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ANSI/AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities >
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ANSI/AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities, 2024
- ANSI/AAMI ST58:2024; Chemical sterilization and high-level disinfection in health care facilities
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- 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 considerations
- 3.2 Processing area [Go to Page]
- 3.2.1 Environmental cleaning [Go to Page]
- 3.2.1.1 Area design
- 3.2.1.2 Housekeeping
- 3.2.1.3 Cleaning schedule
- 3.2.2 Storage of chemical sterilants/high-level disinfectants
- 3.2.3 Disposal of chemical sterilant/high-level disinfectant
- 3.2.4 Disposal of chemical solution containers
- 3.3 Traffic control
- 3.4 Utilities [Go to Page]
- 3.4.1 Mechanical systems
- 3.4.2 Electrical systems
- 3.4.3 Water
- 3.4.4 Heating, ventilation, and air conditioning (HVAC) operating parameters
- 3.4.5 Lighting
- 3.4.6 Hand hygiene
- 3.4.7 Emergency eyewash/shower equipment
- 3.4.8 Spill kit
- 3.4.9 Ventilation systems [Go to Page]
- 3.4.9.1 General considerations
- 3.4.9.2 Room ventilation
- 3.4.10 Local exhaust ventilation
- 3.5 Automated processing equipment for liquid chemical sterilants/high-level disinfectants [Go to Page]
- 3.5.1 Selection of equipment
- 3.5.2 Equipment location
- 3.5.3 Installation
- 3.6 Gaseous chemical sterilizer equipment [Go to Page]
- 3.6.1 Selection of equipment
- 3.6.2 Installation [Go to Page]
- 3.6.2.1 Regulatory requirements
- 3.6.2.2 Manufacturer’s instructions
- 3.6.2.3 Equipment location
- 3.6.3 Installation testing [Go to Page]
- 3.6.3.1 Sterilizers
- 3.6.3.2 Emission control and ventilation systems
- 4 Personnel considerations [Go to Page]
- 4.1 General considerations
- 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 Equipment Service personnel [Go to Page]
- 4.3.2.1 Equipment service personnel working with ethylene oxide
- 4.3.3 Other personnel
- 4.4 Personal protective equipment [Go to Page]
- 4.4.1 General considerations
- 4.4.2 Eye protection for chemical safety (liquid)
- 4.4.3 Skin protection (liquid)
- 4.4.4 Respiratory protection
- 4.5 Health and personal hygiene
- 5 Decontamination and preparation of medical devices [Go to Page]
- 5.1 General considerations
- 5.2 Receiving [Go to Page]
- 5.2.1 Receiving of purchased, repaired and loaned items [Go to Page]
- 5.2.1.1 General considerations
- 5.2.1.2 Newly purchased reusable items and repaired and loaned reusable items
- 5.2.2 Disposition of sterile items [Go to Page]
- 5.2.2.1 Items issued but not used
- 5.2.2.2 Items opened but not used
- 5.3 Handling, collection, and transport of contaminated items [Go to Page]
- 5.3.1 General considerations
- 5.3.2 Separation of waste and reusable items at point of use
- 5.3.3 Point-of-use treatment of contaminated reusable items [Go to Page]
- 5.3.3.1 General handling of medical devices during and after surgical procedure
- 5.3.3.2 Removal of gross soil at point-of-use
- 5.3.3.3 Disassembly of instruments
- 5.3.3.4 Prevention of medical device damage and contamination
- 5.3.4 Containment
- 5.3.5 Communication
- 5.3.6 Transport [Go to Page]
- 5.3.6.1 Segregation of clean/sterile items
- 5.3.6.2 Transportation scheduling and routes
- 5.3.6.3 Transportation equipment
- 5.3.6.4 Hand transport
- 5.3.6.5 Dedicated lifts
- 5.3.6.6 Transport between buildings
- 5.3.6.7 Off-site transportation
- 5.4 Cleaning and other decontamination processes [Go to Page]
- 5.4.1 General considerations
