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eLibrary > ANSI/AAMI ST58:2013/(R)2018 - Chemical sterilization and high-level disinfection in health care facilities >

ANSI/AAMI ST58:2013/(R)2018 - Chemical sterilization and high-level disinfection in health care facilities, 2013

ANSI/AAMI ST58:2013/(R)2018, Chemical sterilization and high-level disinfection in health care facilities
Objectives and uses of AAMI standards and recommended practices
Title page
AAMI Recommended Practice
Copyright information
Contents
Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
1 Scope [Go to Page]
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Definitions and abbreviations
3 Work area design considerations [Go to Page]
3.1 General rationale
3.2 Processing area
3.3 Traffic control
3.4 Ventilation of processing areas and equipment [Go to Page]
3.4.1 General considerations
3.4.2 General room ventilation
3.4.3 Local exhaust ventilation
3.5 Automated processing equipment for chemical sterilants/high-level disinfectants [Go to Page]
3.5.1 Selection of equipment
3.5.2 Installation
3.5.3 Equipment location
3.6 Storage of chemical sterilants/high-level disinfectants
3.7 Disposal of chemical sterilant/high-level disinfectant waste [Go to Page]
3.7.1 Chemical sterilant/high-level disinfectant solutions
3.7.2 Chemical solution containers
3.8 Regulatory requirements
4 Personnel considerations [Go to Page]
4.1 General rationale
4.2 Qualifications [Go to Page]
4.2.1 Supervisory personnel
4.2.2 Processing personnel
4.3 Training and continuing education [Go to Page]
4.3.1 Processing personnel
4.3.2 Service personnel
4.3.3 Other personnel
4.4 Personal protective equipment [Go to Page]
4.4.1 General considerations
4.4.2 Eye protection (liquid)
4.4.3 Skin protection (liquid)
4.4.4 Respiratory protection
4.5 Health and personal hygiene
5 Selection of liquid and gaseous chemical sterilants/high-level disinfectants [Go to Page]
5.1 General rationale
5.2 Categories
5.3 LCS/HLD types
5.4 Gaseous chemical sterilization types
5.5 Selection criteria [Go to Page]
5.5.1 General considerations
5.5.2 Health and safety considerations
5.5.3 Effectiveness
5.5.4 Materials compatibility
5.5.5 Cost-effectiveness
5.5.6 Matrix of selection criteria
6 Decontamination and preparation of instruments [Go to Page]
6.1 General rationale
6.2 Receiving [Go to Page]
6.2.1 Receiving of purchased items [Go to Page]
6.2.1.1 General considerations
6.2.1.2 Newly purchased reusable items and repaired reusable items
6.2.1.3 Disposable items
6.2.2 Disposition of sterile items (issued but not used)
6.3 Handling, collection, and transport of contaminated items [Go to Page]
6.3.1 General considerations
6.3.2 Separation of waste and reusable items at point of use
6.3.3 Care and handling of contaminated reusable items at point of use
6.3.4 Containment
6.4 Transport [Go to Page]
6.4.1 Segregation of clean/sterile items
6.4.2 Transportation scheduling and routes
6.4.3 Transportation equipment
6.4.4 Hand transport
6.4.5 Dedicated lifts
6.4.6 Transport between buildings
6.4.7 Off-site transportation
6.5 Aseptic presentation [Go to Page]
6.5.1 Opening sterile packages
6.5.2 Removing items from sterile packaging and transferring them to the sterile field
6.5.3 Removing devices from HLD equipment and delivery to the point of use
6.6 Cleaning and other decontamination processes [Go to Page]
6.6.1 General considerations
6.6.2 Preparation for cleaning
6.6.3 Disassembly
