Decontamination of Reusable Medical Devices

Decontamination Point of Use Preparation and Transport

• Decontamination is necessary to prevent infection and is essential for reusable medical devices (RMDs) that come into contact with patients or surgical fields.
• Spaulding Classification System: The system categorizes RMDs into three levels based on the risk associated with their use:
  • Non-Critical: Devices used on skin surfaces (e.g., stethoscope)
  • Semi-Critical: Devices that contact mucous membranes or non-intact skin (e.g., Parkes retractor)
  • Critical: Devices used in sterile areas or with blood contact (e.g., Travers retractor)
• Cleaning and Disinfection: The appropriate level of reprocessing depends on the device classification. Critical devices require sterilization, while semi-critical devices require high-level disinfection and non-critical devices generally require cleaning.
• Reprocessing Steps: These are the steps included in the surgical instrument processing:
  • Pre-Preparation (wiping & keeping moist): This occurs in the operating room (OR) or sterile processing department (SPD)
  • Manual Cleaning: Performed at the SPD
  • Ultrasonic Cleaning: Optional, if needed
  • Automated Washer: Performed before instrument care
  • Instrument Care:
  • Sterilization: The final step
• Sorting and Disassembly of Contaminated RMDs: Once RMDs are delivered to SPD, they should be sorted and disassembled efficiently to minimize contamination risk.
• Disassembly:
  • Open all device components like locks and hinges to facilitate cleaning.
  • Place devices in mesh baskets to ensure adequate cleaning and avoid stacking.
  • Arrange items in mesh trays for automated cleaning to expose all surfaces.
  • Place heavy items on the bottom or in separate trays for stability.
  • Secure lighter items to prevent movement during cleaning.
  • Flush lumened devices with a jet-gun, rinsing thoroughly with water.
• Three sinks: Washing, potable water rinse, and purified water rinse
• Disinfection:
  • Eliminates pathogenic micro-organisms on inanimate objects (excluding bacterial spores).
  • Two types:
    • Thermal Disinfection: Achieved in a thermal washer-disinfector at specific temperatures. Monitoring temperature and time is crucial.
    • Chemical Disinfection: Achieved using an appropriate disinfectant with consideration of concentration, contact time, temperature, and pH.
• High-Level Disinfection: Minimum treatment recommended for thermo-labile devices (e.g., endoscopes) used in semi-critical sites
• Low-Level Disinfection: Minimum treatment recommended for instruments used in non-critical sites.
• Water Quality: Crucial to ensure a successful cleaning process and maintain the integrity of devices. Water purity and compatibility with chemicals, devices, and washers are critical.
• Washer-Disinfector Testing: Requires regular testing and quality assurance to ensure it meets standards.
  • Daily: Spray arm rotation, nozzle inspection, strainer and filter cleaning
  • Weekly: Automatic control test, safety checks, water hardness, conductivity, and cleaning efficacy testing (residual soil detection).
  • Quarterly Automatic control test, calibration verification, thermometric test, and cleaning efficacy assessment.
  • Annually: Automatic control test, calibration verification, water system, drainage, doors, door interlocks, fault interlocks, water vapor discharge, aerosol discharge, chemical additive dosing, load carriers, air quality, cleaning efficacy, over-temperature cut-out, thermometric tests for thermal disinfection, load dryness test, and process residues.
• Tunnel Washers: Provide hands-free reprocessing in a cycle of pre-rinse, washing, ultrasonic, rinse, and drying.
• Ultrasonic Cleaners:
  • Require regular testing to ensure they operate effectively.
  • Daily: Strainers and filters, visual inspection of items for visible soil after cleaning (load rejection if soiled)
  • Weekly: Automatic control test, safety checks, cleaning efficacy test.
  • Quarterly: Automatic control test, calibration verification, ultrasonic activity, cleaning efficacy test
  • Annually: Revalidation of commissioning procedures, additional tests may be needed.

Further Reading

• Details on the cleaning steps are available in HTM 01-01 Part D from the nhs website: https://www.wales.nhs.uk/sites3/docopen.cfm?orgid=254&id=223475

This quiz covers the essential decontamination processes for reusable medical devices (RMDs) and the Spaulding Classification System. Understand the categorization of devices based on their risk levels and the appropriate cleaning, disinfection, and sterilization methods required. Perfect for healthcare professionals seeking to enhance their knowledge in infection control practices.