- 5.4.2 Policies and procedures
- 5.4.3 Manufacturer’s written IFU
- 5.4.4 Decontamination [Go to Page]
- 5.4.4.1 Special Considerations [Go to Page]
- 5.4.4.1.1 Reusable textiles
- 5.4.4.1.2 Medical device lubricants
- 5.4.5 Preparation for cleaning [Go to Page]
- 5.4.5.1 Presoaking
- 5.4.5.2 Sorting and disassembly [Go to Page]
- 5.4.5.2.1 General considerations
- 5.4.5.2.2 Rigid sterilization container systems [Go to Page]
- 5.4.5.2.2.1 General considerations
- 5.4.5.2.2.2 Removable filters
- 5.4.5.2.2.3 Interior baskets
- 5.4.5.2.2.4 Process indicators, disposable labels, and disposable locks
- 5.4.5.2.2.5 Container accessories
- 5.4.6 Cleaning [Go to Page]
- 5.4.6.1 General considerations
- 5.4.6.2 Cleaning agents
- 5.4.6.3 Methods of cleaning [Go to Page]
- 5.4.6.3.1 Selection of an appropriate method
- 5.4.6.3.2 Manual cleaning
- 5.4.6.3.3 Mechanical cleaning [Go to Page]
- 5.4.6.3.3.1 General considerations
- 5.4.6.3.3.2 Maintenance of mechanical cleaning and disinfection equipment
- 5.4.6.3.3.3 Selection of mechanical cleaning and disinfection equipment
- 5.4.6.3.3.4 Loading mechanical cleaning and disinfection equipment
- 5.4.6.3.3.5 Unloading mechanical cleaning and disinfection equipment
- 5.4.6.3.4 Ultrasonic cleaning equipment [Go to Page]
- 5.4.6.3.4.1 General considerations
- 5.4.6.3.4.2 Loading ultrasonic cleaning equipment
- 5.4.6.3.4.3 Unloading ultrasonic cleaning equipment
- 5.4.7 Inspection and verification of the cleaning process
- 5.4.8 Excess Moisture
- 6 Safe and effective use of liquid chemical sterilants/high-level disinfectants and equipment [Go to Page]
- 6.1 General considerations [Go to Page]
- 6.1.1 Safety considerations [Go to Page]
- 6.1.1.1 General considerations
- 6.1.1.2 Emergency procedures [Go to Page]
- 6.1.1.2.1 Spill containment team
- 6.1.1.2.2 Spill containment plan
- 6.1.2 Liquid chemical sterilants/high-level disinfectant selection and use [Go to Page]
- 6.1.2.1 General considerations [Go to Page]
- 6.1.2.1.1 Single-use solutions vs. reusable solutions
- 6.1.3 Consideration for selection [Go to Page]
- 6.1.3.1 General considerations
- 6.1.3.2 Process parameters
- 6.1.3.3 Water quality for dilution and rinsing
- 6.1.3.4 Containers used for solution storage
- 6.1.3.5 Monitoring of LCS/HLD
- 6.2 LCS/HLD types
- 6.3 Manufacturer’s instructions/IFU [Go to Page]
- 6.3.1 LCS/HLD manufacturer’s written IFU
- 6.3.2 Automated processing equipment manufacturer’s written IFU
- 6.4 Maintenance
- 6.5 Processing and post-processing considerations after liquid chemical disinfection or high-level disinfection [Go to Page]
- 6.5.1 Manual high-level disinfection and liquid chemical sterilization processes [Go to Page]
- 6.5.1.1 Manual rinsing
- 6.5.2 Considerations after processing [Go to Page]
- 6.5.2.1 Removing devices from HLD equipment and delivery to point of use
- 6.5.2.2 Drying after liquid chemical sterilization or high-level disinfection
- 6.5.2.3 Labelling of LCS/HLD items after processing
- 6.5.2.4 Storage post Liquid chemical sterilization or high-level disinfection
- 7 Safe and effective use of gaseous chemical sterilizers [Go to Page]
- 7.1 General considerations [Go to Page]
- 7.1.1 Safety considerations [Go to Page]
- 7.1.1.1 General considerations
- 7.1.1.2 Emergency procedures [Go to Page]
- 7.1.1.2.1 Spill containment team
- 7.1.1.2.2 Spill containment plan
- 7.2 Gaseous chemical sterilization types
- 7.3 Manufacturer’s Instructions/IFU
- 7.4 Sterilizer Maintenance [Go to Page]
- 7.4.1 Manufacturer’s instructions
- 7.4.2 Routine care of sterilizers
- 7.4.3 Preventive maintenance [Go to Page]
