ST58 Webinar Prust Mar12 · 3/11/2014 1 3M Infection Prevention Solutions 3M™ Sterile U Network...
Transcript of ST58 Webinar Prust Mar12 · 3/11/2014 1 3M Infection Prevention Solutions 3M™ Sterile U Network...
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3M Infection Prevention Solutions
3M™ Sterile U Network3M™ Sterile U Web Meeting – March 11, 2014
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Welcome!Topic: An Overview of ANSI/AAMI ST58: 2013
Speaker: Janet Prust - 3M Director - Standards and Business Development
Facilitators: Diane Koch, 3M Larry Talapa, 3M
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Sterile U Webinar
An Overview of ANSI/AAMI ST58: 2013 Chemical Sterilization and High‐Level Disinfection in Healthcare Facilities
Disclosures
Presenter: Janet Prust
AAMI Sterilization Standards Committee
Working Group 61: Chemical Sterilants Hospital Practices Working Group Co-chair
Member: AAMI Standards Board
3M Director - Standards and Business Development
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1. Understand general content and format in ANSI/AAMI ST58 (2013)
2. Describe important considerations for selection and use of chemical sterilants / high level disinfectants (LCS/HLD)
Learning Objectives
( )
3. Understand ST58 format and how to find information
4. Delineate regulatory considerations and definitions
All content for this presentation sourced from ANSI/AAMI ST 58 (2013): Chemical Sterilization and High Level Disinfection in Health Care Settings. Photos sourced from Google Images or owned by 3M or author.
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Initial ST 58 document published in 1996: Safe Use and handling of Glutaraldehyde – based products in health care facilities
→ TIR 7: Chemical sterilants and high level disinfectants: A guide to selection and use
→ ST58 (2005): Chemical Sterilization and High-Level Disinfection in Health Care Facilities • Incorporated two previous documents in a user practice format following the steam sterilization in health care facilities document
ST 58 History
→ ST 58 (2013): Chemical Sterilization and High-Level Disinfection in Health Care Facilities
Key Updates in ST 58 (2013):• Updated workplace safety information, improved workplace design guidelines and
expanded recommendations for personnel training
• Expansion of annexes to address new chemical sterilants / high -level disinfectants and processes
• Alignment with other AAMI health care facility documents
• Updated quality process recommendations and simplified product testing
Section 1: ST 58 Scope
ST58 addresses selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and chemical sterilizers that have been cleared by the U.S. Food and Drug Administration for use health care facilities
Work area design
Personnel considerations
Criteria for selection
In Scope: Sections Include:
• Steam sterilization (see ANSI/AAMI ST79)• Ethylene oxide sterilization (see ANSI/AAMI ST41)• Chemical systems not cleared by the FDA at the time this document was published• Reprocessing of single use medical devices • Reprocessing devices exposed to Prions, Creutzfeldt-Jakob disease (CJD)
Decontamination and Preparation
Safe and effective use
Storage and transport
Quality control
Quality process improvement
Annexes A - N3/11/2014 8
Out of Scope:
Decontamination: Use of physical or chemical means to remove, inactivate, or destroy blood borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.
Section 2: Definitions and Abbreviations
Processing area: Area of a health care facility where cleaning, disinfection, sterilization is performed.
Chemical sterilant/high-level disinfectant (LCS/HLD):Chemical agent capable of rendering a product free of viable microorganisms. Includes both
Disinfection: Process that kills pathogenic and other microorganisms by physical or chemical means. High level: disinfection is a process that kills all microbial organisms but not necessarily large numbers of bacterial spores.
Sterilization: Validated process used to render a product free from viable microorganisms.
product free of viable microorganisms. Includes both liquid and gaseous chemical sterilants.
Liquid chemical sterilant (LCS): Chemical solution that has been validated to provide microbial kill adequate to obtain FDA clearance for a sterilization label claim.
Chemical sterilization: Process, using a chemical agent, designed to render a product free of viable microorganisms.
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Section Key Points
•Traffic control, engineering controls, ergonomics, and proper equipment installation operation and maintenance necessary to safely use LCSs/HLDs.
