Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation

What You Need to Know? 👇

What are the six FDA criteria for reprocessing instructions for reusable medical devices?

FDA requires reprocessing instructions to: 1) reflect intended use, 2) advise thorough cleaning, 3) indicate appropriate microbicidal process, 4) be technically feasible with legally marketed accessories, 5) be comprehensive, and 6) be understandable to users.

Which medical devices require validation data in 510(k) submissions for reprocessing instructions?

High-risk devices including flexible endoscopes (bronchoscopes, duodenoscopes, gastroscopes), automated reprocessors, water-based heater-cooler systems, and devices with challenging design features like lumens, hinges, or internal channels require complete validation data in 510(k) submissions.

What is the difference between cleaning, disinfection, and sterilization in medical device reprocessing?

Cleaning physically removes soil and contaminants. Disinfection kills most microorganisms but not necessarily spores. Sterilization eliminates all viable microorganisms. Each process must be validated separately, with cleaning being essential before any microbicidal process.

How should manufacturers validate cleaning processes for reusable medical devices?

Validation requires worst-case testing using clinically relevant artificial soil, inoculation of difficult-to-clean areas, simulated use conditions, and at least two quantitative test methods. Testing should use shortest times, lowest temperatures, and weakest concentrations specified in instructions.

What sterilization cycle parameters should be specified in reprocessing instructions?

Instructions should specify validated parameters consistent with FDA-cleared sterilizers: steam (temperature, time, drying), EO (concentration, humidity, temperature, aeration), or manufacturer-specific cycles for H2O2/O3 systems. Ranges should not be used as they imply all intermediate values are validated.

When must reprocessing validation be completed for medical device submissions?

All cleaning, disinfection, and sterilization methods must be validated and completed prior to submission of premarket applications. Reprocessing instructions should reflect the validated methods, and documentation requirements vary by submission type (510(k), PMA, IDE).

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What You Need to Do 👇

Recommended Actions

1. Review device design to optimize cleanability and reprocessing
2. Develop comprehensive reprocessing instructions addressing:
   • Point-of-use processing
   • Cleaning methods and parameters
   • Disinfection/sterilization requirements
   • Inspection criteria
   • Storage conditions
3. Validate reprocessing instructions through:
   • Cleaning validation studies
   • Disinfection/sterilization validation
   • Human factors validation
   • Simulated use testing
4. Document validation results and maintain records
5. Include appropriate warnings and precautions in labeling
6. Establish tracking system for reuse life if applicable
7. Provide user training resources and support contact information
8. Monitor post-market experience and update instructions as needed

Key Considerations

Non-clinical testing

• Validate cleaning processes separately from disinfection/sterilization processes
• Use at least two quantitative test methods to measure clinically relevant soil
• Conduct simulated-use testing under worst-case conditions
• Validate extraction methods for recovery of residual soil
• Validate cleaning endpoints and acceptance criteria

Human Factors

• Develop consistent reprocessing instructions across product lines
• Validate that users can understand and follow the instructions
• Consider use environment and personal protective equipment
• Observe and document participant behavior during validation
• Address any known post-market human factors issues

Labelling

• Provide comprehensive, sequential instructions from initial to terminal processing steps
• Include diagrams, photos, illustrations where helpful
• Specify all required equipment, accessories, and parameters
• Include warnings and precautions
• Provide contact information for questions

Biocompatibility

• Validate that residual cleaning agents and disinfectants are reduced to non-toxic levels
• Consider endotoxin removal requirements for certain devices

Safety

• Include safety warnings and precautions
• Specify appropriate personal protective equipment
• Address chemical exposure risks
• Include disposal instructions for failed devices

Other considerations

• Consider device design features that facilitate cleaning
• Validate reuse life and provide tracking method
• Consider material compatibility with cleaning/sterilization methods
• Address storage conditions and shelf life
• Consider point-of-use processing requirements

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Relevant Guidances 🔗

• Design Considerations for Medical Devices Intended for Home Use
• Applying Human Factors Engineering and Usability Engineering to Medical Devices
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Design Controls for Medical Device Manufacturers

Related references and norms 📂

• AAMI TIR12: Designing, testing and labeling reusable medical devices for reprocessing in health care settings
• AAMI TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
• AAMI/ANSI ST81: Sterilization of medical devices - Information to be provided by the manufacturer
• IEC 62366: Medical devices – Application of usability engineering to medical devices
• ANSI/AAMI HE75: Human Factors Engineering – Design of Medical Devices

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Original guidance

• Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
• HTML / PDF
• Issue date: 2015-03-17
• Last changed date: 2020-03-02
• Status: FINAL
• Official FDA topics: Medical Devices, Premarket Approval (PMA), 510(k), Premarket, Investigational Device Exemption (IDE)
• ReguVirta ID: 6a449cb82a0824f81865e80a72de6024