双语文章 | 洞悉：医疗器械的清洗

洞悉：医疗器械的清洗

Insight: cleaning medical devices

作者: Aaron Papadopoulos

Cleaning has played a central role in the history of humanity for thousands of years. 

清洗在人类历史上一直发挥着核心作用。

Over time, there have been many crucial advancements regarding the technology and process chemicals used, but the principle behind the cleaning process remains unchanged. Laundry started off being washed in rivers before progressing to the washboard and ultimately to the washing machines that can now be found in virtually every household.The chemicals used are also subject to constant development, from simple soft soap to today's innovative and resource-saving cleaning products.

随着时间的推移，清洗技术和在过程中所使用的清洗剂都取得了重大进步，但是清洗过程背后的原则仍然没有改变。清洗衣物一开始是在河里，然后用洗衣板清洗，最后又发展成用洗衣机清洗，现在几乎每个家庭都能找到洗衣机。清洗剂也在持续发展，从简单的软皂，步入今天创新型和资源节约型的清洗产品。

This article discusses the subject of cleaning in general, explains the cleaning process and gives an insight into chemical cleaning substances. The cleaning process can be applied to any type of cleaning, in both private (e.g. washing machine, dishwasher, washing a car) and proessional environments (e.g. cleaning hygienic surfaces). For the sake of simplicity, this article will focus solely on cleaning medical devices.

本文讨论了清洗主题，解释了清洗过程，并深入介绍了化学清洗剂方面的见解。清洗过程适用于任何类型的清洗，包括个人用途（例如洗衣机、洗碗机、洗车）和专业环境（例如清洁卫生的表面）。简单起见，本文将仅关注医疗器械的清洗。 

• Pre-cleaning medical devices

• 预处理医疗器械

The importance of meticulous and effective reprocessing of medical devices in order to prevent infection is indisputable. Reprocessing medical devices starts with pre-cleaning in the operating theatre or examination room. Coarse soiling, residues of haemostatic agents, skin disinfectants, lubricants, etc. should be removed before the instruments are set down if possible. In the case of flexible endoscopes, the insertion part is wiped down immediately after it is removed from the patient and the channels are flushed to prevent any residues from adhering. If residues do adhere, they can be extremely difficult to remove due to the narrow lumina of the endoscopes. Dried-on soiling can also lead to material changes such as corrosion, reducing the value and service life of the instruments.

对医疗器械进行细致有效的再处理以防止感染，这个重要性是毋庸置疑的。医疗器械的再处理是从手术室或检查室的预处理开始。如果可以的话，在器械被登记之前，应清除器械上的大颗粒污物、止血剂、皮肤消毒剂、润滑剂等残留物。在处理软式内镜时，插入部分在从患者身上被取出后应被立即擦拭干净，并冲洗镜腔以防止任何残留附着。如果有残留附着，由于内镜狭窄的腔体，这些残留物会非常难以清除。干涸的污垢也会导致材料变化，像是发生腐蚀、降低器械的价值和使用寿命。

Ultrasonic probes meanwhile, can or must be wrapped in a protective cover. This cover is removed and discarded after the examination, making it easier to (pre-) clean the probes using a cloth.This initial “pre-cleaning” is followed by the actual cleaning process. This must be carried out manually (brush cleaning) for flexible endoscopes. All other instruments can be cleaned by machine. As a general rule, machine cleaning should be favoured over manual cleaning for occupational safety reasons and because it offers better standardisation and reproducibility.

同时，超声探头可以或必须用保护套进行包装。这个套子在检查后被取下并丢弃，这样更容易使用布清洁探头。这个最初的“预处理”之后，将开始实际的清洗过程。软式内镜必须进行手动清洗（刷洗）。所有其他器械都可以用机器清洗。通常来说，出于职业安全的考虑，机器清洗应优先于手工清洗，因为它提供了更好的标准和可重复性。

These initial cleaning steps are immensely important and are crucial to the success of subsequent reprocessing, as effective disinfection and sterilisation can only be achieved  if thorough cleaning has been carried out first. In the event of inadequate cleaning, soiling - particularly proteins - could become attached to the surface. The disinfectant that is subsequently applied may be used up on the soiling reducing its efflicacy. Equally, the function of the medical device being reprocessed could be impaired.

