内窥镜重复使用重要的步骤——功能检测

 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

所有国家监管当局都要求在每次重复使用前对内窥镜进行质量控制。此外，必须保存每一条内镜每次重复使用的记录，包括要有关于功能测试的文件。如你所知，在硬式内镜再处理过程中有一些重要的步骤。

• 预处理
• 清洗
• 消毒
• 功能检测和维护
• 包装
• 灭菌
• 存储

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.

最重要的步骤经常被遗忘，所造成的延误和混乱最为致命，比如让患者在手术台上，焦急地等待着一条新内窥镜。在这些程序中，指定机构负责重复使用的器械，其中包括功能检测。

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. 

总之：对内镜的整个再处理过程以及具体怎样使用它完全负责。如果出错太多，监查人员就会来查找问题所在。

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. 

为了确保质量以及合规，根据法律要求，在整个再处理过程中要有义务做好记录。做好记录将在之后有特殊情况需要进行追溯时非常有帮助，不管是因为消毒不当或是需要召回。

Inspection: Check, verify, document and store

检查：核对、验证、记录、储存

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

如果不能证明已经进行过检查和测试，出了问题就会被追责。

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，要检查与内镜相关的所有零部件是否受到腐蚀、表面是否受损、碎屑和污染。硬式内镜寿命通常是因为使用造成的老化和受损而终结。

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. 

不要忘了人们是不能随着时间的推移去发现内镜的逐渐变化的，但是机器可以。如果在检查过程中发现损坏就可以立刻将受损的内镜送去维修公司或及时进行更换。即使在清洗和消毒过程中非常仔细，内镜中的光学玻璃表面和机械部件上仍有可能存有污渍，仍需要进行再次清洗和消毒。

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

可通过检查以下内容来检查机械装置和内窥镜：

 0. Overall quality 整体质量

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.内窥镜的表面必须完好无损，尤其是没有锋利的边缘。检查由于高频或激光手术设备所造成的凹痕、弯曲、机械/热损伤以及裂纹和剥落。 1. Fibre optics 光纤

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.

将内镜的远端朝向明亮的窗户或明亮的天花板的灯光。注意：在此测试中不要使用冷光源。直接观察从冷光源照射出来的光线会造成眼睛损伤。

2. Light guide connector导光束

• 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.

• 每条纤维束都应该是明亮的
• 将面对天花板灯光的一端稍微上下移动
• 纤维束的亮度会随着移动产生变化
• 如果某一些纤维束是黑暗的也没关系，折损率达到20%-30%才会让内镜手术变得困难。
• 光源进出的光纤表面应该保持光滑和整洁。

粗糙的表面如果有沉积物、有形损耗或缺少光纤，都会造成亮度不足。继续使用和再处理则可能对内镜造成渐进性损伤。光纤损坏的内窥镜应送到制造商或授权维修人员进行检查。 

3. Proximal and distal areas 近端和远端区域

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.

光学玻璃表面必须清洁且无碎屑。应使用适当的清洁品或酒精浸泡的棉签或牙签去除持顽固污垢。清洗和消毒后草草冲洗往往是沉淀的原因。
4. Optical inspection 光学检查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.图像必须是鲜明、清晰和聚焦的。一个模糊的、非圆形的、浑浊的、模糊的图像则意味着内镜受到了损坏。这里有很多内镜相关的光学参数供您参考。覆盖持久污垢的内镜应送到制造商或授权维修人员处进行检查。不应使用具有可观察到碎片、图像质量受损或使表面出现明显损伤和变形的内窥镜。应报废或送到制造商或授权维修人员处进行检查。
5. Document 记录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.编写、归档和存储检查报告，如果将来有任何问题，您可以证明器械已被检查过。您可以在这里找到相关模板。
6. Maintenance 维护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.将拆卸后的内镜（导光束、把手等）重新安装。灭菌前不应在内镜上安装冲洗旋塞。灭菌前不要使用仪器油。灭菌后才能对冲洗旋塞进行润滑。使用仅有生物相容性证明的无菌油。
If processed and checked properly, endoscopes do not require regular maintenance, saving you a ton of money.如果再处理和检查正确，内镜不需要定期维修，可以为您节省了一大笔钱。