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朊毒体不是微生物,比普通的微生物更具抗力。
可重复使用的医疗器械(RMD)的灭菌基于 3 个关键概念
国际标准提出了多种方式来证明给定灭菌过程应用过度杀灭方法达到 SAL 的能力。 其中之一是半周期过度杀灭方式,描述如下:
使用已知对灭菌过程具有高抗力的微生物(通常是细菌芽孢)进行测试。
灭活动力学是线性的,则杀灭 106 微生物的时间或剂量加倍就会产生 10-6 SAL。例如,D 值为 2 分钟的灭菌过程在 12 分钟内灭活 6 log,则在 24 分钟内可达到 SAL。 一旦对过程进行了表征,就必须验证 是否可以有效灭菌RMD。将 106 接种物放置在 RMD 上或内部最难灭菌的位置。 将包装好的RMD放入具有代表性的具有挑战性的负载中。 RMD 制造商的 IFU 指明废置或维修前的最多使用次数。 用于常规控制时,接种物可以放置在过程挑战装置 (PCD) 中 | ![]() |
将 RDM 在包装内进行灭菌,并保持无菌状态直至使用前,这样的灭菌过程称为最终灭菌。
最终灭菌可以在高温或低温下进行。
蒸汽灭菌是最常见的灭菌方法。 也称为湿热灭菌或饱和蒸汽灭菌),
在干热灭菌中,RMD 暴露在干燥的热空气中。 低温灭菌 (LTS) 适用于不耐高温的 RMD。 目前的低温灭菌因子有:环氧乙烷 (EtO)、蒸汽甲醛 (LTSF)、汽化过氧化氢 (VH2O2) 和臭氧 (O3)。 在达到目标 SAL 所需的时间内,RMD 在受控的温度、湿度和/或压力条件下暴露于最低浓度 (Cc) 的灭菌因子。
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辐射灭菌(电离 – 伽马、电子束或高能 X 射线,或非电离紫外线 (UV))通常不用于医疗机构中 RMD 的再处理,本指南中将不讨论。
非最终灭菌方法满足 SAL指标。然而,与最终灭菌不同,RDM 不受包装保护。即时使用蒸汽灭菌(以前称为快速灭菌)是非最终灭菌过程的一个例子。
实施所有灭菌过程都需要职业健康和安全的预防措施。
市场上有各种尺寸和配置的灭菌器。
根据 Spaulding 分类原则和适用的当地法规或专业指南选择灭菌方法。
常见的选择原则或技术趋势可概括如下:
用户可以灵活选择灭菌方法,这取决于当地法规或指南。例如,在某些国家/地区会使用蒸汽,除非 RMD 制造商的 IFU 不允许。在一些国家/地区,LTS 用于耐受蒸汽的器械(例如,光学器件)避免反复暴露于蒸汽而造成性能下降。
当地法规可能要求灭菌过程同时符合国际标准。
蒸汽1、2、3、4、5 干热6、EtO7、8 和LTSF9、10 有专用标准。 ISO 14937 用于 VH2O2(目前正在制定专用标准)12,13。 没有直接适用于液体灭菌剂过程和 IUSS 的国际标准。
灭菌周期可分为 3 个阶段。
书面标准操作程序 (SOP’s) 描述了在灭菌周期之前、期间和之后要执行的操作和控制。 对于新购买的RMD,如果现有的SOP不适用,则定义新的SOP。
每件物品都带有一个化学指示物 (CI)。 国际标准 ISO 11140-114 将化学指示物分为 6 种类型(没有等级意义),如表 1 所示。大多数当地指南要求使用 1 类 CI。 一些指南建议增加 3、4、5 或 6 类指示物。 表格1。
类型 | 名称 | 描述 |
1 | 过程指示物 | 预期用于单个单元(灭菌包或灭菌盒),区分经过灭菌处理过程和未经过灭菌处理过程的单元。一类指示物通常整合在包装材料中或作为包装的附件。 |
2 | 用于特定测试的指示物 | 预期用于特定的测试。如用于测试预真空灭菌程序中空气去除效果的B-D 测试。不同的B-D测试指示物在国际标准ISO11140 -3 到 ISO 11140-6 各部分有详细描述。 |
3 | 单变量指示物 | 对灭菌变量中的其中一个起反应,如时间和温度。并预期用于表达该变量达到了标定值的要求, 如134度。 |
4 | 多变量指示物 | 对灭菌变量中的其中两个或多个起反应,如时间和温度。并预期用于表达该变量达到了标定值的要求, 如134度, 3分钟。 |
5 | 整合指示物 | 对所有灭菌变量起反应,如时间,温度和水蒸汽。并预期等同或超过ISO11138系列标准(见后面章节)所给出的对生物指示物的性能要求。 |
6 | 模拟指示物 | 对所有关键灭菌变量起反应,如时间,温度和水蒸汽。并预期符合特定灭菌周期的要求。 |