这些最初的清洗步骤非常重要，是后续再处理成功的关键，因为只有先进行彻底地清洗，才能实现有效的消毒和灭菌。如果没有足够的清洗，特别是蛋白质等一些污垢很可能会附着在表面上。随后使用的消毒剂可能就作用在了附着物上，进而减少了其功效。同样，再处理中的医疗器械的功能也可能因此受到损害。

Cleaning is defined as the “removal of contamination from an item to the extent necessary for further processing or for intended use”(DINEN ISO 17664). Guidelines such as the “Guideline compiled by DGKH, DGSV and AKI for the validation and routine monitoring of auto-mated cleaning and thermal disinfection processes for medical devices' set out limit values, warning ranges and reference values for classifying and evaluating the cleaning result. The  aim of the daily cleaning routine is to achieve a “visually clean” result. This result is achieved by means of the cleaning process.

清洗的定义是“将物品上的污染物清除以达到进一步处理或预期用途所必须程度”（DIN EN ISO 17664）。一些指南，像是“由DGKH、DGSV和AKI编写的关于医疗器械自动清洗和热消毒过程的验证和常规监测的指南”中对于清洗结果的分类和评估列出了极限值、警示范围和参考值。日常清洗的目的是达到“肉眼清洁”的结果。这一结果是通过清洗过程来实现的。

• Principles of the cleaning process

• 清洗过程所遵循的准则

The principle behind every cleaning process is based on four interrelated factors. This process is also referred to as Sinner's circle, named after Herbert Sinner (*1900 in Chemnitzt 1988 in Hilden) who was a surfactant chemist and head of detergent application technology at Henkel. Sinner discovered that four factors are required to achieve the perfect wash result of “pure white' . With a 90℃ wash programme, these factors must be weighted/set evenly. Sinner's circle can be adapted for dishwashing, manual cleaning, etc. and to take into account the evolution of cleaning chemicals and appliance technologies over the years. Today, optimum cleaning can be achieved by adjusting the individual factors so that they are weighted unevenly in Sinner's circle.

每个清洗过程背后的原理是基于四个相互关联的因素。这个过程也被称为Sinner环，以Herbert Sinner命名（生于1988年的Hilden，死于1900的Chemnitzt），Sinner是表面活性剂化学家和德国汉高（Henkel）公司清洗剂应用技术的负责人。Sinner 发现要达到“纯白”的完美清洗效果需要四个因素。在90℃的清洗程序中，这些因素必须被均匀加权或设置。Sinner 圆可以应用于洗碗、手动清洗等其他情况，并且经过清洗剂和设备技术多年的发展Sinner圆仍然适用。如今，最佳的清洁可以通过调整单个因素来实现，这样它们在Sinner圆中的权重就不均衡了。

The four factors required for a successful cleaning process according to Sinner are described below:

按照 Sinner 的说法，一个成功的清洗过程所需要的四个因素如下：

• Chemistry 
• 化学作用

Refers to the media used; for example, chemicals. These media can remove soiling from surfaces, Catalyse/break down soiling, keep soiling suspended and ensure that particles do not adhere elsewhere.

这个指的是所使用的媒介，例如，清洗剂。这些媒介可以去除表面污物，催化或分解污物，让污物脱离，并确保颗粒物不会附着在其他地方。

• Temperature
• 温度

Refers to the required operating temperature in the cleaning process. The temperature should always be appropriate for the instruments being reprocessed. Some instruments (e.g. flexible endoscopes) are thermolabile and may sustain material damage at high temperatures. Excessively high operating temperatures may also result in protein fixing. The operating  temperature in manual applications is much lower (25℃ on average) than in machine applications (average temperature  55℃ following initial cold pre-cleaning).

指清洗过程中所需的工作温度。温度应始终适合再处理的器械。有些器械（如软式内镜）是不耐热的，在高温下可能会造成材料损伤。过高的工作温度也可能导致蛋白质固化。手工清洗的工作温度（平均25℃）比机器清洗的工作温度（初始预处理低温之后的平均温度为55℃）低得多。

• Mechanical action
• 机械作用

Refers to the method used to remove soiling from the surface. In manual processes, this may involve brushing (for endoscopes) or wiping, or compressed air or a steamer may be used. Another possible method is the use of an ultrasonic bath. In automated processes, the mechanical action is provided by the wash pressure. The media (water and chemicals) are circulated and brought into contact with the surfaces with great force via the spray arms and/or internal circuit, thus removing the soiling. Modern washer-disinfectors use compressed air to blow water through lumina at certain intervals to aid the mechanical action of the water.

