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.
What You Need to Know? 👇
What are the key regulatory requirements for hospitals reprocessing single-use devices?
Hospitals reprocessing single-use devices are considered manufacturers and must comply with all FDA requirements including Quality System regulation (21 CFR Part 820), Medical Device Reporting (MDR), registration and listing, and premarket submission requirements where applicable.
How can I verify if a third-party reprocessor is FDA compliant?
Ask for documentation of FDA clearance/approval, recent inspection results, validation records for cleaning and sterilization processes, and limits on reprocessing cycles. You can also request FDA inspection reports through Freedom of Information Act requests.
What sterilization validation requirements apply to hospital reprocessors of single-use devices?
Hospital reprocessors must validate sterilization equipment and processes, achieve sterility assurance level (SAL) of 10⁻⁶, demonstrate the process doesn’t adversely affect device function, establish process controls, and maintain documentation proving specifications are met for each run.
Are hospitals exempt from Quality System regulations when reprocessing certain single-use devices?
No. Regardless of whether single-use devices require premarket submissions, hospitals reprocessing them must comply with Quality System regulation (21 CFR Part 820) requirements as they are considered device manufacturers under FDA regulations.
What adverse event reporting obligations do hospitals have for reprocessed single-use devices?
Hospitals reprocessing single-use devices must comply with manufacturer Medical Device Reporting (MDR) requirements in addition to their existing user facility reporting obligations, as they are considered the device manufacturer under FDA regulations.
How does FDA coordinate with Medicare/Medicaid regarding hospital reprocessing compliance?
FDA works with the Center for Medicare and Medicaid Services (CMS) to ensure safe reprocessing practices. FDA plans to inform CMS of any hospital single-use device reprocessors not complying with FDA reprocessing requirements.
What You Need to Do 👇
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