6.6.4 Cleaning [Go to Page]
6.6.4.1 General considerations
6.6.4.2 Cleaning agents
6.6.4.3 Methods of cleaning [Go to Page]
6.6.4.3.1 Selection of an appropriate method
6.6.4.3.2 Manual cleaning
6.6.4.3.3 Mechanical cleaning and disinfection
6.6.4.4 Cleaning procedures [Go to Page]
6.6.4.4.1 Instruments
6.6.4.4.2 Devices with lumens
6.6.5 Rinsing
6.6.6 Drying, inspection, and verification of the cleaning process
6.6.7 Microbicidal processes
6.7 Packaging
7 Using chemical sterilants/high-level disinfectants safely and effectively [Go to Page]
7.1 Introduction
7.2 General considerations [Go to Page]
7.2.1 Establishing policies and procedures
7.2.2 Manufacturers’ written IFU [Go to Page]
7.2.2.1 LCS/HLD manufacturer
7.2.2.2 Mechanical LCS/HLD equipment manufacturer
7.2.2.3 Gaseous chemical sterilization equipment manufacturer
7.2.3 Ensuring cleaning effectiveness [Go to Page]
7.2.3.1 Excess moisture
7.3 General safety considerations [Go to Page]
7.3.1 Introduction
7.3.2 Emergency procedures [Go to Page]
7.3.2.1 Spill containment team
7.3.2.2 Spill containment plan
7.4 Liquid chemical sterilants/high-level disinfectants [Go to Page]
7.4.1 General considerations
7.4.2 Relationship between LCSs and HLDs
7.4.3 Single vs. multi-use
7.4.4 Consideration for selection [Go to Page]
7.4.4.1 General considerations
7.4.4.2 Process parameters
7.4.4.3 Water quality for dilution and rinsing
7.4.4.4 Containers used for solution storage
7.4.4.5 Monitoring of LCS/HLD
8 Device storage and transport [Go to Page]
8.1 General rationale
8.2 Devices processed with LCSs/HLDs
8.3 Devices processed with gaseous chemical sterilants
9 Quality control [Go to Page]
9.1 General rationale
9.2 Product identification and traceability [Go to Page]
9.2.1 Lot control numbers
9.2.2 Cycle documentation and record-keeping
9.2.3 Expiration dating
9.3 Monitoring manual processes that use LCSs/HLDs [Go to Page]
9.3.1 General considerations
9.3.2 Use of physical monitors
9.3.3 Solution test strips and chemical monitoring devices [Go to Page]
9.3.3.1 General
9.3.3.2 Using solution test strips and chemical monitoring devices
9.3.3.3 Frequency of use
9.3.3.4 Interpretation
9.3.3.5 Inadequate processing
9.4 Monitoring automated processes that use LCSs/HLDs [Go to Page]
9.4.1 General considerations
9.4.2 Use of physical monitors and process monitoring devices
9.4.3 Automated processing equipment malfunction
9.4.4 Inadequate processing
9.5 Monitoring gaseous chemical sterilization processes [Go to Page]
9.5.1 Use of physical monitors
9.5.2 Gaseous chemical sterilizer malfunction
9.5.3 Chemical indicators [Go to Page]
9.5.3.1 General considerations
9.5.3.2 Using chemical indicators
9.5.3.3 Nonresponsive or inconclusive chemical indicators
9.5.4 Biological indicators [Go to Page]
9.5.4.1 General considerations
9.5.4.2 Using biological indicators and process challenge devices
9.5.4.3 Frequency of use of biological indicators and process challenge devices
9.5.4.4 Sterilizer qualification testing [Go to Page]
9.5.4.4.1 General considerations
9.5.4.4.2 Qualification test procedure with BIs
9.5.4.4.3 Acceptance criteria
9.5.4.5 Routine testing [Go to Page]
9.5.4.5.1 Technical information
9.5.4.5.2 Routine test procedure with BIs
9.5.4.5.3 Acceptance criteria
9.5.4.6 Positive biological indicator results
9.5.4.7 Microbiological testing
9.6 Product release
9.7 Product testing [Go to Page]
9.7.1 General considerations
9.7.2 Gaseous chemical sterilization processes
