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AAMI ST41 2008 RA 2018

AAMI ST41 2008 RA 2018

$172.08

ANSI/AAMI ST41:2008/(R)2018 – Ethylene oxide sterilization in health care facilities: Safety and effectiveness

Published By Publication Date Number of Pages
AAMI 2008 184
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This recommended practice covers the safe and effective use of ethylene oxide as a sterilant in health care facilities. The provisions of this document are intended to promote sterility assurance, help minimize occupational exposure to ethylene oxide, and guide health care personnel in the proper use of processing equipment.

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PDF Pages PDF Title
1 ANSI/AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 AAMI Recommended Practice
Copyright Information
5 Contents
11 Glossary of equivalent standards
13 Committee representation
15 Acknowledgments
16 Foreword
17 Introduction: Need for the recommended practice
18 1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions
19 2 Definitions, symbols, and abbreviations
27 3 Design considerations
3.1 General rationale
3.2 Centralization
3.3 Containment areas
28 3.4 Routing of traffic
3.5 Sterilizer access area
29 3.6 Storage of supplies
3.7 Temperature
3.8 Relative humidity
3.9 Ventilation recommendations for areas housing EO sterilization and aeration equipment
3.9.1 General considerations
30 3.9.2 Local exhaust ventilation
3.9.2.1 Local exhaust ventilation systems
3.9.2.2 Local exhaust ventilation parameters
3.9.2.3 Sites for local exhaust ventilation
3.9.2.4 Location of exhaust hoods
3.9.2.5 Exhaust source
31 3.9.2.6 Exhaust ducts
3.9.2.7 Vent system alarms
3.9.3 General room ventilation
3.9.3.1 Ventilation parameters
3.9.3.2 Ventilation systems
3.9.3.3 Minimum room size
32 3.9.3.4 Air flow
3.9.3.5 Air exchanges
3.9.3.6 Ventilation monitoring
3.10 Emergency eyewash and shower equipment
33 3.11 Environmental discharge controls
3.11.1 Ethylene oxide
3.11.2 Ethylene glycol
3.11.3 Hydrochlorofluorocarbons
35 4 Personnel considerations
4.1 General rationale
4.2 Qualifications
4.2.1 Supervisory personnel
36 4.2.2 Sterilizer and aerator operators
4.3 Training and continuing education
4.3.1 Sterile processing personnel
4.3.1.1 General considerations
37 4.3.1.2 In-service training
4.3.1.3 Manufacturers’ instructions
4.3.1.4 Record keeping
4.3.2 Other personnel
4.4 Personnel health
4.4.1 General considerations
38 4.4.2 Information concerning the potential hazards of exposure to EO
4.4.2.1 General considerations
4.4.2.2 Health effects of short-term exposure to EO
4.4.2.3 Health effects of long-term exposure to EO
4.4.2.4 Health effects of exposure to EO residuals
4.4.3 Medical surveillance and treatment
4.4.3.1 Routine medical examinations
39 4.4.3.2 Medical examinations for acute exposures
4.4.3.3 Record keeping
4.4.4 First aid
4.5 Attire
4.5.1 General considerations
40 4.5.2 Decontamination area
4.5.3 Service personnel
41 4.5.4 Prevention of occupational exposure to EO
43 5 Receiving
5.1 General rationale
5.2 Receiving of purchased or loaner items
5.2.1 General considerations
5.2.2 Newly purchased reusable items and repaired reusable items
5.2.3 Rigid sterilization container systems
44 5.2.4 Disposable items
5.3 Disposition of sterile items (issued but not used)
45 6 Handling, collection, and transport of contaminated items
6.1 General rationale
6.2 Separation of waste and reusable items at point of use
6.3 Care and handling of contaminated reusable items at point of use
46 6.4 Containment
47 6.5 Transport
6.5.1 Transportation scheduling and routes
6.5.2 Transportation equipment
6.5.3 Hand transport
6.5.4 Dedicated lifts
6.5.5 Transport between buildings
48 6.5.6 Off-site transportation
49 7 Cleaning and other decontamination processes
7.1 General rationale
7.2 Policies, procedures, and manufacturers’ instructions
