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
5、used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for us
6、e, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in rep
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
12、 standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities)
13、. The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whos
14、e work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however,
15、 in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-making. Despite periodic re
16、view and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for each of its p
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
18、potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular product as “unsafe“
19、. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific nee
20、ds and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is used in conju
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
22、ident, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of an
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
29、AMI recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this recommended prac
30、tice no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards and recommended practices by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents d
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
