All national regulatory authorities require quality control of endoscopes before each reuse. In addition, a record must be kept of each and every reuse, including a copy of the functional test. As you may know, there are important steps in the reprocessing process of rigid endoscopes.

• Pre-cleaning
• Cleaning 
• Disinfection 
• Functional testing and maintenance
• Packaging
• Sterilization- Storage

所有國(guó)家監(jiān)管當(dāng)局都要求在每次重復(fù)使用前對(duì)內(nèi)窺鏡進(jìn)行質(zhì)量控制。此外，必須保存每一條內(nèi)鏡每次重復(fù)使用的記錄，包括要有關(guān)于功能測(cè)試的文件。如你所知，在硬式內(nèi)鏡再處理過(guò)程中有一些重要的步驟。

• 預(yù)處理
• 清洗
• 消毒
• 功能檢測(cè)和維護(hù)
• 包裝
• 滅菌
• 存儲(chǔ)

The most important step is often forgotten, causing delays and screw ups where it hurts the most: At the table where your patient, anxiously awaits a new endoscope. The involvement of a notified body in these procedures are limited to the reuse of the device, amongst which functional testing.

最重要的步驟經(jīng)常被遺忘，所造成的延誤和混亂最為致命，比如讓患者在手術(shù)臺(tái)上，焦急地等待著一條新內(nèi)窺鏡。在這些程序中，指定機(jī)構(gòu)負(fù)責(zé)重復(fù)使用的器械，其中包括功能檢測(cè)。

In short: You are wholly responsible for this process and how you do it exactly. Too many mistakes and you'll find an auditor at your desk to find out what's going on. 

總之：對(duì)內(nèi)鏡的整個(gè)再處理過(guò)程以及具體怎樣使用它完全負(fù)責(zé)。如果出錯(cuò)太多，監(jiān)查人員就會(huì)來(lái)查找問(wèn)題所在。

For quality purposes and compliancy, by law, it is obligatory to maintain documentation throughout the entire process. Having this on record can be very helpful if there is ever a situation that requires you to backtrack, whether it be due to improper disinfection or a recall. 

為了確保質(zhì)量以及合規(guī)，根據(jù)法律要求，在整個(gè)再處理過(guò)程中要有義務(wù)做好記錄。做好記錄將在之后有特殊情況需要進(jìn)行追溯時(shí)非常有幫助，不管是因?yàn)橄静划?dāng)或是需要召回。

Inspection: Check, verify, document and store

檢查：核對(duì)、驗(yàn)證、記錄、儲(chǔ)存

 If you can't prove that you checked and tested and something goes wrong, you will be held accountable. 

如果不能證明已經(jīng)進(jìn)行過(guò)檢查和測(cè)試，出了問(wèn)題就會(huì)被追責(zé)。

So, check all instruments related to your scope after cleaning for corrosion, damaged surfaces, chips and contamination.The end of product lifetime is usually determined by wear and damage caused by use. 

因此，在清洗后，要檢查與內(nèi)鏡相關(guān)的所有零部件是否受到腐蝕、表面是否受損、碎屑和污染。硬式內(nèi)鏡壽命通常是因?yàn)槭褂迷斐傻睦匣褪軗p而終結(jié)。

Don't forget that humans cannot see gradual change over time. A machine can.If damages are found during inspection, send it to your repair company or replace it. Contaminations of the optics glass surface and mechanic parts might remain even after careful cleaning and disinfection. Still contaminated instruments have to be cleaned and disinfected again. 

不要忘了人們是不能隨著時(shí)間的推移去發(fā)現(xiàn)內(nèi)鏡的逐漸變化的，但是機(jī)器可以。如果在檢查過(guò)程中發(fā)現(xiàn)損壞就可以立刻將受損的內(nèi)鏡送去維修公司或及時(shí)進(jìn)行更換。即使在清洗和消毒過(guò)程中非常仔細(xì)，內(nèi)鏡中的光學(xué)玻璃表面和機(jī)械部件上仍有可能存有污漬，仍需要進(jìn)行再次清洗和消毒。

Inspection of the mechanics and endoscope can be done by checking the following:

可通過(guò)檢查以下內(nèi)容來(lái)檢查機(jī)械裝置和內(nèi)窺鏡：

 0. Overall quality 整體質(zhì)量

The endoscope surfaces have to be undamaged and in particular free of sharp edges.Check for dents, bends, mechanical / thermal damage caused by high frequency or laser surgery equipment as well as for cracks and spalling.內(nèi)窺鏡的表面必須完好無(wú)損，尤其是沒(méi)有鋒利的邊緣。檢查由于高頻或激光手術(shù)設(shè)備所造成的凹痕、彎曲、機(jī)械/熱損傷以及裂紋和剝落。 1. Fibre optics 光纖

Hold the distal endoscope end toward a lighted window or a bright ceiling light. Caution: Do not use a cold-light source for this test. Direct view into the radiated light from a cold light sources can cause eye damage.

