1、ANSI/AAMI ST91:2015Flexible and semi-rigid endoscope processing 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 clear
2、ly 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) the en
3、couragement 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. A vol
4、untary 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
5、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 pr
6、ecautions, 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 c
7、onsensus 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 document
8、ed 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 effectivel
9、y 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 orient
10、ed 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
11、 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 recom
12、mended 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
13、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 re
14、viewed 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
15、 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
16、(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 re
17、view 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 wi
18、th 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 stan
19、dard 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 o
20、f 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
21、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 P
22、olicy 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
23、 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 communi
24、cated 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 ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities Approved 30 March 2015 by Association for t
25、he Advancement of Medical Instrumentation Approved 8 April 2015 by American National Standards Institute Inc. Abstract: Provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) end
26、oscopes, flexible bronchoscopes, surgical flexible endoscopes (e.g., flexible ureteroscopes), and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the proc
27、essing of these devices and accessories. Keywords: flexible endoscopes, high-level disinfection, semi-rigid endoscopes, sterilization AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and
28、provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review,
29、 and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties ma
30、y obtain current information on all AAMI standards 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 judg
31、ment 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 Medic
32、al Instrumentation 4301 N. Fairfax Dr., Ste. 301 Arlington, VA 22203-1633 2015 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 wit
33、hout 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
34、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 at 4301 N. Fairfax Dr., Suite 301
35、, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-585-X Contents PageGlossary of equivalent standards vi Committee representation . vii Foreword . ix Introduction . 1 1 Scope . 3 1.1 Inclusions 3 1.2 Exclusions . 3 2 Definiti
36、ons and abbreviations . 3 3 Design of endoscope processing area . 8 3.1 General considerations . 8 3.2 Work flow 8 3.2.1 General considerations . 8 3.2.2 Physical separation 8 3.2.3 Traffic control 9 3.3 Physical facilities . 9 3.3.1 Space requirements . 9 3.3.2 Sinks and accessories 10 3.3.3 Electr
37、ical systems . 10 3.3.4 Floors and walls 10 3.3.5 Ceilings . 11 3.3.6 Doors 11 3.3.7 Temperature, relative humidity, and ventilation 11 3.3.8 Lighting . 12 3.3.9 Hand hygiene facilities 13 3.3.10 Emergency eyewash/shower equipment 13 3.3.11 Environmental cleaning 14 4 Personnel . 14 4.1 General cons
38、iderations . 14 4.2 Policies and procedures 14 4.3 Education, training, and competency verification 15 4.4 Standard precautions 16 4.5 Hand hygiene 17 4.6 Attire . 17 4.6.1 General considerations . 17 4.6.2 Personal protective equipment . 17 4.7 Immunizations . 18 5 Cleaning and high-level disinfect
39、ion . 19 5.1 General considerations . 19 5.2 Precleaning at the point of use . 19 5.3 Transporting used endoscopes . 19 5.4 Leak testing 20 5.4.1 General considerations . 20 5.4.2 Manual (dry) leak testing 20 5.4.3 Mechanical (wet) leak testing . 20 5.4.4 Mechanical (dry) leak testing 21 5.4.5 Mecha
40、nical leak testing using an AER . 21 5.4.6 Leak test failures 22 5.5 Manual cleaning 22 5.6 Manual rinsing 23 5.7 High-level disinfection and liquid chemical sterilization . 23 5.7.1 General considerations . 23 5.7.2 High-level disinfection . 23 5.7.3 Liquid chemical sterilants/liquid chemical steri
41、lization . 24 5.7.4 Manual liquid chemical sterilization/high-level disinfection . 25 6 Automated endoscope reprocessors . 26 7 Sterile endoscope sheaths used as protective microbial barriers 28 8 Terminal sterilization by gaseous chemical sterilization processes . 28 8.1 General considerations . 28
42、 8.2 Packaging for terminal sterilization . 29 8.2.1 General considerations . 29 8.2.2 Sterilization pouches 29 8.2.3 Sterilization wraps 29 8.2.4 Rigid sterilization containment systems 29 8.3 Ethylene oxide gas (EO) sterilization 29 8.4 Hydrogen peroxide gas sterilization 30 8.5 Ozone sterilizatio
43、n 31 9 Processing of endoscope accessories . 31 10 Storage of reprocessed endoscopes . 32 10.1 General Considerations 32 10.2 Storage of high-level disinfected endoscopes . 33 10.3 Storage of sterilized endoscopes 33 10.4 Hang time for high-level disinfected endoscopes 33 10.4.1 General consideratio
44、ns . 33 10.4.2 Existing guidelines 33 10.4.3 Risk assessment . 34 11 Transport of high-level disinfected endoscopes . 35 12 Quality Control . 35 12.1 General considerations . 35 12.2 Product identification and traceability 37 12.3 Documentation and record-keeping 37 12.3.1 Documentation . 37 12.3.2
45、Expiration dating . 38 12.4 Verification and monitoring of the cleaning process 38 12.4.1 General Considerations 38 12.4.2 Cleaning verification 39 12.4.3 Cleaning verification tests for users 39 12.4.4 Testing cleaning efficacy 40 12.5 Monitoring processes that use liquid chemical sterilization/hig
46、h-level disinfection 40 12.5.1 Manual processes 40 12.5.2 Automated processes . 42 12.6 Monitoring gaseous chemical sterilization processes . 44 12.6.1 Use of physical monitors 44 12.6.2 Gaseous chemical sterilizer malfunction 44 12.7 Chemical indicators . 45 12.7.1 General considerations . 45 12.7.
47、2 Using chemical indicators . 45 12.7.3 Nonresponsive or inconclusive chemical indicators 45 12.8 Biological indicators 46 12.8.1 General considerations . 46 12.8.2 Using biological indicators and process challenge devices 46 12.8.3 Frequency of use of BIs and PCDs 46 12.9 Sterilizer testing 46 12.9
48、.1 General considerations . 46 12.9.2 Qualification test procedure with BIs 47 12.9.3 Qualification testing acceptance criteria . 47 12.9.4 Routine test procedure with BIs 47 12.9.5 Routine testing acceptance criteria . 47 12.9.6 Positive BI results . 47 12.9.7 Microbiological testing 48 12.9.8 Prod
49、uct release 48 12.10 Product recalls . 48 12.10.1 General considerations . 48 12.10.2 Recall procedure 49 12.10.3 Recall order 49 12.10.4 Recall summary report . 49 12.10.5 Outbreak report 49 12.11 Quality process improvement 49 12.11.1 General considerations . 49 12.11.2 Risk analysis. 50 12.11.3 Decontamination . 51 12.11.4 Liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization . 51 12.11.5 Functional areas for product and process improvement . 52 Bibliography 54 Tables 1 IES-recommended illuminance levels for work e
