于 稳定。可能与 NormanMiner 等〔5〕报道的 OPA 能被内
镜管腔自身的聚合材料吸收而持续存在有关。因此， 临床实践进行内镜清洗时，并非清洗时间越长对 OPA 的清除效果越好。参考本研究结果，合理设置内镜清 洗步骤时间，既可有效去除 OPA 在内镜表面的残留， 又可提高清洗效率，从而提高内镜周转率。 和传统消毒剂戊二醛相比，OPA 使用浓度有所 降低，但直接接触仍会引起眼睛、皮肤和粘膜的损 伤〔
6〕。我国现有清洗消毒规范对内镜等器械消毒剂残留量及清洗环节均未有明确规定〔
7〕，因此使用 内镜机构对消毒剂相关化学性胃肠炎、过敏反应等 亦缺乏重视。本研究结果证实，不充分的清洗会导 致 OPA 残留量升高，因而规范内镜清洗环节流程、 制定相关标准及规范是提高清洗消毒效果，保障患 者安全的重要保障。
入口近，细菌相对容易进入体内，感染发生率高。导 管动脉端为侧孔开口，应用过程中常因血流不畅致 血栓发生率高〔4〕，处理血栓过程亦又增加了感染机 会。血液透析患者一般每周需进行 2 ～ 3 次，每 2 次 透析至少间隔 24 h 以上，期间留置中心静脉导管可 能被细菌污染，而普通的消毒液在消毒完成后并无 持久的抑菌效果，以致增加感染。置管部位和留置 时间是影响导管感染的主要因素，股静脉置管较颈 部更容易感染。导管感染率也随留置时间延长而呈 直线性上升〔5〕。 葡萄糖酸氯己定是氯己定的葡萄糖酸盐，属于 阳离子表面活性剂和常用皮肤黏膜消毒剂，主要是 破坏细菌胞膜上的渗透屏障，低浓度可导致细菌部 分胞浆渗漏，高浓度则可致胞浆凝聚变性，从而达到 杀灭细菌的作用〔6〕。乙醇不仅能促进葡萄糖酸氯 己定杀菌作用，起到协同增效作用，能快速杀灭细菌 繁殖体及分枝杆菌、真菌孢子、亲脂病毒，并具有速 效、速干的特点，还具有持续抑菌的效果〔7〕。 大量研究表明，股静脉留置导管的感染发生率高 于颈内静脉〔8〕。本研究结果显示，使用葡萄糖酸氯己 定醇进行消毒，股静脉组与颈内静脉组患者感染率并无显著统计学意义，而使用碘伏消毒液的两组患者的
感染发生率则有显著统计学意义。此现象可能是由于 葡萄糖酸氯己定醇更有利于局部保持持久抑菌有关。 有文献报道，随着置管时间的延长，感染的发生 率也随之升高9〕，本研究结果也支持这种观点。但 置管时间大于 2 周时，实验组的感染发生率明显低 于对照组，提示葡萄糖酸氯己定醇能有效降低血液 透析患者因长时间留置中心静脉导管所导致的导管 相关感染的发生。因此，葡萄糖酸氯己定醇与碘伏 比较，用于中心静脉血管留置消毒效果更确切，且具 有良好的长效抑菌能力，能有效降低血液透析患者 中心静脉导管感染的发生率，值得临床推广和应用。
o-phthalaldehyde(Orthophthalaldehyde,OPA)Due to itsSmall pungent odor,Advantages of short disinfection time as second-generation endoscopesCleaning disinfectants have been widely used in recent years.,Japan's NeighborsThe usage rate of phthalaldehyde is45%,The United States is41%〔1>> 〕.but dueIts susceptibility to sensitization is prohibited for cystoscopy disinfection,and residualOPAWillDamage to the patient's gastrointestinal mucosa〔2>> 〕,lead to isopropyl alcohol shock reactionShould〔3>> 〕.Although the existing domestic and international endoscopy guidelines emphasize cleaningRemoval of Residual Disinfectant by Steps〔4>> 〕,But for the actual endoscopyofOPANo related research report on residue and effective removal method.Therefore,This study was validated from a multi-level processing schemeOPAby different clearResidual amount after washing time and method,with a view to developing clinical norms andprovide theoretical basis for application
Materials and Methods
1． 1Test Materialshigh performance liquid chromatograph,1200 HPLC(Agilent technologiesCompany) ;Vortex Oscillator:SL － A256(Scientific IndustriesCompany) ;2,4 －Dinitrophenylhydrazine:Content99%(Guangzhou Chemistry·2611 ·Chinese Journal of Disinfection 2016;33(12)Reagent Factory) ;Acetonitrile:chromatographically pure(BRANDCompany) ;o-phthalaldehyde:Content99%(SIGMA - ALDRICHCompany).The endoscopy used in this study wasGIF － Q260J(OlympusMaleDivision) ，0． 55% CIDEXKanOPADisinfectant(Johnson & Johnson) ，OneCleaning and disinfection sink of chemical endoscope1 Sleeve(Shenzhen Coryl) ，automatic sprayType endoscope cleaning and disinfection tank1 Sleeve(national utility model patent:ZL2013 2 0185558． 2) ，Automatic endoscope cleaning and disinfection machine1 Taiwan(StrongHealth Company).
1． 2Test Method