在 自含式生物指示物SCBI 中,用于培养和恢复测试微生物所需的生物指示物和培养基被封闭在无菌屏障系统中。暴露后,介质在无菌条件下与 BI 接触。 SCBI 提供的结果是二选一:生长或没有生长。 读取时间从 48 小时到几小时不等,新一代 BI 甚至更短。快速阅读型 BI 可检测到可靠地模拟测试微生物生长反应的酶 |
灭菌器制造商必须提供措施以避免控制系统的软件或硬件故障未被检测到,导致无效周期看起来“有效”。 在实践中,独立传感器会相互检查过程变量是否在规定的公差范围内。 例如,在蒸汽灭菌的情况下,控制过程温度的温度传感器由同一位置的另一个独立的温度传感器监测。 独立传感器技术不需要相同,只要可靠地检测到控制功能的偏差即可。 制造商的 IFU应会向用户提供指引,当检测到偏差的处理措施。 必须记录独立数据以进行追溯。 |
产品放行(即分发 RDM 以进行存储和使用的正式授权)由有资质的人员执行。 理想情况下,负责产品放行的人员与负责卸载控制的人员不同。 产品放行的最低要求是:
标准操作程序 (SOP) 可能需要使用额外的 CI(类型 1 除外)。放置在包装内的 CI 由手术室人员在使用点检查。检查结果不是产品放行的先决条件。但是,在 CI 为阳性时,将执行风险分析以确定是否必须重新处理或召回部分或所有物品。 当使用 BI 时,根据 BI 制造商的 IFU 对它们进行培养和分析。医疗机构 SOP 定义了 BI 阳性的措施。 风险分析确定它是假阳性(已知这种情况会发生)还是问题的真实反映。 根据风险分析的书面结论,决策可以是:产品放行(因为其他控制措施确保了周期的符合性)、部分放行或重新处理整个负载。 产品放行的要求因国家和灭菌技术而异。
在任何情况下,BI 和 CI 都是对上述产品放行最低要求的补充,但不能因此取消检查周期参数、目视检查和 CI 控制。 |
在蒸汽灭菌中,热饱和蒸汽在根据指南设定的时间内覆盖所有 RMD 表面。 饱和意味着蒸汽保持在液相和气相之间转换的稳定状态,且液相的百分比非常低。 Regnault 表给出了蒸汽饱和的压力和温度条件。
高于 100°C 的温度是通过将灭菌室中的压力增加到大气压以上来获得的。
根据国际标准的推荐或当地法规的规定定期(通常每天)进行渗透测试和泄漏测试。
蒸汽灭菌周期的 3 个阶段如下:
后处理:通过真空和加热去除冷凝物。打开门让负载冷却,以便操作员可以安全地处理负载。
干热通过热传导实现灭菌。热量被 RMD 吸收并在 RMD 内逐层移动。要使 RMD 完全灭菌,需要达到所需的温度。与蒸汽灭菌相比,干热T°C和起效所需时间更高更长,渗透性能差,冷却时间更长。由于其固定蛋白质的特性,越来越多的国家禁止干热。如何进行干式灭菌:
在 SAL 所需的处理时间内,汽化过氧化氢灭菌使 RMD 表面与一定浓度的汽化过氧化氢 (VH2O2) 接触。 VH2O2 是通过液态灭菌剂溶液(常见的浓度在 50% 以上)汽化获得的。 一些周期会在VH2O2进入腔体之前增加其浓度。
甲醛 (HCHO) 是一种无色气体,极易溶于水。 甲醛是通过将不同浓度甲醛(低于 40%)的溶液蒸发而获得的。 湿度的存在大大提高了甲醛的灭活能力。
EtO 是一种无色有毒气体,可攻击微生物的细胞蛋白质和核酸。 EtO 过程温度范围为 25 – 55°C。较低的温度会导致效率较低的过程和较长的暴露时间。 EtO 对人类具有致癌性且易燃。需要特殊的房间条件、安全设备和单独的通风系统。
即时使用蒸汽灭菌 (IUSS) 是蒸汽灭菌的一种,用于使用点紧急的非最终灭菌。 RMD是裸露的。立即转移给使用者,并在受控环境中小心实施。与蒸汽灭菌相比,RMD 没有包装,干燥和冷却通常会缩短以限制周期时间。因此,RMD 可能在周期完成时仍然是湿的,从而增加了受环境污染的风险。
IUSS 的 3 个阶段如下:
前处理:真空和蒸汽注入,从腔体和负载中抽出空气,用饱和蒸汽代替。负载温度逐渐升高。
暴露:饱和蒸汽注入完成并保证在整个负载中扩散的时间。
后处理:通过真空和加热去除冷凝物。在打开门后允许负载冷却使操作员安全处理。
一些国家禁止 IUSS,其他国家可能会允许。专业指南通常建议对在使用点处理的必要性进行评估。 RMD备用数量可能需要调整才能支持集中处理。
将RMD所有表面暴露于液体灭菌剂中以控制时间、温度和浓度,从而达到目标 SAL。 冲洗必须保持 SAL。
最常见的灭菌剂是过氧乙酸。 清洁步骤通常与灭菌剂应用分开。
接受液体灭菌剂的概念取决于地区。 在某些国家/地区,它可能被允许作为某些易碎或热敏感 RMD 的高温或低温灭菌之外的替代方法。 在其他国家,这种做法可能被认为是背离了 Spaulding 分类原则。
