Provides guidelines for point of use treatment, transporting, leak testing (where indicated), cleaning, packaging (where indicated), high-level disinfecting and/or sterilizing, storage, and quality control procedures of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, flexible ear, nose, and throat endoscopes, flexible urology endoscopes, and other types of reusable flexible endoscopes used in procedural and surgical settings, and semi-rigid operative endoscopes (e.g., choledochoscopes) used in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these reusable devices and accessories to render them safe for patient use.

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PDF Pages	PDF Title
1	ANSI/AAMI ST91:2021; Flexible and semi-rigid endoscope processing in health care facilities
3	Title page
4	AAMI Standard Copyright information
5	Contents Page
7	Committee representation
12	Acknowledgments
13	Foreword
14	Introduction
17	1 Scope 1.1 Inclusions 1.2 Exclusions
18	2 Normative references 3 Terms and definitions 3.1 automated endoscope reprocessor AER 3.2 bioburden 3.3 biofilm 3.4 biological indicators BIs
19	3.5 borescope 3.6 case/cassette 3.7 certification 3.8 challenge test pack 3.9 chemical indicators CIs
20	3.11 cleaning 3.12 clinical soil 3.13 competency 3.14 competency verification 3.15 CQI 3.16 critical device 3.17 critical water 3.18 decontamination 3.19 decontamination area
21	3.20 education 3.21 endoscope sheath 3.22 engineering controls 3.23 ethylene oxide (EO) sterilization 3.24 expiration date 3.25 expiration statement 3.26 exposure control plan 3.27 exposure time 3.28 gaseous and vapor chemical sterilization 3.29 high-level disinfectant HLD
22	3.30 high-level disinfection 3.31 high-risk endoscopes 3.32 hydrogen peroxide sterilization 3.33 hydrogen peroxide–ozone sterilization 3.34 iatrogenic 3.35 inspect 3.36 installation qualification IQ 3.37 instrument air 3.38 labeling 3.39 liquid chemical sterilant LCS
23	3.40 liquid chemical sterilant processing system LCSPS 3.41 liquid-resistant material 3.42 lot control number 3.43 magnification 3.44 manufacturer’s written instructions for use IFU 3.45 medical device 3.46 minimum effective concentration MEC 3.47 minimum recommended concentration MRC
24	3.48 occupational exposure 3.49 operational qualification OQ 3.50 OSHA 3.51 performance qualification PQ 3.52 personal protective equipment PPE 3.53 point of use treatment 3.54 preventive maintenance
25	3.55 process challenge device PCD 3.56 processing 3.57 processing area 3.58 pseudoinfection 3.59 reprocessing 3.60 reusable containment device 3.61 reusable medical device 3.62 rigid sterilization container system 3.63 safety data sheet SDS
26	3.64 semi-critical device 3.65 shelf life 3.66 solid container 3.67 solution test strip 3.68 Spaulding classification 3.69 spore test strip 3.70 standard precautions 3.71 steam sterilization 3.72 sterile 3.73 sterile processing area
27	3.74 sterilization 3.75 sterilization cycle 3.76 sterilizer 3.77 terminal cleaning 3.78 terminal sterilization 3.79 training 3.80 user verification 3.81 utility water 3.82 validation 4 Design of endoscope processing area 4.1 General considerations
28	4.2 Workflow 4.2.1 General considerations
29	4.2.2 Physical separation
30	4.2.3 Traffic control 4.3 Physical facilities 4.3.1 General space requirements 4.3.1.1 Space requirements in the decontamination area
31	4.3.1.2 Space requirements in the preparation area
32	4.3.1.3 Space requirements for terminal sterilization 4.3.1.4 Space requirements for manual high-level disinfection or manual liquid chemical sterilization 4.3.1.5 Space requirements for automated high-level disinfection or liquid chemical sterilization
33	4.3.2 Sinks and accessories 4.3.3 Electrical systems
34	4.3.4 Floors and walls 4.3.5 Ceilings 4.3.6 Doors 4.3.7 Heating, ventilation, and air conditioning (HVAC) operating parameters
35	4.3.8 Lighting
36	4.3.9 Hand hygiene facilities 4.3.10 Emergency eyewash/shower equipment
