新华手术器械有限公司

网站首页 > 用户服务 > 常见问题

【双语文章】器械表面变色/残留并非是因清洁不彻底造成的(上篇)

2017-07-04 14:40:40 新华手术器械有限公司 阅读

器械表面变色/残留并非是因清洁不彻底造成的

Staining/residues on medical instruments are not always caused by lack of hygiene


在过去几周里,德国黑森州数家医院消毒供应中心的关闭引起了诸多关注。据报道,器械再处理过程中曾出现过清洁问题。因此,这类事件的发生,会让人们觉得德国医院医疗器械的再处理过程存在诸多的卫生安全问题。然而,我们认为,大众媒体对此问题的评判并非完全准确,而且将此状况归因于由清洗不彻底造成的卫生隐患过于草率。


The closure of several Central Sterilization Service Departments (CSSDs) in Hessian hospitals has attracted a lot of attention in the last few weeks. There have been reports of deficient hygiene in instrument reprocessing and thus the impression has been given that grave hygienic deficits exist for medical devices in German hospitals. The scenarios described by the press however, have not in our opinion all been correctly evaluated and therefore prematurely categorized as a hygiene risk due to inadequate cleaning.


专业人员对其中一家涉事医院进行了清洗效果检测,但并未发现清洗不彻底的情况。消毒供应中心及相关操作人员都不认为器械再处理过程中的清洗结果存在问题。

In one of the affected hospitals experts could not confirm inadequate hygiene for instruments even using test. Neither did CSSD or operating staff consider cleaning results of reprocessing inadequate at any time.


进一步研究才发现这些器械表面变色来自于硅酸盐的沉积,毫无疑问这的确不是再处理过程欠妥所引发的卫生问题。

It turned out later that the stains on some instruments were silicate deposits, which definitely do not indicate a problem for hygiene due to inadequate reprocessing.


灭菌过程中的蒸汽质量不合格很可能会造成此类沉积的形成。即使对医疗器械进行适宜的再处理操作,也会发生表面变色或污染的情况。无论如何,我们认为因此情况而要求CSSD停业有失公正。通常来说这类变色或残留并不会威胁病人的健康或有任何毒理学方面的风险。我们应该对器械外观的变化进行探讨,而非再处理质量的缺欠。

The formation of these deposits was probably due to inadequate steam quality in the sterilization process. Formation of deposits or stains on instrument surfaces can happen in any good medical device reprocessing procedure-but in our opinion this does not justify shutting down the CSSD concerned. These residues do not generally constitute a hygienic or toxicological risk for patients. We are talking here about a cosmetic change and not a deficit in reprocessing quality.


即使对此类问题的危害做出了如上评估和论断,但我们仍需要特别警惕的是,它的发生不仅会损害消毒供应部门的声誉,也会损害医院的声誉及其经济利益。因此,妥当的处理方法是邀请有相关经验的第三方的专家介入此类事件,并协助监管部门去应对。但是必须确保所采取的强制措施不受经济利益的驱使。

It is very alarming that such a decision has been reached even so, because it not only damages the reputation of the department, but also that of hospital and therefor its economic success. Generally it is a good thing that external experts are brought in such cases, to support the supervisory authorities with relevant know-how from a special area. But it must be ensured that mandated measures are not subject to economic interests.


因此,不受经济利益驱使、专业的、基于实际情况的真实评估及其快速优化应该是最重要的。此时,由于主流媒体对医院及相关责任部门的压力,可以理解涉事医院几乎不会质疑所推荐的改进方案。因此很可能会出现,花费较高且采取了没经过验证的不必要措施的情况。

Therefore, independently of economic interests, a professional, realistic evaluation of the situation on the ground and its swiftest optimization should be paramount. Because of the prevailing public pressure on hospital and those carrying responsibility at such times, the measures recommended are understandably rarely questioned by those affected. It is far more likely that the often very expensive and partly unnecessary measures are implemented without further examination of the facts.


来自器械再处理工作组(AKI)的专家成员对现今这种至少在一定程度上过分夸张的方案用公开声明的方法予以回应,来防止进一步的过度反应和可能因不公正评判造成的消毒供应部门停业。

The expert group from the Working Group Instrument Reprocessing (AKI) has already given its reaction to the current situation with a public statement on these at least partially exaggerated measures, to try to prevent further over reaction and possibly unjustified department closures.


众所周知,CSSD所处理的器械上,经常会出现器械表面变色的情况。在CSSD最常见的沉积或表层变色是哪一类?如何评估潜在的风险和采取适当的补救措施?

