ANSI ST79-2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Incorporates Amendment 1 2010 Amendment 2 2011 Amendment 3 2012 and Ame.pdf

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1、ANSI/AAMI ST79:2010 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

2、 the criteria 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

3、 is used safely 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 recommen

4、ded practice 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

5、 personnel on 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 whe

6、ther an AAMI 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

7、authorities). 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 represent

8、atives, whose 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 limit

9、ed, however, 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

10、 periodic review 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 e

11、ach of its provisions. 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

12、observed or 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

13、 as “unsafe“. 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

14、specific needs 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 u

15、sed in conjunction 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 AA

16、MI Vice President, 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 exha

17、ustion of any 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

18、not been developed 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 ST79:2010 staff qualifications, education, and other personnel considerations; processing proc

19、edures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement. Keywords: ambulatory care facilities, cleaning, continuous quality improvement, decontamination, dentaloffice, immediate-use steam sterilization (IUSS), moist heat sterilization, packa

20、ging, quality control, quality system, saturated steam, sterile storage, sterilization containers, surgical instruments, table-top sterilizers AAMI Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substantia

21、lly concerned with its scope 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

22、 recommended practice. AAMI 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 withdr

23、aw this recommended practice no later than five years from the date of publication. Interested parties can obtain current information on all AAMI documents by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents dev

24、eloped 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 respon

25、sible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, rep

26、roduction, 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, et

27、 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 offens

28、e. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703525-1067. Printed in the United States of America ISBN 1570204209 C

29、ontents Glossary of equivalent standards . ix Committee representation . xii Acknowledgments xiv Foreword . xv Background on Amendments . xvi Introduction: Need for the recommended practice . 1 1 Scope . 5 1.1 General 5 1.2 Inclusions . 5 1.3 Exclusions 5 2 Definitions and abbreviations . 7 3 Design

30、 considerations 19 3.1 General rationale . 19 3.2 Work area design and functional workflow 19 3.2.1 Definitions of work areas . 19 3.2.2 Design criteria 20 3.2.3 Functional workflow patterns . 23 3.2.4 Traffic control . 23 3.3 Physical facilities 25 3.3.1 Space requirements 25 3.3.2 Mechanical syste

31、ms 25 3.3.3 Electrical systems 25 3.3.4 Steam for sterile processing 25 3.3.5 Utility monitoring and alarm systems . 27 3.3.6 General area requirements 27 3.3.7 Special area requirements and restrictions . 31 3.3.8 Emergency eyewash/shower equipment . 35 3.4 Housekeeping procedures . 35 4 Personnel

32、considerations. 37 4.1 General rationale . 37 4.2 Qualifications . 37 4.2.1 Supervisory personnel . 37 4.2.2 Sterile processing personnel . 37 4.3 Training and continuing education . 38 4.3.1 Sterile processing personnel . 38 4.3.2 Service personnel 39 4.3.3 Other personnel . 39 4.4 Health and perso

33、nal hygiene . 39 4.5 Attire 39 4.5.1 General considerations 39 4.5.2 Decontamination area . 40 4.5.3 Sterilization area (immediate-use steam sterilization) . 41 4.5.4 Service personnel 41 4.6 Standard/transmission-based precautions 41 5 Receiving . 43 5.1 General rationale . 43 5.2 Receiving of purc

34、hased or loaner items 43 5.2.1 General considerations 43 5.2.2 Newly purchased reusable items and repaired reusable items . 43 5.2.3 Rigid sterilization container systems . 43 5.2.4 Disposable items . 44 5.3 Disposition of sterile items (issued but not used) 44 6 Handling, collection, and transport

35、of contaminated items 47 6.1 General rationale . 47 6.2 Separation of waste and reusable items at point of use 47 6.3 Care and handling of contaminated reusable items at point of use . 47 6.4 Containment 48 6.5 Transport . 49 6.5.1 Segregation of clean/sterile items . 49 6.5.2 Transportation schedul

36、ing and routes . 49 6.5.3 Transportation equipment 49 6.5.4 Hand transport . 49 6.5.5 Dedicated lifts 49 6.5.6 Transport between buildings . 50 6.5.7 Off-site transportation 50 7 Cleaning and other decontamination processes 53 7.1 General rationale . 53 7.2 Policies, procedures, and manufacturers wr

37、itten IFU . 53 7.2.1 Policies and procedures 53 7.2.2 Manufacturers written IFU. 53 7.3 Presoaking . 54 7.4 Disassembly 54 7.4.1 Sorting and disassembly of instrumentation 54 7.4.2 Disassembly of rigid sterilization container systems . 54 7.5 Cleaning . 55 7.5.1 General considerations 55 7.5.2 Clean