37	4.3.11 Water quality 5 Environmental cleaning
38	6 Personnel 6.1 General considerations 6.2 Policies and procedures
39	6.3 Education, training, and competency verification 6.3.1 General considerations 6.3.2 Frequency of education, training, and competency verification 6.3.3 Responsibilities of personnel providing training
40	6.3.4 Education and training 6.3.4.1 Personnel handling flexible endoscopes at the point of use 6.3.4.2 Endoscope processing personnel
41	6.3.5 Competency verification 6.3.6 Documentation 6.4 Standard precautions
42	6.5 Hand hygiene 6.6 Attire 6.6.1 General considerations
43	6.6.2 Personal protective equipment
44	7 Decontamination processes 7.1 General considerations
45	7.1.1 The appropriate cleaning methods for flexible endoscopes are based on: 7.1.2 Endoscope, cleaning equipment, and cleaning solution IFU should be followed during the cleaning process for endoscopes. In the event of conflict, the endoscope manufacturer should be contacted for clarification. Cleaning steps include the follow… 7.2 Point of use treatment 7.2.1 General considerations
46	7.2.2 Procedure
47	7.3 Transport of contaminated endoscopes 7.3.1 General considerations 7.3.2 Procedure
48	7.4 Leak testing 7.4.1 General considerations 7.4.2 Leak testing procedures
49	7.4.3 Manual (dry) leak testing 7.4.4 Manual (wet) leak testing
50	7.4.5 Mechanical (dry) leak testing 7.4.6 Mechanical (wet) leak testing
51	7.4.7 Mechanical leak testing using an AER 7.4.8 Leak test failures
52	7.5 Cleaning 7.5.1 General considerations 7.5.2 Detachable parts 7.6 Manual cleaning steps
54	7.7 Automated cleaning, rinsing, and drying 7.8 Inspection and cleaning verification 7.8.1 General considerations
55	7.8.2 Visual inspection 7.8.3 Borescopic inspection
56	7.8.4 Cleaning verification 8 High-level disinfection, liquid chemical sterilization, and terminal sterilization systems for flexible endoscopes 8.1 General considerations 8.2 High-level disinfectant systems and liquid chemical sterilant processing systems and procedures 8.2.1 General considerations
57	8.2.2 Spill kits
58	8.2.3 Automated high-level disinfection and liquid chemical sterilization processes 8.2.3.1 Automated high-level disinfection/liquid chemical sterilization features 8.2.3.2 Automated high-level disinfection/liquid chemical sterilization procedure
60	8.2.4 Manual high-level disinfection and liquid chemical sterilization processes 8.2.4.1 Manual processing procedure
61	8.2.4.2 Manual rinsing 8.2.5 Endoscope drying 8.2.5.1 General considerations
62	8.2.5.2 Manual drying 8.3 Terminal sterilization by gaseous or vaporized chemical sterilization processes 8.3.1 General considerations
63	8.3.2 Packaging for terminal sterilization 8.3.2.1 General considerations 8.3.2.2 Sterilization pouches 8.3.2.3 Sterilization wraps
64	8.3.2.4 Rigid sterilization containment systems 8.3.3 Terminal sterilization procedures
65	8.3.4 Ethylene oxide gas sterilization
66	8.3.5 Hydrogen peroxide and hydrogen peroxide–ozone sterilization
67	9 Sterile endoscope sheaths used as protective microbial barriers 10 Processing of endoscope accessories 10.1 General considerations 10.2 Procedure
68	11 Storage of processed endoscopes 11.1 General considerations 11.2 Storage of high-level disinfected or liquid chemically sterilized endoscopes 11.2.1 Storage procedures
69	11.2.2 Storage cabinets 11.2.2.1 Endoscope drying cabinets 11.2.2.2 Conventional drying cabinets
70	11.2.3 Identification of endoscopes during storage 11.2.4 Maximum safe storage time for high-level disinfected endoscopes 11.2.4.1 General considerations 11.2.4.2 Risk assessment
71	11.2.5 Storage of liquid chemically sterilized endoscopes
72	11.3 Storage of terminally sterilized endoscopes and accessories 11.3.1 General considerations 11.3.2 Storage area
73	12 Transport of processed endoscopes 13 Quality control 13.1 General considerations 13.2 Establishing policy and procedures for quality assurance and safety program
