Reprocessing of Single-Use Medical Devices: Requirements for Third-Party and Hospital Reprocessors
This guidance provides clarification on the requirements for third-party and hospital reprocessors of single-use devices (SUDs), addressing their responsibilities as manufacturers under FDA regulations. It covers aspects from facility registration to quality systems, sterilization processes, and adverse event reporting.
Recommended Actions
- Register facility as a manufacturer with FDA using form FDA 2891
- Implement Quality System regulation requirements
- Establish and validate sterilization processes
- Develop documentation system for process controls and validation
- Set up adverse event reporting procedures
- Train staff on quality system requirements and procedures
- Establish management oversight of quality system
- Create procedures for device release after reprocessing
- Maintain records of all reprocessing activities
- Consider implementing relevant consensus standards for sterilization processes
Key Considerations
Non-clinical testing
- Validation studies must demonstrate that sterilization processes achieve a sterility assurance level (SAL) of 10-6 for devices used in normally sterile areas
- Evidence must show that sterilization process does not adversely impact materials or device functioning
Safety
- Hospitals must comply with Medical Device Reporting (MDR) requirements for adverse events
- Process controls must ensure specifications for sterilization parameters are always met
- Documentation of sterility validation and routine processing must be maintained
Other considerations
- Hospitals reprocessing SUDs must register as manufacturers with FDA
- Quality System regulation compliance is mandatory regardless of premarket submission requirements
- CEO/Management is responsible for quality policy and implementation
- Documentation must be maintained for equipment installation, process validation, and routine controls
Relevant Guidances
- Registration and Listing Requirements for Single-Use Device Reprocessors and Hospitals
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Quality System Information Requirements for Premarket Submissions
Related references and norms
- ISO 11135: Industrial EO sterilization
- ISO 11134: Industrial moist heat sterilization
- ANSI/AAMI ST 41: Healthcare facility EO sterilization
- ANSI/AAMI ST 46: Healthcare facility moist heat sterilization
Original guidance
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