Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices
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Transcript of Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices
Cleaning, Disinfection, and Sterilization Validations:
Design Considerations for Engineers
Webinar Overviewo What is a cleaning and disinfection/sterilization validation?
• Types of cleaning, disinfection, and sterilization validations Residuals
• Categories of reusable medical devices• Acceptance criteria
o Case Studies• Surgical Forceps• Blood Glucose Meter• Colonoscope
o Design Considerationso Questions
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Today’s Goals
o Develop a more thorough understanding of the cleaning, disinfection, and sterilization processes
o Learn what to consider when designing a device to increase suitability for reprocessing for reuse
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Poll
What Phase are you at in your design process?
A. Early Stage: designing a device and need more information on how to make it more friendly for reprocessing.
B. Pre-FDA Submission: Need to validate a reprocessing procedure for submission
C. Post-FDA Submission: Product is on the market but now need to perform a reprocessing validation
D. Just looking for more information
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What is a cleaning and disinfection/sterilization validation
o Purpose and need for validating procedure• Set standards for the reprocessing procedure to render device
safe for patient use.o What does the FDA say?
• “Cleaning is the physical removal of organic soil from an item to the extent necessary for further processing or for intended use”
• “Disinfection destroys pathogens and other microorganisms by physical or chemical means”
• “Sterilization validation renders a product free from viable microorganisms”
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What is a Cleaning Validation?o Cleaning: Removal of soil residues.
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Cleaning Validation Procedureo Inoculate the device.
• Organic Soils• Microorganisms
o Subject device to cleaning procedure.• Usually with use of water and detergents.
o Extract remaining residues.• Microbial, protein, hemoglobin, carbohydrate, endotoxin
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Cleaning Validation Acceptance Criteria
o Visually Cleano Microorganisms – minimum of 3-log reductiono Residual Limits Levels:
• Protein < 6.4µg• Hemoglobin < 2.2µg• Carbohydrate < 1.8µg• Endotoxin < 2.2µg
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What is a Disinfection Validation?
Definition: Process that kills pathogenic
and other microorganisms by physical
or chemical means
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Disinfection Validation Procedureo Inoculate device with microbes and organic soilo Process device with validated cleaning procedureo Subject device to disinfection procedure:
• Disinfectants• Thermal applications (under 100°C)
o Perform microbial recovery
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Disinfection Validation Acceptance Criteria
o Visually clean
o Microorganisms: 6-log reduction
o Total Organic Carbon (TOC) screen for residual disinfectant
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What is a Sterilization Validation?
o Definition: A process that renders a product free from viable microorganisms
o Measured by SAL (sterility assurance level): probability that a product is non-sterile• Ex: SAL 106 is a one in one million chance of a non-sterile event
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Sterilization Validation Procedure
o Introduce biological indicators to device• Biological spores
o Subject device to sterilization process
o Retrieve biological indicators and perform sterility test
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Sterilization Validation Acceptance Criteria
o Non-critical device: SAL 10-3
o Critical device: SAL 10-6
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Simply Put…o We have to contaminate the device, clean it and
disinfect or sterilize the device according to the procedure being validated.
o Then we have to check the level of contamination remaining on the device after the cleaning/disinfection/sterilization procedure.
o If all checks are acceptable, the procedure will be validated for use.
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Types of Cleaning, Disinfection and Sterilization Processes
Cleaning Disinfection SterilizationManualCleaning with or without use of brushes, specialized tools
Automated CleaningUltrasonicMedical Washers
Low LevelKills most vegetative bacteria, some viruses and some fungi.
Intermediate LevelKills vegetative bacteria, viruses, fungi and mycobacterium.
High LevelKills all microbial organisms – potential to render device sterile.
ThermalDisinfection via thermal applications under 100°C.
High TemperatureMoist heat/steamDry heat
Low TemperatureOzone
ChemicalLiquid - SterisHydrogen peroxide
GasEthylene OxideHydrogen peroxide (gas plasma) - Sterrad
Radiation-Gamma, E-beam
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Reusable Device Classification
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Device Classification
Definition Examples
Critical• Introduced directly into bloodstream or other normally sterile areas of the
body
• Surgical instruments, needles, catheters, Implants, invasive
endoscopes
Semi-Critical• Intact mucous membranes
•Does not penetrate the bloodstream or normally sterile areas of the body
• Non-invasive flexible and rigid fiber optic endoscopes, aspirator
tubes, respiratory therapy equipment
Non-Critical • Intact skin of patient • Blood pressure cuffs, stethoscope, external sensors
*Adapted from AAMI
Acceptance Criteria SummaryDevice Classification Treatment Options Criteria
Critical(Must be Sterile) Sterilization •Sterilization: SAL – 10-6
Semi-Critical(Sterile or disinfected)
Sterilizationor
High Level Disinfection
•Sterilization: SAL – 10-6
•Disinfection: 6 log reduction
Non-Critical(Does not need to be
sterile)
Simple cleaningor
Low level disinfectionor
Intermediate level disinfection
•Sterilization: SAL – 10-3
•Cleaning: Removal of residuals, visually clean•Disinfection: 3-log
reduction
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*Note: Devices must be cleaned prior to disinfection or sterilization
Case Study #1: Surgical Forcepso Use: For surgical procedures and may potentially contact
bloodstreamo Device Category: Criticalo Complexity: Simpleo Requirements: Cleaned and Sterilized
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Forceps Limitations and Risks
o Limitation: Stainless steel is not compatible with many chemicals• Risk: Rust and corrosion can occur
