文獻
消毒供應頻道
2019-03-26


醫療器械再處理部門中的環境條件控制

Control of environmental conditions in a Reprocessing?Unit for Medical Devices?


Foreword

前言

The Committee for Hygiene, Construction and Technology (FA HBT) of the German Society of Sterile Supply (DGSV) together with the DGSV board invited experts to meetings in 2016 and 2017 to discuss in detail the topic of control of?environmental conditions in a Reprocessing Unit for Medical Devices (RUMED).

德國無菌物品供應協會(DGSV)下屬的衛生、建筑與技術委員會(FA HBT)分別于2016 年和2017 年,聯合DGSV 理事會邀請專家參加會議,并詳細討論了醫療器械再處理部門(RUMED)的環境條件控制相關問題。


These participants were microbiologists from infection control laboratories, hospital infection control medical and nursing staff, RUMED management personnel, experts from certification bodies and as guest a representative from the Robert Koch Institute (RKI). Our thanks to the participants of this “Expert Panel”.

參會者都是微生物學專家,他們或來自感控實驗室,或是醫院中從事感染控制的醫護人員,或是醫療器械再處理部門中的管理人員,亦或是認證機構的專家以及作為特邀嘉賓的羅伯特科赫研究所(RKI)的代表。我們對專家團的參與表示感謝。


Introduction

引言

This present article is now being published following a series of questions submitted to the Committee for Hygiene, Construction and Technology (FA HBT) regarding the need for, and feasibility of, control of environmental conditions. There is uncertainty about the control methods, test sites, control intervals and evaluation of the findings. Likewise, who is responsible for conduct and assessment of control measures is often unclear. At the time of certification of a Quality Management System in RUMEDs it is revealed time and again that control of environmental conditions is not being, or not adequately, observed.

在向衛生、建筑與技術委員會(FA HBT)提交了一系列有關環境條件控制的必要性和可行性的說明后,本文正式發表。當前,在控制方法、試驗地點、控制間隔和結果評價方面都存在不確定性。同樣,由誰負責控制措施的實施和評估也不明確。在醫療器械再處理部門進行質量管理體系認證時,一次又一次地揭示出,環境條件的控制沒有或未被充分關注。



The aim of this publication is to provide information on the current state of knowledge and applicable requirements and present the experiences made by hospital infection control teams, microbiologists and auditors. The requirements for air quality (microbiological, physical) and occupational health and safety aspects shall not be addressed.

這篇文章的目的是提供當前相關知識和規范的信息,并介紹醫院感染控制團隊、微生物學家和審查員的經驗??掌柿浚ㄎ⑸鎦副?、物理特性)和職業健康、以及安全方面的要求不在本文解決問題的范圍內。


The article is intended for RUMED operators, RUMED managements as well as for hospital infection control medical and nursing staff and the supervisory authorities.

本文旨在為醫療器械再處理部門操作員、管理層以及醫院感染控制醫護人員和監管部門提供幫助。


Are there guidelines for environmental conditions in a RUMED?

目前是否有關于醫療器械再處理部門環境條件方面的指南呢?

In Germany, for example, this topic is addressed in the KRINKO/BfArm Recommendation* “Hygiene requirements for reprocessing medical devices” [1], stating that “Contamination of the environment must be avoided as far as possible when reprocessing medical devices.”

如,在德國這個主題在KRINKO / BfArM 推薦指南* 中的“ 醫療器械再處理的衛生要求”中有提及,其指出“在醫療器械再處理時,必須盡可能避免對環境的污染?!?/span>


Attention is also drawn to the KRINKO Recommendation “Hygiene requirements for cleaning and disinfection of surfaces” [8]: “For assessment of the inanimate environment (all surfaces surrounding the patients and personnel) the following must be viewed as potential infection risks: the ubiquitous presence of microorganisms and persistence and infectiousness of pathogens (in the inanimate environment) and their transmission pathways as well as the infectious dose …”. “Reliance on identification of visible soils alone is not an appropriate criterion for assessment of the contamination levels of inanimate surfaces [8, 9]. For example, no longer visible soils harbouring blood may contain a hepatitis B viral load of 102–103 infectious particles [10]”.

KRINKO推薦指南“ 表面清潔和消毒的衛生要求”還提到,“ 對于無生命環境(患者和人員周邊的所有物表)的評估,必須被視作潛在的感染風險有:無處不在的微生物、病原菌的持久性和傳染性(在無生命的環境中)以及其傳播路徑和感染劑量…… ”“ 僅依靠對可見污物的識別不是評估無生命表面污染水平的恰當標準,例如,含有血液的不可見污物可能含有102-103 個傳染性顆粒的乙型肝炎病毒”。



“Following cleaning and disinfection processes, recontamination of surfaces occurs within a few hours depending on use [56, 69, 70, 72]; initial recontamination is predominantly with apathogenic environmental microorganisms [68].”