- 7.4.3.1 General considerations
- 7.4.3.2 Scheduled maintenance
- 7.4.3.3 Calibration
- 7.4.3.4 Emission control systems
- 7.4.3.5 Record keeping
- 7.5 Packaging, preparation and sterilization [Go to Page]
- 7.5.1 Selection of sterile barrier systems
- 7.5.2 Rigid container inspection
- 7.5.3 Post-process handling of devices processed with gaseous chemical sterilants
- 8 Quality control [Go to Page]
- 8.1 General considerations
- 8.2 Monitoring of mechanical cleaning equipment
- 8.3 Verification and monitoring of the cleaning process [Go to Page]
- 8.3.1 General considerations
- 8.3.2 Visual inspection after manual cleaning
- 8.3.3 Cleaning verification test for users
- 8.3.4 Testing cleaning efficacy
- 8.3.5 Product identification and traceability [Go to Page]
- 8.3.5.1 Lot control numbers
- 8.3.6 Cycle documentation and record-keeping [Go to Page]
- 8.3.6.1 High-level disinfection cycle
- 8.3.6.2 Gaseous chemical sterilization cycle
- 8.3.7 Expiration dating
- 8.4 Monitoring manual processes that use LCSs/HLDs [Go to Page]
- 8.4.1 General considerations
- 8.4.2 Use of physical monitors
- 8.4.3 Solution test strips and chemical monitoring devices [Go to Page]
- 8.4.3.1 General considerations
- 8.4.3.2 Using solution test strips and chemical monitoring devices
- 8.4.3.3 Frequency of use
- 8.4.3.4 Interpretation
- 8.4.3.5 Inadequate concentration level
- 8.5 Monitoring automated processes that use LCSs/HLDs [Go to Page]
- 8.5.1 General considerations
- 8.5.2 Physical monitors
- 8.5.3 Use of physical monitors and process monitoring devices
- 8.5.4 Automated processing equipment malfunction
- 8.5.5 Inadequate processing
- 8.6 Monitoring gaseous chemical sterilization processes [Go to Page]
- 8.6.1 General Considerations
- 8.6.2 Use of physical monitors
- 8.6.3 Gaseous chemical sterilizer malfunction
- 8.6.4 Chemical indicators [Go to Page]
- 8.6.4.1 General considerations
- 8.6.4.2 Using chemical indicators
- 8.6.4.3 Nonresponsive or inconclusive chemical indicators
- 8.6.5 Biological indicators and process challenge devices [Go to Page]
- 8.6.5.1 General considerations
- 8.6.5.2 Using biological indicators and process challenge devices
- 8.6.5.3 Frequency of use of biological indicators and process challenge devices
- 8.6.5.4 Routine efficacy testing [Go to Page]
- 8.6.5.4.1 Routine efficacy test procedure with BIs
- 8.6.5.4.2 Acceptance criteria
- 8.6.5.5 Sterilizer qualification testing [Go to Page]
- 8.6.5.5.1 General considerations
- 8.6.5.5.2 Sterilizer qualification test procedure with BIs
- 8.6.5.5.3 Acceptance criteria
- 8.6.5.6 Actions to take when BIs, CIs, or physical monitors/indicators indicate a sterilization process failure
- 8.6.6 Process challenge devices
- 8.7 Product release
- 8.8 Product testing [Go to Page]
- 8.8.1 General considerations
- 8.8.2 Product testing for gaseous chemical sterilization processes
- 8.8.3 Product testing for LCS/HLD automated processes
- 8.9 Product recalls [Go to Page]
- 8.9.1 General considerations
- 8.9.2 Recall procedure
- 8.9.3 Recall order
- 8.9.4 Recall summary report
- 8.9.5 Outbreak report
- 9 Quality process improvement [Go to Page]
- 9.1 General rationale
- 9.2 Quality process [Go to Page]
- 9.2.1 General considerations
- 9.2.2 Risk analysis
- 9.2.3 Decontamination
- 9.2.4 Liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization
- 9.3 Functional areas for product and process improvement [Go to Page]
- 9.3.1 Workplace design
- 9.3.2 Processing policies and procedures
- 9.3.3 Product use
- 9.4 Implementation of product and process improvements
