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1、American National Standard ANSI/AAMI ST35:2003 AAMI Association for the Advancement of Medical Instrumentation Safe handling and biological decontamination of reusable medical devices in health care facilities and in nonclinical settings Copyright Association for the Advancement of Medical Instrumen
2、tation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:35:37 MDTNo reproduction or networking permitted without license from IHS -,-,- The Objectives and Uses of AAMI Standards and Recommended Practices It is most important tha
3、t the objectives and potential uses of an AAMI 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 incre
4、ase in the safe and effective application of 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
5、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 con- sidered in qu
6、alifying 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 per- formance characteristics of different products. Some standards em- phasize the information that should be
7、 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 nec
8、essitates 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
9、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
10、, 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 manufac- turer, it may also be of value to the potential purchaser or user of the device as a
11、fume of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards health care 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 n
12、ot 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 c
13、are 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 (u
14、nless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recom- mended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective e
15、xpertise 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, ultimatel
16、y, 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 deci
17、sion-making, but it should never replace responsible decisionmaking. 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 reaso
18、ns 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
19、 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 equip- men
20、t. 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 consideration
21、s. 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
22、 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
23、of AAMI standards and recommended practices must be made in writing, to the Manager for Technical Development. 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
24、official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpre- tation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization
25、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
26、 Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:35:37 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI ST35:2003 (Revision of ANSI/AAMI ST35:1996) Safe handling and
27、biological decontamination of reusable medical devices in health care facilities and in nonclinical settings Developed by Association for the Advancement of Medical Instrumentation Approved 17 March 2003 by American National Standards Institute, Inc. Abstract:This recommended practice covers the saf
28、e handling and biological decontamination of reusable medical devices, including design criteria for decontamination areas in health care facilities; staff qualifications, education, and other personnel considerations; immediate handling of contaminated items; transport of contaminated items; and de
29、contamination processes. This recommended practice also includes definitions of terms and reference documents, as well as informative annexes providing supplementary information on the principles of infection transmission; the selection and use of chemical disinfectants; thermal disinfection; the sa
30、fe handling and decontamination of medical devices returned to manufacturers for servicing, repair, or failure investigation; and the OSHA bloodborne pathogen regulation. Keywords:cleaning, disinfection, hazardous materials, infection control, microbicidal processes, sterilization Copyright Associat
31、ion for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:35:37 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Recommended Practice This Association for t
32、he 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,
33、 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
34、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 standards and recommended practices by callin
35、g 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 te
36、chnical 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,
37、VA 22201-4795 2003 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
38、 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
39、 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) 5
40、25-1067. Printed in the United States of America ISBN 1570201935 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:35:37 MDTNo reproduction or networking permit
41、ted without license from IHS -,-,- Contents Page Glossary of equivalent standardsvi Committee representation. viii Forewordx Introduction: Need for the recommended practicexi 1Scope1 1.1General1 1.2Inclusions.1 1.3Exclusions1 2Definitions, symbols, and abbreviations .2 3Design considerations 4 3.1Ge
42、neral rationale .4 3.2Centralization of decontamination4 3.3Design criteria4 3.4Work area design.6 3.4.1Physical layout.6 3.4.2Functional work flow patterns7 3.4.3Ceilings, floors, walls, and work stations.7 3.4.4Ventilation7 3.4.5Temperature and humidity.8 3.4.6Lighting8 3.5Traffic control.8 3.6Han
43、dwashing facilities .8 3.7Emergency eyewash/shower equipment .9 3.8Housekeeping procedures.9 4Personnel considerations .9 4.1General rationale .9 4.2Staff education and development 9 4.2.1Qualifications.9 4.2.2Training and continuing education.10 4.3Health and personal hygiene.11 4.4Attire.11 4.5Sta
44、ndard precautions.13 5Immediate handling of contaminated items at point of use.13 5.1General rationale .13 5.2Separation of waste and reusable items at point of use13 5.3Care and handling of contaminated reusable items at point of use.14 6Transportation.14 6.1General rationale .14 6.2Containment.14
45、6.3Transportation equipment15 6.4Transportation scheduling and routes15 6.5Transportation between buildings15 6.6Off-site transportation 15 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS
46、Not for Resale, 07/30/2008 01:35:37 MDTNo reproduction or networking permitted without license from IHS -,-,- 7Decontamination processes .15 7.1General rationale .15 7.2Presoaking.16 7.3Sorting and disassembly16 7.4Cleaning.16 7.4.1General16 7.4.2Cleaning agents.17 7.4.3Methods of cleaning.17 7.4.4V
47、erification of the cleaning process.18 7.5Microbicidal processes.18 7.5.1General18 7.5.2Disinfection processes.19 7.5.3Sterilization processes.20 8Servicing and repair of contaminated devices in the health care facility 21 8.1General rationale .21 8.2Potential for exposure22 8.3Protective measures f
48、or service personnel22 8.3.1General22 8.3.2Education and training.22 8.3.3Vaccination22 8.3.4Personal protective equipment22 8.3.5Work practices.23 8.4Postexposure program.23 8.5Devices that cannot be repaired in-house .23 9Process performance23 9.1General rationale .23 9.2Quality process23 Annexes
49、AExamples of workplace design .25 BInfection transmission.34 CSelection and use of chemical disinfectants.38 DThermal disinfection44 EDevices returned to the manufacturer 45 FOccupational exposure to bloodborne pathogens (29 CFR Part 1910.1030).51 GBibliography65 Tables 1IES-recommended illuminance levels for work environments 8 C.1 Levels of disinfection accordi