3/11/ M Sterile U Network 3M Sterile U Web Meeting March 11, Welcome! Topic: An Overview of ANSI/AAMI ST58: 2013

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1 3M Infection Prevention Solutions 3M Sterile U Network 3M Sterile U Web Meeting March 11, 2014 Today s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST To hear audio, call and enter access code Phone lines are muted. Audio will commence when the webinar begins. How do I get a CE Certificate? Next week, all of today s meeting participants will be sent an containing instructions for obtaining a CE Certificate for today s meeting. The will be sent to the address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate to them. 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 Housekeeping Questions Mute feature (*7 = unmute; *6 = mute) Chat feature Technical difficulties Post session follow-up For more information: 1

2 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 3/11/ Learning Objectives 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) 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. 2

3 ST 58 History 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 (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 In 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 Sections Include: Work area design Personnel considerations Criteria for selection Out of Scope: Decontamination and Preparation Safe and effective use Steam sterilization (see ANSI/AAMI ST79) Ethylene oxide sterilization (see ANSI/AAMI Storage and transport ST41) Chemical systems not cleared by the FDA at Quality control the time this document was published Reprocessing of single use medical devices Quality process improvement Reprocessing devices exposed to Prions, Creutzfeldt-Jakob disease (CJD) 3/11/2014 Annexes A - N 8 Section 2: Definitions and Abbreviations 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. 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. 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 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. 3

4 Section 3: Work Area Design Considerations Section Key Points Traffic control, engineering controls, ergonomics, and proper equipment installation operation and maintenance necessary to safely use LCSs/HLDs. Designated, clean area separate from cleaning/decontamination or patient care areas Considerations for storage and disposal of LCSs/HLDs 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. Restricted, controlled access Adequate ventilation with local exhaust ventilation near the LCSs/HLDs use Processing Area Ventilation Traffic Control Equipment & LCS/HLD Section 3 continued: Work Area Design Considerations Section Key Points Automated processing equipment for LCS/HLD Typically designed to reduce exposure to chemical Semi-automatic or automatic Considerations 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 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 IFU and state and local requirements should be followed Chemical waste container with proper labeling Empty containers disposed of following IFU/ product label Processing Area Traffic Control Ventilation Equipment & LCS/HLD 11 Section 4: Personnel Considerations Section Key Points Qualifications: Supervisory 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 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. Training and continuing education for processing personnel Initial and on-the job training Comprehensive program including demonstrated skills and competency 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 4

5 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. Categories o Liquid chemical sterilant or high-level disinfectant o Gaseous chemical sterilants Effectiveness Considerations Material compatibility Cost effectiveness FDA cleared Section 6: Decontamination and Preparation of Instruments Sterility assurance measures should be used from the time that items are received into the health care facility until they are used. Process: Cleaning of newly received or returned repaired instruments Point-of-use pre-cleaning Containment during transport Safe transport Handling of soiled instruments Separation of waste Cleaning practices must consider: Facility policy and device IFUs Preparation for process type Transport and return Contained and segregated Location - on or off site Aseptic presentation Section 6 continued: Decontamination and Preparation of Instruments - Cleaning 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 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 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 Concentration, temperature, time Method Manual and/or automated Types of automated systems Maintenance on the equipment Procedures for specific devices Rinsing 5

6 Section 6 continued: Decontamination and Preparation of Instruments Cleaning Verification 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 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 Section 7 : Safe and Effective Use The safety and performance characteristics of a gaseous chemical sterilization or LCS/HLD can General Considerations be categorized by: (a) microbial effectiveness, (b) effects on device materials.. (c) toxicity and Establish policy and procedures potential to harm health care personnel and patients. Follow manufacturer s IFU Device manufacturer Equipment manufacturer Chemical sterilant t or high h level l disinfectant i t 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 6

7 Section 7 continued: Safe and Effective Use - Chemicals Annexes provide specific considerations and reference for each CS/HLD current in use Safety Efficacy Compatibility Section 7 continued: Safe and Effective Use Considerations for Selection Product Type HLD or Chemical Sterilant LC Sterilization Process Dispensing and Dilution Product IFUs Process Parameters Water Quality Dilution and Rinsing TIR 34 Monitoring Test Strips Documentation Section 8: Device Storage and Transport Important considerations Prevention of cross-contamination Items must be appropriately handled and stored to ensure they are not contaminated before they are used on the patient. Facility specific needs and requirements Liquid processes Instructions for Use Immediate use or drying-storage Gaseous processes Instructions for Use Correct storage conditions Inspection 21 7

8 Section 9: Quality Control 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. Important Considerations Recommendations are consistent with ST79 and applies to all process types Manual using LCS/LHD 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 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 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 Section 9 continued: Quality Control - Monitoring Monitoring Automated Processes using LCSs/HLDs Physical monitoring with recording capability Chemical 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 Frequency of use LCS/ HLD should be tested prior to each use Inadequate processing and troubleshooting 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 Section 9 continued: Quality Control - Monitoring Monitoring Gaseous Chemical Sterilization Processes Physical monitoring Chemical indicators External process indicator Internal CI inside each package Biological indicators Use in process challenge device Frequency: At least daily preferably in every cycle Sterilizer malfunction Inadequate processing and troubleshooting Follow IFU to troubleshoot problem Observe appropriate safety precautions and wear PPE. Remove from service Notify appropriate personnel and service Retest or requalify after issue identified and corrected 8

