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存储
存储- 关键原则

灭菌或消毒后,复用医疗器械 (RMD) 可立即使用或存储直至使用。

存储条件取决于Spaulding分类原则下 RMD 的风险程度。

  • 最终灭菌后,RMD 的包装保护其免受环境和操作过程污染。
  • 非最终灭菌后,高度危险性 RMD 不受包装保护,不得存放。
  • 消毒后,中度危险性 RMD 可在受控条件下暂时存储。 使用前存储的最长时间由当地法规规定(通常为 3 至 12 小时)。 如果超过时间限制,RMD必须重新处理。

 

在一些国家,中度危险性软式内窥镜的临时存放可以通过使用存放柜来延长。 最长存储时间由当地法规或指南规定。 阀门必须在干燥和无尘的条件下拆卸和单独存放。


    些国家要求存储柜符合国际标准 EN 16442-1。


   软式内窥镜不得存放在运输箱中。

 

  • 低度危险性RMD 的存储按照医疗机构内部规定执行。
无菌物品存储

在消毒供应中心或使用现场存储。

  • 存储区是一个专用于无菌物品的封闭空间。

 

在存储区外的拆箱区域将物品从外部运输容器中取出。

仅限于授权人员进入存储区域。

 

  • 存储区域面积和存储设施是适应需要的。 在存储设施周围留有足够的空间,以允许空气流通,并避免包装物品与存储设施内表面可能形成的冷凝水接触。 距离地面留有足够的空间以便清洁(即至少 8 至 10 英寸,约 20 厘米)。 地面光滑、防水、完好且易于清洁。 与天花板和洒水喷头的距离由当地消防规范规定。 不可以将物品直接放在地面上,即使是暂时的。
  • RMD 存放于灰尘、光线和湿度条件受控的环境中。

 

避免开放式的排放设施、供水设施、管线。 如果存在这样的情况,包括使用灭菌容器包装在内的所有无菌物品均不可以存放在水槽旁边或下方、与水接触的地方或下水管线的下方,或存放在任何可能被打湿的位置.
不要将无菌包材暴露在阳光直射下。 紫外线会加速包装材料老化。 避免温度和湿度的变化以防止水分(冷凝物)在器械表面积聚。
避免温度大幅度波动防止水分(冷凝物)积聚。 推荐的温度和相对湿度范围随当地指南而异(温度从 15°C 或 18°C到 25°C,RH大约 为60% 或在 40%到75% 之间)。 对于某些敏感的物品,制造商 IFU 可能需要指定湿度范围。

存储区域没有空气质量或气流污染限制的标准。参考当地指南。

 

  • 根据环境,物品类型和包装材料选择存储系统,

 

 

开放式货架(网状金属架或实心货架)适用于人员物品流动和通风受控的密闭存储区域。
人员物品流动频繁区域可能积聚灰尘,需要封闭或有盖的盒子。
储物车或货架的底架最好是无缝隙的。
可使用底部为无缝隙的或网状的运输用托盘,以防止在搬运过程中包装材料或包装袋子破裂。
包装袋和纸塑袋垂直或平放在篮筐里。无菌包间相互的挤压会迫使空气和微生物进入包装内容物并导致封口爆裂或刺破包装。
无菌包类器械不得堆叠。 当这类无菌物品与灭菌容器包装物品存放在同一货架时,不能放置在灭菌容器包装物品的下方。

 

  • 定期执行和登记保洁措施。用于存储无菌物品的货架、推车和盒子保持井然有序、清洁干燥.
  • 为了安全和便于搬运,重器械托盘存放在货架的中间高度。
  • 存储按照先进先出原则进行安排以便RMD的周转。定期检查包装完整性和有效期。失效日期根据风险分析结果来规定。

 

无菌 RMD 的有效期是与事件相关的,取决于包装材料的质量、存储条件、运输方法和条件以及操作物品的次数和条件。损坏的可能性随着时间和操作次数的增加而增加。

 

存储和质量

存储和质量

根据质量管理原则制定书面的存储标准操作程序 (SOP)。

存储过程确认控制以下内容:

