技術(shù)交流

前言

  在加工醫(yī)療產(chǎn)品時(shí)，高質(zhì)量絕對(duì)是至關(guān)重要的。德國(guó)無(wú)菌供應(yīng)學(xué)會(huì)（DGSV e.V.）的目標(biāo)是提高醫(yī)療產(chǎn)品加工的整體質(zhì)量。實(shí)現(xiàn)這一質(zhì)量改進(jìn)的方法之一是提高工藝可靠性，這是我們的主要目標(biāo)?；颊呤俏覀兯鲆磺械闹攸c(diǎn)。此外，實(shí)際的行業(yè)經(jīng)驗(yàn)也可以幫助提高質(zhì)量。紅銹是蒸汽滅菌過(guò)程中一個(gè)眾所周知的質(zhì)量問(wèn)題。但是實(shí)際上是什么導(dǎo)致了紅銹的出現(xiàn)，操作人員如何消除這些原因并防止它們成為一個(gè)問(wèn)題呢？在這本手冊(cè)中，你會(huì)發(fā)現(xiàn)對(duì)這個(gè)非常高質(zhì)量的問(wèn)題的描述，以及你可以采取的步驟來(lái)成功地解決這個(gè)問(wèn)題本身和找到它的起因。

Maik Roitsch

DGSV主席

Foreword

  When processing medical products, a high level of quality is absolutely critical. The mis- sion of the German Society of Sterile Sup- ply (DGSV e.V.) is to improve the overall quality of medical products processing. One of the ways to achieve this quality im- provement is by increasing process reliabi- lity, which is our primary objective. The patient is the focus of everything we do. In addition to this, actual industry experience can also help to improve quality. Rouging is a well known quality issue in the steam sterilization process. But what actually cau ses rouging, and how can operators elimi- nate these causes and prevent them from becoming a problem? In this brochure, you'll find a description of this very quality issue, as well as steps that you can take to successfully address both the issue itself and its causes.

Maik Roitsch

DGSV Chairman

介 紹

圖1：狀況良好的腔室的典型圖像

圖2：重復(fù)使用后的腔室狀況（可見(jiàn)腔室變色）

    當(dāng)醫(yī)療器械被再加工時(shí)，它們會(huì)在蒸汽消毒器中進(jìn)行消毒，這是專(zhuān)門(mén)為手頭的任務(wù)而特別優(yōu)化的。作為一種公認(rèn)的觀念，蒸汽滅菌是一種研究充分、可靠的處理方法。在腔室的技術(shù)設(shè)計(jì)中，使用高合金奧氏體不銹鋼合金，如1.4301、1.4404、1.4571和其他類(lèi)似合金作為結(jié)構(gòu)材料。圖1和圖2顯示了一個(gè)典型的蒸汽消毒器的例子，可以看到快速滅菌柜的內(nèi)部。

    在許多應(yīng)用情況下，實(shí)際操作經(jīng)驗(yàn)顯示，在滅菌室的使用壽命中，滅菌室內(nèi)部的不銹鋼拋光表面經(jīng)常出現(xiàn)不希望的變色。這些所謂的抗銹不銹鋼表面的變化（見(jiàn)圖2）的變化往往使負(fù)責(zé)MPPU/CSSD（醫(yī)療產(chǎn)品處理單元/中央無(wú)菌服務(wù)部門(mén)）儀器運(yùn)行的員工感到不安。

    本指南的目的是在某些情況下深入解釋上面所描述的變化背后極其復(fù)雜的相關(guān)原因，并展示各種不同的影響因素。然而，我們應(yīng)該首先注意到，這些類(lèi)型的表面改變通常是幾個(gè)不同因素造成的結(jié)果，這些因素甚至可以根據(jù)個(gè)別場(chǎng)景相互作用和/或相互惡化。

    在分析與不銹鋼表面不常見(jiàn)的沉積物有關(guān)的變色問(wèn)題背后的原因時(shí)（這在單個(gè)的韌性方面差別很大），通常的反應(yīng)是首先聯(lián)系以下一個(gè)或多個(gè)組織：建造服務(wù)商、WD制造商和所使用的工藝化學(xué)品的供應(yīng)商。

    上述每個(gè)接觸點(diǎn)從其自身的主觀角度選擇性地處理不銹鋼表面上的變色/（不希望的）膜的問(wèn)題，然后可以回答其系統(tǒng)或產(chǎn)品正在完美地運(yùn)行，并且不承擔(dān)造成變色的責(zé)任。從操作人員的角度來(lái)看，這種處理方法通常對(duì)需要進(jìn)行的問(wèn)題分析沒(méi)有幫助，也不有利于有效地解決問(wèn)題。

    在分析根本原因時(shí)，需要首先檢查供應(yīng)給設(shè)備的水的質(zhì)量，以及從滅菌蒸汽中產(chǎn)生的凝析水的組成。

    此外，建議一個(gè)專(zhuān)家對(duì)從受影響的不銹鋼表面的變色中提取的拭子/磨損樣品進(jìn)行化學(xué)物理分析。對(duì)這一分析結(jié)果的解釋將得出關(guān)于薄層的來(lái)源和原因的初步結(jié)論。

    然而，所有必要的介質(zhì)供應(yīng)參數(shù)即使符合，永久的薄膜/變色也完全有可能出現(xiàn)在滅菌器室的內(nèi)表面。

    這本手冊(cè)提供了關(guān)于表面變色的潛在原因的基本和補(bǔ)充的提示和信息，以及處理這些典型的麻煩現(xiàn)象的建議。

    文本隨附的插圖和數(shù)據(jù)有助于確保涵蓋問(wèn)題的整個(gè)范圍，包括所有相關(guān)因素。已經(jīng)特別標(biāo)注解釋蒸汽滅菌的主題，以及在這種背景下如何發(fā)生變色的潛在原因。