指用于清除有关表面污物的方法。在手工处理过程中，这可能涉及刷洗（内镜刷洗）或擦拭，或可能使用压缩空气或蒸汽清洗机。另一种可能的方法是使用超声清洗。在机洗过程中，机械作用是由水压提供的。通过喷臂和/或内部电路，使介质（水和化学品）循环并以巨大的力量与表面接触，冲洗掉污物。现代清洗消毒器利用压缩空气，以一定的间隔将水喷射到管腔，以加强水的机械作用。

• Time
• 时间

Refers to the process time required to achieve the desired cleaning result. In manual processes, this refers to the time until the surface is visually clean. In machine processes, the time is programmed in and is usually 10 minutes. Longer wash phases offer more intensive wetting of the load items and lead to better cleaning/wash results.

指达到预期清洗效果所需要的处理时间。在手工清洗过程中，时间指的是表面被清洗到肉眼可见的清洁所需要的时间。在机器清洗过程中，时间是被规定程序化的，通常是10分钟。较长时间的清洗阶段提供了对于负载物品更集中的浸润过程，并带来更好的清洗或者洗涤的结果。

All factors are dependent on each other but their weighting within a process can be adapted and changed. In the case of manual cleaning, a lower temperature is used which means that the mechanical action and powerful cleaning chemicals play a greater role in achieving the desired results. In a washer-disinfector, the temperature and mechanical action over the specified time are the key factor, while the cleaning chemicals support these factors in order to achieve optimum results.

所有的因素都是相互依赖的，但是它们在一个过程中的比重是可以调整和改变的。在手工清洗的情况下，使用较低的温度意味着机械作用和强力清洗剂在达到预期效果方面发挥更大的作用。在清洗消毒器中，温度和规定时间内的机械作用是关键因素，而清洗剂支持着这些要素从而达到最佳效果。

Water is essential throughout the cleaning process as it serves as a reactant, solvent and means of transport in/ with the four different factors. It is therefore extremely important that the water does not contain any substances which may impair its quality. Substances such as calcium carbonate and magnesium carbonate can leave behind limescale residues. Other substances can cause evaporation residue stains on the load items at high temperatures.

在整个清洗过程中，水是必不可少的，因为它在这四种不同的要素中担任的是反应物、溶剂和运输工具的角色。因此，水里面不能含有任何可能损害其质量的物质，这点极其重要的。碳酸钙和碳酸镁等物质会留下水垢残留物。在高温下，其他物质会在载体上留下蒸发残留污物。

Demineralisedwater (DI water) is therefore the best choice for machine reprocessing of medical devices as this produces the best possible results from all four factors of Sinner's circle. 

因此，去离子水（DI水）是医疗器械再处理设备的最佳选择，因为这可以让Sinner圆所有四个要素产生最好的结果。

• Cleaning components in the reprocessing process
• 再处理过程中的清洗成分

With regard to chemicals, standard cleaning agents for reprocessing medical  devices use the following key components, depending on the application:

根据用途不同，医疗器械再处理的清洗剂中的标准清洗介质包含以下关键成分：

( When selecting the cleaning chemicals,it is important to ensure that they are compatible/coordinated with the cleaning process in question.)

（在选择清洗化学剂时，重要的是要确保它们与相关的清洗过程相兼容或协调。）

• Surfactants
• 表面活性剂

Surfactants are crucial to the cleaning result and are present in virtually all cleaning agents. Due to their method of operation, they are also referred to as wash-active substances. They consist of a hydro phobic part and a hydrophilic part. Surfactants lower the surface tension of water and remove, break up, emulsify and disperse the soiling. When the surface tension of the water is lowered, the water wets a larger area and penetrates into lumina and narrow spaces in order to cover the particles of soiling.For example, water droplets sitting on a surface will only wet a small area due to surface tension. If a surfactant is added, the  surface tension is reduced and the water wets a larger area.

表面活性剂对清洗效果至关重要，它几乎存在于所有清洗剂中。考虑到他们的作用方式，表面活性剂也被称为清洗活性物质。它们是由疏水部分和亲水部分组成。表面活性剂降低水的表面张力，去除、分解、乳化和分散污垢。当水的表面张力降低时，水湿润的面积更大，并渗透到缝隙和狭窄的空间，以覆盖污垢颗粒。例如，水滴在表面上，由于表面张力，只会润湿一小块区域。加入表面活性剂后，表面张力降低，水润湿面积增大。

Another way in which surfactants improve cleaning is via their emulsifying properties.  Emulsification is the process of mixing two incompatible liquids to form a single liquid. These incompatible liquids will separate out again over time, but the surfactant slows down this process (example: oil and water).

