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就本指南而言,复用医疗器械 (RMD) 是指:
本指南不涉及一次性医疗器械的再处理.
RMD 可能是:
医疗器械法规因地区而异。 有些物品在某些地区可能不会作为医疗器械注册。
欧洲医疗器械法规将再处理定义为:
“对使用后的器械规范处置的过程,以保证其重复使用的安全。包括清洁、消毒、灭菌和相关程序,以及测试和保持使用后的器械的性能和功能的安全性”。
美国食品和药品监督局 (FDA) 将再处理定义为:
“对于用过或受到污染的医疗器械,执行经验证的过程使其适合下一次使用。这些过程旨在通过清洁去除污渍和污染物,并通过消毒或灭菌来灭活微生物。复用器械的再处理包括在器械使用现场附近开始的规范步骤,通常依次包括以下三个步骤:使用现场预处理……、彻底清洁……消毒或灭菌……”
再处理可由医疗机构执行或根据外包合同由外部组织完成。
再处理规范适用于从包装中取出的所有 RMD,即使它们没有被使用。
还可以对以下物品进行再处理:
为了器械保养人员的安全,送去进行保养的RMD必须进行清洁和消毒(提供再处理证书)
在 1960 年代后期E.H. Spaulding对用于患者护理的器械和物品根据其使用中的感染风险进行了分类。
Spaulding分类的核心原则仍然有效,但随着时间的推移发生了变化。 例如:
热敏 RMD 需要若干个适合其材料和结构特性的周期。 一些耐热的微创手术器械使用高温灭菌时存在加速老化的现象(例如,腹腔镜设备)。一些国家允许使用低温灭菌;而其他国家则没有。 最近,也有器械的应用出现了高度危险性与中度危险性之间的交叉重叠。例如,使用无菌活检钳进行上消化道检查的内窥镜。 并非所有指南都遵循下面定义的 3 个消毒级别。
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国际标准 ISO 17664-11 描述了要求 RMD 制造商提供高度危险性和中度危险性医疗器械的再处理信息。 RMD 制造商制定的指南应基于必要的风险分析和测试。 RMD 制造商确认所推荐的再处理方法是否在销售 RMD 的国家/地区是可用的 |
朊毒体是一种小的有感染性的蛋白质单位,出现在各种人类和动物神经退行性疾病中,包括克雅氏病 (CJd)、牛海绵状脑病 (BSE,也称为疯牛病) 和痒病。
朊毒体病一直存在,但通常非常罕见。 朊毒体蛋白来源于一种正常的身体蛋白质,它会不可逆转地错误折叠。 朊毒体蛋白主要在中枢神经系统 (CNS) 中增殖。
1980 年代,在一些西欧国家牛肉被BSE感染,一种变异的克雅氏病在食用了受感染牛肉的人中传播。
朊毒体对消毒和灭菌具有很强的抵抗力。 在存在导致蛋白质凝固的物质时它们的抵抗力还会增加。
因此,一些国家实施了应对朊毒体的法规或指南,指导从 RMD上中去除或灭活朊毒体蛋白。 此类法规或指南是适用于特定国家的。 以下章节提供了有关应对朊毒体的信息(参考了某些国家或地区的建议或规范)。
通常基于患者筛查和对 CNS 手术(脑、脊髓或眼后部)的特别关注措施来制定策略。
有风险的患者或手术的应对措施示例如下:
国际标准 ISO 17664-11 描述了要求 RMD 制造商提供高度危险性和中度危险性医疗器械的再处理信息。 RMD 制造商制定的指南应基于必要的风险分析和测试。 RMD 制造商确认所推荐的再处理方法是否在销售 RMD 的国家/地区是可用的 |
应对朊毒体的法规或指南强调避免 RMD 上的污渍干涸的预防措施,并对涉及蛋白质凝固的工艺过程的使用提出相关的风险警告
已知的一些灭菌、清洁和消毒配方中会加强蛋白质(包括朊毒体)在 RMD 表面上的凝固。 例如,干热、环氧乙烷、醛类消毒灭菌剂如甲醛,戊二醛或酒精。已制定朊毒体监管法规的国家可能会禁止或不鼓励使用包含凝固剂成分的制剂,或要求在使用有潜在凝固后果的制剂之前,采用不含凝固剂的工艺进行彻底清洁 |
此外,一些地区可能会制定本地区的 RMD 蛋白质残留量标准,并对特定操作中使用的 RMD 采取额外的预防措施,例如与大脑、脊髓或眼后部相关的流程。
由于朊毒体管理因国家而异,故朊毒体的风险管理是由国家法规规定
医疗设备警戒系统用于提高患者安全,通过减少与RMD使用相关的事件再次发生的可能性,来保护医疗保健专业人员和其他RMD使用者的健康和安全。
各国制定了收集和分析事故报告的法规。
一些风险可能与RMD再处理流程有关。 RMD再处理部门必须做出降低风险的努力。
已知的一些灭菌、清洁和消毒配方中会加强蛋白质(包括朊毒体)在 RMD 表面上的凝固。 例如,干热、环氧乙烷、醛类消毒灭菌剂如甲醛,戊二醛或酒精。已制定朊毒体监管法规的国家可能会禁止或不鼓励使用包含凝固剂成分的制剂,或要求在使用有潜在凝固后果的制剂之前,采用不含凝固剂的工艺进行彻底清洁 |
遵循以下质量管理原则进行安全的再处理流程:
通过过程确认,用户验证下面内容:
WFHSS 对 RMD 再处理的建议
SOP’s according to Spaulding classification principles, Manufacturers IFU’s and applicable regulation
Go to Recommendations of WFHSS for reprocessing of RMD’s →
contact with intact skin
Go to Spaulding classification principles →
2 of 13 l中度危险性contact with mucous or injured skin
Go to Spaulding classification principles →
3 of 13 高度危险性Contact with sterile tissue and vascular system
Go to Spaulding classification principles→
4 of 13 根据之前的使用情况评估风险(传染病爆发 - 朊毒体)In partnership with care or surgical user and infection control
Go to Recommendations of WFHSS for reprocessing of RMD’s →
Thorough cleaning and preparation of RMD
Go to recommendation of WFHSS for RMD →
Level of disinfection according to risk
Go to recommendation of WFHSS for RMD →
Sterilization method according to RMD manufacturer IFU and applicable regulation
Go to Recommendations of WFHSS for reprocessing of RMD’s →
According to applicable regulation
Go to prion risk →
9 of 13 RMD 可安全使用Functional, reprocessed according to manufacturer IFU’s and applicable regulation
Go to Recommendations of WFHSS for reprocessing of RMD’s →
Consult services in charge of reprocessing before purchase of a new RDM
Go to Recommendations of WFHSS for reprocessing of RMD’s →
Validated processes
Go to recommendation of WFHSS for reprocessing of RMD’s →
Controls
Go to RMD and quality →
13 of 13“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.