Section 3: Work Area Design Considerations
Traffic control, engineering controls .., ergonomics, and proper installation, operation, and maintenance of equipment can reduce ...exposure of health care personnel, patients and visitors to chemical sterilants/high-level disinfectants.
• Designated, clean area separate from cleaning/decontamination or patient care areas
• Considerations for storage and disposal of LCSs/HLDs
• Restricted, controlled access
• Adequate ventilation with local exhaust ventilation near the LCSs/HLDs use
ProcessingArea
Ventilation
TrafficControl
Equipment& LCS/HLD
Section Key Points
Automated processing equipment for LCS/HLD
• Typically designed to reduce
exposure to chemical
• Semi-automatic or automatic
Considerations
Section 3 continued: Work Area Design Considerations
Storage of CS/HLD
• IFU and SDS should be followed
• Tightly closed, properly marked containers in a cool, secure, properly ventilated area
• Should not be stored under sinks which are considered uncontrolled environment and not suitable for storage
Disposal of CS/HLD• Space requirements and appropriate location to provide accessibility
• Manufacturer’s IFU and installation requirements
• Safety features and Mid-cycle inspection capability
• Special plumbing requirements
• Filter requirements; Heating system
• Capabilities (e.g. prewashing, post-disinfection Air and alcohol purge, etc) and capacity
• Means to change and dispose of chemical solutions
Disposal of CS/HLD
• IFU and state and local requirements should be followed
• Chemical waste container with proper labeling
• Empty containers disposed of following IFU/ product label
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ProcessingArea
Ventilation
TrafficControl
Equipment& LCS/HLD
Section Key Points
Qualifications:
Supervisory personnelS i li d i i
Section 4: Personnel Considerations
Training and continuing education for processing personnel•Initial and on-the job training
•Comprehensive program including demonstrated skills and competency
The decontamination subsequent chemical sterilization or high-level disinfection of reusable medical devices is a complex process and requires the knowledge and competency of trained and qualified personnel.
• Specialized in reprocessing • Knowledgeable and experienced• Participated in facility and Continuing education programs• Knowledge of regulations
Processing personnel•Demonstrated knowledge and documented competency
•Certification recommended for both supervisory and processing personnel• Health and Personnel Hygiene
•Training manual
Service Personnel and Other Personnel• Hazard training and OSHA Requirements
• Appropriate use of PPE, protective work practices, emergency procedures, exposure procedures
PPE Provided and Used• Eye and Skin (liquid)
• Respiratory Protection
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Categories o Liquid chemical sterilant or high-level disinfectant
o Gaseous chemical sterilants
Section 5: Selection of Liquid and Gaseous Chemical Sterilants and High-Level Disinfectants
This section provides… questions users should [consider] when choosing disinfection and sterilizing agents and equipment.
Effectiveness Considerations
• Material compatibility
• Cost effectiveness
• FDA cleared http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.htm
Process:
• Cleaning of newly received or returned repaired instruments
Section 6: Decontamination and Preparation of Instruments
Cleaning practices must consider:
• Facility policy and device IFUs
• Preparation for process type
Sterility assurance measures should be used from the time that items are received into the health care facility until they are used.
• Point-of-use pre-cleaning
• Containment during transport
• Safe transport
• Handling of soiled instruments
• Separation of waste
Transport and return
• Contained and segregated
• Location - on or off site
• Aseptic presentation
Definition: The use of physical or chemical means to remove, inactivate or destroy bloodborne pathogens on a surface or item … where no longer capable of transmitting infectious particles and the ..item is .. safe for handling, use or disposal.
Cleaning is a critical process step that when performed improperly can cause: • Device damage/malfunction• Inadequate disinfection/sterilization
Toxicity from detergent residues
Section 6 continued: Decontamination and Preparation of Instruments - Cleaning
Factors that impact cleaning process:
IFU requirements
Water quality• AAMI TIR 34 provides a guideline including WQ for cleaning
Cleaning chemistry• Types and choice
• Variables for use• Toxicity from detergent residues
Cleaning is a multi-step process
1. Manual or automated cleaning include the various sub-steps
2. Adequate rinsing with proper type and flow of water
3. Drying, inspection, verification
• Variables for use
• Concentration, temperature, time
Method• Manual and/or automated
• Types of automated systems
• Maintenance on the equipment
Procedures for specific devices
Rinsing
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• Cleaning effectiveness should be verified• Visual inspection should always be performed under satisfactory light and magnification
• Visual alone may not be sufficient for assessing the effectiveness of the cleaning process.