7.2.1 Policies and procedures
7.2.2 Manufacturers’ instructions
50 7.3 Presoaking
7.4 Disassembly
7.4.1 Sorting and disassembly of instrumentation
7.4.2 Disassembly of rigid sterilization container systems
7.4.2.1 Removable filters
7.4.2.2 Valves
7.4.2.3 Interior baskets
51 7.4.2.4 Labeling
7.4.2.5 Process indicators, disposable labels, and disposable locks
7.4.2.6 Dividers and sorting pins
7.5 Cleaning
7.5.1 General considerations
7.5.2 Cleaning agents
52 7.5.3 Methods of cleaning
7.5.3.1 Selection of an appropriate method
7.5.3.2 Manual cleaning
53 7.5.3.3 Mechanical cleaning
7.5.4 Rinsing
54 7.5.5 Verification of the cleaning process
7.5.6 Cleaning of instruments
55 7.5.7 Utensils
7.5.8 Reusable textiles
7.5.9 Rigid sterilization container systems
56 7.6 Microbicidal processes
7.6.1 General considerations
57 7.6.2 Processes to decontaminate devices for safe handling
7.6.2.1 Chemical disinfection
58 7.6.2.2 Chemical sterilization for decontamination
59 7.6.2.3 Thermal (hot-water) disinfection
7.6.3 Terminal sterilization processes to prepare devices for the next patient use
7.6.3.1 General considerations
60 7.6.3.2 Chemical terminal sterilization
7.6.3.3 Thermal terminal sterilization
7.7 Servicing and repair of devices in the health care facility
7.7.1 General considerations
7.7.2 Potential for exposure
61 7.7.3 Protective measures for service personnel
7.7.3.1 General
7.7.3.2 Education and training
7.7.3.3 Vaccination
7.7.3.4 Personal protective equipment
7.7.3.5 Work practices
7.7.4 Postexposure program
7.7.5 Devices that cannot be repaired in-house
63 8 Packaging, preparation, and sterilization
8.1 General rationale
8.2 Items suitable for EO sterilization
8.3 Preconditioning (humidification)
8.4 Packaging
8.4.1 Selection of packaging materials
64 8.4.2 Package configurations and preparation
8.4.2.1 Package closures
65 8.4.2.2 Package labels
8.4.2.3 Package configurations
8.5 Loading the sterilizer
8.5.1 Load composition
8.5.2 Load configuration
8.6 Sterilization parameters
8.6.1 General considerations
8.6.2 Sterilizer manufacturer’s instructions
66 8.6.3 Device and packaging manufacturers’ instructions
8.6.4 Monitoring
8.7 Unloading the sterilizer
8.7.1 General considerations
8.7.2 Sterilizers without purge cycles
8.7.3 Sterilizers with purge cycles
8.7.4 Sterilizers with integral aeration
67 8.7.5 Sterilizers with “detoxification”
8.7.6 Handling of EO-sterilized items before aeration
8.8 Aeration recommendations
8.8.1 General considerations
8.8.2 Metal and glass items
68 8.8.3 Aeration capacity
8.8.4 Aeration times
8.9 Sterile storage
8.9.1 Handling and inspection
8.9.2 Sterility maintenance covers
69 8.9.3 Storage facilities
70 8.9.4 Shelf life
8.10 Distribution
8.10.1 Handling and inspection
8.10.2 Distribution containers
71 9 Installation, venting, routine care, and maintenance of EO sterilization and aerationequipment and EO gas sources
9.1 General rationale
9.2 Installation
9.2.1 Regulatory requirements
9.2.2 Manufacturer’s instructions
9.2.3 Equipment location
9.3 Installation testing
9.3.1 Sterilizers
9.3.2 Emission control and ventilation systems
72 9.4 Venting of EO sterilizers
9.4.1 General considerations
9.4.2 Sterilizers venting to the outside atmosphere
9.4.2.1 Chamber vent lines
9.4.2.2 Venting of sterilizer relief valves
73 9.4.2.3 Ventilation of sterilizer door areas
9.4.3 Sterilizers venting to a sanitary floor drain
9.4.4 Sterilizers without exhaust to the outside atmosphere or a sanitary floor drain
74 9.4.5 Ventilation of EO gas cylinders
9.5 Venting of EO aeration cabinets
9.5.1 Vent lines
9.5.2 Equipment modifications
9.6 Ventilation system alarms
9.7 Maintenance of EO sterilizers, aerators, emission control systems, and ventilation systems
9.7.1 Manufacturer’s instructions
75 9.7.2 Routine care of sterilizers and aerators
9.7.3 Preventive maintenance
9.7.3.1 General considerations
9.7.3.2 Scheduled maintenance