75	13.3 Product identification and traceability 13.4 Documentation and record-keeping 13.4.1 Documentation
77	13.4.2 Expiration dating for terminally sterilized endoscopes 13.5 Verification and monitoring of the cleaning process 13.5.1 General Considerations
78	13.5.2 Visual inspection after manual cleaning 13.5.3 Cleaning verification tests for users
79	13.5.4 Testing cleaning efficacy
80	13.6 Monitoring of liquid chemical sterilization/high-level disinfection 13.6.1 Monitoring of manual processes 13.6.1.1 Physical monitors 13.6.1.2 Solution test strips or chemical monitoring devices 13.6.1.2.1 General considerations
81	13.6.1.2.2 Using solution test strips or chemical monitoring devices 13.6.1.2.3 Frequency of use 13.6.1.2.4 Interpretation 13.6.1.2.5 Inadequate processing
82	13.6.2 Monitoring of automated processes 13.6.2.1 General considerations 13.6.2.2 Use of physical monitors and process monitoring devices
83	13.6.2.3 Automated processing equipment malfunction 13.6.2.4 Inadequate processing
84	13.6.3 Microbiological surveillance of endoscopes
85	13.7 Monitoring gaseous and vapor chemical sterilization processes 13.7.1 Physical monitors
86	13.7.2 Gaseous and vaporized chemical sterilizer malfunction
87	13.8 Chemical indicators 13.8.1 General considerations 13.8.2 Using chemical indicators 13.8.3 Nonresponsive or inconclusive chemical indicators
88	13.9 Biological indicators 13.9.1 General considerations 13.9.2 Using biological indicators and process challenge devices 13.10 Sterilizer testing 13.10.1 General considerations
89	13.10.2 Qualification test procedure and acceptance criteria 13.10.3 Routine test procedure
90	13.10.4 Routine test acceptance criteria 13.10.5 Positive BI results
91	13.10.6 Positive BI microbiological verification testing 13.11 Product release 13.12 Product recalls 13.12.1 General considerations 13.12.2 Recall procedure 13.12.3 Recall order
92	13.12.4 Recall summary report 13.13 Outbreak report 13.14 Quality process improvement 13.14.1 General considerations
93	13.14.2 Risk analysis 13.14.3 Point of use
94	13.14.4 Decontamination 13.14.5 Liquid chemical sterilization, high-level disinfection, and gaseous and vaporized chemical sterilization
95	13.14.6 Functional areas for product and process improvement 13.14.6.1 Workplace design
96	13.14.6.2 Processing policies and procedures 13.14.6.3 Product use 13.14.6.4 Implementation of product and process improvements
98	14 Device repair and loaned endoscopes 14.1 General considerations 14.2 Point of use detection and communication
99	14.3 Processing area detection and communication 14.4 Health care facility point of repair transfer 14.5 Return to health care facility from repair
100	14.6 Loaned endoscopes 14.6.1 Policy and procedure 14.7 Use of loaned endoscopes during microbial surveillance 14.8 Quality measures for repairs
101	15 New product evaluation 15.1 General rationale 15.2 Considerations
103	Annex A (informative) Alternatives for keeping cool in the processing environment A.1 Introduction A.2 Decontamination environment
104	A.3 Protective attire A.4 Alternative cooling methods for personnel working in the decontamination area/room
106	Annex B (informative) Purchase considerations in selecting AERs and LCSPSs
108	Annex C (normative) Reference material for repairs C.1 Repair of flexible endoscopes
109	C.2 Loaned flexible endoscopes C.3 Qualification considerations for repair providers
110	Annex D (informative) Manufacturer’s written instructions for use (IFU) conflict management
111	Annex E (informative) Endoscope visual inspection E.1 General considerations E.2 Overview E.3 Anatomy of an endoscope
112	E.4 Visual Inspection process
113	E.5 Implementation of visual inspection of endoscopes E.6 Borescope inspection of an endoscope E.7 Damaged adhesive E.8 Inspection of components E.8.1 Light guide connector, light guide tube, control body (including valves and switches)
114	E.8.2 Insertion tube
116	E.8.3 Biopsy port E.8.4 Distal tip