9.7.3 LCS/HLD automated processing equipment
9.8 Product recalls [Go to Page]
9.8.1 General considerations
9.8.2 Recall procedure
9.8.3 Recall order
9.8.4 Recall summary report
9.8.5 Outbreak report
10 Quality process improvement [Go to Page]
10.1 General rationale
10.2 Quality process [Go to Page]
10.2.1 General considerations
10.2.2 Risk analysis
10.2.3 Decontamination
10.2.4 Liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization
10.3 Functional areas for product and process improvement [Go to Page]
10.3.1 Workplace design
10.3.2 Processing policies and procedures
10.3.3 Product use
10.4 Implementation of product and process improvements
Annex A Microbial lethality, materials compatibility, and toxicity [Go to Page]
A.1 Introduction
A.2 Microbial lethality
A.3 Materials compatibility [Go to Page]
A.3.1 General considerations
A.3.2 Effects on polymeric materials
A.3.3 Effects on metals
A.3.4 Conclusion
A.4 Toxicity
Annex B Glutaraldehyde solutions [Go to Page]
B.1 Introduction
B.2 Properties and applications of glutaraldehyde
B.3 Effective use of glutaraldehyde
B.4 Safe use of glutaraldehyde [Go to Page]
B.4.1 Occupational exposure [Go to Page]
B.4.1.1 General considerations
B.4.1.2 Health effects of glutaraldehyde
B.4.1.2.1 Potential health effects of short-term exposure
B.4.1.2.2 Potential health effects of long-term exposure
B.4.1.3 Occupational exposure limits
B.4.1.4 Personal protective equipment and first aid
B.4.1.4.1 Eye protection
B.4.1.4.2 Skin protection
B.4.1.4.3 Respiratory protection
B.4.2 Ventilation
B.4.3 Preparing activated solutions
B.4.4 Pouring activated solutions
B.4.5 Transporting solutions
B.4.6 Storing activated and unused solutions
B.4.7 Immersing items to be high-level disinfected or sterilized
B.4.8 Rinsing high-level-disinfected or sterile items
B.5 Procedures for cleaning up glutaraldehyde spills [Go to Page]
B.5.1 General considerations
B.5.2 Deactivating chemicals
B.5.3 Drips and splashes
B.5.4 Large spills
B.6 Disposal of glutaraldehyde solutions
Annex C Hydrogen peroxide solutions [Go to Page]
C.1 Introduction
C.2 Properties and applications of hydrogen peroxide
C.3 Effective use of hydrogen peroxide solutions
C.4 Safe use of hydrogen peroxide solutions [Go to Page]
C.4.1 Occupational exposure [Go to Page]
C.4.1.1 General considerations
C.4.1.2 Health effects of hydrogen peroxide
C.4.1.2.1 Potential health effects of short-term exposure
C.4.1.2.2 Potential health effects of long-term exposure
C.4.1.3 Occupational exposure limits
C.4.1.4 Personal protective equipment and first aid
C.4.1.4.1 Eye protection
C.4.1.4.2 Skin protection
C.4.1.4.3 Respiratory protection
C.4.2 Ventilation
C.4.3 Pouring solutions
C.4.4 Transporting solutions
C.4.5 Storing unused solutions
C.4.6 Immersing items to be high-level disinfected or sterilized
C.4.7 Rinsing disinfected or sterile items
C.5 Hydrogen peroxide spills
C.6 Disposal of hydrogen peroxide solutions
C.7 Vapor monitoring
Annex D Ortho-phthalaldehyde solutions [Go to Page]
D.1 Introduction
D.2 Properties and applications of OPA
D.3 Effective use of OPA
D.4 Safe use of OPA [Go to Page]
D.4.1 Occupational exposure [Go to Page]
D.4.1.1 General considerations
D.4.1.2 Health effects of OPA
D.4.1.2.1 Potential health effects of short-term exposure
D.4.1.2.2 Potential health effects of long-term exposure
D.4.1.3 Occupational exposure limits
D.4.1.4 Personal protective equipment and first aid
D.4.1.4.1 Eye protection
D.4.1.4.2 Skin protection
