1、ANSI/AAMI ST58:2013Chemical sterilization and high-level disinfection in health care facilitiesAmerican 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 practice are
2、 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 care, and (2)
3、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 are avoided.
4、 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 used to dete
5、rmine 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 use, warnings
6、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 reporting; reac
7、hing 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 criteria must be do
8、cumented 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 safely and effe
9、ctively 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 is usually
10、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 on such subje
11、cts 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 standard or
12、 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). The applic
13、ation 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, whose work has b
14、een 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, in the sens
15、e 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 review and rev
16、ision (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 provisions. T
17、his 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 potential ri
18、sks 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“. A voluntar
19、y 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 needs and resou
20、rces 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 conjunction with
21、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 President, Stand
22、ards 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 any appeals an
23、d 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 developed and c
24、ommunicated 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 ST58:2013 (Revision of ANSI/AAMI ST58:2005(R)2010) Chemical sterilization and high-level disinfection in health care f
25、acilities Developed by Association for the Advancement of Medical Instrumentation Approved 21 August 2013 American National Standards Institute Inc. Abstract: This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs)
26、and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration for use in hospitals and other health care facilities. Included within the scope of this recommended practice are functional and physical design criteria for chemical sterilization and high
27、-level disinfection processing areas; staff qualifications, education, and other personnel considerations; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use of LCSs/HLDs and gaseous chemical sterilizers; preparation of devices for proces
28、sing by chemical sterilization or high-level disinfection; quality control methods; and quality process improvement. Definitions of terms and informative annexes are also provided. Keywords: chemical sterilization, chemical sterilizers, chemical vapor, formaldehyde, gaseous chemical sterilants, glut
29、araldehyde, high-level disinfectants, high-level disinfection, hydrogen peroxide, hydrogen peroxide gas plasma, liquid chemical sterilants, materials compatibility, ortho-phthalaldehyde, ozone, peracetic acid, sodium hypochlorite AAMI Recommended Practice This Association for the Advancement of Medi
30、cal 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 approved the recommended practice or not, from manufacturing, m
31、arketing, purchasing, or using products, processes, or procedures not conforming to the standard. 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.
32、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 may obtain current information on all AAMI documents by calling or writing AAMI. All AAMI standards, recommended practices
33、, 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, voluntary technical documents are adopted by government regulatory agenc
34、ies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for th
35、e 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 Instrumentation is s
36、trictly 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. Violators risk legal actio
37、n, 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 at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-48
38、90; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1570205051 Contents Page Glossary of equivalent standards . vii Committee representation viii Acknowledgments x Foreword . xi 1 Scope . 1 1.1 General 1 1.2 Inclusions . 1 1.3 Exclusions 2 2 Definitions and abbreviations . 3 3 Wor
39、k area design considerations . 9 3.1 General rationale . 9 3.2 Processing area . 9 3.3 Traffic control . 9 3.4 Ventilation of processing areas and equipment . 10 3.4.1 General considerations 10 3.4.2 General room ventilation . 10 3.4.3 Local exhaust ventilation . 10 3.5 Automated processing equipmen
40、t for chemical sterilants 12 3.5.1 Selection of equipment 12 3.5.2 Installation . 12 3.5.3 Equipment location 12 3.6 Storage of chemical sterilants 12 3.7 Disposal of chemical sterilant waste 13 3.7.1 Chemical sterilant solutions . 13 3.7.2 Chemical solution containers . 13 3.8 Regulatory requiremen
41、ts 13 4 Personnel considerations . 14 4.1 General rationale . 14 4.2 Qualifications . 14 4.2.1 Supervisory personnel . 14 4.2.2 Processing personnel 14 4.3 Training and continuing education . 15 4.3.1 Processing personnel 15 4.3.2 Service personnel 16 4.3.3 Other personnel . 16 4.4 Personal protecti
42、ve equipment 16 4.4.1 General considerations 16 4.4.2 Eye protection (liquid) 17 4.4.3 Skin protection (liquid) . 17 4.4.4 Respiratory protection . 17 4.5 Health and personal hygiene . 18 5 Selection of liquid and gaseous chemical sterilants . 19 5.1 General rationale . 19 5.2 Categories . 19 5.3 LC
43、S/HLD types 19 5.4 Gaseous chemical sterilization types . 20 5.5 Selection criteria 20 5.5.1 General considerations 20 5.5.2 Health and safety considerations . 21 5.5.3 Effectiveness . 22 5.5.4 Materials compatibility . 23 5.5.5 Cost-effectiveness . 24 5.5.6 Matrix of selection criteria 24 6 Deconta
44、mination and preparation of instruments . 25 6.1 General rationale . 25 6.2 Receiving . 25 6.2.1 Receiving of purchased items 25 6.2.2 Disposition of sterile items (issued but not used). 25 6.3 Handling, collection, and transport of contaminated items . 26 6.3.1 General considerations 26 6.3.2 Separ
45、ation of waste and reusable items at point of use 26 6.3.3 Care and handling of contaminated reusable items at point of use . 27 6.3.4 Containment 27 6.4 Transport . 28 6.4.1 Segregation of clean/sterile items 28 6.4.2 Transportation scheduling and routes . 28 6.4.3 Transportation equipment 28 6.4.4
46、 Hand transport . 28 6.4.5 Dedicated lifts 29 6.4.6 Transport between buildings 29 6.4.7 Off-site transportation 29 6.5 Aseptic presentation 29 6.5.1 Opening sterile packages 29 6.5.2 Removing items from sterile packaging and transferring them to the sterile field 30 6.5.3 Removing devices from HLD
47、equipment and delivery to the point of use 30 6.6 Cleaning and other decontamination processes 31 6.6.1 General considerations 31 6.6.2 Preparation for cleaning 31 6.6.3 Disassembly 31 6.6.4 Cleaning 32 6.6.5 Rinsing 37 6.6.6 Drying, inspection, and verification of the cleaning process 37 6.6.7 Micr
48、obicidal processes 37 6.7 Packaging 38 7 Using chemical sterilants safely and effectively 39 7.1 Introduction 39 7.2 General considerations 39 7.2.1 Establishing policies and procedures 39 7.2.2 Manufacturers written IFU. 39 7.2.3 Ensuring cleaning effectiveness 40 7.3 General safety considerations
49、. 41 7.3.1 Introduction 41 7.3.2 Emergency procedures . 41 7.4 Liquid chemical sterilants/high-level disinfectants 42 7.4.1 General considerations 42 7.4.2 Relationship between LCSs and HLDs 42 7.4.3 Single vs. multi-use . 43 7.4.4 Consideration for selection 43 8 Device storage and transport 45 8.1 General rationale . 45 8.2 Devices processed with LCSs/HLDs . 45 8.3 Devices processed with gaseous chemical sterilants 45 9 Quality control . 46 9.1 General rationale . 46 9.2 Product identification and traceability. 46 9.2.1 Lot control numbers . 46 9.2.2 Cycle documentation and record