- Annex A (informative) 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 (informative) Selection of liquid and gaseous chemical sterilants/ high-level disinfectants [Go to Page]
- B.1 Introduction
- B.2 Categories of items to be disinfected or sterilized
- B.3 LCS/HLD types
- B.4 Gaseous chemical sterilization types
- B.5 Activity levels of disinfectants
- B.6 Labeling of disinfectant products
- B.7 Criteria for selecting LCS/HLD and gaseous chemical sterilants
- B.8 Factors to consider in chemical disinfection and gaseous chemical sterilization
- B.9 General considerations and selection criteria [Go to Page]
- B.9.1 Health and safety considerations
- B.9.2 Effectiveness
- B.9.3 Materials compatibility
- B.9.4 Cost-effectiveness
- B.9.5 Rigid sterilization container systems
- Annex C (normative) Glutaraldehyde solutions [Go to Page]
- C.1 Introduction
- C.2 Properties and applications of glutaraldehyde
- C.3 Effective use of glutaraldehyde
- C.4 Safe use of glutaraldehyde [Go to Page]
- C.4.1 Occupational exposure [Go to Page]
- C.4.1.1 General considerations
- C.4.1.2 Health effects of glutaraldehyde [Go to Page]
- 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 [Go to Page]
- C.4.1.4.1 Eye protection
- C.4.1.4.2 Skin protection
- C.4.2 Ventilation
- C.4.3 Preparing activated solutions
- C.4.4 Pouring activated solutions
- C.4.5 Transporting solutions
- C.4.6 Storing activated and unused solutions
- C.4.7 Immersing items to be high-level disinfected or sterilized
- C.4.8 Rinsing high-level-disinfected or sterile items
- C.5 Procedures for cleaning up glutaraldehyde spills [Go to Page]
- C.5.1 General considerations
- C.5.2 Deactivating chemicals
- C.5.3 Drips and splashes
- C.5.4 Large spills
- C.6 Disposal of glutaraldehyde solutions
- Annex D (normative) Hydrogen peroxide solutions [Go to Page]
- D.1 Introduction
- D.2 Properties and applications of hydrogen peroxide
- D.3 Effective use of hydrogen peroxide solutions
- D.4 Safe use of hydrogen peroxide solutions [Go to Page]
- D.4.1 Occupational exposure [Go to Page]
- D.4.1.1 General considerations
- D.4.1.2 Health effects of hydrogen peroxide [Go to Page]
- 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 [Go to Page]
- D.4.1.4.1 Eye protection
- D.4.1.4.2 Skin protection
- D.4.2 Ventilation
- D.4.3 Pouring solutions
- D.4.4 Transporting solutions
- D.4.5 Storing unused solutions
- D.4.6 Immersing items to be high-level disinfected or sterilized
- D.4.7 Rinsing disinfected or sterile items
- D.5 Hydrogen peroxide spills
- D.6 Disposal of hydrogen peroxide solutions
- D.7 Vapor monitoring
- Annex E (normative) Ortho-phthalaldehyde solutions [Go to Page]
- E.1 Introduction
- E.2 Properties and applications of OPA
- E.3 Effective use of OPA
- E.4 Safe use of OPA [Go to Page]
- E.4.1 Occupational exposure [Go to Page]
- E.4.1.1 General considerations
- E.4.1.2 Health effects of OPA [Go to Page]
- 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 [Go to Page]
- E.4.1.4.1 Eye protection
- E.4.1.4.2 Skin protection
- E.4.2 Ventilation
- E.4.3 Pouring solutions
- E.4.4 Transporting solutions
- E.4.5 Storing opened solutions
- E.4.6 Immersing items to be high-level disinfected
- E.4.7 Rinsing disinfected items
- E.5 OPA spills
- E.6 Disposal of OPA solutions
- E.7 Vapor monitoring
- Annex F (normative) Peracetic acid–hydrogen peroxide solutions [Go to Page]
- F.1 Introduction
- F.2 Properties and applications of peracetic acid–hydrogen peroxide solutions
- F.3 Effective use of peracetic acidhydrogen peroxide solutions
