What is the combination of processes used to ensure a re-usable medical device is safe for further use?

Decontamination: The Process for Ensuring Reusable Medical Device Safety

Decontamination is the combination of processes including cleaning, disinfection and/or sterilization used to make a re-usable medical device safe to be handled by staff and safe for further use on patients. 1

Understanding Decontamination Components

Decontamination consists of three key processes that work together to ensure medical device safety:

1. Cleaning: The first and critical step that involves:

   • Removal of foreign material from an item
   • Washing with detergent to remove contamination
   • Rinsing and drying
   • Essential prerequisite for effective disinfection or sterilization
   • Particularly important for reducing prion transmission risk 1

2. Disinfection: Process that eliminates many or all pathogenic microorganisms on inanimate objects:

   • Level depends on device risk classification:
     • High-level disinfection for semi-critical items (contact with mucous membranes)
     • Low-level disinfection for non-critical items (contact intact skin only) 1

3. Sterilization: The most rigorous process that:

   • Eliminates all forms of microbial life
   • Required for critical items that enter sterile tissue or vascular spaces
   • Various methods available including steam autoclave, ethylene oxide, and liquid chemical sterilization 2

Risk-Based Approach to Decontamination

The Spaulding classification system guides the appropriate level of decontamination based on infection risk:

1. Critical items (enter sterile tissues or vascular spaces):

   • Require sterilization
   • Examples: surgical instruments, biopsy forceps, injection needles 1, 3
   • High-risk endoscopes like duodenoscopes are increasingly being reclassified into this category 1

2. Semi-critical items (contact mucous membranes):

   • Require at least high-level disinfection
   • Examples: endoscopes, respiratory equipment, anesthesia equipment 1, 4

3. Non-critical items (contact intact skin only):

   • Require low-level disinfection or cleaning
   • Examples: blood pressure cuffs, stethoscopes 1, 4

Decontamination Process Flow

The complete decontamination process follows this sequence:

1. Pre-cleaning: Immediate removal of gross contamination at point of use
2. Cleaning: Thorough removal of all organic debris (blood, tissue, body fluids)
3. Inspection: Verification of cleanliness before proceeding
4. Disinfection or Sterilization: Based on Spaulding classification
5. Storage: In clean, dry areas to prevent recontamination 2

Special Considerations

• Single-use vs. reusable devices: Single-use equipment eliminates decontamination challenges but presents cost, storage, and disposal issues 1

• High-risk devices: Complex devices like duodenoscopes may require enhanced processing:

  • Liquid chemical sterilization
  • Ethylene oxide sterilization
  • Double high-level disinfection 1

• Common pitfalls to avoid:

  • Inadequate cleaning before disinfection/sterilization
  • Overloading sterilization equipment
  • Improper packaging
  • Insufficient monitoring of processes
  • Improper storage of processed items 2

Monitoring and Quality Assurance

Effective decontamination requires:

• Following manufacturer's instructions
• Using appropriate mechanical, chemical, and biological indicators
• Regular validation of processes
• Proper documentation
• Staff training 2, 5

By understanding and implementing proper decontamination procedures, healthcare facilities can significantly reduce the risk of healthcare-associated infections while ensuring the safe reuse of medical devices.