9 Section 9 continued: Quality Control Monitoring Monitoring Gaseous Chemical Sterilization Processes Qualification Testing Follow sterilizer IFU/ Operators Manual Use BI in PCD: Upon installation Relocation Sterilizer malfunctions Major repairs Sterilization process failures 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 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 Section 9 continued: Quality Control Product Testing 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 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 Section 10: Quality Process Improvement Quality Processes measure objective performance criteria and should be integrated with the overall quality process of the healthcare facility. Risk Analysis Continuous quality improvement programs are recognized as an effective means of improving the performance of any process. Key Components Written policy and procedures Manufacturers written IFU Risk Management Communication Staff training, education and competency 9

10 Section 10: Quality Process Improvement - Risk Analysis 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 6. Develop plan to mitigate the risks of something does go wrong 7. Communicate plan to all stakeholders Cleaning & Decontamination Inspection/ Functionality Testing & Assembly Packaging & Labeling Loading & Documentation Sterilisation & Release Storage & Distribution Gaseous Chemical Sterilization Process example Informative Annex A-N 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 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 29 Annex B I - Types Liquid chemical sterilants and high-level disinfectants 2 % hydrogen peroxide disinfectant Glutaraldehyde formulations OPA formulations Peracetic acid (hydrogen peroxide) formulations Gaseous sterilization methods Hydrogen peroxide gas with plasma Hydrogen peroxide gas without plasma Ozone 10

11 Annex A: Microbial lethality, materials compatibility and toxicity Sterilization: Measured by Sterility Assurance Level (SAL) log linear kill kinetics HLD: Qualitative test based on total kill endpoints at time and temp conditions Microbial Lethality Key Points This list of organisms is provided as a guide. Least (bottom) to most resistant. 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. Annex B: Glutaraldehyde Solutions Cleared Products 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 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 Annex C: Hydrogen Peroxide Solutions Cleared Products 2% hydrogen peroxide formulation 8 mins at 20 o C (68 o F) 21 day reuse 7.5% hydrogen peroxide formulation 30 mins at 20 o C (68 o F) 21 day reuse 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 1. PPE use Eye and skin protection 2. Correct handling/ventilation Reduce splashing/spraying 3. Understand potential health effects Short term Product dependant Mild to severe irritant 11

12 Annex D: Ortho-phthalaldehyde Solutions Cleared Products % OPA in formulation Manual: 12mins at 20 o C (68 o F) Automated: 5mins at 25 o C (77 o F) 14 day reuse 5.75% OPA concentrate in formulation Diluted to 0.05% 10mins at o C ( o F) Single-use 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 1. Restrictions with urological instruments 2. PPE use Eye and skin protection 3. Correct handling/ventilation Reduce splashing/spraying 4. Health effects Short term Irritant and sensitizer Staining 5. Neutralization (spill and disposal) Annex E: Peracetic Acid Hydrogen Peroxide Solutions Cleared Products Automated 0.2% PAA in formulation 6mins at o C ( o F) Single use 1% HP, 0.08% PAA in formulation HLD at 25mins at 20 o C (68 o F) 14 day reuse 8.3% HP, 7% PAA in formulation HLD at 5mins at 25 o C (77 o F) 5 day reuse 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 1.PPE use Eye and skin protection 2. Correct handling/ventilation Reduce splashing/spraying 3. Health effects Short term Product dependant (SDS) Irritant Skin and eye contact risks No specific OSHA PEL for PAA Annex F: Sodium Hypochlorite Solutions Cleared Products HLD generating system Electrochemical generation from NaCl vppm at 10mins 25 o C (77 o F) No image available 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 1. PPE use Eye and skin protection 2. Correct handling/ventilation Reduce splashing/spraying 3. Health effects Short term Irritant and sensitizer OSHA PEL for gas at 1ppm 12

13 Annex G: Alcohol and Formaldehyde Cleared Product System include top sterilizer using a high temperature/ chemical process 0.25% formaldehyde in alcohol and water Condensed on surfaces at 132 o C (270 o F) under pressure (20psig) for 20mins Key Points for Effective Use 1. 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 1. 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 Annex H: Hydrogen Peroxide Gas Sterilization Cleared products: Low temperature (<55 o C) 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 neutralized H2O2 at end of cycle Key Points for Effective Use: 1. Follow IFU of device and sterilizer manufacturer for compatibility of device to process 2. Can not process liquids and cellulosic materials 3. Uses can include rigid and flexible lumen endoscopes 4. Devices must be completely dry 5. 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) 1. 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) Annex I: Ozone Sterilization Cleared Product 85mg/L of ozone Ozone generated by sterilizer from an oxygen source C 6 hour cycle Key Points for Effective Use: 1. Follow IFU of device and sterilizer manufacturer for compatibility of device to process 2. Can not process liquids and cellulosic materials not recommended 3. Can include rigid and flexible lumen endoscopes 4. Devices should be dry 5. Packed in compatible non-woven wrap or container 6. Quality control checks: chemical and biological indicators 7. Process conditions (e.g., temperature, pressure, ozone concentration 1. 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 13

14 Annex N: NEW Gas and Vapor Monitoring 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 Gas and Vapor Monitoring i Instrumentation t ti 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 Summary ST58 (2013) ANSI/AAMI ST58 provides a comprehensive companion document for LCS/HLD processes and gaseous chemical sterilization processes Consistent with ST79 on common procedures 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 Thank you! Next 3M Sterile U Web Meeting When: Topic: Thursday, April 17th When the Auditors Come Knocking How to Prepare Register at 3M All rights reserved. 14

15 References 43 3M All rights reserved. References ANSI/AAMI ST58: 2013 Chemical Sterilization and High-Level Disinfection in Healthcare Facilities Thank you 45 3M All rights reserved. 15