- F.4 Safe use of peracetic acid–hydrogen peroxide 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 peracetic acid and hydrogen peroxide [Go to Page]
- F.4.1.2.1 Potential health effects of short-term exposure
- F.4.1.2.2 Potential health effects of long-term exposure
- F.4.1.3 Occupational exposure limits
- F.4.1.4 Personal protective equipment and first aid [Go to Page]
- F.4.1.4.1 Eye protection
- F.4.1.4.2 Skin 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 Peracetic acid–hydrogen peroxide spills
- F.6 Disposal of peracetic acid–hydrogen peroxide solutions
- F.7 Vapor monitoring
- Annex G (normative) Sodium hypochlorite solutions [Go to Page]
- G.1 Introduction
- G.2 Properties and applications of sodium hypochlorite solutions
- G.3 Effective use of sodium hypochlorite solutions
- G.4 Safe use of sodium hypochlorite solutions [Go to Page]
- G.4.1 Occupational exposure [Go to Page]
- G.4.1.1 General considerations
- G.4.1.2 Health effects of sodium hypochlorite [Go to Page]
- 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 [Go to Page]
- 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 Pouring solutions
- G.4.4 Transporting solutions
- G.4.5 Storing solutions
- G.4.6 Immersing items to be high-level disinfected or sterilized
- G.4.7 Rinsing disinfected or sterile items
- G.4.8 Transport and storage of processed devices
- G.5 Sodium hypochlorite spills
- G.6 Disposal of sodium hypochlorite solutions
- G.7 Vapor monitoring
- Annex H (normative) Chemical vapor sterilants using alcohol and formaldehyde [Go to Page]
- H.1 Introduction
- H.2 Properties and applications of chemical vapor sterilants
- H.3 Effective use of chemical vapor sterilizers
- H.4 Safe use of chemical vapor 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 formaldehyde and alcohol [Go to Page]
- H.4.1.2.1 Potential health effects of short-term exposure
- H.4.1.2.2 Potential health effects of long-term health exposure
- H.4.1.3 Occupational exposure limits
- H.4.1.4 Personal protective equipment and first aid [Go to Page]
- 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 Chemical vapor spills
- H.6 Disposal of chemical vapor sterilants
- H.7 Vapor monitoring
- Annex I (normative) Vaporized hydrogen peroxide sterilization [Go to Page]
- I.1 Introduction
- I.2 Properties and applications of vaporized hydrogen peroxide sterilization systems
- I.3 Effective use of vaporized hydrogen peroxide sterilizers
- I.4 Safe use of vaporized hydrogen peroxide 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 hydrogen peroxide [Go to Page]
- 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 [Go to Page]
- 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
- I.6 Sterilant disposal
- I.7 Vapor monitoring
- Annex J (normative) Hydrogen peroxide-ozone sterilization [Go to Page]
- J.1 Introduction
- J.2 Properties and applications of hydrogen peroxide-ozone gas sterilization systems
- J.3 Effective use of hydrogen peroxide-ozone gas sterilization
- J.4 Safe use of hydrogen peroxide-ozone gas sterilizer [Go to Page]
- J.4.1 Occupational exposure [Go to Page]
- J.4.1.1 General considerations
- J.4.1.2 Health effects of hydrogen peroxide [Go to Page]
- J.4.1.2.1 Potential health effects of short-term exposure
- J.4.1.2.2 Potential health effect of long-term exposure
- J.4.1.3 Health effects of ozone [Go to Page]
- J.4.1.3.1 Potential health effects of short-term exposure
- J.4.1.3.2 Potential health effects of long-term exposure
- J.4.1.4 Occupational exposure limits [Go to Page]
- J.4.1.4.1 Hydrogen peroxide
- J.4.1.4.2 Ozone