118	E.8.5 Bending section
120	E.8.6 Channel
121	Annex F (informative) User verification of cleaning processes0F F.1 General considerations
122	F.2 Markers (analytes)
123	F.2.1 ATP F.2.2 Protein F.2.3 Hemoglobin
124	F.2.4 Carbohydrates F.3 Cleaning verification tests for users F.3.1 Verification tests for ultrasonic cleaners F.3.2 Verification test for mechanical washers
125	F.4 A program for verification of the efficacy of the manual cleaning during endoscope processing: An example
128	Annex G (informative) Effects of simethicone on flexible endoscopes
129	Annex H (informative) Safety considerations for high-level disinfectants and liquid chemical sterilants H.1 Glutaraldehyde solutions H.1.1 Introduction H.1.2 Properties and applications of glutaraldehyde
131	H.1.3 Effective use of glutaraldehyde
132	H.1.3.1 Safe use of glutaraldehyde H.1.3.1.1 General considerations for occupational exposure H.1.3.2 Health effects of glutaraldehyde H.1.3.2.1 Potential health effects of short-term exposure
133	H.1.3.2.2 Potential health effects of long-term exposure H.1.3.2.2.1 Occupational exposure limits H.1.3.2.3 Personal protective equipment and first aid H.1.3.2.3.1 Eye protection
134	H.1.3.2.3.2 Skin protection H.1.3.2.3.3 Respiratory protection H.1.3.3 Ventilation H.1.3.4 Preparing activated solutions H.1.3.5 Pouring activated solutions
135	H.1.3.6 Transporting solutions H.1.3.7 Storing activated and unused solutions H.1.3.8 Immersing items to be high-level disinfected or sterilized H.1.3.9 Rinsing high-level-disinfected or sterilized items
136	H.1.4 Procedures for cleaning up glutaraldehyde spills H.1.4.1 General considerations H.1.4.2 Deactivating chemicals H.1.4.3 Drips and splashes
137	H.1.4.4 Large spills H.1.5 Disposal of glutaraldehyde solutions
138	H.2 Hydrogen peroxide solutions H.2.1 Introduction H.2.2 Properties and applications of hydrogen peroxide H.2.3 Effective use of hydrogen peroxide solutions
139	H.2.4 Safe use of hydrogen peroxide solutions H.2.4.1 Occupational exposure H.2.4.1.1 General considerations H.2.4.1.2 Health effects of hydrogen peroxide H.2.4.1.2.1 Potential health effects of short-term exposure H.2.4.1.2.2 Potential health effects of long-term exposure H.2.4.1.3 Occupational exposure limits
140	H.2.4.1.4 Personal protective equipment and first aid H.2.4.1.4.1 Eye protection H.2.4.1.4.2 Skin protection H.2.4.1.4.3 Respiratory protection H.2.4.2 Ventilation H.2.4.3 Pouring solutions H.2.4.4 Transporting solutions H.2.4.5 Storing unused solutions
141	H.2.4.6 Immersing items to be high-level disinfected or sterilized H.2.4.7 Rinsing disinfected or sterilized items H.2.5 Hydrogen peroxide spills H.2.6 Disposal of hydrogen peroxide solutions
142	H.2.7 Vapor monitoring H.3 Ortho-phthalaldehyde solutions H.3.1 Introduction H.3.2 Properties and applications of OPA H.3.3 Effective use of OPA
143	H.3.4 Safe use of OPA H.3.4.1 Occupational exposure H.3.4.1.1 General considerations H.3.4.1.2 Health effects of OPA H.3.4.1.2.1 Potential health effects of short-term exposure H.3.4.1.2.2 Potential health effects of long-term exposure H.3.4.1.3 Occupational exposure limits
144	H.3.4.1.4 Personal protective equipment and first aid H.3.4.1.4.1 Eye protection H.3.4.1.4.2 Skin protection H.3.4.1.4.3 Respiratory protection H.3.4.2 Ventilation H.3.4.3 Pouring solutions H.3.4.4 Transporting solutions H.3.4.5 Storing opened solutions
145	H.3.4.6 Immersing items to be high-level disinfected H.3.4.7 Rinsing disinfected items H.3.5 OPA spills
146	H.3.6 Disposal of OPA solutions H.3.7 Vapor monitoring H.4 Peracetic acid–hydrogen peroxide solutions H.4.1 Introduction
147	H.4.2 Properties and applications of peracetic acid–hydrogen peroxide solutions
148	H.4.3 Effective use of peracetic acid-hydrogen peroxide solutions
149	H.4.4 Safe use of peracetic acid–hydrogen peroxide solutions H.4.4.1 Occupational exposure H.4.4.1.1 General considerations H.4.4.1.2 Health effects of peracetic acid and hydrogen peroxide H.4.4.1.2.1 Potential health effects of short-term exposure H.4.4.1.2.2 Potential health effects of long-term exposure H.4.4.1.3 Occupational exposure limits