9.7.3.3 Leak testing
76 9.7.3.4 Calibration
9.7.3.5 Emission control systems
9.7.3.6 Record keeping
9.8 Storage and handling of EO gas sources
9.8.1 Unit-dose containers of 100 % EO
9.8.1.1 Storage of unit-dose containers
77 9.8.1.2 Transport of unit-dose containers
9.8.1.3 Disposal of unit-dose containers
9.8.2 Storage and handling of EO gas cylinders (tanks) and supply line filters
9.8.2.1 Storage of EO gas cylinders
9.8.2.2 Transport of EO gas cylinders
78 9.8.2.3 EO supply lines
9.8.2.4 Changing EO gas cylinders and supply line filters
9.8.2.5 Supply line filter disposal
9.9 EO leaks and spills
9.9.1 General considerations
9.9.2 Emergency team
9.9.3 Emergency plan
79 9.9.4 First aid
9.9.4.1 Liquid EO
9.9.4.2 EO gas
80 9.10 Personal protective equipment
9.11 Equipment manuals
81 10 Quality control
10.1 General rationale
10.2 Monitoring of mechanical cleaning equipment
10.3 Product identification and traceability
10.3.1 Lot control numbers
10.3.2 Sterilizer records
82 10.3.3 Expiration dating
10.4 Overview of sterilization process monitoring
84 10.5 Sterilization process monitoring devices
10.5.1 Physical monitors
10.5.2 Chemical indicators
10.5.2.1 General considerations
85 10.5.2.2 Using chemical indicators
10.5.2.2.1 External chemical indicators
10.5.2.2.2 Internal chemical indicators
86 10.5.3 Biological indicators
10.5.3.1 General considerations
10.5.3.2 Using biological indicators
87 10.5.4 Process challenge devices
10.6 Routine load release
10.6.1 Process monitoring devices
10.6.2 Release criteria for nonimplants
88 10.6.3 Release criteria for implants
10.6.4 Sterilization process failures
89 10.7 Routine sterilizer efficacy monitoring
10.7.1 General considerations
10.7.2 Composition of the PCD (routine BI test pack)
10.7.3 Placement of the PCD (routine BI test pack)
91 10.7.4 Test procedure
10.7.5 Acceptance criteria
10.7.6 Positive BI results
10.7.6.1 General procedure
92 10.7.6.2 Microbiological testing
10.8 Qualification testing
10.8.1 General considerations
93 10.8.2 Composition of the PCD (challenge BI test pack)
95 10.8.3 Placement of the PCDs (challenge BI test packs)
96 10.8.4 Test procedure
10.8.5 Acceptance criteria
10.8.6 Positive BIs
98 10.9 Periodic product quality assurance testing of routinely processed items
10.10 Periodic product quality assurance testing of rigid sterilization container systems
10.10.1 General considerations
10.10.2 Responsibilities of the manufacturer
10.10.2.1 Suitability of the container system for specific sterilization cycles
99 10.10.2.2 Sterilization
10.10.2.3 EO residual removal
10.10.2.4 Sterility maintenance
100 10.10.3 User responsibilities
10.10.3.1 General considerations
10.10.3.2 Prepurchase evaluation
10.10.3.2.1 General considerations
10.10.3.2.2 Sterilization process conditions
101 10.10.3.2.3 Test protocol
10.10.3.2.3.1 Intent
10.10.3.2.3.2 Test container
10.10.3.2.3.3 Test procedure
102 10.11 Aeration of PCDs
10.12 Product recalls
10.12.1 General considerations
10.12.2 Recall procedure
10.12.3 Recall order
103 10.12.4 Recall report
10.13 Quality process improvement
10.13.1 General rationale
10.13.2 Quality process
10.13.2.1 General considerations
10.13.2.2 Functional areas for product and process improvements
104 10.13.2.3 Implementing product and process improvements
105 11 Environmental and employee monitoring

11.1 General rationale
11.2 Instrumentation
11.2.1 Selection of monitoring methods
11.2.2 Reliability and use of instrumentation
11.3 Procedures
11.3.1 Monitoring sites
106 11.3.2 Frequency of monitoring
11.3.3 Sterilizer system leak checks
11.3.4 Ventilation system monitoring
107 11.3.5 Short-term exposures
11.4 Calculations and interpretation of data
108 11.5 Record keeping
111 Annex A Occupational exposure to ethylene oxide, final standard (29 CFR 1910.1047)
§1910.1047 Ethylene oxide
a) Scope and application
b) Definitions
c) Permissible exposure limits.