- J.4.1.5 Personal protective equipment and first aid [Go to Page]
- J.4.1.5.1 Eye protection
- J.4.1.5.2 Skin protection
- J.4.1.5.3 Respiratory protection
- J.4.1.6 Ventilation
- J.4.1.7 Safety guidelines
- J.5 Spills
- J.6 Sterilant disposal
- J.7 Vapor monitoring
- Annex K (informative) Sonicated hydrogen peroxide mist [Go to Page]
- K.1 Introduction
- K.2 Properties and applications of sonicated hydrogen peroxide mist
- K.3 Effective use of sonicated hydrogen peroxide mist
- K.4 Safe use of sonicated hydrogen peroxide mist [Go to Page]
- K.4.1 Occupational exposure [Go to Page]
- K.4.1.1 General considerations
- K.4.1.2 Health effects of sonicated hydrogen peroxide mist [Go to Page]
- K.4.1.2.1 Potential health effects of short-term exposure
- K.4.1.2.2 Potential health effects of long-term exposure
- K.4.1.3 Occupational exposure limits
- K.4.1.4 Personal protective equipment and first aid [Go to Page]
- K.4.1.4.1 Eye protection
- K.4.1.4.2 Skin protection
- K.4.1.4.3 Respiratory protection
- K.4.2 Ventilation
- K.4.3 Safety guidelines
- K.5 Hydrogen peroxide spills and leaks
- Annex L (informative) Government regulation [Go to Page]
- L.1 Introduction
- L.2 FDA regulation of medical devices
- L.3 History of FDA regulation of LCSs/HLDs
- L.4 Current FDA regulation of LCSs/HLDs [Go to Page]
- L.4.1 Premarket notification submissions
- L.4.2 Labeling
- L.5 FDA medical device reporting (MDR) regulation
- L.6 OSHA regulation of chemical sterilants/high-level disinfectants [Go to Page]
- L.6.1 General
- L.6.2 Occupational exposure limits
- L.6.3 Safety Data Sheets
- L.6.4 OSHA area offices, regional offices, state-plan offices, and consultation project state directory
- L.6.5 OSHA standard for occupational exposure to ethylene oxide
- L.7 State and local regulations
- Annex M (informative) Development of a prepurchase evaluation protocol for rigid sterilization container systems [Go to Page]
- M.1 Introduction [Go to Page]
- M.1.1
- M.1.2
- M.2 General considerations
- M.3 Instruments and devices to be containerized
- M.4 Cleaning and decontamination considerations
- M.5 Preparation and assembly considerations
- M.6 Matching the rigid sterilization container system and sterilization cycle
- M.7 Loading the sterilizer
- M.8 Choosing the appropriate exposure and drying times
- M.9 Unloading the sterilizer and cooling the load
- M.10 Sterility maintenance
- M.11 Sterile storage
- M.12 Transportation
- M.13 Aseptic presentation
- Annex N (informative) User verification of cleaning processes9F [Go to Page]
- N.1 General considerations
- N.2 Markers [Go to Page]
- N.2.1 ATP
- N.2.2 Protein
- N.2.3 Hemoglobin
- N.2.4 Carbohydrates
- N.3 Cleaning verification tests for users [Go to Page]
- N.3.1 Verification tests for ultrasonic cleaners
- N.3.2 Verification test for mechanical washers
- N.4 A program for verification of the efficacy of the manual cleaning during endoscope processing: An example
- Annex O (informative) Example of documentation of premature release of implants
- Annex P (informative) Gas and vapor monitoring [Go to Page]
- P.1 General considerations
- P.2 Instrumentation [Go to Page]
- P.2.1 Monitoring methods
- P.2.2 Reliability and use of instrumentation
- P.3 Procedures [Go to Page]
- P.3.1 Monitoring sites
- P.3.2 Frequency of monitoring
- P.3.3 Time-weighted average and ceiling exposures
- P.3.4 Record-keeping
- P.4 Selecting vapor-monitoring equipment or services [Go to Page]
- P.4.1 General considerations
- P.4.2 Personal and area monitoring
- P.4.3 Personal monitoring
- P.4.4 Area monitoring
