ANSI ST41-2008 Ethylene oxide sterilization in health care facilities Safety and effectiveness (FDA RECOGNIZED).pdf

1、ANSI/AAMI ST41:2008/(R)2012Ethylene oxide sterilization in health care facilities: Safety and effectivenessAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended

2、practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient ca

3、re, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses

4、are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be

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7、orting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteri

8、a must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used saf

9、ely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice

10、 is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel o

11、n such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI

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17、rovisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or

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21、nction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice Pres

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23、y appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been dev

24、eloped and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI ST41:2008/(R)2012 (Revision of ANSI/AAMI ST41:1999/(R)2005) Corrected 31 March 2010: Includes change to su

25、bclause 10.7.6.1 Ethylene oxide sterilization in health care facilities: Safety and effectiveness Developed by Association for the Advancement of Medical Instrumentation Approved 31 July 2008 and reaffirmed 29 November 2012 by American National Standards Institute Inc. Abstract: This recommended pra

26、ctice covers the safe and effective use of ethylene oxide as a sterilant in health care facilities. The provisions of this document are intended to promote sterility assurance, help minimize occupational exposure to ethylene oxide, and guide health care personnel in the proper use of processing equi

27、pment. Keywords: chemical sterilization, gas sterilization, ethylene oxide emission control, ethylene oxide monitoring AAMI Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substantially concerned with its s

28、cope and provisions. The existence of an AAMI recommended practice does not in any respect preclude anyone, whether they have approved the recommended practice or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the recommended practice. A

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31、eveloped by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is resp

32、onsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2008 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, re

33、production, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. 101, e

34、t seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offen

35、se. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-316-4 Contents Page Glossary of equivalent standards .ix C

36、ommittee representation.xi Acknowledgments .xiii Foreword.xiv Introduction: Need for the recommended practice 1 1 Scope.2 1.1 General.2 1.2 Inclusions2 1.3 Exclusions.2 2 Definitions, symbols, and abbreviations .3 3 Design considerations11 3.1 General rationale 11 3.2 Centralization11 3.3 Containmen

37、t areas11 3.4 Routing of traffic12 3.5 Sterilizer access area12 3.6 Storage of supplies .13 3.7 Temperature .13 3.8 Relative humidity.13 3.9 Ventilation recommendations for areas housing EO sterilization and aeration equipment13 3.9.1 General considerations.13 3.9.2 Local exhaust ventilation 14 3.9.

38、3 General room ventilation.15 3.10 Emergency eyewash and shower equipment .16 3.11 Environmental discharge controls 17 3.11.1 Ethylene oxide 17 3.11.2 Ethylene glycol17 3.11.3 Hydrochlorofluorocarbons.17 4 Personnel considerations.19 4.1 General rationale 19 4.2 Qualifications 19 4.2.1 Supervisory p

39、ersonnel19 4.2.2 Sterilizer and aerator operators 20 4.3 Training and continuing education 20 4.3.1 Sterile processing personnel 20 4.3.2 Other personnel21 4.4 Personnel health.21 4.4.1 General considerations.21 4.4.2 Information concerning the potential hazards of exposure to EO .22 4.4.3 Medical s

40、urveillance and treatment 22 4.4.4 First aid.23 4.5 Attire .23 4.5.1 General considerations.23 4.5.2 Decontamination area.24 4.5.3 Service personnel.24 4.5.4 Prevention of occupational exposure to EO25 5 Receiving .27 5.1 General rationale 27 5.2 Receiving of purchased or loaner items27 5.2.1 Genera

41、l considerations.27 5.2.2 Newly purchased reusable items and repaired reusable items.27 5.2.3 Rigid sterilization container systems.27 5.2.4 Disposable items 28 5.3 Disposition of sterile items (issued but not used)28 6 Handling, collection, and transport of contaminated items .29 6.1 General ration

42、ale 29 6.2 Separation of waste and reusable items at point of use29 6.3 Care and handling of contaminated reusable items at point of use.29 6.4 Containment .30 6.5 Transport 31 6.5.1 Transportation scheduling and routes.31 6.5.2 Transportation equipment.31 6.5.3 Hand transport31 6.5.4 Dedicated lift

43、s.31 6.5.5 Transport between buildings.31 6.5.6 Off-site transportation .32 7 Cleaning and other decontamination processes 33 7.1 General rationale 33 7.2 Policies, procedures, and manufacturers instructions 33 7.2.1 Policies and procedures .33 7.2.2 Manufacturers instructions.33 7.3 Presoaking34 7.

44、4 Disassembly34 7.4.1 Sorting and disassembly of instrumentation .34 7.4.2 Disassembly of rigid sterilization container systems .34 7.5 Cleaning35 7.5.1 General considerations.35 7.5.2 Cleaning agents35 7.5.3 Methods of cleaning .36 7.5.4 Rinsing37 7.5.5 Verification of the cleaning process 38 7.5.6

45、 Cleaning of instruments38 7.5.7 Utensils.39 7.5.8 Reusable textiles 39 7.5.9 Rigid sterilization container systems.39 7.6 Microbicidal processes40 7.6.1 General considerations.40 7.6.2 Processes to decontaminate devices for safe handling41 7.6.3 Terminal sterilization processes to prepare devices f

46、or the next patient use43 7.7 Servicing and repair of devices in the health care facility44 7.7.1 General considerations.44 7.7.2 Potential for exposure.44 7.7.3 Protective measures for service personnel.45 7.7.4 Postexposure program .45 7.7.5 Devices that cannot be repaired in-house 45 8 Packaging,

47、 preparation, and sterilization .47 8.1 General rationale 47 8.2 Items suitable for EO sterilization47 8.3 Preconditioning (humidification)47 8.4 Packaging .47 8.4.1 Selection of packaging materials 47 8.4.2 Packaging configurations and preparation48 8.5 Loading the sterilizer.49 8.5.1 Load composit

48、ion .49 8.5.2 Load configuration 49 8.6 Sterilization parameters 49 8.6.1 General considerations.49 8.6.2 Sterilizer manufacturers instructions49 8.6.3 Device and packaging manufacturers instructions.50 8.6.4 Monitoring.50 8.7 Unloading the sterilizer .50 8.7.1 General considerations.50 8.7.2 Steril

49、izers without purge cycles.50 8.7.3 Sterilizers with purge cycles50 8.7.4 Sterilizers with integral aeration50 8.7.5 Sterilizers with “detoxification“ 51 8.7.6 Handling of EO-sterilized items before aeration .51 8.8 Aeration recommendations 51 8.8.1 General considerations.51 8.8.2 Metal and glass items.51 8.8.3 Aeration capacity 52 8.8.4 Aeration times.52 8.9 Sterile storage52 8.9.1 Handling and inspection .52 8.9.2 Sterility maintenance covers.52 8.9.3 Storage facilities .53 8.9.4 Shelf life54 8.10 Distribution .54 8.10.1 Handling and inspection .54 8.10.2 Distribution containers 5