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1、American National Standard ANSI/AAMI ST:41:1999 AAMI Association for the Advancement of Medical Instrumentation Ethylene oxide sterilization in health care facilities: Safety and effectiveness Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAM
2、I Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:34 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI ST41:1999 (Revision of ANSI/AAMI ST41:1992 and ANSI/AAMI ST43:1993) Ethylene oxide sterilization in
3、 health care facilities: Safety and effectiveness Developed by Association for the Advancement of Medical Instrumentation Approved 27 May 1999 by American National Standards Institute, Inc. Abstract:This recommended practice covers the safe and effective use of ethylene oxide as a sterilant in healt
4、h care facilities. The provisions of this document are intended to promote assurance of sterility, help minimize occupational exposure to ethylene oxide, and guide health care personnel in the proper use of processing equipment. Keywords:chemical sterilization, gas sterilization, ethylene oxide emis
5、sion control, ethylene oxide monitoring Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:34 MDTNo reproduction or networking permitted without license fro
6、m IHS -,-,- AAMI Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI recommended practice does not in any respect preclude anyone,
7、 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. AAMI recommended practices are subject to periodic review, and users are cautioned to obtain the latest edit
8、ions. CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time.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 practice no later than 5 years from the date of publication. Interested parties may obtain current information
9、on all AAMI recommended practices by calling or writing AAMI. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 2000 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is
10、subject to copyright claims of AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this draft should be submitted to AAMI. It is illegal under federal law (1
11、7 U.S.C. 101, et 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 $10
12、0,000 per offense. For permission regarding the use of all or any part of this document, contact Kurt C. Larrick, Director, Technical Publishing, at AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America
13、 ISBN 1-57020-121-8 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:34 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents
14、 Page Committee representationvii Acknowledgments.viii Foreword .ix Introduction: Need for the recommended practice x 1Scope .1 1.1General1 1.2Inclusions.1 1.3Exclusions1 2Definitions, symbols, and abbreviations .1 3Design considerations6 3.1General rationale .6 3.2Centralization.6 3.3Containment ar
15、eas.7 3.4Routing of traffic.8 3.5Sterilizer access area.8 3.6Storage of supplies8 3.7Temperature and humidity.8 3.8Ventilation recommendations for areas housing EO sterilization/aeration equipment.8 3.8.1General considerations8 3.8.2Local exhaust ventilation .9 3.8.3General room ventilation .10 3.9E
16、mergency eyewash/shower equipment .11 3.10Environmental discharge controls11 3.10.1Ethylene oxide.11 3.10.2Ethylene glycol 12 3.10.3Hydrochlorofluorocarbons .12 4Installation, venting, care, and maintenance of EO sterilization/aeration equipment and EO gas sources12 4.1General rationale .12 4.2Insta
17、llation12 4.2.1Regulatory requirements .12 4.2.2Manufacturers instructions12 4.2.3Equipment location13 4.3Installation testing13 4.3.1Sterilizers.13 4.3.2Emission control and ventilation systems13 4.4Venting of EO sterilizers 13 4.4.1General considerations13 4.4.2Sterilizers venting to outside atmos
18、phere13 4.4.3Sterilizers venting to sanitary floor drain14 4.4.4Sterilizers without exhaust to outside atmosphere or sanitary floor drain15 4.4.5Ventilation of EO gas cylinders15 4.5Venting of EO aeration cabinets15 4.5.1Vent lines.15 4.5.2Equipment modifications .15 4.6Ventilation system alarms16 4
