1、www.aami.orgANSI/AAMI ST79: 2017American National StandardANSI/AAMI ST79:2017Comprehensive guide to steam sterilization and sterility assurance in health care facilitiesObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an A
2、AMI product standard or recommended 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 o
3、f current technologies to patient care, 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
4、that arbitrary and restrictive uses 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
5、 measurement techniques that can be 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
6、characteristics, instructions for use, 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 met
7、hods to facilitate uniformity in reporting; 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
8、reasons for establishing 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 h
9、elp ensure that a device 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
10、, even though a recommended 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
11、guidelines to industrial 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 pract
12、ices. In determining whether 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 re
13、gulatory or procurement 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
14、and industrial representatives, 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 recom
15、mended practice is limited, 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
16、decision-making. Despite 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
17、specific rationale for each 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 procedur
18、es and practices. While 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 ident
19、ify a particular product 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 analyze
20、d in the context of the 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
21、useful only when it is used 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 ma
22、de in writing, to the AAMI 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 As
23、sociation only upon exhaustion 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 recomme
24、nded practice which has 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 ST79:2017 (Revision of ANSI/AAMI ST79:2010/(R)2014 staff qualification
25、s, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement. Keywords: ambulatory care facilities, cleaning, continuous quality improvement, decontamination, dentaloffice, immediat
26、e-use steam sterilization (IUSS), moist heat sterilization, packaging, quality control, quality system, saturated steam, sterile storage, sterilization containers, surgical instruments, table-top sterilizers AAMI Single user license. Further copying, networking, and distribution prohibited. AAMI Rec
27、ommended 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, whether they have a
28、pproved 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 editions. CAUTION NOTICE
29、: 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 five years from the date of publication. Interested parties can obtain current information on all AAMI docum
30、ents by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally
31、, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 by the
32、Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, 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 In
33、strumentation is strictly prohibited by law. It is illegal under federal law (17 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. Violator
34、s risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. 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:
35、+1-703-525-4890; Fax: +1-703-525-1067. With the permission of Canadian Standards Association, (operating as CSA Group), material is reproduced from CSA Group standard Z314.8-00, Decontamination of reusable medical devices which is copyrighted by Canadian Standards Association, 178 Rexdale Blvd., Tor
36、onto, ON, M9W 1R3. This material is not the complete and official position of CSA Group on the referenced subject, which is represented solely by the standard in its entirety. While use of the material has been authorized, CSA Group is not responsible for the manner in which the data is presented, n
37、or for any interpretations thereof. No further reproduction is permitted. For more information or to purchase standards from CSA Group, please visit http:/shop.csa.ca/ or call 1-800-463-6727. Printed in the United States of America ISBN 978-1-57020-675-7 AAMI Single user license. Further copying, ne
38、tworking, and distribution prohibited. Contents PageGlossary of equivalent standards ix Committee representation xii Foreword xv Introduction: Need for the recommended practice . 1 1 Scope. 3 1.1 General . 3 1.2 Inclusions 3 1.3 Exclusions 3 2 Definitions and abbreviations . 4 3 Design consideration
39、s 12 3.1 General considerations . 12 3.2 Work area design and functional workflow . 12 3.2.1 Design criteria 12 3.2.2 Functional workflow patterns . 14 3.2.3 Traffic control . 15 3.3 Utilities 17 3.3.1 Mechanical systems 17 3.3.2 Electrical systems 17 3.3.3 Steam for sterile processing 17 3.3.4 Util
40、ity monitoring and alarm systems . 18 3.3.5 General facility design requirements . 18 3.3.6 Special area requirements and restrictions . 21 3.3.7 Emergency eyewash/shower equipment . 24 4 Personnel considerations . 25 4.1 General considerations . 25 4.2 Qualifications 25 4.2.1 Supervisory personnel
41、. 25 4.2.2 Sterile processing personnel . 25 4.3 Education and training 26 4.3.1 Sterile processing personnel . 26 4.3.2 Service personnel 26 4.3.3 Other personnel . 27 4.4 Health and personal hygiene 27 4.5 Attire . 27 4.5.1 General considerations 27 4.5.2 Decontamination area/room 28 4.6 Standard
42、and transmission-based precautions . 29 5 Receiving . 30 5.1 General considerations . 30 5.2 Receiving of purchased or loaned items . 30 5.2.1 General considerations 30 5.2.2 New, repaired, and refurbished reusable items . 30 5.2.3 Loaned or borrowed instrumentation . 30 5.2.4 Rigid sterilization co
43、ntainer systems 31 5.2.5 Disposable items . 32 5.3 Disposition of sterile items (issued but not used) 32 6 Handling, collection, and transport of contaminated items . 33 6.1 General considerations . 33 6.2 Separation of waste and reusable items at point of use . 33 6.3 Point-of-use care and handling
44、 of contaminated reusable items 34 6.4 Containment . 35 6.5 Transport 36 AAMI Single user license. Further copying, networking, and distribution prohibited. 6.5.1 Segregation of clean/sterile items 36 6.5.2 Transportation scheduling and routes . 36 6.5.3 Transportation equipment 36 6.5.4 Hand transp
45、ort . 36 6.5.5 Dedicated lifts 37 6.5.6 Transport between buildings 37 6.5.7 Off-site transportation 37 7 Cleaning, disinfection (microbicidal processes), and other decontamination steps . 39 7.1 General considerations . 39 7.2 Policies and procedures . 39 7.3 Manufacturers written IFU 40 7.4 Decont
46、amination . 40 7.4.1 General considerations for all devices and utensils . 40 7.4.2 Special considerations . 41 7.5 Preparation for cleaning 41 7.5.1 Presoaking. 41 7.5.2 Sorting and disassembly . 41 7.6 Cleaning . 43 7.6.1 General considerations 43 7.6.2 Devices with lumens 44 7.6.3 Cleaning agents
47、 . 44 7.6.4 Methods of cleaning 44 8 Preparation and assembly of instruments 50 8.1 General considerations . 50 8.2 Instruments . 50 8.3 Devices with lumens . 51 8.4 Basins and basin sets . 51 8.5 Textile packs . 51 9 Packaging 52 9.1 General considerations . 52 9.2 Selection of sterile barrier syst
48、ems . 52 9.3 Package labeling 52 9.4 Package closures . 53 9.5 Sterilization wrap 53 9.5.1 General considerations 53 9.5.2 Woven wraps . 53 9.5.3 Nonwoven wraps . 53 9.5.4 Paperplastic pouches 54 9.6 Wrapping techniques 55 9.6.1 Simultaneous double-wrapping: envelope fold 55 9.6.2 Simultaneous doubl
49、e-wrapping: square fold 56 9.6.3 Sequential wrapping: envelope fold . 57 9.6.4 Sequential wrapping: square fold 58 9.7 Sterility maintenance covers . 59 9.8 Rigid sterilization container systems . 59 10 Sterilization 61 10.1 Loading the sterilizer . 61 10.1.1 General considerations 61 10.1.2 Paperplastic pouches 61 10.1.3 Instrument sets 61 10.1.4 Textile packs 61 10.1.5 Utensils and glassware 61 10.1.6 Rigid sterilization container systems 62 10.1.7 Liquids . 62 10.1.8 Powders and oils . 63 10.2 Sterilization parameters 63 10.2.1 General considerations 63 10.2.2 Sterilization cycle
