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检查和装配
检查和装配 – 原则

检查和装配 – 原则

 

RMD (RMD)使用或进行灭菌

在装配多部件 RMD 或 RMD 组合(例如手术包)之前和之后进行检查(即目视检查或/和技术功能测试)。

检查和装配工作站应满足工作需要(例如,操作台面和光线)。

 


保养和维修的RMD返回时,需特别注意。

 

多部件 RMD 和RMD组合的检查和装配,要参考 RMD 制造商使用说明 (IFU)

手术包的装配是与诊疗部门和手术部门合作准备的。共同制定的指导书中明确:

  • 属于该手术包的器械,和每种器械的数量
  • 托盘类型(密网状、排孔状、热成型)和尺寸(足够大以允许重量和金属质量均匀分布)
  • 使用固定和保护装置(如保护尖锐易碎物品、避免运输过程中移位或震动的楔子、托盘衬垫等)
  • 为满足使用现场安全取用要求,必要时应规定RMD 的摆放位置。 

适用的一般规则:

  • 重器械的摆放方式不会损坏其他精密器械物品。
  • 具有较大凹面、扁平面或两者兼有的物品,可能会存水,将其侧放。
  • 对于带管腔的 RMD,管腔端口是敞开的。
  • 器械关节应张开,应备有将器械关节保持在张开位置所需附件的说明书。 

器械标识符和图片有助于简化复杂器械包的装配。

需检验:

  • 可提供RMD,RMD打包装配方式和RMD保护装置与预期使用的灭菌周期的兼容性证书
  • 灭菌剂与RMD 表面可充分接触。 尖端保护器(如果使用)允许灭菌剂穿透,松紧合适,并根据制造商的书面 IFU 使用。 仅使用经认可的附件。
  • 重量不超过职业健康和安全限制(根据每个国家/地区的指南,包括包装在内的物品的最大重量在 10 公斤至 11 公斤(25 磅)之间变化)

对于碗类物品,所有碗盆都采用同一方向摆放,并在叠放的碗盘之间放入无毛絮的吸水材料。

对于敷料,咨询产品制造商以获取针对蒸汽灭菌周期验证的包装大小、尺寸和密度的使用建议。敷料包是使用清洗过的敷料制作的。

检查,装配和质量

书面的检查标准操作流程 (SOP) 是根据质量管理原则制定的。

验证检查和装配的过程时关注:

  • SOP 是最新的,遵循 RMD 制造商的 IFU,并且符合诊疗部门和手术部门的期望
  • 执行培训并提供培训证书。
  • 职业健康和安全措施到位。
  • 追溯是可行的且有效
Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS 检查和装配建议

  1. 检查和装配的标准操作流程 (SOP) 遵循 RMD 制造商 IFU 并符合最终用户的期望。
  2. 检验RMD与保护装置的兼容性
  3. 检查和装配过程按照质量管理原则实施并经过过程确认
运输流程图
清洗和消毒后的RMD

Used on patient or withdrawn from packaging

Go to Control & Assembly – Principles 

1 of 5
检查和装配

RMD or multi-component RMD or surgical set

Go to Control and Assembly – Principles 

2 of 5
可用于下一步处理的RMD

Next step: use or sterilization

Go to Control and Assembly – Principles

3 of 5

SOP prpeared in partnership with user

Go to WFHSS recommendation for Control and Assembly

4 of 5

User feedback

Go to Control and Assembly and quality

5 of 5
参考文献
  1. ISO 17664-1 :医疗保健产品的处理 – 医疗器械制造商需要提供的处理医疗器械的信息 (2017)

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Comments on WFHSS guidelines

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“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.

They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.

Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.

We wish you interesting reading!

On behalf of the Executive Committee

Dr Christine DENIS, President”  

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“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.

They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.

Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.

We wish you interesting reading!

On behalf of the Executive Committee

Dr Christine DENIS, President” 

Reusable medical device (RMD)

For the present guidlelines reusable medical device (RMD) means:

  • an item that is not intended by its manufacturer for single use.
  • A medical device designated or inrtended by the manufacturer as suitable for reprocessing.

The reprocessing of single use medical device is outside the scope of theses guidelines.
Medical device regulations vary between regions. Some items may not be registered as medical devices in some regions.

Sterilization

Sterilization is intended to renders the reusable medical device free from viable microorganisms. Sterilization is implemented on a clean RMD. Most common Sterilization process is steam. Low temperature sterilization processes are available for heat sensitive RMD

Disinfection :

Process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose (ISO 11139 : 2018) 

Cleaning :

Removal of contaminants to the extent necessary for its further processing or for intended use (ISO 11139 : 2018)  

Other definition: The first step required to physically remove contamination by foreign material, e.g. dust soil. It will also remove organic material such as blood, secretion, excretion and microorganisms, to prepare a medical device for sterilization or disinfection (WHO : 2016) 

Cleaning may be combined to disinfection in cleaning & disinfections processes (for instance in automated washer-disinfectors)

Tooltip Content

Sterilization :

Process used to render product free from viable microorganisms (ISO 11139 : 2018)

Reusable Medical device (RMD) 

Medical devices wich are not single use i.e. which can be reused under appropriate reprocessing conditions, for an undelimited number of time or for a predetermined number of use.