  • 对所有允许在存储区域的工作员进行培训,并获得培训证书。
  • 建立与处理重器械相关的职业健康和安全措施。
  • 存储规则和存储区域清洁的标准操作程序 (SOP) 是最新的。
  • 执行风险分析来确定失效日期。
Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS 对存储的建议

  1. 存储区专用于存放无菌物品。 仅限于授权和受过培训的人员进入。根据现场条件布置合适的存储空间和存储设施。存储条件(光照、温度、湿度)都在控制范围内。根据物品和包装特性建立存储注意事项。
  2. 存储流程按质量管理原则实施,并经过过程确认。
  3. 由存储现场条件的风险分析结果确定失效期。
存储流程图
RMD 灭菌或消毒

Sterile in packaging or sterilized but not packaged or disinfected

Go to Storage – Key principles

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存储 - 立即使用

Transfer under controlled conditions

Go to Storage – Key principles

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低度危险性物品的存放

According to type of RMD and hospital policy

Go to Storage – Key principles

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度危险性 RMD 的存储

Maximum storage times according to local regulation

Might be prolonged with flexible scopes storage cabinets

Go to Storage – Key principles

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无菌物品的存放

In storage area under controlled conditions

Go to Storage of sterile items

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RMD 安全使用

RMD safe for delivery to final users

Go to Storage – Key principles

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According to SOP’s

Go to WFHSS recommendation for storage

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House keeping of storage area and control of expiration dates according to SOP’s

Go to Storage and quality

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参考文献
  1. EN 16442 : 提供受控环境存放经处理的不耐热内窥镜的储存柜

“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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Maintenance

Combination of all technical and associated administrative actions intended to keep equipment at a state in which it can perform its required function, or restore it to such a state (ISO 11139 : 2018)

Packaging

Packaging is intended to preserve the sterility of teh reusable medical device (RMD) until its use.

Reusable containers

Rigid sterile barrier system designed to be repeatedly used (ISO 11607-1 2018)

International standards

For the puropose of these guidelines, International Standard means standardsor guidance published by international standardization organizations such as ISO or CEN.
Go to the international standards paragraph or Regulation and standards chapter 

Prion

Prion is a small proteinaceous infectious unit that appear in a variety of neurodegenerative diseases, including bovine spongiform encephalopathy, Creutzfeldt-Jakob disease, and scrapie. They derive from a normal body protein that becomes irreversibly misfolded and proliferates primarily in the central nervous system.
Prions are highly resistant to disinfection and sterilization

Fixative properties

Some sterilizing, cleaning and disinfecting formulations are known to favor the adherence and resistance of proteins, including prion on RMD surfaces.

Air quality

Levels of purity of ambient air and compressed air used for drying.

Water quality

Chemical, physical, biological, and radiological characteristics of water used for cleaning, disinfection, rinsing and steam sterilization of RMD.

Point of use reprocessing

Processing operation performed at point of use of the Reusable Medical Device (i.e. operating theatre or care unit)

Quality management 

Quality management includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives. They also include quality planning, quality control, quality assurance, and quality improvement.
In the present guide the quality management chapter includes a description of the processus approach, performance evaluation, risk and non-conformity management, documentation management and traceability

Go to quality management chapter →

Spaulding classification

The Spaulding classification qualify the RMD as non critical when they touch intact skin, semi-critical when they are brought in contact with mucous membranes and critical when they enter sterile body cavities. Processing requirements increase with level of risk involved in their use.

Occupational health and safety (OHS)

OHS deals with all aspects of health and safety in the workplace and has a strong focus on primary prevention of hazards (WHO : 2016)

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)

  • courthouse-3-1 Sterilization is intended to renders the reusable medical device (RMD) free from viable microorganisms.