o Limitation: Uneven grooves on tip and grip points• Risk: High levels of residuals may be trapped in grooves
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Forceps Cleaning Procedureo Step 1: Cleaned with sponge and Alconox
Detergent• Alconox is widely used in hospitals and
will not cause corrosion• Sponge aids in removing residue from
grooveso Step 2: Rinsed device under running water
• Rinsing removes residuals and detergent residues
o Step 3: Screened for total organic carbon from both soil and detergent• Screening confirms that levels of
residuals are acceptable
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Forceps Sterilization Procedure
o Steam sterilization using an autoclave was validated• Autoclaves are readily available• High heat of an autoclave sterilizes
devices• No chemicals are involved
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Case Study #2: Blood Glucose Meter
o Use: Repeatedly used for blood glucose monitoring. Body of meter may contact blood
o Category: Semi-criticalo Complexity: Medium complexity. Has electronic partso Requirements: Cleaned and disinfected
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Glucose Meter Limitations and Risks
o Limitation: Cannot be immersed• Risk: Difficult to clean and disinfect without immersion, which
could affect electronics
o Limitation: Button and crevices limit cleaning ability• Risk: Residuals may become trapped if procedure is not effective
o Limitation: Device cannot withstand high heat• Risk: Steam sterilization of thermal disinfection cannot be used
because they could damage the device
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Glucose Meter Cleaning Procedureo Step 1: Cleaned with Sani-Cloth wipes
• Wipes are widely used in hospitals for quick and thorough cleaning
o Step 2: Screened for TOC• Screening will confirm if unacceptable levels of residuals are
present
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Glucose Meter Disinfection Procedure
o Disinfected with Sani-Cloth wipes; liquid left on device for 5 minutes• Wipes are convenient• Does not use high heat• Does not require immersion of device
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Case Study #3: Colonoscope
o Use: Non-invasive diagnostic device used to examine the colono Device Category: Semi-critical (contacts mucosal surfaces)o Complexity: High complexityo Requirements: Cleaned and Disinfected
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Colonoscope Limitations and Riskso Limitation: Complex design
• Risk: Difficult to design a cleaning process that is both simple and effective
o Limitation: Device composed of multiple materials including metals, silicone, and glass• Risk: Susceptible to scratches
and deformitieso Limitation: Not compatible with
some cleaning agents• Risk: Corrosion or release of
toxic byproducts
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o Limitation: Knobs and screws• Risk: May retain high
residuals levelso Limitation: Not all parts are
immersible• Risk: Immersion could
destroy camera or electronicso Limitation: Repeated
reprocessing• Risk: Reprocessing could
affect device functionality
Colonoscope Cleaning Procedureo Step 1: Clean with sponge and water
• Initial cleaning removes visible contaminants• Soft sponge will not scratch device
o Step 2: Device partially immersed in Cidex OPA• Some parts are immersible; these are best cleaned by soaking
o Step 3: Wipe non-immersed parts with Cidex OPAo Step 4: Rinse with water
• Removes excess chemicals and soil
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Colonoscope Disinfection Procedure
o Step 1: Wiped and disinfected with Cidex Activated for 12 minutes• Autoclaving not an option, disinfection
appropriate• Using same type of reagent is convenient• Longer time of exposure needed to
achieve disinfectiono Step 2: Rinsed under running watero Step 3: Screened for residuals with TOC
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The Importance of Design
1. Proper design ensures device will perform and function correctly and safely
2. Good design allows the device to be thoroughly cleaned and effectively disinfected or sterilized
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Design Considerationso Material Design
o Physical Design
o Total System Design
o Misuse-related Design
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Material Design Considerationso Biocompatibility
• Non-toxic• Compatible with cleaning/disinfection reagents
o Potential release of toxic byproducts• Reactivity to reagents• Leaching of materials
o Capacity to retain residuals• porous/non-porous• Scoring by cleaning materials• Smooth vs. rough surfaces
o Metals vs. polymeric materials• Polymers may react to chemicals• Metals are susceptible to corrosion and pitting
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Physical Design Considerationso Size, shape, and configuration
• Long, narrow interior channels/lumens• Rough or discontinuous surfaces, ridges,
crevices, sharp angles, joints• Small openings
o Will the device be disassembled and reassembled?• Should be easy• Limit use of adhesives or lubricants• Small pieces may be lost
o Is there an interior space?• Consider adding an open port to facilitate
flushing soil fluids
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Total System Design Considerations
o Design elements• All components and subassemblies should handle stress of reprocessing
procedure• Certain materials don’t mix
Ex: Stainless steel and aluminum, brass, copper, or chrome platingo How does cleaning process affect delicate instruments
• Small screws• Coatings, glues, and amalgam
o Effects of reprocessing• Will toxic byproducts be released?• Possibility of corrosion?• Are there electronics?
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Misuse-related Design Considerations
o Effects of improper cleaning• Device deformities• Scratches and leaching
o Effects of incorrect sterilization or disinfection• Corrosion• Toxic byproducts• Rust or discoloration
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Goal: Identify any potential damage to the device resulting from improper use or reprocessing
o Consequences of improper reassembly• Broken devices• Lose parts• Damage equipment• Loss of time
Note: Manufacturer should attach warning to instructions for use (IFU) if serious damage could occur
Summaryo Cleaning and Disinfection/Sterilization Validation is a major factor
in achieving FDA approval
o Many design factors can positively or negatively impact validation
o An understanding of cleaning, disinfection, and sterilization processes will aid in designing a more easily validated and reprocessed device.
Thank you!
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