In many central sterilization service departments the appearance of stains is known to occur from time to time. Which are the most common types of deposits or surface discolorations appearing inthe CSSD? How can their risk potential be assessed and which suitable remediescan help?


以下是对一些表面变色类型的总结,这些被认为是CSSD中最频繁出现的情况。在此对多家灭菌服务部门的所遇到的情况进行收集汇总。

The following is a summary of some types of stains, those that from the point of view of users appear in the CSSD most frequently. These are gathered from individual’s experience from various sterile service departments.


硅酸盐沉积变色 Silicate deposits

图片关键词
经验表明,硅酸盐沉积的现象在很多中央灭菌部门都曾经发生过。它在一些医院一再发生,并且无法彻底解决。

Experience shows that the phenomenon of silicate deposits has occurred at least once in the history of any central sterilization departments. It occurs repeatedly in some hospital and can never be entirely ruled out.


在"红皮书"(AKI)中对此有全面深入的解读,这类沉积既有黄褐色又有蓝紫色,出现在器械上、清洗消毒器及灭菌器的腔体内。

As described in depth in the "Red Brochure" (AKI) this type of deposit is a yellow-brown to blue-purple stain on instrument, in the chambers of washer-dis-infector(WD) and also sterilisers.


它的来源可能是在使用离子交换器和反渗透水处理设备生产纯水时,发生硅酸渗漏。罪魁祸首可能是交换盒,其用尽时会导致二氧化硅从给水进入加工循环。这种硅酸泄露现象在纯水的电导率低于建议水平时也可能发生。

It can arise due to the occurrence of silicic acid slippage during production of fully demineralized water (FD water). The culprit can be the ion exchangers and the reverse osmosis water treatment plant, which when the exchange cartridge is exhausted allows silicon oxide from the feed water into the reprocessing circulation. This silicic acid slippage can even be present when the microsiemens value (uS/cm) of the fully demineralized water lies below there commended level.


硅酸盐沉积也可能来自终末漂洗用水中的矿物成分或终末漂洗所使用的清洗剂中过量的硅酸盐成分。但大多数情况下是与纯水的质量相关的。

Silicate deposits can also from on surfaces when minerals are present in the process water and in the final rinse water orvary carrying – over of detergent containing silicates in the final rinse of the WD. But in most case the cause is in some way connected to the fully demineralized water quality.


图片关键词
当然第一次看到肯定会被器械外观上的变化感到震惊,但当前科学知识表明,外观上的变化并不会对患者或环境造成卫生方面的风险。单纯外观上的变化实际上也为相关的医疗设备提供了一定的保护(钝化层)。

Of course the cosmetic effect is quiteshocking the first time you see it- but current scientific knowledge shows that there is no hygienic risk for patients or for the environment. It is simply acosmetic effect, which actually provides a certain protection (passive layer)for the medical device concerned.


找出硅酸盐沉积的原因,最重要的是首先查看纯水的处理并与相关技术人员进行探讨。例如离子交换器是否进行过更换或更新及最近一次更换或更新是什么时候?制取纯水的处理过程是否发生变化?最近一次的水或蒸汽的质量检查何时进行?这也是经常会建议相关实验室对水质进行常规监测的原因。 (蒸汽灭菌时水质符合EN 285标准(附录B-表B1)或DIN 58946标准第6部分)。

To find out of the cause of the silicate deposits, it is important first of all to look at fully demineralized water treatment and discuss with the technicians involved. For example whether and when the ion exchanger was last changed or renewed, whether there have been process changesin the treatment of fully demineralized water, and even when the quality of the water or steam was last checked. This is why it is also always advisable to have regular water monitoring conducted by the relevant laboratories (See Water Quality for Steam Sterilisation according to EN 285, App. B, Table B1 or DIN58946 Part 6).


图片关键词

除此之外,有必要检查清洗消毒器的加剂功能,是否按照预期进行了中和和中间冲洗。清洗消毒器和清洗剂必须是能够匹配的。有些医院可能安装了不合适的水管,这类水管也会导致器械表面、清洗消毒器和灭菌器舱体的变色。

In addition it is necessary to check whether the dosage applicance is correctly connected to the WD, whether neutralization and intermediate rinse occurs adequately as intended. Here WD and chemical manufacturers can support each other. In hospitals with less than modern water pipes have been installed. This sort of pipe work can also cause discolouration on instruments, WDs and sterilizers.