- P.4.5 Devices available for gas or vapor monitoring [Go to Page]
- P.4.5.1 Characteristics and ratings of air monitoring devices
- P.4.5.2 Diffusion and sample-draw continuous monitors
- P.4.5.3 Active sampling devices
- P.4.5.4 Passive sampling devices
- P.4.5.5 Questions that should be asked of monitoring device manufacturers
- P.5 Contracted services [Go to Page]
- P.5.1 General considerations
- P.5.2 Finding contract service organizations
- P.5.3 Selection criteria
- Annex Q (informative) Infection transmission and standard precautions [Go to Page]
- Q.1 Introduction
- Q.2 Chain of infection [Go to Page]
- Q.2.1 Etiologic agent [Go to Page]
- Q.2.1.1 General
- Q.2.1.2 Pathogenicity
- Q.2.1.3 Dose
- Q.2.2 Reservoir
- Q.2.3 Portal of exit
- Q.2.4 Mode of transmission
- Q.2.5 Portal of entry
- Q.2.6 Susceptible host
- Q.3 Barrier protection and protective clothing
- Annex R (informative) General considerations for cleaning and disinfection [Go to Page]
- R.1 Introduction
- R.2 Mechanical (automated) cleaning and disinfection [Go to Page]
- R.2.1 General considerations
- R.2.2 Ultrasonic cleaning equipment [Go to Page]
- R.2.2.1 Overview
- R.2.2.2 Basic ultrasonic washers
- R.2.2.3 Ultrasonic irrigators
- R.2.2.4 Ultrasonic irrigator washers
- R.2.2.5 Ultrasonic irrigator washer–disinfectors
- R.2.3 Washer–pasteurizers
- R.2.4 Washer–disinfectors [Go to Page]
- R.2.4.1 Overview
- R.2.4.2 Single-chamber washer–disinfectors
- R.2.4.3 Multi-chamber washer–disinfectors
- R.2.4.4 Cart washers
- Annex S (normative) Considerations for ethylene oxide gas sterilization [Go to Page]
- S.1 Introducton
- S.2 Properties and applications of ethylene oxide gas sterilization
- S.3 Design considerations [Go to Page]
- S.3.1 General rationale for EO sterilization
- S.3.2 Centralization
- S.3.3 Ethylene oxide containment areas
- S.3.4 Routing of traffic
- S.3.5 EO Minimum room size
- S.4 Ventilation recommendations for areas housing EO sterilization [Go to Page]
- S.4.1 General considerations for EO sterilization
- S.4.2 Local exhaust ventilation [Go to Page]
- S.4.2.1 Local exhaust ventilation systems
- S.4.2.2 Local exhaust ventilation parameters
- S.4.2.3 Sites for local exhaust ventilation
- S.4.2.4 Location of exhaust hoods
- S.4.2.5 Exhaust source
- S.4.2.6 Exhaust ducts
- S.4.3 Ventilation system alarms
- S.4.4 General room ventilation [Go to Page]
- S.4.4.1 Ventilation parameters
- S.4.4.2 Air flow
- S.4.4.3 Air exchanges
- S.4.4.4 Ventilation monitoring
- S.4.5 Environmental discharge controls [Go to Page]
- S.4.5.1 Ethylene oxide
- S.4.5.2 General rationale
- S.4.6 Venting of EO sterilizers [Go to Page]
- S.4.6.1 General considerations
- S.4.6.2 Sterilizers venting to the outside atmosphere
- S.5 Occupational health [Go to Page]
- S.5.1 Information concerning the potential hazards of exposure to EO [Go to Page]
- S.5.1.1 General considerations
- S.5.1.2 Health effects of short-term exposure to EO
- S.5.1.3 Health effects of long-term exposure to EO
- S.5.1.4 Health effects of exposure to EO residuals
- S.5.2 Medical surveillance and treatment [Go to Page]
- S.5.2.1 Routine medical examinations
- S.5.2.2 Medical examinations for acute exposures
- S.5.2.3 Record keeping
- S.6 Packaging, preparation, and sterilization [Go to Page]
- S.6.1 EO General rationale [Go to Page]
- S.6.1.1 Effective use of ethylene oxide sterilizers
- S.6.2 Items suitable for EO sterilization
- S.6.3 Preconditioning (humidification)
- S.6.4 Packaging [Go to Page]
- S.6.4.1 Selection of packaging materials [Go to Page]
