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微创外科手术内窥镜及附件的去污处理

Decontamination of minimally invasive surgical endoscopes and accessories.

作者信息

Ayliffe G

出版信息

J Hosp Infect. 2000 Aug;45(4):263-77. doi: 10.1053/jhin.2000.0767.

Abstract

(1) Infections following invasive endoscopy are rare and are usually of endogenous origin. Nevertheless, infections do occur due to inadequate cleaning and disinfection and the use of contaminated rinse water and processing equipment. (2) Rigid and flexible operative endoscopes and accessories should be thoroughly cleaned and preferably sterilized using properly validated processes. (3) Heat tolerant operative endoscopes and accessories should be sterilized using a vacuum assisted steam sterilizer. Use autoclavable instrument trays or containers to protect equipment during transit and processing. Small bench top sterilizers without vacuum assisted air removal are unsuitable for packaged and lumened devices. (4) Heat sensitive rigid and flexible endoscopes and accessories should preferably be sterilized using ethylene oxide, low temperature steam and formaldehyde (rigid only) or gas plasma (if appropriate). (5) If there are insufficient instruments or time to sterilize invasive endoscopes, or if no suitable method is available locally, they may be disinfected by immersion in 2% glutaraldehyde or a suitable alternative. An immersion time of at least 10 min should be adopted for glutaraldehyde. This is sufficient to inactivate most vegetative bacteria and viruses including HIV and hepatitis B virus (HBV). Longer contact times of 20 min or more may be necessary if a mycobacterial infection is known or suspected. At least 3 h immersion in glutaraldehyde is required to kill spores. (6) Glutaraldehyde is irritant and sensitizing to the skin, eyes and respiratory tract. Measures must be taken to ensure glutaraldehyde is used in a safe manner, i.e., total containment and/or extraction of harmful vapour and the provision of suitable personal protective equipment, i.e., gloves, apron and eye protection if splashing could occur. Health surveillance of staff is recommended and should include a pre-employment enquiry regarding asthma, skin and mucosal sensitivity problems and lung function testing by spirometry. (7) Possible alternative disinfectants to glutaraldehyde include peracetic acid (0.2-0.35%), chlorine dioxide (700-1100 ppm) and superoxidized water. These are very effective, killing vegetative bacteria, including mycobacteria, and viruses in 5 min and bacterial spores in 10 min. An endorsement of compatibility with endoscopes, accessories and processing equipment is required from both the solution/device manufacturer and the endoscope manufacturer. Other important considerations are stability, cost and safety from the user and environmental standpoints. (8) Cleaning and disinfection or sterilization should be undertaken by trained staff in a dedicated area, e.g., SSD or TSSU. A suitable training programme is described. (9) If endoscopes are processed by immersion in disinfectants, harmful residues must be removed by thorough rinsing. Sterile or bacteria free water is essential for rinsing all invasive endoscopes and accessories to prevent recontamination. (10) If an automated washer disinfector is used it must be effective, non-damaging, reliable, easy to use and its performance regularly monitored. (11) If used, washer disinfectors and other processing equipment should be disinfected on a regular basis, i.e., between patients or at the start of each session. This will prevent biofilm formation and recontamination of instruments during rinsing. Disinfection should include the water treatment system, if present. (12) To comply with the Medical Devices Directive, manufacturers are obliged to provide full details on how to decontaminate the reusable devices they supply. This should include details of compatibility with heat, pressure, moisture, processing chemicals and ultrasonics. (13) The Infection Control Team should always be involved in the formulation and implementation of decontamination policies. Wherever possible, the national good practice guidelines produced by the Medical Devices Agency and/or professional societies shoul

摘要

(1) 侵入性内镜检查后的感染很少见,通常为内源性感染。然而,由于清洁和消毒不充分以及使用受污染的冲洗水和处理设备,确实会发生感染。(2) 硬性和软性手术内镜及其附件应彻底清洁,最好使用经过适当验证的方法进行灭菌。(3) 耐热的手术内镜及其附件应使用真空辅助蒸汽灭菌器进行灭菌。使用可高压灭菌的器械托盘或容器在运输和处理过程中保护设备。没有真空辅助排气功能的小型台式灭菌器不适用于包装好的有腔器械。(4) 对热敏感的硬性和软性内镜及其附件最好使用环氧乙烷、低温蒸汽和甲醛(仅适用于硬性内镜)或气体等离子体(如适用)进行灭菌。(5) 如果没有足够的器械或时间对侵入性内镜进行灭菌,或者当地没有合适的方法,可将其浸入2%的戊二醛或合适的替代品中进行消毒。戊二醛的浸泡时间应至少为10分钟。这足以灭活大多数包括艾滋病毒和乙型肝炎病毒(HBV)在内的繁殖期细菌和病毒。如果已知或怀疑有分枝杆菌感染,可能需要20分钟或更长时间的更长接触时间。杀死孢子需要在戊二醛中浸泡至少3小时。(6) 戊二醛对皮肤、眼睛和呼吸道有刺激性和致敏性。必须采取措施确保安全使用戊二醛,即完全封闭和/或抽取有害蒸气,并提供合适的个人防护设备,即手套、围裙和眼部防护装置(如果可能发生飞溅)。建议对工作人员进行健康监测,应包括入职前询问哮喘、皮肤和粘膜敏感性问题以及通过肺活量测定进行肺功能测试。(7) 戊二醛的可能替代消毒剂包括过氧乙酸(0.2 - 0.35%)、二氧化氯(700 - 1100 ppm)和超氧化水。这些消毒剂非常有效,能在5分钟内杀死繁殖期细菌,包括分枝杆菌和病毒,在10分钟内杀死细菌孢子。溶液/器械制造商和内镜制造商都需要认可其与内镜、附件和处理设备的兼容性。从用户和环境角度考虑的其他重要因素包括稳定性、成本和安全性。(8) 清洁和消毒或灭菌应由经过培训的人员在专门区域进行,例如消毒供应室(SSD)或终端消毒供应室(TSSU)。描述了一个合适的培训计划。(9) 如果通过将内镜浸入消毒剂中来进行处理,必须通过彻底冲洗去除有害残留物。无菌或无细菌的水对于冲洗所有侵入性内镜及其附件以防止再次污染至关重要。(10) 如果使用自动清洗消毒器,它必须有效、无损害、可靠、易于使用且其性能要定期监测。(11) 如果使用,清洗消毒器和其他处理设备应定期消毒,即在患者之间或每个疗程开始时。这将防止生物膜形成和器械在冲洗过程中再次污染。如果有水处理系统,消毒应包括该系统。(12) 为符合《医疗器械指令》,制造商有义务提供关于如何对其供应的可重复使用设备进行去污的全部详细信息。这应包括与热、压力、湿度、处理化学品和超声波的兼容性细节。(13) 感染控制团队应始终参与去污政策的制定和实施。只要有可能,应遵循医疗器械机构和/或专业协会制定的国家良好实践指南。

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