表面活性剂改善清洗效果的另一种方式是通过其乳化的性能。乳化是将两种不相容的液体混合成单一液体的过程。随着时间的推移，这些不相容的液体会再次分离出来，但表面活性剂会减缓这一过程（例如：油和水）。

Finally, surfactants improve the cleaning power of water by suspending particles of soiling. This suspension prevents the particles of soiling from settling back on instruments and surfaces after they have been removed. Surfactants keep the particles of soiling separated  and suspended in the solution, preventing them from collecting and settling back on the instruments when they are removed from the cleaning tank.

最后，表面活性剂通过分离污垢颗粒来提高水的清洗能力。这种分离作用可以防止污垢颗粒在被清除后在器械和其他表面上沉积。表面活性剂使污垢颗粒分离并悬浮在溶液中，防止它们从清洗槽中取出时聚集并沉降到器械上。

There are four different types of surfactants which are used in the chemicals depending on the application in question:

清洗剂中使用的表面活性剂有四种不同类型，这取决于所涉及的应用场景：

Anionicsurfactants: excellent cleaning performance, high foam formation.

阴离子表面活性剂：清洁性能优良，泡沫形成率高。

Cationic surfactants: disinfection component.

阳离子表面活性剂：具有消毒成分。

Amphotericsurfactants: no cleaning perforance, used to regulate foam.

两性表面活性剂：无清洁性能，可用于调节泡沫。

Non-ionicsurfactants: good cleaning perforance, low foam formation.

非离子表面活性剂：清洁性能好，泡沫形成率低。

• Enzymes
• 酶

Enzymes are molecules that act as catalysts in a cleaning agent in order to improve the processing of particles of soiling. Enzymes can catalytically break down soiling such as proteins, carbohydrates or fats in order to remove them from the surfaces. There are many different enzymes for all kinds of soiling and application areas. The enzymes most commonly used in instrument cleaning agents (for both manual and machine processes) are proteas- es,lipases and amylases. The type of cleaning agent used should be tailored to the type of soiling being removed. With regard to the enzyme reaction, it is important to note that time, concentration and temperature affect the enzymes' ability to remove soiling. 

酶是一种分子，在清洗剂中起到催化剂的作用，以改善对污垢颗粒的处理。酶可以催化分解蛋白质、碳水化合物或脂肪等污垢，将它们从表面清除。有许多不同的酶适用于各种各样的污垢和应用领域。仪器清洗剂中最常用的酶是蛋白酶、脂肪酶和淀粉酶（手工清洗和机器清洗）。使用的清洗剂类型应根据要清除的污垢类型而定。关于酶的反应，需要注意的是，时间、浓度和温度会影响酶去除污垢的能力。

Enzymes need time to break down soiling If the instruments do not have at least 3-5 minutes of activation time, the use of enzymes will not improve the overall cleaning process. Enzymes must be used at the right temperature and concentration in order to deliver optimum results. Concentrations and water temperatures above or below the manufacturer's recommendation may reduce the efficacy of the cleaning agents. 

酶需要时间分解污垢，如果医疗器械没有至少3-5分钟的时间去激活，那么使用酶也不会改善整个清洁过程。酶必须在合适的温度和浓度下使用，以达到最佳效果。浓度和水温高于或低于制造商的建议，都可能会降低清洗剂的功效。

When selecting the cleaning chemicals, it is important to ensure that they are compatible/coordinated with the cleaning process in question. 

在选择化学清洗剂时，重要的是要确保它们与相关的清洗过程相兼容或协调。

If foam develops during machine cleaning, this can cause a technical fault in the washer-disinfector and form a barrier layer between the load items and the cleaning factors of temperature, mechanical action and cleaning chemicals, resulting in inadequate cleaning results. In manual processes, there is an increased risk of injury for the staff member as the instruments are no longer visible in the cleaning tank. When using chemicals, the manufacturer's instructions regarding dispensing and application area must always be followed.

如果在机洗过程中出现泡沫，则可能导致清洗消毒器出现技术故障，阻碍温度、机械作用以及清洗剂作用在待清洗的物品上，从而导致清洗效果不佳。在人工清洗过程中，如果水槽中的器械不能被清楚地辨识，那么工作人员受伤的风险也会随之增加。当使用清洗剂时，必须始终遵循制造商关于配比和适用范围的说明。

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