- S.6.4.1.1 Periodic product quality assurance testing of rigid sterilization container systems
- S.6.4.1.2 Package configurations and preparation [Go to Page]
- S.6.4.1.2.1 Package closures
- S.6.4.1.2.2 Package labels
- S.6.4.1.2.3 Package configurations
- S.6.4.2 Loading the sterilizer [Go to Page]
- S.6.4.2.1 Load composition
- S.6.4.2.2 Load configuration
- S.6.4.3 Sterilization parameters [Go to Page]
- S.6.4.3.1 General considerations
- S.6.4.3.2 Sterilizer manufacturer’s instructions
- S.6.4.3.3 Device and packaging manufacturers’ instructions
- S.7 Safely Unloading the sterilizer [Go to Page]
- S.7.1 Sterilizers with integral aeration
- S.7.2 Aeration times
- S.8 Storage and handling of EO gas sources [Go to Page]
- S.8.1 Storage of unit-dose containers of 100% EO
- S.8.2 Disposal of unit-dose containers of 100 % EO
- S.9 EO leaks and spills [Go to Page]
- S.9.1 General considerations
- S.9.2 Emergency team
- S.9.3 Emergency plan
- S.9.4 First aid [Go to Page]
- S.9.4.1 Liquid EO
- S.9.4.2 EO gas
- S.10 Quality control [Go to Page]
- S.10.1 EO sterilization qualification testing
- S.10.2 Simulated load and placement of the PCDs (challenge BI test packs) [Go to Page]
- S.10.2.1 EO sterilization qualification testing
- S.10.3 Routine sterilizer efficacy monitoring [Go to Page]
- S.10.3.1 Composition of an alternative(user assembled) EO PCD (routine BI test pack)
- S.10.3.2 Placement of the EO PCD (routine BI test pack)
- S.10.3.3 Test procedure
- S.10.4 Round-robin study of the PCD (routine BI test pack) [Go to Page]
- S.10.4.1 Introduction
- S.10.5 Materials and methods [Go to Page]
- S.10.5.1 Test strategy
- S.10.5.2 Test laboratories
- S.10.5.3 Sterilization equipment
- S.10.5.4 Test pack components and assembly
- S.10.5.5 Exposure conditions
- S.10.5.6 Test procedure
- S.10.5.7 Data collected
- S.10.6 Results
- S.11 Environmental and employee monitoring [Go to Page]
- S.11.1 General rationale
- S.11.2 Instrumentation [Go to Page]
- S.11.2.1 Selection of monitoring methods
- S.11.2.2 Reliability and use of instrumentation
- S.11.3 Procedures [Go to Page]
- S.11.3.1 Monitoring sites
- S.11.3.2 Frequency of monitoring
- S.11.3.3 Short-term exposures
- S.11.4 Record keeping
- S.12 Selecting equipment or services for monitoring airborne ethylene oxide at an EO sterilization facility [Go to Page]
- S.12.1 Introduction
- S.12.2 General approaches to EO environmental and personnel monitoring [Go to Page]
- S.12.2.1 Personnel monitoring
- S.12.2.2 Area monitoring
- S.12.3 Area and personnel monitoring devices [Go to Page]
- S.12.3.1 General considerations [Go to Page]
- S.12.3.1.1 Applications
- S.12.3.2 Detection technologies [Go to Page]
- S.12.3.2.1 Chemical methods for the detection of EO [Go to Page]
- S.12.3.2.1.1 Activated carbon tubes
- S.12.3.2.1.2 Passive sampling devices
- S.12.3.2.1.3 Gas detector tubes
- S.12.3.2.1.4 Gas collection devices
- S.12.3.2.1.5 Impingers
- S.12.3.2.1.6 Instrumental methods for the detection of EO
- S.12.3.2.1.7 Metal oxide semiconductors
- S.12.3.2.1.8 Electrochemical sensors
- S.12.3.2.1.9 Gas chromatographs
- S.12.3.2.1.10 Infrared spectrophotometers
- S.12.3.2.1.11 Photoionization detectors (PID) (without gas chromatographs)
- S.12.3.2.2 Instrumental EO detection technologies
- S.12.3.2.3 Continuous monitoring
- S.12.3.3 Summary
- S.12.4 Contract services [Go to Page]
- S.12.4.1 Advantages and disadvantages of contract services
- S.12.4.2 Finding contract service organizations
- S.12.4.3 Selection criteria
- Bibliography
- Blank Page [Go to Page]
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