Mitigating Cross-Contamination Risks in Irrigation Valves and Accessories Used with Flexible Gastrointestinal Endoscopes
This guidance focuses on mitigating cross-contamination risks associated with irrigation valves and accessories used with flexible gastrointestinal endoscopes. It provides recommendations for device design and labeling to prevent contamination between patients, particularly addressing the risk of backflow from irrigation channels into water bottles and tubing.
Recommended Actions
- Implement backflow-prevention features in irrigation system design
- Develop comprehensive labeling that clearly identifies device components and their proper use
- Establish validation protocols for backflow-prevention features
- Create clear reprocessing instructions for reusable components
- Implement proper disposal procedures for single-use components
- Establish 24-hour use limits for multi-patient use components
- Maintain design validation documentation
- Develop clear instructions for device installation and compatibility
- Create protocols for testing backflow-prevention effectiveness
- Establish quality control measures for reprocessing procedures
Key Considerations
Non-clinical testing
- Performance testing of backflow-prevention valves under worst-case conditions
- Testing should include quantitative chemical and/or microbiological assays
- Test protocol must identify relevant conditions (pressures, fluid volumes, flow conditions, etc.)
- Include appropriate positive and negative controls
Labeling
- Clear instructions for device installation and compatibility
- Identification of backflow-prevention features
- Clear identification of proximal and distal irrigation system components
- Specification of single-use vs. reusable components
- Clear reprocessing or disposal instructions
- Maximum duration of use specifications (24-hour limit for multi-patient use devices)
Safety
- At least one backflow-prevention valve or feature in the irrigation system
- Distal irrigation system components must be either reprocessed or discarded after each patient use
- Proximal irrigation system components must be reprocessed or discarded within 24 hours
Other considerations
- Proper device handling procedures
- Validation of reprocessing instructions for reusable devices
- Design validation to ensure device meets user needs and intended uses
Relevant Guidances
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
Related references and norms
- ANSI/AAMI ST91: Flexible and semi-rigid endoscope processing in health care facilities
Original guidance
- Mitigating Cross-Contamination Risks in Irrigation Valves and Accessories Used with Flexible Gastrointestinal Endoscopes
- HTML / PDF
- Issue date: 2016-11-29
- Last changed date: 2019-03-05
- Status: FINAL
- Official FDA topics: Medical Devices, Gastroenterology-Urology, Premarket
- ReguVirta summary file ID: 74f2458817fa03960a36b3ee2aeca338
This post is licensed under CC BY 4.0 by the author.