“ 在清潔和消毒過程之后,根據使用情況在幾小時內發生表面再污染;最初的再污染主要是致病環境微生物?!?/span>


There are legal regulations stipulating the need for a quality management (QM) system. In Germany, for example, this is enshrined in the German Code of Social Law (SGB V Section 135a).

法規規定了質量管理(QM)體系的必要性。例如,在德國,《德國社會法典》對此有嚴格要求(SGBV篇章135a)。


The need for a QM applies regardless of the pertinent risk classification, reprocessing is to be conducted in accordance with the state of the art, see reference to standards (KRINKO/ BfArM Recommendation, Section 1) .

無論相關風險如何分類,質量管理的要求都適用,醫療器械再處理是根據最新技術進行的,相關標準參見推薦指南(KRINKO/BfArM 推薦指南, 第1 篇章) 。


Standard EN ISO 17665-1 regulating steam sterilization calls for control of the environment in which a product (medical device) is manufactured, assembled and packed. Environmental control tests can be conducted at regular intervals in areas that could impact the microbial burden on the device.

規定蒸汽滅菌的標準EN ISO 17665-1 要求對產品(醫療器械)的制造、裝配和包裝的環境進行控制,環境控制測試定期進行,測試的區域為能夠影響器械生物負載的區域。



Standard EN ISO 13485 regulating QM systems calls for requirements for the work environment as well as for monitoring, control and formulation of requirements for the microbial and particulate cleanliness of sterile products and for measures to ensure compliance with such regulations. “If the working environment conditions could adversely affect the product quality, the organization must document the requirements addressed to the working environment and processes for monitoring and management of the working environment.”

規定質量管理系統的標準EN ISO 13485 對工作環境提出了要求,也要求對無菌物品的微生物和顆粒清潔度的需求進行監測、控制和規劃,以及要求采取措施確保符合這些規定?!?如果環境條件可能對產品質量產生不利影響,組織必須記錄針對工作環境的要求以及監測和管理工作環境的過程?!?/span>


There are no specific guidelines for RUMEDs, as opposed to pharmaceutical products (Good Manufacturing Practice – GMP) [2]. However, the provisions of GMP Grade D can serve as a guide.

目前還沒有針對醫療器械再處理部門的具體指南,這與藥品生產不同(藥品生產質量管理規范–GMP)。但是,GMP D 級(譯者注:潔凈度等級相當于ISO 8 級)的規定可以作為指導。


For medical devices that are disinfected but not sterile when used, stringent requirements are addressed to the environment and handling to prevent recontamination. These measures must be applied to the reprocessing processes and subsequent processes such as packaging, transport and storage.

對于已消毒但使用時不需要進行滅菌的醫療器械,對環境和操作提出了更嚴格的要求,以防止再次污染。這些措施必須應用于再處理和后續處理過程,如包裝、運輸和儲存。


A “risk-based hygiene (infection control) concept” is needed, including error analysis, definition of room use/space utilization and classification in terms of cleanliness requirements.

一種“ 基于風險的衛生(感染控制)概念”是有必要的,它包括差錯分析、空間使用/ 場所優化、以及按照清潔度的要求進行分類。


The environment – what is that?

環境-到底是什么?

All surfaces in a RUMED – whether animate (people) or inanimate (room, implement, work materials) are contaminated; particles, including microorganisms, are spread through contact or airborne transmission.

醫療器械再處理部門中的所有表面——無論是有生命的(人)還是無生命的(房間、器具、工作材料)都會被污染;污染是包括微生物在內的顆粒通過接觸傳播或空氣傳播形成的。


Control of environmental conditions is based on separation of rooms or working areas/zones into “unclean” and “clean” to prevent the spread of unwanted microorganisms or of other contaminants such as e.g. soils, wetness from the cleaning and disinfection zone (C+D zone) to the packing zone and sterilization zone.

對環境條件的控制是通過把房間或工作面積/區域分成“非清潔”或“清潔”來進行的,以阻止微生物或其他污染物的傳播,例如污物、濕氣從清洗消毒區擴散到包裝區和滅菌區。



■ 未完待續 ■



注:以上內容由"消毒供應頻道"翻譯組進行翻譯,若有紕漏或錯意,以原文版本為準。

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