为了更有针对性的解决再处理过程中的沉积问题,建议是:在特定的时间段内,对某一器械进行重复地灭菌或用清洗消毒器进行反复的清洗和消毒。此时就可以辨别沉积来自这两个流程中的哪个。当找出产生沉积的原因并采取改善措施后,应对医疗器械及设备内舱都进行彻底的清洁。

In order to work out more exactly where the deposits are coming from in the reprocessing procedure, it is to be recommended, for a defined period of time, to sterilize one instrument in the sterilizer again and again or to fix one instrument into the WD and to washand disinfect it repeatedly. Thus a distinction can be made between causes of deposits can be from these two processes. When the causes have been found and remedied, basic cleaning of the medical devices including appliance chambers should be carried out.


图片关键词

水垢、氧化变色 Lime scale, oxidation

图片关键词
器械表面会因为水滴残留引起钙盐水垢积层或变色导致外观变化。钙盐水垢的主要起因是由于清洁用水或终末漂洗用水中的钙和镁离子含量过高。在终末漂洗阶段使用纯水,可防止机器清洗消毒处理时形成乳白色的污垢残留。

Sporting from water droplets caused lime scale and discolouration of surfaces by oxidation are commonly seen on instruments and are one of alterations that are purely cosmetic. Lime scale residues (chalk) often form where the calcium and the magnesium ion content of the process water used for cleaning or in the final rinse is too high. Using fully demineralized water in the final rinse of the WD can prevent these milky chalk residues.


图片关键词
经氧化导致的器械表面变色可能会形成灰黑色的钝化层。这类变色与不锈钢器械材料中铬含量和碳含量的比例相关。碳的含量越高,颜色变为灰黑色的速度就越快。

Discoloration of the surfaces caused by oxidation shows as a grey-black stain. These stains are related tothe material composition of the stainless steel instruments, the proportion of chrome to carbon. The higher the carbon content of the material, the faster agrey-black appears.


钛及阳极氧化铝变色 Alterations to material likeTitanium and anodized aluminium

图片关键词在CSSD中钛金属材料变色几乎无法避免。因为这种材料在清洗消毒处理时会受到周围环境条件(温度、湿度、清洗过程化学品)的影响,导致表层氧化形成透明的、彩色的氧化层,但并不存在卫生方面的安全风险和毒性。

It is almost impossible to avoid the discoloration of titanium materials in the central sterilization service department. The factors necessary for reprocessing-temperature, moist heat and process chemicals-react with the material surface and colorful,iridescent oxide layers form, which are however definitely hygienically speaking harmless and toxic.


要避免阳极氧化铝材料变色同样困难。铝阳极氧化处理后对酸和碱反应灵敏。甚至仅仅将软化水的pH(取决温度和时间)升高都可能导致阳极氧化处理的铝材料表面出现白色粉状的残留。

Anodised aluminum is similarly difficult. Eloxal reacts sensitively to both alkalinity and acidity. Here, eventhe rising pH value (dependent on temperature and time) of softened water cancause changes to Eloxal surfaces, which appear as a white, floury residue on surfaces.


经过几次灭菌周期后,阳极氧化处理的铝表面对外部影响有更高的耐受性。但是建议优化阳极氧化铝和彩色阳极氧化铝再处理的过程参数如水质、清洗剂剂量、漂洗的次数的来防止碱性清洗剂的残留。

After several sterilization cycles Eloxal surfaces become more durable to external influences. It is however recommended when reprocessing Eloxal and colored Eloxal to optimize theinterplay between all the process parameters such as water quality, dosage and sufficient number of rinses to prevent carry-over of alkalinity.


弯盘的变色 Residues on OT dishes

在CSSD经常看到弯盘变色。这些弯盘外壁是有光泽的,但其内部是蓝色、紫色或灰色的残留变色。产生残留变色的原因是:弯盘承装氯化钠溶液、棉签等物品,在手术室使用过程中停留了过长时间。长时的接触使盐在液体中结晶析出,导致所用器具变色。颜色的改变通常是由氧化反应引起,因此并不存在卫生或毒理学问题。

In central sterilization departments one often notices discoloration of OT dishes. Here the exterior ofthe dish is suitably shiny, but on the interior here is a blue/purpleiridescent, sometimes greyish residue. The reason for this is that the dishesare heated over lengthy sessions in the operating theatre, which sodium chloride solution, swabs etc. are in them. Heating causes the salts in the fluids to crystallise out, causing encrustations discoloring the utensil. The alterations in color are generally caused by an oxidative reaction and aretherefore not a problem for hygiene or toxicology.


转自“消毒供应频道”