书面的清洁和消毒标准操作程序 ( SOP’s) 是根据质量管理原则制定的。
用户监督或执行和控制过程验证:
根据最终灭菌方法,134°C 或 132°C 的蒸汽是首选的灭菌温度,在 RMD 制造商的 IFU 指定时即可使用。维持时间因国家/地区法规或指南而异。
干热灭菌应用蒸汽灭菌替代。
对于与 132°C 或 134°C蒸汽不兼容的 RMD,医疗器械制造商的 IFU应指明在 121°C 至 125°C 蒸汽灭菌或低温灭菌中可以使用的灭菌方法。 LTS 方法的选择可根据法规、指南、实践或职业健康和安全来考虑。
液体灭菌的相关声明仍有待评估。
获得无菌和安全的器械需要根据质量管理原则以及 RMD 和灭菌器制造商的 IFU来定义过程验证。
IUSS to be replaced by steam sterilization
Go to IUSS sterilization →
1 of 16 液体灭菌剂To be evaluated by WFHSS
Go to Liquid sterilization →
2 of 16 蒸汽Steam 134°C or 132°C preferred when allowed by RMD IFU
Go to Steam sterilization →
3 of 16 低温蒸汽甲醛Cycle according to RMD IFU
Go to Low temperature steam formaldehyde →
4 of 16 汽化过氧化氢Cycle according to RMD IFU
Go to Vaporized H2O2 →
5 of 16 环氧乙烷Cycle according to RMD IFU
Go to Ethylene Oxide →
6 of 16 清洁、干燥、打包的 RMDNon packaged for non terminal sterilization
Go to choice of sterilization process →
7 of 16 无菌医疗器械Non packaged RMD for immediate use when non terminal sterilization
Packaged RMD for storage when terminal sterilization
Go to choice of sterilization process →
Terminal sterilization preferred to
non terminal
Go to choice of sterilization process →
9 of 16 非最终灭菌The RMD is not protected by a packaging and must be immediately used after sterilization
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10 of 16 +Terminal sterilization preferred
Go to recommendation of WFHSS for sterilization →
11 of 16 +Steam sterilization at 132°C or 134°C preferred when allowed by RMD IFU
Go to recommendation of WFHSS for sterilization →
12 of 16 +Visual control and routine controls
Go to Sterilization and quality management →
13 of 16 +According to RMD IFU
Go to choice of sterilization process →
14 of 16 +Steam sterilization at 132°C or 134°C preferred when allowed by RMD IFU
Go to recommendation of WFHSS for sterilization →
15 of 16 +Visual control and routine controls
Go to Sterilization and quality management →
16 of 16“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.