• Cleaning Verification indicators for manual or
Section 6 continued: Decontamination and Preparation of Instruments– Cleaning Verification
automated process• Recommended for consideration of use
• Automated equipment frequency - at least weekly preferably daily (ST 79)
• Method of controlling the process
• Quantitative indicators measure cleaning
efficacy
• Qualitative indicators may measure
temperature, time, chemistry concentration
General Considerations
• Establish policy and procedures
• Follow manufacturer’s IFU
• Device manufacturer• Equipment manufacturer
Ch i l t il t hi h l l di i f t t f t
Section 7 :Safe and Effective Use
The safety and performance characteristics of a gaseous chemical sterilization or LCS/HLD can be categorized by: (a) microbial effectiveness, (b) effects on device materials .. (c) toxicity and potential to harm health care personnel and patients.
• Chemical sterilant or high level disinfectant manufacturer
• Ensure cleaning effectiveness
• General safety considerations• Training in safe handling and emergency procedures• SDS file• PPE and ventilation• Storage consideration
Section 7 continued:Safe and Effective Use - PPE
Figure 3 ‐Microbial processes and use of PPE
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Safety
CompatibilityEfficacy
Section 7 continued:Safe and Effective Use - Chemicals
Annexes provide specific considerations and reference for each CS/HLD current in use
Section 7 continued:Safe and Effective Use
Product Type
HLD or Chemical Sterilant
LC Sterilization Process
Dispensing and Dilution
Considerations for Selection
Product IFUs
Process Parameters
Water Quality
Dilution and Rinsing
TIR 34
Monitoring
Test Strips
Documentation
Important considerations
• Prevention of cross-contamination
• Facility specific needs and requirements
• Liquid processes
• Instructions for Use
Section 8:Device Storage and Transport
Items must be appropriately handled and stored to ensure they are not contaminated before they are used on the patient.
• Instructions for Use
• Immediate use or drying-storage
• Gaseous processes
• Instructions for Use
• Correct storage conditions
• Inspection
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Important Considerations
Recommendations are consistent with ST79 and applies to all process types
• Manual using LCS/LHD
Section 9: Quality Control
Monitoring Manual Processes using LCSs/HLDs
• Physical monitors with thermometer and timer
• Solution test strips and chemical monitoring devices to determine MEC or MRC of LCS/HLD
Quality control includes not only product and process monitoring but also involves continuous supervision of personnel performance and work practices and ongoing verification of adherence to established policy and procedures.
g
• Automated using LCS/HLD
• Gaseous chemical sterilization
Product identification and traceability
Lot control and expiration dating
Cycle identification, documentation and record keeping
• Applies to automated and manual HLD processes
devices to determine MEC or MRC of LCS/HLD
Frequency of use • LCS/ HLD should be tested prior to each use
Inadequate Processing
•Notify appropriate personnel
•Collect data
•Retrieve items if possible
•Identify cause and correct
•Test LCS/HLD solution
Photo source: Google images
Monitoring Automated Processes
using LCSs/HLDs
• Physical monitoring with recording capability
• Chemical Process monitoring devices
Section 9 continued: Quality Control - Monitoring
Frequency of use
• LCS/ HLD should be tested prior to each use
Inadequate processing and troubleshootingChemical Process monitoring devices
• Solution test strips, spore test strips, BI or CI or other chemical monitoring device• Solution test strips are available for each type of LCS/HLD
• Spore Test Strip cleared for one type of Automated Processing system using peracetic acid
g
• Follow IFU to troubleshoot problem
1. Remove from service
2. Notify appropriate personnel and service
3. Retest after issue identified and corrected
Photo source: Google images
Monitoring Gaseous Chemical Sterilization Processes
Physical monitoring
Chemical indicators
Section 9 continued: Quality Control - Monitoring
Sterilizer malfunction
Inadequate processing and troubleshooting
• Follow IFU to troubleshoot problem
• External process indicator
• Internal CI inside each package
Biological indicators•Use in process challenge device
• Frequency: At least daily preferably in every cycle
• Observe appropriate safety precautions and wear PPE.