1． 2． 1Grouping method test is divided4 Group:Section1 Group is blank pairPhoto group,Sampling directly after washing with filtered water;Section2 Group for single waterFlow Group,Traditional faucet for cleaning;Section3 Group is spray cleaningWashing group,Based on flow pump,Installed on each wall of the cleaning tank bodyRotating sprinkler head,Cleaning water can be concentrated from the sprinkler head,uniform coverageFlushing all external surfaces of the endoscope;Section4 group is an automatic cleaning and disinfection unit,Use automatic washing and disinfecting machine for cleaning.Except blank control group endoscopyNo soakingOPAOutside,Endoscopes in the experimental group were soaked firstOPA 5 min.Each group12 strip endoscope,Cleaning time is divided1,2,3,4 minTotal4 level..Control inlet pipe pressure,The amount of cleaning water for each method is10 L /min.
1． 2． 2Sampling method The cleaned endoscope is dried with a high-pressure air gun,Immerse the outer surface of the insert with purified water5 minAfter collecting;Use highAnalysis of Residues by Liquid ChromatographyOPAConcentration.role respectively1,2,3,4 min.
1． 2． 3high performance liquid chromatography chromatographic analysisC18Column(CanSelectionLunna - C18 Column,150mm × 4.6mm,5 (m) ，FlowPhase:Acetonitrile:Water= 50:50 (v /v) ，Column temperature:25 ℃,Flow rate:1 ml /min,Detection wavelength:220 nm,Injection volume:20 μl.
1． 3
Statistical Methods
dataxA.± sRepresentation,AdoptSPSS 13． 0statistical software pairdata for analysis,The treatment is analyzed by multi-factor factorial design variance.methods and processing time for statistical analysis,Different levels between the same groupofOPAResidual amount is usedLSDmethod to compare,P＜ 0． 05RepresentationThe difference is statistically significant.2 ResultsApplication of factorial design data variance analysis of different cleaning methods and locationsAfter the timeOPADifference between residues,There are statistical differences,Needs to be adoptedLSDmake multiple comparisons.2． 1different cleaning methodsOPAresidual amountLSDmultiple comparisonAutomatic cleaning and disinfection unitOPAMinimum residue,Pair with blankThere was no statistical difference between the groups.,Best Clear.Single stream groupofOPAMaximum Residue,There were significant differences with each group..Residual amount of glutaraldehyde between spray cleaning unit and automatic cleaning and disinfecting unitAlthough there is no statistical difference,But the mean comparison spray cleaning group is more automatic.The cleaning and disinfection machine group and the blank control group were both high.(Table1).Table1 Different cleaning methods on the outer surface of the endoscopeOPAComparison of the effects of residuesProcessing method(I)Processing method(J)MD(I － J)SEP95%confidence intervalLower upper limitBlank control single stream-0． 597*0． 085 0． 000 -0． 770 -0． 423Spray-0． 265*0． 085 0． 004 -0． 438 -0． 092automatic decontamination machine-0． 127 0． 085 0．144 -0． 301 0． 046
Single stream flow blank control0． 597*0． 085 0． 000 0． 423 0． 770Spray0． 332*0． 085 0． 000 0． 159 0． 505automatic decontamination machine0． 469*0． 085 0． 000 0． 296 0． 643
Spray blank control0． 265*0． 085 0． 004 0． 092 0． 438
single stream-0． 332*0． 085 0． 000 -0． 505 -0． 159
automatic decontamination machine0． 137 0． 085 0． 116 -0． 036 0． 311
Automatic decontamination machine blank control0． 127 0． 085 0． 144 -0． 046 0． 301
single stream-0． 469*0． 085 0． 000 -0． 643 -0． 296
Spray-0． 137 0． 085 0． 116 -0． 311 0． 036
Note:Based on the observed mean.*:The mean difference in0． 05More significant level.
