AAMI ST91 2015
$140.32
ANSI/AAMI ST91:2015 – Flexible and semi-rigid endoscope processing in healthcare facilities
| Published By | Publication Date | Number of Pages |
| AAMI | 2015 | 70 |
Provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes, 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 processing of these devices and accessories.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST91:2015, Flexible and semi-rigid endoscope processing in health care facilities |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 8 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Definitions and abbreviations |
| 20 | 3 Design of endoscope processing area 3.1 General considerations 3.2 Work flow 3.2.1 General considerations 3.2.2 Physical separation |
| 21 | 3.2.3 Traffic control 3.3 Physical facilities 3.3.1 Space requirements |
| 22 | 3.3.2 Sinks and accessories 3.3.3 Electrical systems 3.3.4 Floors and walls |
| 23 | 3.3.5 Ceilings 3.3.6 Doors 3.3.7 Temperature, relative humidity, and ventilation 3.3.7.1 Temperature and relative humidity 3.3.7.2 Ventilation |
| 24 | 3.3.8 Lighting |
| 25 | Table 1—IES-recommended illuminance levels for work environments 3.3.9 Hand hygiene facilities 3.3.10 Emergency eyewash/shower equipment |
| 26 | 3.3.11 Environmental cleaning 4 Personnel 4.1 General considerations 4.2 Policies and procedures |
| 27 | 4.3 Education, training, and competency verification |
| 28 | 4.4 Standard precautions |
| 29 | 4.5 Hand hygiene 4.6 Attire 4.6.1 General considerations 4.6.2 Personal protective equipment |
| 30 | 4.7 Immunizations |
| 31 | 5 Cleaning and high-level disinfection 5.1 General considerations 5.2 Precleaning at the point of use 5.3 Transporting used endoscopes |
| 32 | 5.4 Leak testing 5.4.1 General considerations 5.4.2 Manual (dry) leak testing 5.4.3 Mechanical (wet) leak testing |
| 33 | 5.4.4 Mechanical (dry) leak testing 5.4.5 Mechanical leak testing using an AER |
| 34 | 5.4.6 Leak test failures 5.5 Manual cleaning |
| 35 | 5.6 Manual rinsing 5.7 High-level disinfection and liquid chemical sterilization 5.7.1 General considerations 5.7.2 High-level disinfection |
| 36 | 5.7.3 Liquid chemical sterilants/liquid chemical sterilization |
| 37 | 5.7.4 Manual liquid chemical sterilization/high-level disinfection 5.7.4.1 Disinfection 5.7.4.2 Manual rinsing 5.7.4.3 Manual drying |
| 38 | 6 Automated endoscope reprocessors |
| 40 | 7 Sterile endoscope sheaths used as protective microbial barriers 8 Terminal sterilization by gaseous chemical sterilization processes 8.1 General considerations |
| 41 | 8.2 Packaging for terminal sterilization 8.2.1 General considerations 8.2.2 Sterilization pouches 8.2.3 Sterilization wraps 8.2.4 Rigid sterilization containment systems 8.3 Ethylene oxide gas (EO) sterilization |
| 42 | 8.4 Hydrogen peroxide gas sterilization |
| 43 | 8.5 Ozone sterilization 9 Processing of endoscope accessories |
| 44 | 10 Storage of reprocessed endoscopes 10.1 General Considerations |
| 45 | 10.2 Storage of high-level disinfected endoscopes 10.3 Storage of sterilized endoscopes 10.4 Hang time for high-level disinfected endoscopes 10.4.1 General considerations 10.4.2 Existing guidelines |
| 46 | 10.4.3 Risk assessment |
| 47 | Table 2—Endoscope storage risk assessment checklist 11 Transport of high-level disinfected endoscopes 12 Quality Control 12.1 General considerations |
| 49 | 12.2 Product identification and traceability 12.3 Documentation and record-keeping 12.3.1 Documentation |
| 50 | 12.3.2 Expiration dating 12.4 Verification and monitoring of the cleaning process 12.4.1 General Considerations |
| 51 | 12.4.2 Cleaning verification 12.4.3 Cleaning verification tests for users |
| 52 | 12.4.4 Testing cleaning efficacy 12.5 Monitoring processes that use liquid chemical sterilization/high-level disinfection 12.5.1 Manual processes 12.5.1.1 Use of physical monitors 12.5.1.2 Solution test strips or chemical monitoring devices 12.5.1.2.1 General considerations 12.5.1.2.2 Using solution test strips or chemical monitoring devices 12.5.1.2.3 Frequency of use |
| 53 | 12.5.1.2.4 Interpretation 12.5.1.2.5 Inadequate processing |
| 54 | 12.5.2 Automated processes 12.5.2.1 General considerations 12.5.2.2 Use of physical monitors and process monitoring devices 12.5.2.3 Automated processing equipment malfunction |
| 55 | 12.5.2.4 Inadequate processing 12.5.3 Routine testing of stored endoscopes |
| 56 | 12.6 Monitoring gaseous chemical sterilization processes 12.6.1 Use of physical monitors 12.6.2 Gaseous chemical sterilizer malfunction |
| 57 | 12.7 Chemical indicators 12.7.1 General considerations 12.7.2 Using chemical indicators 12.7.3 Nonresponsive or inconclusive chemical indicators |
| 58 | 12.8 Biological indicators 12.8.1 General considerations 12.8.2 Using biological indicators and process challenge devices 12.8.3 Frequency of use of BIs and PCDs 12.9 Sterilizer testing 12.9.1 General considerations |
| 59 | 12.9.2 Qualification test procedure with BIs 12.9.3 Qualification testing acceptance criteria 12.9.4 Routine test procedure with BIs 12.9.5 Routine testing acceptance criteria 12.9.6 Positive BI results |
| 60 | 12.9.7 Microbiological testing 12.9.8 Product release 12.10 Product recalls 12.10.1 General considerations |
| 61 | 12.10.2 Recall procedure 12.10.3 Recall order 12.10.4 Recall summary report 12.10.5 Outbreak report 12.11 Quality process improvement 12.11.1 General considerations |
| 62 | 12.11.2 Risk analysis |
| 63 | 12.11.3 Decontamination 12.11.4 Liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization |
| 64 | 12.11.5 Functional areas for product and process improvement 12.11.5.1 Workplace design 12.11.5.2 Processing policies and procedures 12.11.5.3 Product use 12.11.5.5 Implementation of product and process improvements |
| 66 | Annex A: Bibliography |