• Remove from service
• Notify appropriate personnel and service
• Retest or requalify after issue identified and corrected
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Monitoring Gaseous Chemical Sterilization Processes
Qualification Testing
• Follow sterilizer IFU/ Operators Manual
Use BI in PCD:
Section 9 continued: Quality Control – Monitoring
Positive BI results
• Similar to steam process
• Notify appropriate personnel
• Collect all data
• Retrieve items from last negative BI
• Micro lab ID organisms in positive BI
D t i f f il d t• Upon installation
• Relocation
• Sterilizer malfunctions
• Major repairs
• Sterilization process failures
• Determine case of failure and correct
• Requalify sterilizer and if pass, return to service
Recall procedure
Product testing
• Gaseous Chemical Sterilization Processes
• LCS/HLD Automated Processes
Purpose: Verify the manufacturer’s IFU can be successfully performed at the User facility. Chemical sterilization and high-level disinfection procedures are typically restrictive to types of device and loads that can be processed
What to test: Representative product from device Family = Master product
Section 9 continued: Quality Control – Product Testing
When to test: Upon initial receipt of the device
• When major changes in the process occurs
• Product testing does not need to be performed on a routine basis
How to determine the Family and Master product: to test:
Family = Similar design
Master = Design and construction of the device with the Family that is most challenging to the LCS/HLD process
Quality Processes measure objective performance criteria and should be integrated with the overall quality process of the healthcare facility.
Section 10: Quality Process Improvement
Key Components
• Written policy and proceduresRisk
Continuous quality improvement programs are recognized as an effective means of improving the performance of any process.
• Manufacturers written IFU
• Staff training, education and competency
Analysis
CommunicationRisk
Management
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1. Identify all critical risks in process steps
2. Describe what could reasonably go wrong
3. Determine how often it could occur
4. Determine the impact of the problem if it occurs
5 Implement preventative action to avoid or reduce the risk
Section 10: Quality Process Improvement - Risk Analysis
5. Implement preventative action to avoid or reduce the risk
6. Develop plan to mitigate the risks of something does go wrong
7. Communicate plan to all stakeholders
Cleaning & Decontami‐
nation
Inspection/Function‐ality Testing & Assembly
Packaging & Labeling
Loading & Documen‐tation
Sterilisation &
Release
Storage &
Distribution
Gaseous Chemical Sterilization Process ‐ example
Purpose – To provide INFORMATIVE content designed to provide reference information and additional detail not covered in main document
• Annex A: General info of microbial lethality, materials compatibility and toxicity related to chemical sterilants/ high-level disinfectant
•Annex B – I: Describe specific LCS/HLD in consistent format
Informative Annex A-N
• Annex J and K: Regulatory Information
• Annex L: User verification of Cleaning Process
• Annex M: Premature release of implant form
• New Annex N: Gas and Vapor Monitoring
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Liquid chemical sterilants and high-level disinfectants
• 2 % hydrogen peroxide disinfectant
• Glutaraldehyde formulations
• OPA formulations
• Peracetic acid (hydrogen peroxide) formulations
Annex B – I - Types
Gaseous sterilization methods
• Hydrogen peroxide gas with plasma
• Hydrogen peroxide gas without plasma
• Ozone
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Microbial Lethality Key Points • This list of organisms is provided as a guide. Least (bottom) to most resistant.
Annex A:Microbial lethality, materials compatibility and toxicitySterilization: Measured by Sterility Assurance Level (SAL) ‐log linear kill kineticsHLD: Qualitative test based on total kill endpoints at time and temp conditions
• Lethality measures can be chemical or product-specific
• Methods to validate sterilization processes differ from methods for HLD processes
Toxicity Key Points• HC personnel must be protected from occupation exposure LCS/HLD/GSC
• Many may cause short-term issues.
• Others may cause long-term health hazards and SDS must be followed.
• Patients must be protected from residues of LCS/HLD/GSC on the device.