2． 2
different cleaning timeOPAresidual amountLSDmultiple comparisonCleaning time is1 minWhen,OPAResidue with otherSignificant difference between points,2 minwith3 min,4 minTime GroupNo significant difference.Processing time up2 minAfter the pairOPAofNo change in the effect of residue removal(Table2).Table2 Different cleaning time on the outer surface of the endoscopeOPAComparison of the effects of residuesProcessingTime(min)(I)ProcessingTime(min)(J)MD(I － J)SEP95%confidence intervalLower upper limit1 2 0． 300*0． 085 0． 001 0． 126 0． 4733 0． 306*0． 085 0． 001 0． 133 0． 4794 0． 258*0． 085 0． 005 0． 085 0． 4312 1 － 0． 300*0． 085 0． 001 － 0． 473 － 0． 1263 0． 006 0． 085 0． 941 － 0． 167 0． 1804 － 0． 042 0． 085 0． 628 － 0． 215 0． 1323 1 － 0． 306*0． 0850． 001 － 0． 479 － 0． 1332 － 0． 006 0． 085 0． 941 － 0． 180 0． 1674 － 0． 048 0． 085 0． 576 － 0． 221 0． 1254 1 － 0． 258*0． 085 0． 005 － 0．431 － 0． 0852 0． 042 0． 085 0． 628 － 0． 132 0． 2153 0． 048 0． 085 0． 576 － 0． 125 0． 221Note:Based on the observed mean.*:The mean difference in0． 05More significant level.
3 Discussion
The existing endoscopic institutions in China mostly use automatic perfusion devices.(or pressurePower Water Gun)Flushing of the lumen of the endoscope,flush with the liquid it producesBrush force to achieve rinsing effect.However, the flushing of the outer surface of the endoscope still makesFlushing method with traditional faucet,The method exists water flow distribution is notUniformity and pressure limiting problems,Easy to cause disinfectant on the outer surface of the endoscopeResidue high.Improving endoscopic cleaning methods,DecreaseOPAResidues areIssues of Concern in Clinical Work.The results of this study show,FromDynamic cleaning and disinfection unitOPAMinimum residue,Spray cleaning tank timesof,Single stream highest,Description of spray cleaning tank and automatic cleaningPoison machine can be more effective to removeOPAResidue,The reason may be both.Flushing with full pressure spray principle,Its scouring force and waterThe effect of the uniform distribution of the flow onOPACleanup is more effective.Wherein spray typeBecause the cost of the cleaning tank is much lower than that of the automatic cleaning and disinfecting machine,in line with our countryactual clinical demand,worthy of popularization and application.
·3611 ·
Chinese Journal of Disinfection2016 Year No.33 Volume No.12 PeriodSet cleaning time reasonably,Improve cleaning efficiency Endoscope surface residueOPAnegatively correlated with the length of the cleaning process.The results of this study show,WhenCleaning time up2 min(Quantity= 20 L)When,OPAResidues tendStable.may be relatedNormanMinerWait〔5>> 〕ReportedOPACan be inside.