D.4.1.4.3 Respiratory protection
D.4.2 Ventilation
D.4.3 Pouring solutions
D.4.4 Transporting solutions
D.4.5 Storing opened solutions
D.4.6 Immersing items to be high-level disinfected
D.4.7 Rinsing disinfected items
D.5 OPA spills
D.6 Disposal of OPA solutions
D.7 Vapor monitoring
Annex E Peracetic acid–hydrogen peroxide solutions [Go to Page]
E.1 Introduction
E.2 Properties and applications of peracetic acid–hydrogen peroxide solutions
E.3 Effective use of peracetic acidhydrogen peroxide solutions
E.4 Safe use of peracetic acid–hydrogen peroxide solutions [Go to Page]
E.4.1 Occupational exposure [Go to Page]
E.4.1.1 General considerations
E.4.1.2 Health effects of peracetic acid and hydrogen peroxide
E.4.1.2.1 Potential health effects of short-term exposure
E.4.1.2.2 Potential health effects of long-term exposure
E.4.1.3 Occupational exposure limits
E.4.1.4 Personal protective equipment and first aid
E.4.1.4.1 Eye protection
E.4.1.4.2 Skin protection
E.4.1.4.3 Respiratory protection
E.4.2 Ventilation
E.4.3 Pouring solutions
E.4.4 Transporting solutions
E.4.5 Storing solutions
E.4.6 Immersing items to be high-level disinfected or sterilized [Go to Page]
E.4.7 Rinsing disinfected or sterile items
E.4.8 Transport and storage of processed devices
E.5 Peracetic acid–hydrogen peroxide spills
E.6 Disposal of peracetic acid–hydrogen peroxide solutions
E.7 Vapor monitoring
Annex F Sodium hypochlorite solutions [Go to Page]
F.1 Introduction
F.2 Properties and applications of sodium hypochlorite solutions
F.3 Effective use of sodium hypochlorite solutions
F.4 Safe use of sodium hypochlorite solutions [Go to Page]
F.4.1 Occupational exposure [Go to Page]
F.4.1.1 General considerations
F.4.1.2 Health effects of sodium hypochlorite
F.4.1.2.1 Potential health effects of short-term exposure
F.4.1.2.2 Potential health effects of long-term health exposure
F.4.1.3 Occupational exposure limits
F.4.1.4 Personal protective equipment and first aid
F.4.1.4.1 Eye protection
F.4.1.4.2 Skin protection
F.4.1.4.3 Respiratory protection
F.4.2 Ventilation
F.4.3 Pouring solutions
F.4.4 Transporting solutions
F.4.5 Storing solutions
F.4.6 Immersing items to be high-level disinfected or sterilized
F.4.7 Rinsing disinfected or sterile items
F.4.8 Transport and storage of processed devices
F.5 Sodium hypochlorite spills
F.6 Disposal of sodium hypochlorite solutions
F.7 Vapor monitoring
Annex G Chemical vapor sterilants using alcohol and formaldehyde [Go to Page]
G.1 Introduction
G.2 Properties and applications of chemical vapor sterilants
G.3 Effective use of chemical vapor sterilizers
G.4 Safe use of chemical vapor sterilizers [Go to Page]
G.4.1 Occupational exposure [Go to Page]
G.4.1.1 General considerations
G.4.1.2 Health effects of formaldehyde and alcohol
G.4.1.2.1 Potential health effects of short-term exposure
G.4.1.2.2 Potential health effects of long-term health exposure
G.4.1.3 Occupational exposure limits
G.4.1.4 Personal protective equipment and first aid
G.4.1.4.1 Eye protection
G.4.1.4.2 Skin protection
G.4.1.4.3 Respiratory protection
G.4.2 Ventilation
G.4.3 Safety guidelines
G.5 Chemical vapor spills
G.6 Disposal of chemical vapor sterilants
G.7 Vapor monitoring
Annex H Hydrogen peroxide gas sterilization [Go to Page]
H.1 Introduction
H.2 Properties and applications of hydrogen peroxide gas sterilization systems
H.3 Effective use of hydrogen peroxide gas sterilizers
H.4 Safe use of hydrogen peroxide gas sterilizers [Go to Page]
