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解读美国医疗器械促进协会(AAMI)ST108标准中医疗器械安全处理的水质要求

Navigating AAMI ST108 Water Quality Requirements for Safe Processing of Medical Devices.

作者信息

Gordon Patrick S, Mehrotra Preeti

出版信息

AORN J. 2025 Feb;121(2):151-156. doi: 10.1002/aorn.14284.

DOI:10.1002/aorn.14284
PMID:39878385
Abstract

Water quality plays a critical role in health care, particularly in the processing of medical devices. This article highlights the infection control risks associated with water sources and the regulatory requirements for water management plans in health care facilities. The guidance on water quality has evolved from the initial technical information report provided by the Association for the Advancement of Medical Instrumentation in 2014 to the more recent 2023 publication of the American National Standards Institute and Association for the Advancement of Medical Instrumentation standard for water used in medical device processing. The new standard emphasizes the importance of consistent water and steam quality in instrument processing and outlines the chemical and microbiological parameters for water quality. This article also addresses the challenges of implementing these standards, discusses the implications for patient safety and instrument integrity, and provides strategies for health care teams to ensure compliance.

摘要

水质在医疗保健中起着至关重要的作用,尤其是在医疗设备的处理过程中。本文重点介绍了与水源相关的感染控制风险以及医疗机构水管理计划的监管要求。水质指南已从2014年医疗仪器促进协会提供的初始技术信息报告发展到美国国家标准学会和医疗仪器促进协会最近于2023年发布的医疗设备处理用水标准。新标准强调了仪器处理过程中水质和蒸汽质量一致性的重要性,并概述了水质的化学和微生物参数。本文还探讨了实施这些标准所面临的挑战,讨论了对患者安全和仪器完整性的影响,并为医疗团队提供了确保合规的策略。

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