Standard operating procedures

SOP’s are written, step-by-step instructions that describe how to perform a routine activity. SOP’s aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

Routine control (or routine test)

technical operation conducted periodically to establish that the operational performance of the equipment or process remains within the limits established during validation (ISO 11139 : 2018) 

Fixative properties

Some sterilizing, cleaning and disinfecting formulations are known to favor the anchorage of proteins, including prion on RMD surfaces. For instance, dry heat, ethylene oxide, aldehyde based sterilizing and disinfecting agent such formaldehyde or glutaraldehyde, alcohol used to accelerate drying of some RMD. For this reasons, some national guidelines recommend to avoid use of this subtances or require specific precautions (for instance thorough cleaning)

“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” 

Non terminal sterilization

Non terminal sterilization is a process whereby product is not sterilized in a sterile barrier system and hence not protected from environmental and handling contamination after the sterilization cycle.

Terminal sterilization

Process whereby product is sterilized within its sterile barrier system (ISO 11139 : 2018)

Standard operating procedures (SOP's)

SOP’s are written, step-by-step instructions that describe how to perform a routine activity. SOP’s aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

Outsourcing

For the needs of the present guidelines outsourcing means a process in which a healthcare facility employs another organization to perform some or all reusable medical device reprocessing tasks. The organization can be another healthcare facility, a shared reprocessing unit or a private service company. The services can be perfomed within the healthcare facility or externalized.

Pyrogen

Pyrogen are substances that induces fever. Endogenous pyrogen are low-molecular weight protein produced by phagocytic leukocytes in response to stimulation by exogenous pyrogens. Exogenous pyrogens are produced by bacterial endotoxins and other microbial product such as antigen, antibody complexes, virus

Endotoxin

Endotoxins are lipopolysaccharide components of the cell wall of Gram-negative bacteria that are heat stable and elicits a variety of inflammatory responses in animals and humans (ISO 11139: 2018)

Traceability

Ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.

Training

For the purpose of theses guidelines, training means the certified acquisition of the theoricital, practical skills and behavior adapted to the assignment. Skills are periodically controlled and updated as needed.

Routine controls

Routine control check that performances of process or equipment are maintained over time between 2 process validations. Routine controls can be systematic (at each cycle) or at predefined periodicities. For instance, for the sterilization process, at end of each cycle, it is checked that process parameterare are within the validated tolerances, leak tests are performed daily or at periodicity defined by local recommandations. 

Go to process validation chapter →

Instruction for use (IFU)

Written indication provided by the manufacturer to ensure correct and safe use of a products (including but not limited to reusable medical device, reprocessing equipment and consumables). IFU of RMD include the instruction for reprocessing. IFU are also available for reprocessing equipment and consumables.   

Risk analysis

Identification and analyzis of potential issues that could negatively impact a given process. Risk analysis includes an evaluation of the consequence and likelihood. The issues with the more severe consequences and higher likelihood of occurence are addressed in priority. As needed measure are then to minimize the occurence or consequence. Methods are available to improve the reliability of the risk analysis. 

Storage

Storage concerns mainly sterile medical device. Storage of disinfected devices may be allowed by local regulation in defined conditions.

Transport

Transport includes:

  • The transfer of soiled reusable medical device from the point of use to the reprocessing site and
  • the transfer of the sterilized or disinfected RMD to the point of use.

Process validation

Process validation means establising, by objective evidence that a process consistently produces a results or product meeting its predeternined objective. Process validation applies to all steps of RMD reprocessing from point of use processing to storage. When equipments are used validation include their installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
Process validation is perfomed before implementation of a new process or equipment (initial validation). Revalidation takes place periodically (usually each year) or after event justifying total or partial revalidation (change in the process, maintenance of equipments).

Waste management

Waste management groups all activities and actions required to manage waste including the collection, transport, treatment and disposal of waste together with monitoring of the waste management process. Instrument reprocessing waste are are solid (i.e., single use packaging, detergent or disinfectant empty bottles, cleaning brushes, possibly sharp devices), liquid (i.e., cleaning, disinfecting, rinsing solutions) or gazeous (i.e., sterilization, cleaning or disinfection effluent). Waste might be non hazardous, infectious, or toxic. Waste management regulation limits impact on environment and protects staff. Waste management rules are country dependent.

Traceability

Traceability is the ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.

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.