將內(nèi)鏡的遠(yuǎn)端朝向明亮的窗戶或明亮的天花板的燈光。注意：在此測(cè)試中不要使用冷光源。直接觀察從冷光源照射出來(lái)的光線會(huì)造成眼睛損傷。

2. Light guide connector導(dǎo)光束

• The individual fibres should appear bright.

• Move the bright ceiling light facing side slightly up and down.

• The brightness of the fibres changes a bit.

• It's ok if a couple of individual fibres remain dark. A fracture rate of about 20 to 30% makes endoscopic procedures difficult.

• The surfaces of the light entry and exit surfaces should be smooth and clean. 

Rough surfaces with deposits, tangible or withdrawn individual fibres cause insufficient lighting. Further application and processing may result in progressive endoscope damage.

Endoscopes with damaged fibre optics should be sent in to the manufacturer or an authorized service specialist for checking.

• 每條纖維束都應(yīng)該是明亮的
• 將面對(duì)天花板燈光的一端稍微上下移動(dòng)
• 纖維束的亮度會(huì)隨著移動(dòng)產(chǎn)生變化
• 如果某一些纖維束是黑暗的也沒(méi)關(guān)系，折損率達(dá)到20%-30%才會(huì)讓內(nèi)鏡手術(shù)變得困難。
• 光源進(jìn)出的光纖表面應(yīng)該保持光滑和整潔。

粗糙的表面如果有沉積物、有形損耗或缺少光纖，都會(huì)造成亮度不足。繼續(xù)使用和再處理則可能對(duì)內(nèi)鏡造成漸進(jìn)性損傷。光纖損壞的內(nèi)窺鏡應(yīng)送到制造商或授權(quán)維修人員進(jìn)行檢查。 

3. Proximal and distal areas 近端和遠(yuǎn)端區(qū)域

Glass surfaces have to be clean and debris-free. Persistent encrustation should be removed with appropriate cleaning pastes or alcohol-soaked cotton swab or toothpick.Sloppy rinsing of the optics after cleaning and disinfection is often the cause of precipitates.

光學(xué)玻璃表面必須清潔且無(wú)碎屑。應(yīng)使用適當(dāng)?shù)那鍧嵠坊蚓凭莸拿藓灮蜓篮炄コ诸B固污垢。清洗和消毒后草草沖洗往往是沉淀的原因。
4. Optical inspection 光學(xué)檢查The image has to be sharp, clear and focused. A fuzzy, non-circular, cloudy, foggy, image points to damage. Here are more optical parameters you could check.Endoscopes with indelible persistent encrustations should be sent in to the manufacturer or an authorized service specialist for checking.Endoscopes with visible chips, impaired image quality or striking surface damage and deformation should not be used. They should be discarded or sent in to the manufacturer or an authorized service specialist for checking.圖像必須是鮮明、清晰和聚焦的。一個(gè)模糊的、非圓形的、渾濁的、模糊的圖像則意味著內(nèi)鏡受到了損壞。這里有很多內(nèi)鏡相關(guān)的光學(xué)參數(shù)供您參考。覆蓋持久污垢的內(nèi)鏡應(yīng)送到制造商或授權(quán)維修人員處進(jìn)行檢查。不應(yīng)使用具有可觀察到碎片、圖像質(zhì)量受損或使表面出現(xiàn)明顯損傷和變形的內(nèi)窺鏡。應(yīng)報(bào)廢或送到制造商或授權(quán)維修人員處進(jìn)行檢查。
5. Document 記錄Write, file and store an inspection report, so if there are any questions in the future, you can prove what was checked. A template can be found here.編寫(xiě)、歸檔和存儲(chǔ)檢查報(bào)告，如果將來(lái)有任何問(wèn)題，您可以證明器械已被檢查過(guò)。您可以在這里找到相關(guān)模板。
6. Maintenance 維護(hù)Put the disassembled endoscopes (fibre optic light guide, handles) together again.Irrigation stopcocks should not be installed on the endoscope before sterilization. Don't use Instrument oils before sterilization.Grease the rinsing taps only after sterilization. Use sterile fat that has a proven biocompatibility only.將拆卸后的內(nèi)鏡（導(dǎo)光束、把手等）重新安裝。滅菌前不應(yīng)在內(nèi)鏡上安裝沖洗旋塞。滅菌前不要使用儀器油。滅菌后才能對(duì)沖洗旋塞進(jìn)行潤(rùn)滑。使用僅有生物相容性證明的無(wú)菌油。
If processed and checked properly, endoscopes do not require regular maintenance, saving you a ton of money.如果再處理和檢查正確，內(nèi)鏡不需要定期維修，可以為您節(jié)省了一大筆錢(qián)。