ANSI ST91-2015 Flexible and semi-rigid endoscope processing in health care facilities.pdf

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

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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

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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