AAMI-ST79-2008.pdf

Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 01/31/2009 23:51:01 MSTNo reproduction or networking permitted without license from IHS -,-,- Objectives 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 clearly understood. The objectives of AAMI's technical development program derive from AAMI's 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) the encouragement of new technologies. It is AAMI's 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. 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 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 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 methods 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 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 help 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, 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 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 practices. 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 regulatory 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 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 recommended 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 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 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 procedures 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 identify 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 analyzed 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 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 made 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 Association 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 recommended 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. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 01/31/2009 23:51:01 MSTNo reproduction or networking permitted without license from IHS -,-,- American National Standard ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2008 (Consolidated Text) (Revision of ANSI/AAMI ST33:1996, ANSI/AAMI ST37:1996, ANSI/AAMI ST42:1998, ANSI/AAMI ST46:2002, and a partial revision of ANSI/AAMI ST35:2002) Comprehensive guide to steam sterilization and sterility assurance in health care facilities Developed by Association for the Advancement of Medical Instrumentation Approved 24 July 2006 Amendment 1 Approved 27 August 2008 by American National Standards Institute Inc. Abstract: This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote sterility assurance and to guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement. Keywords: cleaning, continuous quality improvement, decontamination, moist heat sterilization, packaging, quality control, quality system, saturated steam, sterile storage, surgical instruments, ambulatory care facilities, dentist office, flash sterilization, sterilization containers, table-top sterilizers Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 01/31/2009 23:51:01 MSTNo reproduction or networking permitted without license from 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, 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 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 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, 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 agencies 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 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, 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 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. Violators 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, 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 1570202567 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 01/31/2009 23:51:01 MSTNo reproduction or networking permitted without license from IHS -,-,- Contents Glossary of equivalent standards ix Committee representation. xi Acknowledgmentsxiii Foreword. xiv Introduction: Need for the recommended practice .1 1 Scope.5 1.1 General5 1.2 Inclusions.5 1.3 Exclusions5 2 Definitions and abbreviations.6 3 Design considerations15 3.1 General rationale .15 3.2 Work area design and functional workflow.15 3.2.1 Definitions of work areas .15 3.2.2 Design criteria16 3.2.3 Functional workflow patterns .18 3.2.4 Traffic control.19 3.3 Physical facilities21 3.3.1 Space requirements 21 3.3.2 Mechanical systems 21 3.3.3 Electrical systems21 3.3.4 Steam for sterile processing21 3.3.5 Utility monitoring and alarm systems.23 3.3.6 General area requirements23 3.3.7 Special area requirements and restrictions27 3.3.8 Emergency eyewash/shower equipment .30 3.4 Housekeeping procedures.30 4 Personnel considerations.31 4.1 General rationale .31 4.2 Qualifications .31 4.2.1 Supervisory personnel.31 4.2.2 Sterile processing personnel .31 4.3 Training and continuing education.32 4.3.1 Sterile processing personnel .32 4.3.2 Service personnel32 4.3.3 Other personnel.33 4.4 Health and personal hygiene .33 4.5 Attire 33 4.5.1 General considerations33 4.5.2 Decontamination area34 4.5.3 Sterilization area (flash sterilization)34 4.5.4 Service personnel35 4.6 Standard/transmission-based (enhanced) precautions35 5 Receiving.36 5.1 General rationale .36 5.2 Receiving of purchased or loaner items.36 5.2.1 General considerations36 5.2.2 Newly purchased reusable items and repaired reusable items36 5.2.3 Rigid sterilization container systems36 5.2.4 Disposable items .37 5.3 Disposition of sterile items (issued but not used).37 Background on Amendment 1xiii Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 01/31/2009 23:51:01 MSTNo reproduction or networking permitted without license from IHS -,-,- 6 Handling, collection, and transport of contaminated items.38 6.1 General rationale .38 6.2 Separation of waste and reusable items at point of use.38 6.3 Care and handling of contaminated reusable items at point of use38 6.4 Containment 39 6.5 Transport .40 6.5.1 Transportation scheduling and routes40 6.5.2 Transportation equipment40 6.5.3 Hand transport.40 6.5.4 Dedicated lifts40 6.5.5 Transport between buildings40 6.5.6 Off-site transportation41 7 Cleaning and other decontamination processes 43 7.1 General rationale .43 7.2 Policies, procedures, and manufacturers instructions.43 7.2.1 Policies and procedures 43 7.2.2 Manufacturers instructions43 7.3 Presoaking.44 7.4 Disassembly.44 7.4.1 Sorting