ST58 Webinar Prust Mar12 · 3/11/2014 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.,

3/11/2014

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3M Infection Prevention Solutions

3M™ Sterile U Network3M™ Sterile U Web Meeting – March 11, 2014

Today’s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CSTTo hear audio, call 800‐937‐0042 and enter access code 7333633Phone lines are muted. Audio will commence when the webinar begins.

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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.


• Immediate use or drying-storage

• Gaseous processes


• 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


1. Understand formulation differences and requirements

2. Follow IFU


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


• Reduce splashing/spraying4. Health effects

•Short term•Irritant and sensitizer•Staining

5. Neutralization (spill and disposal)


1. Understand formulation differences and requirements

2. Follow IFU – specific labeling requirements


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


Annex E: Peracetic Acid – Hydrogen Peroxide Solutions


•5 day reuse

Key Points for Safe Use1.PPE use


•Reduce splashing/spraying3. Health effects

• Short term•Product dependant (SDS)•Irritant•Skin and eye contact risks

• No specific OSHA PEL for PAA


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



• Reduce splashing/spraying

3. Health effects

• Short term

• Irritant and sensitizer

• OSHA PEL for gas at 1ppm


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


• 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

Thank youThank you

45 © 3M 2014. All rights reserved.

Documents

ST58 Webinar Prust Mar12 · 3/11/2014 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.,