Persistent presence of polymeric material absorption in the lens lumen itself is related.Therefore,Clinical practice when cleaning endoscopes,It's not that the longer the cleaning time, the moreOPAthe better the removal effect.Refer to the results of this study,Set the endoscope reasonablyWashing step time,Both can be effectively removedOPAResidue on the surface of the endoscope,And can improve the cleaning efficiency,thereby increasing endoscopic turnover.Compared with the traditional disinfectant glutaraldehyde,OPAUse of concentrationDecrease,But direct contact can still cause eye,Lesions of the skin and mucous membranesInjury〔
6>> 〕.Disinfection of endoscopes and other instruments by existing cleaning and disinfection standards in ChinaThere are no clear regulations on the amount of agent residues and cleaning links.〔
7>> 〕,Therefore useEndoscopic agency for disinfectant-related chemical gastroenteritis,Allergic reactions, etc.Also lack of attention.The results of this study confirm,Inadequate cleaning can leadToOPAResidue increased,Therefore, standardize the process of endoscopic cleaning,The development of relevant standards and norms is to improve the effect of cleaning and disinfection.,SafeguardAn important guarantee for the safety.
Near the entrance.,Bacteria enter the body relatively easily,High incidence of infection.GuideThe arterial end of the tube is a side hole opening.,The application process is often caused by poor blood flowHigh incidence of thrombosis〔4>> 〕,The process of dealing with thrombosis also increases the infection machine.Will.Hemodialysis patients generally need weekly2 ～ 3Times,Every2 TimesDialysis at least interval24 hAbove,During indwelling central venous catheterCan be contaminated by bacteria,And ordinary disinfectant after disinfection is notLasting bacteriostatic effect,increased infection..Catheterization site and indwellingTime is the main factor affecting catheter infection,femoral vein catheterization is more neckDepartment more susceptible to infection.Catheter infection rates also increased with indwelling time.linear rise〔5>> 〕.Chlorhexidine gluconate is the gluconate salt of chlorhexidine,BelongsCationic surfactants and common skin and mucous membrane disinfectants,is mainlyDestruction of the permeability barrier on the bacterial cell membrane,Low concentrations can cause bacteriacytosolic leakage,High concentration can cause cytoplasmic condensation and degeneration,thereby reachingThe role of killing bacteria〔6>> 〕.Ethanol can not only promote the chlorine gluconatehexidine bactericidal effect,Play a synergistic role,Can quickly kill bacteriaPropagules and Mycobacteria,fungal spores,lipophilic virus,And with speed.effect,Features of Quick Drying,Also has a sustained bacteriostatic effect〔7>> 〕.Numerous studies have shown,High incidence of infection with indwelling femoral vein cathetersat the internal jugular vein〔8>> 〕.The results of this study show,Use of chlorhexyl gluconateDisinfection with alcohol,The infection rate of femoral vein group and internal jugular vein groupNo significant statistical significance,The use of iodophor disinfectant in two groups of patients
The incidence of infection was statistically significant..This phenomenon may be dueChlorhexidine Gluconate is more conducive to local maintenance of durable bacteriostasis related.There are literature reports,With the extension of the tube time,Occurrence of infectionrate also increased9>> 〕,The results of this study also support this view..But...Catheterization time is greater2 Weeks,The incidence of infection was significantly lower in the experimental groupin the control group,It suggests that chlorhexidine gluconate alcohol can effectively reduce bloodCatheters caused by prolonged indwelling central venous catheters in dialysis patientsOccurrence of associated infections.Therefore,Chlorhexidine Gluconate and IodophorsCompare,For central venous vascular indwelling disinfection effect is more accurate,and hasHave good long-term antibacterial ability,Can effectively reduce hemodialysis patientsIncidence of central venous catheter infection,worthy of clinical promotion and application.
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