Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices

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This presentation provides important details on how to save time and money in the process of reusable medical device design. The main focus is on how device material choice and design affects the cleaning and disinfection process, and what considerations design engineers need to make when creating reusable medical devices.

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Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices

  1. 1. Design Considerations for Engineers
  2. 2. Webinar Overview o 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 Considerations o Questions Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 2
  3. 3. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 3
  4. 4. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 4
  5. 5. 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” Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 5
  6. 6. What is a Cleaning Validation? o Cleaning: Removal of soil residues. Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 6
  7. 7. Cleaning Validation Procedure o 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 7
  8. 8. Cleaning Validation Acceptance Criteria o Visually Clean o Microorganisms – minimum of 3-log reduction o Residual Limits Levels: • Protein < 6.4μg • Hemoglobin < 2.2μg • Carbohydrate < 1.8μg • Endotoxin < 2.2μg Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 8
  9. 9. What is a Disinfection Validation? Definition: Process that kills pathogenic and other microorganisms by physical or chemical means Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 9
  10. 10. Disinfection Validation Procedure o Inoculate device with microbes and organic soil o Process device with validated cleaning procedure o Subject device to disinfection procedure: • Disinfectants • Thermal applications (under 100°C) o Perform microbial recovery Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 10
  11. 11. Disinfection Validation Acceptance Criteria o Visually clean o Microorganisms: 6-log reduction o Total Organic Carbon (TOC) screen for residual disinfectant Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 11
  12. 12. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 12
  13. 13. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 13
  14. 14. Sterilization Validation Acceptance Criteria o Non-critical device: SAL 10-3 o Critical device: SAL 10-6 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 14
  15. 15. 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. Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 15
  16. 16. Types of Cleaning, Disinfection and Sterilization Processes Cleaning Disinfection Sterilization Manual Cleaning with or without use of brushes, specialized tools Automated Cleaning Ultrasonic Medical Washers Low Level Kills most vegetative bacteria, some viruses and some fungi. Intermediate Level Kills vegetative bacteria, viruses, fungi and mycobacterium. High Level Kills all microbial organisms – potential to render device sterile. Thermal Disinfection via thermal applications under 100°C. High Temperature Moist heat/steam Dry heat Low Temperature Ozone Chemical Liquid - Steris Hydrogen peroxide Gas Ethylene Oxide Hydrogen peroxide (gas plasma) - Sterrad Radiation-Gamma, E-beam Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 16
  17. 17. Reusable Device Classification 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 17
  18. 18. Acceptance Criteria Summary Device Classification Treatment Options Criteria Critical (Must be Sterile) Sterilization •Sterilization: SAL – 10-6 Semi-Critical (Sterile or disinfected) Sterilization or High Level Disinfection •Sterilization: SAL – 10-6 •Disinfection: 6 log reduction Non-Critical (Does not need to be sterile) Simple cleaning or Low level disinfection or Intermediate level disinfection •Sterilization: SAL – 10-3 •Cleaning: Removal of residuals, visually clean •Disinfection: 3-log reduction *Note: Devices must be cleaned prior to disinfection or sterilization Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 18
  19. 19. Case Study #1: Surgical Forceps o Use: For surgical procedures and may potentially contact bloodstream o Device Category: Critical o Complexity: Simple o Requirements: Cleaned and Sterilized Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 19
  20. 20. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 20
  21. 21. Forceps Cleaning Procedure o 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 grooves o 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 21
  22. 22. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 22
  23. 23. Case Study #2: Blood Glucose Meter o Use: Repeatedly used for blood glucose monitoring. Body of meter may contact blood o Category: Semi-critical o Complexity: Medium complexity. Has electronic parts o Requirements: Cleaned and disinfected Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 23
  24. 24. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 24
  25. 25. Glucose Meter Cleaning Procedure o 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 25
  26. 26. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 26
  27. 27. Case Study #3: Colonoscope o Use: Non-invasive diagnostic device used to examine the colon o Device Category: Semi-critical (contacts mucosal surfaces) o Complexity: High complexity o Requirements: Cleaned and Disinfected Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 27
  28. 28. Colonoscope Limitations and Risks o 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 deformities o Limitation: Not compatible with some cleaning agents • Risk: Corrosion or release of toxic byproducts o Limitation: Knobs and screws • Risk: May retain high residuals levels o Limitation: Not all parts are immersible • Risk: Immersion could destroy camera or electronics o Limitation: Repeated reprocessing • Risk: Reprocessing could affect device functionality Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 28
  29. 29. Colonoscope Cleaning Procedure o 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 OPA o Step 4: Rinse with water • Removes excess chemicals and soil Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 29
  30. 30. 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 disinfection o Step 2: Rinsed under running water o Step 3: Screened for residuals with TOC Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 30
  31. 31. 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 31
  32. 32. Design Considerations o Material Design o Physical Design o Total System Design o Misuse-related Design Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 32
  33. 33. Material Design Considerations o 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 33
  34. 34. Physical Design Considerations o 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 34
  35. 35. 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 plating o 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? Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 35
  36. 36. Misuse-related Design Considerations Goal: Identify any potential damage to the device resulting from improper use or reprocessing o Effects of improper cleaning • Device deformities • Scratches and leaching o Effects of incorrect sterilization or disinfection • Corrosion • Toxic byproducts • Rust or discoloration 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 Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 36
  37. 37. Summary o 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! Cleaning, Disinfection, and Sterilization Validations: Design Considerations 12/8/2011 37

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