d) Exposure monitoring
113 e) Regulated areas
f) Methods of compliance
114 g) Respiratory protection and personal protective equipment
115 h) Emergency situations
i) Medical surveillance
116 j) Communication of EtO hazards to employees
118 k) Record keeping
119 l) Observation of monitoring
m) Dates
n) Appendices
120 Appendix A to §1910.1047—Substance Safety Data Sheet for Ethylene Oxide (Non-Mandatory)
I. Substance identification
II. Health hazard data
III. Emergency first aid procedures
121 IV. Respirators and protective clothing
V. Precautions for safe use, handling, and storage
122 VI. Access to information
VII. Sterilant use of EtO in hospitals and health care facilities
126 Appendix B to §1910.1047—Substance Technical Guidelines for Ethylene Oxide (Non-Mandatory)
I. Physical and chemical data
II. Fire, explosion, and reactivity hazard data
127 III. Spill, leak, and disposal procedures
IV. Monitoring and measurement procedures
V. Protective clothing and equipment
128 VI. Miscellaneous precautions
VII. Common operations
129 Appendix C to §1910.1047—Medical Surveillance Guidelines for Ethylene Oxide (Non-Mandatory)
I. Route of entry
II. Toxicology
III. Signs and symptoms of acute overexposure
IV. Surveillance and preventive considerations
131 Appendix D to §1910.1047—Sampling and Analytical Methods for Ethylene Oxide (Non-Mandatory)
1 General Discussion.
133 2 Sampling Procedure
134 3 Analytical Method
136 4 Backup Data
139 5 References
141 Annex B Ethylene oxide and hydrochlorofluorocarbon emission control technologies
B.1 Introduction
B.2 Emission control technologies
B.2.1 Catalytic conversion
B.2.2 Acid hydrolysis
B.2.3 Absorption
B.2.4 Recovery–reclamation systems
142 Annex C Processing CJD-contaminated patient care equipment and environmentalsurfaces
143 Annex D Selection and use of chemical disinfectants
D.1 Introduction
D.2 Categories of items to be disinfected
144 D.3 Activity levels of disinfectants
D.4 Labeling of disinfectant products
145 D.5 Criteria for selecting a chemical disinfectant
146 D.6 Quality control in chemical disinfection
147 D.7 Safety considerations in chemical disinfection
149 Annex E User verification of cleaning processes
E.1 General considerations
150 E.2 Markers
151 E.3 Cleaning verification tests for users
154 Annex F Thermal disinfection
F.1 Introduction
F.2 Microbial destruction by heat
F.3 Items suitable for thermal sanitization or disinfection
F.4 Manufacturers’ instructions
F.5 Quality control in thermal disinfection
F.6 Safety considerations in thermal disinfection
155 Annex G Devices returned to the manufacturer
G.1 Introduction
G.2 Overview
G.3 Manufacturer’s instructions to the user
156 G.4 User responsibilities
G.4.1 General
G.4.2 Decontamination at the health care facility
G.4.3 Packaging, labeling, and shipment to the manufacturer’s facility
157 G.5 Receiving at the manufacturer’s facility
158 G.6 Cleaning, decontamination, and sterilization methods at the manufacturer’s facility
G.7 Personal protective equipment at the manufacturer’s facility
G.8 Work practices for infection control at the manufacturer’s facility
159 G.9 Housekeeping and waste disposal
160 G.10 Device failure investigation
G.11 Documentation to the user
161 Annex H Round-robin study of the PCD (routine BI test pack)
H.1 Introduction
H.2 Materials and methods
H.2.1 Test strategy
H.2.2 Test laboratories
H.2.3 Sterilization equipment
H.2.4 Test pack components and assembly
H.2.5 Exposure conditions
162 H.2.6 Test procedure
H.2.7 Data collected
H.3 Results
163 Annex I Development of a prepurchase evaluation protocol for rigid sterilization containersystems
I.1 Introduction
164 I.2 General considerations
I.3 Instruments and devices to be containerized
I.4 Cleaning and decontamination considerations
165 I.5 Preparation and assembly considerations
I.6 Matching the rigid sterilization container system and sterilization cycle
I.7 Loading the sterilizer
166 I.8 Choosing the appropriate exposure and aeration times
I.9 Unloading the sterilizer and cooling the load
I.10 Sterility maintenance
167 I.11 Sterile storage
I.12 Transportation
I.13 Aseptic presentation
I.14 Conclusion
169 Annex J Selecting equipment or services for monitoring airborne ethylene oxide at an EOsterilization facility
J.1 Introduction
J.2 General approaches to EO monitoring
J.2.1 Personnel monitoring
170 J.2.2 Area monitoring
J.3 Area and personnel monitoring devices
J.3.1 General considerations
171 J.3.2 Personnel monitoring devices
173 J.3.3 Area monitoring devices
176 J.4 Contract services
J.4.1 Advantages and disadvantages of contract services
177 J.4.2 Finding contract service organizations
J.4.3 Selection criteria
179 Annex K Bibliography and cited references
K.1 Cited references
183 K.2 For further reading
AAMI ST41 2008 RA 2018
$172.08