38、ing agents. 55 7.5.3 Methods of cleaning 56 7.5.4 Rinsing. 58 7.5.5 Verification of the cleaning process . 58 7.5.6 Cleaning of instruments . 59 7.5.7 Utensils 60 7.5.8 Reusable textiles . 60 7.5.9 Rigid sterilization container systems . 60 7.6 Microbicidal processes 61 7.6.1 General considerations

39、61 7.6.2 Processes to decontaminate devices so that they are safe to handle. 62 7.6.3 Terminal sterilization processes to prepare devices for the next patient use 64 7.7 Servicing and repair of devices in the health care facility 64 7.7.1 General considerations 64 7.7.2 Potential for exposure 65 7.7

40、.3 Protective measures for service personnel . 65 7.7.4 Postexposure program 66 7.7.5 Devices that cannot be repaired in-house . 66 8 Packaging, preparation, and sterilization . 67 8.1 General rationale . 67 8.2 Selection of packaging materials . 67 8.3 Package configurations and preparation . 67 8.

41、3.1 General considerations 67 8.3.2 Package labels 68 8.3.3 Package closures 68 8.3.4 Paperplastic pouches 73 8.3.5 Textile packs 73 8.3.6 Basins and basin sets . 74 8.3.7 Surgical supplies . 75 8.3.8 Devices with lumens 75 8.4 Preparation and assembly of surgical instrumentation 75 8.4.1 General co

42、nsiderations 75 8.4.2 Weight and density of sets 75 8.4.3 Inspection 76 8.4.4 Instrument placement 76 8.4.5 Use of tray liners or containment devices 78 8.5 Loading the sterilizer 78 8.5.1 General considerations 78 8.5.2 Paperplastic pouches 78 8.5.3 Instrument sets 78 8.5.4 Textile packs 79 8.5.5 U

43、tensils and glassware 79 8.5.6 Rigid sterilization container systems . 80 8.5.7 Liquids and solutions . 81 8.5.8 Powders and oils . 81 8.6 Sterilization parameters . 81 8.6.1 Sterilization parameters for wrapped or containerized items . 81 8.6.2 Sterilization for immediate use 83 8.6.3 Specialty ins

44、truments 84 8.7 Monitoring sterilization cycles 84 8.8 Unloading the sterilizer 85 8.8.1 Large-chamber sterilizers 85 8.8.2 Table-top sterilizers . 85 8.8.3 Open-tray sterilization cycles for immediate use . 86 8.8.4 Sterilization cycles for immediate use with single wrappers or other textile packag

45、es 86 8.8.5 Sterilization cycles for immediate use with sealed containment devices . 86 8.8.6 Handling and inspection 86 8.9 Sterile storage 87 8.9.1 Sterility maintenance covers 87 8.9.2 Storage facilities 87 8.9.3 Shelf life . 88 8.10 Distribution (general) . 88 8.10.1 Handling and inspection 88 8

46、.10.2 Distribution containers . 88 8.11 Transport of sterile packaged items 89 8.11.1 General considerations 89 8.11.2 Tables and carts (open or closed) . 89 8.11.3 Hand transport . 89 8.11.4 Dedicated lifts 89 8.11.5 Off-site transportation 89 8.11.6 Policies and procedures 89 8.12 Aseptic presenta

47、tion 89 8.12.1 Opening sterile packages 89 8.12.2 Removing items from sterile packaging and transferring them to the sterile field . 90 9 Installation, care, and maintenance of sterilizers . 93 9.1 General rationale . 93 9.2 Instruction manuals 93 9.3 Installation 93 9.4 Routine care 93 9.5 Preventi

48、ve maintenance 93 9.5.1 General considerations 93 9.5.2 Scheduled maintenance 94 9.6 Calibration 94 9.7 Record-keeping . 94 10 Quality control 97 10.1 General rationale . 97 10.2 Monitoring of mechanical cleaning equipment 97 10.3 Product identification and traceability 97 10.3.1 Lot control numbers

49、 . 97 10.3.2 Sterilizer records 98 10.3.3 Expiration dating 98 10.4 Overview of sterilization process monitoring . 99 10.5 Sterilization process monitoring devices . 102 10.5.1 Physical monitors 102 10.5.2 Chemical indicators (CIs) 102 10.5.3 Biological indicators . 104 10.5.4 Process challenge devices (PCDs) . 105 10.6 Routine load release . 106 10.6.1 Process monitoring devices. 106 10.6.2 Release criteria for nonimplants 107 10.6.3 Release criteria for implants 107 10.6.4 Sterilization process failures 107 10.7 Routine sterilizer efficacy monitoring . 108 10.7.1 General