Cleared Products
Annex B: Glutaraldehyde Solutions
Key Points for Effective Use
1.Follow IFU
2.Compatible with processing equipment
3.Mix and store according to label instructions
4.Device clean and dry
5.Completely immerse
6.Use solution test strip
Key Points for Safe Use
1.Follow procedures to protect HCW from vapors
• Wear PPE: eye and skin protection
2. Prepare solution in well ventilated areas or in chemical vent hood
3. Safely activate, pour, transport and store solutions
4. Follow procedures and use right materials for spills and disposal
Cleared Products
2% hydrogen peroxide formulation • 8 mins at 20oC (68oF)• 21 day reuse
7.5% hydrogen peroxide formulation
• 30 mins at 20oC (68oF)
• 21 day reuse
Annex C: Hydrogen Peroxide Solutions
y
Key Points for Safe Use1. PPE use
• Eye and skin protection2. Correct handling/ventilation
• Reduce splashing/spraying3. Understand potential health effects
• Short term• Product dependant• Mild to severe irritant
Key Points for Effective Use
1. Understand formulation differences and requirements
2. Follow IFU
3.Compatible with processing equipment
4.Mix and store according to label instructions
5.Device clean and dry
6.Completely immerse
7.Use solution test strip
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Cleared Products0.55-0.60% OPA in formulation
• Manual: 12mins at 20oC (68oF)
• Automated: 5mins at 25oC (77oF)
•14 day reuse
5.75% OPA concentrate in formulation
•Diluted to 0.05%
•10mins at 50-55oC (122-131oF)
Annex D: Ortho-phthalaldehyde Solutions
•Single-use
Key Points for Safe Use1. Restrictions with urological instruments2. PPE use
• Eye and skin protection3. Correct handling/ventilation
• Reduce splashing/spraying4. Health effects
•Short term•Irritant and sensitizer•Staining
5. Neutralization (spill and disposal)
Key Points for Effective Use
1. Understand formulation differences and requirements
2. Follow IFU – specific labeling requirements
3.Compatible with processing equipment
4. No sterilization claim; some mycobacterium and protozoa show high resistance
5. Device clean and dry
6. Use proper solution test strip
Cleared ProductsAutomated 0.2% PAA in formulation
•6mins at 46-60oC (115-140oF)
•Single use
1% HP, 0.08% PAA in formulation
•HLD at 25mins at 20oC (68oF)
•14 day reuse
8.3% HP, 7% PAA in formulation
•HLD at 5mins at 25oC (77oF)
Annex E: Peracetic Acid – Hydrogen Peroxide Solutions
•HLD at 5mins at 25oC (77oF)
•5 day reuse
Key Points for Safe Use1.PPE use
• Eye and skin protection2. Correct handling/ventilation
•Reduce splashing/spraying3. Health effects
• Short term•Product dependant (SDS)•Irritant•Skin and eye contact risks
• No specific OSHA PEL for PAA
Key Points for Effective Use
1.Follow IFU – understand formulation differences
2. Needs extensively treated water for rinsing
3. Compatible with processing equipment
4. Store according to label instructions
5.Quality control: Use solution test strip and use spore test strip
Cleared Products
HLD generating system
Electrochemical generation from NaCl• 650-675vppm at 10mins
• 25oC (77oF)
Annex F: Sodium Hypochlorite Solutions
No image available
Key Points for Safe Use1. PPE use
• Eye and skin protection2. Correct handling/ventilation
• Reduce splashing/spraying
3. Health effects
• Short term
• Irritant and sensitizer
• OSHA PEL for gas at 1ppm
Key Points for Effective Use
1.Follow IFU – understand chlorine correct usage
2. Use only cleared, labeled products specific for device application
3. Determine compatibility
4.Follow specific labeling requirements Store according to label instructions
5.Quality control: Use solution test strip before use
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Cleared Product
System include top sterilizer using a high temperature/ chemical process
0.25% formaldehyde in alcohol and water
Condensed on surfaces at 132oC (270oF) under pressure (20psig) for 20mins
Annex G: Alcohol and Formaldehyde
Key Points for Safe Use1. PPE use
• Eye and skin protection
2. Correct handling/ventilation
3. Health effects
• Short term
• Irritant and burn risk
• Long term
• Formaldehyde is carcinogenic
• OSHA PEL at 0.75ppm
