- ISO 17664 is an international standard that specifies requirements for information to be provided by medical device manufacturers for the processing of resterilizable medical devices. This standard ensures that healthcare facilities receive appropriate instructions for cleaning, disinfection, and sterilization of reusable medical devices.
- The standard outlines comprehensive requirements for processing instructions, covering the entire reprocessing cycle from point of use through sterilization and storage. It ensures that manufacturers provide detailed, validated instructions that enable healthcare facilities to safely and effectively reprocess medical devices.
- Point-of-use handling requirements specify information that must be provided regarding immediate post-use treatment of devices. This includes instructions for preventing contaminants from drying on devices, safe transportation to processing areas, and any specific precautions needed during initial handling.
- Cleaning requirements detail how manufacturers must provide information about validated cleaning processes. This includes manual cleaning procedures, automated cleaning parameters, appropriate cleaning agents, water quality requirements, and specific cleaning tools or accessories needed.
- Disinfection information requirements specify how manufacturers must communicate validated disinfection procedures. This includes chemical disinfection parameters, thermal disinfection requirements, and any specific considerations for different types of disinfection processes.
- Sterilization process requirements detail the information needed for proper sterilization of devices. This includes validated sterilization methods, cycle parameters, packaging requirements, and any limitations on the number of reprocessing cycles.
- Inspection and function testing requirements specify how devices should be examined and tested between processing steps to ensure they remain safe and effective. This includes criteria for visual inspection, functional testing procedures, and acceptance criteria.
- Packaging and storage requirements detail how processed devices should be packaged and stored to maintain sterility or cleanliness. This includes specifications for packaging materials, environmental conditions, and storage duration limits.
- The standard addresses validation requirements for processing instructions, ensuring that manufacturers have verified that their recommended procedures are effective and reproducible. This includes requirements for documenting validation studies and their results.
- Material compatibility information must be provided, including details about the device’s ability to withstand repeated processing and any limitations on processing chemicals or methods. This helps prevent damage to devices during reprocessing.
- Quality control requirements specify what information manufacturers must provide regarding monitoring and verification of processing effectiveness. This includes recommendations for routine testing and quality assurance measures.
- Documentation requirements detail how processing instructions should be formatted and maintained. This includes specifications for clarity, completeness, and accessibility of instructions to processing personnel.
- Safety precautions must be clearly communicated, including information about personal protective equipment, handling of contaminated devices, and any specific hazards associated with processing procedures.
- The standard requires information about processing limitations, including the maximum number of reprocessing cycles, signs of material degradation, and criteria for device retirement.
- Water quality requirements must be specified, including the type and quality of water needed for different processing steps and any specific treatment or filtering requirements.
- Equipment specifications must be provided, detailing any specific requirements for cleaning, disinfection, or sterilization equipment needed to properly process the device.
- Chemical compatibility information must include specific details about appropriate and inappropriate processing chemicals, concentrations, exposure times, and temperatures.
- The standard addresses requirements for different types of healthcare facilities, recognizing that processing capabilities may vary between locations. This includes providing alternative validated methods when appropriate.
- Training requirements must be specified, including any special skills or knowledge needed to properly process the device and recommendations for staff training programs.
- Troubleshooting guidance must be provided, including common problems that may be encountered during processing and appropriate corrective actions.
- The standard requires information about process monitoring, including appropriate indicators (chemical, biological, etc.) and their proper use in verifying process effectiveness.
- Environmental considerations must be addressed, including proper disposal of processing chemicals and any environmental impact considerations related to the processing procedures.
- Maintenance requirements for both the device and any specialized processing equipment must be detailed, including routine maintenance procedures and schedules.
- The standard promotes standardization of processing instructions across different manufacturers and device types, facilitating consistent and effective reprocessing in healthcare facilities.
- Updates and revisions to processing instructions must be managed effectively, ensuring that healthcare facilities have access to current, validated procedures.
