Medical Device Reprocessing

Infection Prevention & Control

Medical Device Reprocessing (MDR) in collaboration with Infection Prevention and Control (IPC) has developed two educational videos that provides detailed information on how to reprocess critical and semi-critical medical devices correctly to ensure patient and staff safety. The two videos address reprocessing activities in centralized and decentralized reprocessing areas.

Centralized Medical Device Reprocessing

This training video is for reprocessing staff in a centralized area that is dedicated to reprocessing medical devices such as surgical instruments, endoscopes, respiratory equipment, etc.

Section 1 - Introduction
Section 2 - Quality Systems
Section 3 - Infection Prevention
Section 4 - Workplace Health
Section 5 - Decontamination Process
Section 6 - High Level Disinfection
Section 7 - Assembly
Section 8 - Sterilization of Devices
Section 9 - Flash Sterilization
Section 10 - Storage and Transport
Section 11 - Flexible Endoscopes
Section 12 - Loaned, Trialed and Damaged Devices

Decentralized Medical Device Reprocessing

This training video is for reprocessing staff in a decentralized area located outside the centralized reprocessing department and reprocess medical devices such as surgical or dental instruments, endoscopes, diagnostic probes, etc.

Section 1 - Introduction
Section 2 - Quality Systems
Section 3 - Infection Prevention
Section 4 - Workplace Health
Section 5 - Decontamination Process
Section 6 - High Level Disinfection
Section 7 - Assembly
Section 8 - Sterilization of Devices
Section 9 - Storage and Transport
Section 10 - Flexible Endoscopes
Section 11 - Loaned, Trialed and Damaged Devices

Standard Operating Procedures

*Note: Some SOPs are still in stages of final approval and will be linked here when complete. For more information, email ipcsurvstdadmin@ahs.ca.

• 1.0 - Sterilization and High-Level Disinfection
  • 1.1 – Pre-process
    • Identification and Handling of Devices that are Difficult to Clean
    • Transportation of Contaminated Items to Reprocessing Area
    • Inspection Identification and Disposal of Damaged/Defective Devices
  • 1.2 – Process
    • Cleaning Medical Devices, According to Manufacturer’s Instructions
    • Reprocessing Critical Reusable
    • Reprocessing of Semi-Critical Reusable Medical Devices
    • Steam Sterilization
    • Immediate Use Steam Sterilization (IUSS)
    • Chemical High-Level Disinfection
    • Thermal High-Level Disinfection
    • Reprocessing of Flexible Endoscopes: General Requirements
  • 1.3 –  Post-process
    • Packaging of Reusable Critical Medical Devices
  • 1.4 –  Environment
    • Environmental Cleaning
    • Pipes and Fittings
  • 1.5 –  Equipment Used
    • Use of Maintenance of Containers Designed for IUSS
    • Rigid Sterilization Container Systems
• 2.0 - Support
  • 2.1 – Safety
    • Management of Sharps and Biomedical Waste Disposal
  • 2.2 – Supplies
    • Purchase and Evaluation of Reprocessing Supplies
  • 2.3 –  Contingency
    • Contingency Plans as a Result of Steam, Water Interruptions
    • Contingency Plans for Sterilizer Shutdowns
    • Contingency Plans for Automated Equipment S/D
    • Contingency Plans for Large Scale Inventory Loss
    • Delayed After Hours Reprocessing of Flexible Endoscopes
• 2.4 –  Quality Assurance
  • Quarantine of Implantable Medical Devices Pending Biological Indicator (BI) Result
  • Management of Positive Biological Indicator (BI) or failed Sterilization Mode
  • Steam Sterilizers Daily Routine Biological Monitoring
  • Quality Monitoring, Routine Testing of Automated Cleaning Equipment
  • Sterility Assurance Monitoring
  • Preventative Maintenance of Automated Equipment
  • Operational & Performance Qualification of Pouches 
• 2.5 –  Response
  • Management and Reporting of Adverse Events in MDR Area
  • Evaluation and Response to Incidents of Temperature and Humidity
  • Customer Concerns
• 3.0 - Human Resources
  • Specifying Management and Staff Responsibilities Specific to MDR
  • Management and Staff Qualification, Education and Training Specific to MDR
  • Personal Protective Equipment
  • Staff Health Management
  • Dress Code and Prohibited Activities

Resources

• Canadian Association of Medical Device Reprocessing (CAMDR)
• Communicable Disease Assessment
• Medical Device Reprocessing of Reusable Critical and Semi-critical Medical Devices: Review Criteria and Supporting Standards (RCSS)
• Management of Loaned, Reusable Critical and Semi-Critical Medical Devices
  • Frequently Asked Questions 
• Occupational Exposure to Blood and Body Fluids
• Records Management
• Records Retention Schedule
• Reusable & Single-Use Medical Devices Standards