150	H.4.4.1.4 Personal protective equipment and first aid H.4.4.1.4.1 Eye protection H.4.4.1.4.2 Skin protection H.4.4.1.4.3 Respiratory protection H.4.4.2 Ventilation
151	H.4.4.3 Pouring solutions H.4.4.4 Transporting solutions H.4.4.5 Storing solutions H.4.4.6 Immersing items to be high-level disinfected or sterilized
152	H.4.4.7 Rinsing disinfected or sterilized items H.4.4.8 Transport and storage of processed devices H.4.5 Peracetic acid–hydrogen peroxide spills
153	H.4.6 Disposal of peracetic acid–hydrogen peroxide solutions H.4.7 Vapor monitoring H.5 Hydrogen peroxide gas sterilization H.5.1 Introduction H.5.2 Properties and applications of hydrogen peroxide gas sterilization systems
154	H.5.3 Effective use of hydrogen peroxide gas sterilizers H.5.4 Safe use of hydrogen peroxide gas sterilizers H.5.4.1 Occupational exposure H.5.4.1.1 General considerations H.5.4.1.2 Health effects of hydrogen peroxide H.5.4.1.2.1 Potential health effects of short-term exposure H.5.4.1.2.2 Potential health effects of long-term exposure H.5.4.1.3 Occupational exposure limits
155	H.5.4.1.4 Personal protective equipment and first aid H.5.4.1.4.1 Eye protection H.5.4.1.4.2 Skin protection H.5.4.1.4.3 Respiratory protection H.5.4.2 Ventilation H.5.4.3 Safety guidelines H.5.5 Spills H.5.6 Sterilant disposal H.5.7 Vapor monitoring
156	H.6 Hydrogen peroxide–ozone sterilization H.6.1 Introduction H.6.2 Properties and applications of hydrogen peroxide–ozone gas sterilization systems H.6.3 Effective use of hydrogen peroxide–ozone gas sterilization
157	H.6.4 Safe use of hydrogen peroxide-ozone gas sterilizer H.6.4.1 Occupational exposure H.6.4.1.1 General considerations H.6.4.1.2 Health effects of hydrogen peroxide H.6.4.1.2.1 Potential health effects of short-term exposure H.6.4.1.2.2 Potential health effect of long-term exposure
158	H.6.4.1.3 Health effects of ozone H.6.4.1.3.1 Potential health effects of short-term exposure H.6.4.1.3.2 Potential health effects of long-term exposure H.6.4.1.4 Occupational exposure limits H.6.4.1.4.1 Hydrogen peroxide H.6.4.1.4.2 Ozone H.6.4.1.5 Personal protective equipment and first aid H.6.4.1.5.1 Eye protection H.6.4.1.5.2 Skin protection H.6.4.1.5.3 Respiratory protection
159	H.6.4.2 Ventilation H.6.4.3 Safety guidelines H.6.5 Spills H.6.6 Sterilant disposal H.6.7 Vapor monitoring H.7 Ethylene oxide sterilization H.7.1 Introduction H.7.2 Properties and applications of ethylene oxide sterilization
160	H.7.3 Effective use of ethylene oxide sterilization
161	H.7.4 Safe use of ethylene oxide sterilizers H.7.4.1 Occupational exposure H.7.4.1.1 General considerations H.7.4.1.2 Health effects of ethylene oxide H.7.4.1.2.1 Potential health effects of short-term exposure H.7.4.1.2.2 Potential health effects of long-term exposure
162	H.7.4.1.3 Occupational exposure limits H.7.4.1.4 Personal protective equipment and first aid H.7.4.1.4.1 Eye protection H.7.4.1.4.2 Skin protection H.7.4.1.4.3 Respiratory protection H.7.4.2 Ventilation H.7.4.3 Safety guidelines
163	H.7.5 Spills and leaks H.7.6 Sterilant disposal H.7.7 Vapor monitoring
164	Annex I (informative) Endoscope microbiocidal methods
166	Annex J (informative) Endoscope storage risk assessment
167	Annex K (informative) Endoscope drying K.1 Introduction K.2 Importance of drying K.2.1 Literature review
168	K.3 Drying verification
169	K.4 Outstanding issues
170	K.5 Summary K.6 Commonly accepted terminology
171	Bibliography

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AAMI	2021	190


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Standard Title	ANSI/AAMI ST91:2021, Flexible and semi-rigid endoscope processing in health care facilities
Published Code	AAMI
Publication Date	2021
Pages Count	190

AAMI ST91 2021

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