    在這個(gè)連接處，應(yīng)當(dāng)注意的是，這種被稱(chēng)為均勻腐蝕的形式，這些不銹鋼表面的薄膜/變色也可以由除了本手冊(cè)中描述的造成紅銹以外許多其他極其多樣化的影響因素引起。例如，無(wú)腐蝕性不銹鋼合金表面的變色和與腐蝕相關(guān)的變化可能有以下已知的原因：

?水或蒸汽的質(zhì)量不夠好   

?腔室表面沒(méi)有按照正確制造、和/或按照相同標(biāo)準(zhǔn)的材料

?合金質(zhì)量不好

?制造腔室使用了不適合的制造技術(shù)

?滅菌材料中使用了不合適的物質(zhì)

?被引入或帶入化學(xué)物質(zhì)進(jìn)入了腔室

?不銹鋼表面工作的不當(dāng)方法的應(yīng)用

?對(duì)腔室和裝載推車(chē)的化學(xué)攻擊，例如：不適合清潔的化學(xué)物質(zhì)

?化學(xué)指示物或貼紙

?造成腐蝕風(fēng)險(xiǎn)的二級(jí)工藝(例如：磨擦腐蝕、點(diǎn)蝕、接觸腐蝕等）

在每一種特定的情況下，其他因素也可能作為一個(gè)潛在的原因加以考慮。

Introduction

     When medical instruments are reprocessed, they are sterilized in steam sterilizers that have been specially optimised for the task at hand. As a concept that has been known about for years, steam sterilization is a well researched and reliable processing method. For the technical design of the chambers, high-alloyed austenitic stainless steel alloys, such as 1.4301, 1.4404, 1.4571, and other similar alloys, are used as structural materials. Figures 1 and 2 show examples of a typical steam sterilizer, with a view of the sterilization chamber interior.

     In many application cases, actual operating experience has shown that, over the course of the sterilization chamber's service life, undesired discolouration often appears on the initially bright finish of the stainless steel surfaces in the chamber's interior regions. These types of changes in supposedly rustresistant stainless steel surfaces (see Figure 2) are often disconcerting to the employees in charge of the MPPU/CSSD (medical products processing unit / central sterile services department) and to those responsible for instrument processing.

     The goal of this guide is to provide an in- depth explanation of the, in some cases, extremely complex interrelated causes behind the changes described above, and to also present various different influencing factors. However, we should start by noting that these type of surface alterations are typically the result of several different factors that can even interact with and/or exacerbate one another depending on the individual scenario.

     The usual response when analysing the causes behind the discolouration problems (which vary greatly in terms of individual tenacity) found in connection with the typically unfamiliar deposits on stainless steel surfaces is to first contact one or more of the following groups: building services, the manufacturer of the WD and the suppliers of the process chemicals used.

     Each of the aforementioned points of contact approaches the issue of discolouration / (undesired) film on the stainless steel surfaces selectively, from its own individual, subjective perspective, and may then reply that its system or product is working flawlessly, and is therefore not responsible for causing the discolourations. From an operator's point of view, this approach is usually not very helpful for the problem analysis that needs to be performed, nor is it conducive to effectively resolving the problem.

     When analysing the root cause, it is important to first check the quality of the water being supplied to the devices, as well as the composition of the condensate from the sterilizing steam.

     In addition, a chemical-physical analysis of swab/abrasion samples taken by a specialist from the discolourations on the affected stainless steel surfaces is recommended. The interpretation of the results from this analysis will allow initial conclusions to be drawn about the sources and causes of the film. 

     However, it is entirely possible that, even if all of the necessary media-supply parameters are complied with, permanent films/ discolourations can appear on the interior surfaces of sterilizer chambers.

     This brochure provides basic and supplementary tips and information about the potential causes of surface discolourations, as well as recommendations for dealing these typically bothersome phenomena.

     The illustrations and figures accompanying the text help to ensure that the entire scope of the problem, including all of the related factors, is covered. Particular attention has been given to explaining the topic of steam sterilization and how potential causes of dis- colouration can occur in this context.

     At this junction it should be noted that, as what is referred to as form of uniform corrosion, these films/discolourations on stainless steel surfaces can also be caused by a host of other extremely diverse influencing factors aside from the rouging effect described in this brochure. Discolourations and corrosion-related alterations in the surface of noncorrosive stainless steel alloys can, for example, have the following known causes:

? Inadequate quality of water or steam

?Chamber surfaces that were not manufactured properly and/or in conformity with standards

? Unsatisfactory alloy quality

? Application of unsuitable methods for working stainless steel surfaces

? Unsuitable manufacturing techniques used in producing the chamber

? Unsuitable substances in the sterilization materials

? Introduction or carry-over of chemicals into the chamber

? Chemical indicators or stickers

? Chemical attacks on the chamber or loading trolleys, e.g. through the use of chemicals not suitable for cleaning

? Secondary processes posing corrosion risks (e.g. fretting corrosion, pitting,contact corrosion, etc.)

In each specific case, other factors may also come into consideration as a potential cause.

                                                                                   來(lái)自：德國(guó)的錢(qián)伯斯工作組(德語(yǔ)縮寫(xiě)：AKK)的手冊(cè)