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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。
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。
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在消毒供应中心或使用现场存储。
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。 |
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。 |
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。 |
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
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:
Sterile in packaging or sterilized but not packaged or disinfected
Go to Storage – Key principles →
1 of 8 存储 - 立即使用Transfer under controlled conditions
Go to Storage – Key principles →
2 of 8 低度危险性物品的存放According to type of RMD and hospital policy
Go to Storage – Key principles →
3 of 8 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 →
4 of 8 无菌物品的存放In storage area under controlled conditions
Go to Storage of sterile items →
5 of 8 RMD 安全使用RMD safe for delivery to final users
Go to Storage – Key principles →
6 of 8According to SOP’s
Go to WFHSS recommendation for storage →
House keeping of storage area and control of expiration dates according to SOP’s
Go to Storage and quality →
8 of 8EN 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”
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 is intended to preserve the sterility of teh reusable medical device (RMD) until its use.
Rigid sterile barrier system designed to be repeatedly used (ISO 11607-1 2018)
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 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
Some sterilizing, cleaning and disinfecting formulations are known to favor the adherence and resistance of proteins, including prion on RMD surfaces.
Levels of purity of ambient air and compressed air used for drying.
Chemical, physical, biological, and radiological characteristics of water used for cleaning, disinfection, rinsing and steam sterilization of RMD.
Processing operation performed at point of use of the Reusable Medical Device (i.e. operating theatre or care unit)
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 →
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.
OHS deals with all aspects of health and safety in the workplace and has a strong focus on primary prevention of hazards (WHO : 2016)
For the present guidlelines reusable medical device (RMD) means:
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 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)
Sterilization :
Process used to render product free from viable microorganisms (ISO 11139 : 2018)
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.
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)
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 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.
Go to Sterilization chapter →
Process whereby product is sterilized within its sterile barrier system (ISO 11139 : 2018)
Go to Sterilization chapter →
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.
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 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
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)
Ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.
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 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 →
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.
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 concerns mainly sterile medical device. Storage of disinfected devices may be allowed by local regulation in defined conditions.
Transport includes:
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 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 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.