19、.7Maintenance of EO sterilizers, aerators, emission control systems, and ventilation systems .16 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:34 MDTNo
20、 reproduction or networking permitted without license from IHS -,-,- 4.7.1Manufacturers instructions16 4.7.2Routine care of sterilizers and aerators.16 4.7.3Preventive maintenance16 4.8Storage and handling of EO gas sources18 4.8.1Unit-dose containers of 100% EO .18 4.8.2Storage and handling of EO g
21、as cylinders (tanks) and supply line filters18 4.9EO leaks and spills 19 4.9.1General19 4.9.2Emergency team .20 4.9.3Emergency plan.20 4.9.4First aid20 4.10Personal protective equipment 21 4.11Equipment manuals.22 5Personnel considerations.22 5.1General rationale .22 5.2Qualifications .22 5.2.1Super
22、visory personnel.22 5.2.2Sterilizer and aerator operators.22 5.3Training and continuing education.23 5.3.1Sterilization personnel .23 5.3.2Other personnel.23 5.4Personnel health24 5.4.1Information concerning the potential hazards of exposure to EO24 5.4.2Medical surveillance and treatment.24 5.4.3Fi
23、rst aid25 5.5Attire.25 6Processing recommendations25 6.1General rationale .25 6.2Items suitable for EO sterilization 25 6.3Receiving.25 6.3.1General considerations25 6.3.2Contaminated items.26 6.3.3Clean, nonsterile, disposable items.26 6.3.4Sterile items.26 6.4Cleaning.27 6.5Ethylene oxide decontam
24、ination27 6.6Preconditioning (humidification).27 6.7Packaging27 6.7.1Selection of packaging materials.27 6.7.2Package configurations and preparation.28 6.8Loading the sterilizer29 6.8.1Load composition 29 6.8.2Load configuration.29 6.9Sterilization parameters.29 6.9.1General29 6.9.2Sterilizer manufa
25、cturers instructions.29 6.9.3Device and packaging manufacturers instructions.29 6.9.4Monitoring29 6.10Unloading the sterilizer 29 6.10.1General considerations29 6.10.2Sterilizers without purge cycles .29 6.10.3Sterilizers with purge cycles 30 6.10.4Sterilizers with integral aeration.30 6.10.5Sterili
26、zers with “detoxification”.30 6.10.6Handling of EO sterilized items before aeration 30 6.11Aeration recommendations31 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/2
27、1/2007 02:49:34 MDTNo reproduction or networking permitted without license from IHS -,-,- 6.11.1General considerations31 6.11.2Metal and glass items31 6.11.3Aeration capacity.31 6.11.4Aeration times31 6.12Sterile storage32 6.12.1Handling and inspection32 6.12.2Plastic dust covers.32 6.12.3Storage of
28、 supplies33 6.12.4Storage shelving33 6.12.5Shelf life.33 6.13Distribution.33 6.13.1Handling and inspection33 6.13.2Distribution containers.33 7Quality control.34 7.1General rationale .34 7.2Product identification and traceability 34 7.2.1Lot control numbers.34 7.2.2Sterilizer records34 7.2.3Expirati
29、on dating35 7.3Physical monitoring35 7.3.1Use of electronic or mechanical monitors35 7.3.2Sterilizer malfunction .35 7.4Chemical indicators .35 7.4.1Definition35 7.4.2Selecting chemical indicators35 7.4.3Using chemical indicators36 7.5Biological indicators.36 7.5.1Definition36 7.5.2Selecting biologi
30、cal indicators .37 7.5.3Frequency of use of biological indicators 37 7.6Qualification, installation, and periodic quality assurance testing37 7.6.1Challenge test pack.37 7.6.2Qualification testing by sterilizer manufacturers41 7.6.3Installation testing41 7.6.4Periodic quality assurance testing.43 7.
31、6.5Product testing.44 7.7Routine biological monitoring.44 7.7.1Frequency of monitoring44 7.7.2Routine test pack.44 7.7.3Positioning of the test pack45 7.7.4Test procedure 45 7.7.5Acceptance criteria46 7.7.6Positive biological indicator results46 7.8Aeration of test packs 46 7.9Microbiological testin
32、g47 7.10Product release47 7.11Product recalls.47 8Environmental and employee monitoring .47 8.1General rationale .47 8.2Instrumentation48 8.2.1Selection of monitoring methods.48 8.2.2Reliability and use of instrumentation48 8.3Procedures.48 8.3.1Monitoring sites .48 8.3.2Frequency of monitoring48 8.