H.4.1 Occupational exposure [Go to Page]
H.4.1.1 General considerations
H.4.1.2 Health effects of hydrogen peroxide
H.4.1.2.1 Potential health effects of short-term exposure
H.4.1.2.2 Potential health effects of long-term exposure
H.4.1.3 Occupational exposure limits
H.4.1.4 Personal protective equipment and first aid
H.4.1.4.1 Eye protection
H.4.1.4.2 Skin protection
H.4.1.4.3 Respiratory protection
H.4.2 Ventilation
H.4.3 Safety guidelines
H.5 Spills
H.6 Sterilant disposal
H.7 Vapor monitoring
Annex I Ozone sterilization [Go to Page]
I.1 Introduction
I.2 Properties and applications of ozone as a sterilant
I.3 Effective use of ozone sterilizers
I.4 Safe use of ozone sterilizers [Go to Page]
I.4.1 Occupational exposure [Go to Page]
I.4.1.1 General considerations
I.4.1.2 Health effects of ozone
I.4.1.2.1 Potential health effects of short-term exposure
I.4.1.2.2 Potential health effects of long-term exposure
I.4.1.3 Occupational exposure limits
I.4.1.4 Personal protective equipment and first aid
I.4.1.4.1 Eye protection
I.4.1.4.2 Skin protection
I.4.1.4.3 Respiratory protection
I.4.2 Ventilation
I.4.3 Safety guidelines
I.5 Spills and leaks
I.6 Sterilant disposal
I.7 Vapor monitoring
Annex J Government regulation [Go to Page]
J.1 Introduction
J.2 FDA regulation of medical devices [Go to Page]
J.2.1 Statutory authority
J.2.2 FDA regulatory classification of medical devices [Go to Page]
J.2.2.1 Classification process
J.2.2.2 Class I devices
J.2.2.3 Class II devices
J.2.2.4 Class III devices
J.3 History of FDA regulation of LCSs/HLDs
J.4 Current FDA regulation of LCSs/HLDs [Go to Page]
J.4.1 Premarket notification submissions
J.4.2 Labeling
J.5 FDA medical device reporting (MDR) regulation
J.6 OSHA regulation of chemical sterilants/high-level disinfectants [Go to Page]
J.6.1 General
J.6.2 Occupational exposure limits
J.6.3 Safety Data Sheets
J.6.4 OSHA area offices, regional offices, state-plan offices, and consultation project state directory
J.7 State and local regulations
Annex K Occupational exposure to bloodborne pathogens (29 CFR Part 1910.1030) [Go to Page]
§1910.1030 Bloodborne pathogens
Annex L User verification of cleaning processes [Go to Page]
L.1 General considerations
L.2 Markers
L.3 Cleaning verification tests for users
Annex M Example of documentation of premature release of implants
Annex N Gas and vapor monitoring [Go to Page]
N.1 General considerations
N.2 Instrumentation [Go to Page]
N.2.1 Monitoring methods [Go to Page]
N.2.2 Reliability and use of instrumentation
N.3 Procedures [Go to Page]
N.3.1 Monitoring sites
N.3.2 Frequency of monitoring
N.3.3 Time-weighted average and ceiling exposures
N.3.4 Record-keeping
N.4 Selecting vapor-monitoring equipment or services [Go to Page]
N.4.1 General considerations
N.4.2 Personal and area monitoring
N.4.3 Personal monitoring
N.4.4 Area monitoring
N.4.5 Devices available for vapor monitoring [Go to Page]
N.4.5.1 Characteristics and ratings of air monitoring devices
N.4.5.2 Diffusion and sample-draw continuous monitors
N.4.5.3 Active sampling devices
N.4.5.4 Passive sampling devices
N.4.5.5 Questions that should be asked of monitoring device manufacturers
N.5 Contracted services [Go to Page]
N.5.1 General considerations
N.5.2 Finding contract service organizations
N.5.3 Selection criteria
Annex O Bibliography [Go to Page]
O.1 Cited references
O.2 For further reading [Go to Page]

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