4. Specific handling on disposal
Key Points for Effective Use1. Follow IFU of device and sterilizer
manufacturer for compatibility of device to process
2. Know limitation on some materials and packaging
3. Process conditions (e.g., temperature,
pressure)4. Quality control checks: chemical and biological
indicators
Cleared products: Low temperature (<55oC) vacuum processes using hydrogen peroxide gas
• Include plasma phase• Do not include plasma
Each process uses different cycle conditions
Cycles specific for defined loads / devices
Conditioning can include: Drying, moisture detection, H2O2 concentration
Sterilization processes differ in vacuum levels, number of exposure pulses, uses of plasma during pulses, Aeration and method to
Annex H: Hydrogen Peroxide Gas Sterilization
p , p g p ,neutralized H2O2 at end of cycle
Key Points for Safe Use1. Peroxide gas degrades to water and oxygen
2. PPE use
• Eye and skin protection
3.Correct ventilation
4.Health effects
• Short term
• Irritant
5. OSHA PEL at 1ppm
6. Disposal with water or auto-disposal (some systems)
Key Points for Effective Use: 1. Follow IFU of device and sterilizer manufacturer for
compatibility of device to process2. Can not process liquids and cellulosic materials
3. Uses can include rigid and flexible lumen endoscopes
4. Devices must be completely dry5. Packed in compatible non-woven wrap or container
6. Quality control checks: chemical and biological indicators
7. Process conditions (e.g., temperature, pressure,
H2O2 concentration and injection)
Cleared Product
85mg/L of ozone
• Ozone generated by sterilizer from an oxygen source
• 30 – 36˚C
• 6 hour cycle
Annex I: Ozone Sterilization
Key Points for Effective Use: Key Points for Safe UseKey Points for Effective Use: 1. Follow IFU of device and sterilizer manufacturer for
compatibility of device to process2. Can not process liquids and cellulosic materials not
recommended
3. Can include rigid and flexible lumen endoscopes4. Devices should be dry
5. Packed in compatible non-woven wrap or container6. Quality control checks: chemical and biological
indicators
7. Process conditions (e.g., temperature, pressure, ozone concentration
Key Points for Safe Use1. Health effects
• Short term: Irritant
• OSHA PEL at 0.1ppm (8 hr TWA) and STEL of 0.3 ppm (15 min TWA)
2. PPE use
• Not needed unless malfunction
3. Correct ventilation
4. Spills and leaks: self-contained system
5. Vapor monitoring: Consult SDS and IFU
6.Disposal: Unnecessary with current cleared system
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Key Considerations
• Air sampling and monitoring techniques are available to help ensure a safe work environment and comply with regulatory and voluntary guidelines
• OSHA General Duty clause designed to ensure that employers provide a workplace free from recognized hazards that are causing or likely to cause death or serious physical harm to employees
• Aldehydes (glutaraldehyde and OPA) have known toxicity concerns
• Many oxidizing chemistries do not have known long term toxicity concerns but have short term
G d V M it i I t t ti
Annex N: NEWGas and Vapor Monitoring
• Gas and Vapor Monitoring Instrumentation
• Monitoring methods, reliability and use
•Procedures
• Monitoring sites in work areas
• Frequency, TWA and ceiling exposures
• Record-keeping
• Considerations for Selection of both personal and area monitoring systems
• ANSI/AAMI ST58 provides a comprehensive companion document for LCS/HLD processes and gaseous chemical sterilization processes
• Consistent with ST79 on common procedures
SummaryST58 (2013)
• Improved clarity of recommendations for manual processes
• Updated and expanded information on Quality Control aspects
• Comprehensive Annexes provide up-to-date information on efficacy and safety of cleared LCS/HLD/GCS
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ReferencesReferences
43 © 3M 2014. All rights reserved.
References
ANSI/AAMI ST58: 2013 Chemical Sterilization and High-Level Disinfection in Healthcare Facilities
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45 © 3M 2014. All rights reserved.