33、3.3Sterilizer system leak checks 49 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:34 MDTNo reproduction or networking permitted without license from IH
34、S -,-,- 8.3.4Ventilation system monitoring49 8.3.5Short-term exposures49 8.4Calculations and interpretation of data 49 8.5Recordkeeping.51 Annexes ABiological-indicator test packs52 BSelecting airborne ethylene oxide monitoring equipment or services for an EO sterilization facility55 CEthylene oxide
35、 and hydrochlorofluorocarbon emission control technologies.65 DOccupational exposure to ethylene oxide, final standard (29 CFR 1910.1047) .67 EBibliography and cited references 97 Tables 1Packaging for EO sterilization28 A.1 Mean kill time (minutes) and standard deviation for biological indicators i
36、nside the test pack vs. outside the test pack.53 Figures 1Example of an EO sterilization containment area 7 2Folding of surgical towels.38 3Placement of biological indicator in syringe.39 4Some components of the challenge test pack .39 5Placement of components in challenge test pack40 6Wrapping the
37、challenge test pack40 7Positioning of challenge test packs42 8Components of the routine BI test pack.45 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:3
38、4 MDTNo reproduction or networking permitted without license from IHS -,-,- 2000 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST41:1999vii Committee representation Association for the Advancement of Medical Instrumentation Sterilization Standards Committee This recommended
39、practice was developed by the AAMI Ethylene Oxide Sterilization Hospital Practices Working Group under the auspices of the AAMI Sterilization Standards Committee. Committee approval of the recommended practice does not necessarily mean that all committee and working group members voted for its appro
40、val. The AAMI Sterilization Standards Committee has the following members: Cochairs:Virginia C. Chamberlain, PhD William E. Young Members:Carl W. Bruch, PhD, Consultant, Hudson, WI Virginia C. Chamberlain, PhD, VC Chamberlain and Associates, Hendersonville, NC Neal E. Danielson, Ds Enterprise, Wichi
41、ta, KS Judith Dowler, Medical Devices Bureau, Health Canada, Ottawa, ON Frank B. Engley, Jr., PhD, University of Missouri, Columbia, MO Victoria Hitchins, PhD, U.S. Food and Drug Administration Robert Morrissey, PhD, Johnson and of Dan Mayworm, who participated in public review of the recommended pr
42、actice. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:49:34 MDTNo reproduction or networking permitted without license from IHS -,-,- 2000 Association for
43、 the Advancement of Medical Instrumentation ! ANSI/AAMI ST41:1999ix Foreword This recommended practice was developed by the AAMI Ethylene Oxide Sterilization Hospital Practices Working Group under the auspices of the AAMI Sterilization Standards Committee. The guidelines in this document are intende
44、d to help assure the achievement of sterilization with inhospital ethylene oxide (EO) sterilizers, the maintenance of sterility of processed items until the point of use, and the reduction of occupational exposure to EO. This document incorporates two previously published recommended practices: the
45、second edition of Good hospital practice: Ethylene oxide sterilization and sterility assurance (ANSI/AAMI ST411992) and the third edition of Good hospital practice: Ethylene oxide gasVentilation recommendations and safe use (ANSI/AAMI ST431993). Combining these two recommended practices provides all
46、 of AAMIs recommendations concerning inhospital EO sterilization in a single document for ease of reference. The provisions of the previously published recommended practices have been updated to reflect new regulatory and technological developments, especially with respect to EO monitoring, EO emiss
47、ion control, and new diluents that have come into use as substitutes for chlorofluorocarbon- 12 (CFC-12). In todays cost-conscious health care environment, it is important not to lose sight of the need for economy. However, cost-effectiveness in EO sterilization processing is not just a matter of th
48、e purchase price of instrumentation or the direct cost of quality assurance procedures. The effectiveness of risk management, the level of performance and longevity of equipment, and other factors should be integrated into the overall system for optimum assurance of safety, effectiveness, and true economy. This recommended practice reflects the conscientious efforts of health care professionals, in cooperation with manufacturers of EO sterilization and aeration equipment, to develop recommendations for optimum performance levels in