Reusable Medical Device Reprocessing and Testing (GLP Compliant) services
Ensure your reusable medical devices meet strict safety and regulatory requirements with comprehensive reprocessing validation and testing services. From initial R&D through final validation, our GLP-compliant testing supports your complete reprocessing cycle validation needs while addressing complex regulatory challenges. You can rely on our expert guidance on cleaning, disinfection, and sterilization parameters.
What are Reusable Medical Device Reprocessing and Testing (GLP Compliant) services at Element?
Reusable medical device reprocessing ensures devices can be safely cleaned, disinfected, or sterilized between uses. At Element, we provide comprehensive GLP-compliant testing services to validate or redesign your reprocessing Instructions for Use (IFU), ensuring they effectively remove contaminants and meet regulatory requirements for patient and staff safety.
What can Element offer you for Reusable Medical Device Reprocessing and Testing (GLP Compliant) services?
Components and materials we test
Components and materials we test
We validate reusable medical devices across all criticality levels, from those requiring basic cleaning to devices needing high-level disinfection or sterilization. Our testing covers devices with various materials, surface finishes, and cleaning challenge levels.
Key tests offered
Key tests offered
- Cleaning validation with artificial soil testing
- Disinfection efficacy validation (low, intermediate, high-level)
- Sterilization parameter validation
- Post-sterilization dry time studies
- Environmental impact evaluation on device markings
- Functionality testing after repeated sterilization
- Reprocessing cycle
- Disinfection or sterilization validation
Methods and solutions offered
Methods and solutions offered
We develop custom testing protocols for each processing category, incorporating controls alongside test replicates to verify methodology appropriateness for your specific device. Our approach includes R&D testing to finalize parameters before validation, worst-case scenario testing, and comprehensive documentation support. Our team serves on a number of standards committees and can provide guidance in determining worst-case soiling, cleaning, and disinfection procedures to ensure your validation is sufficiently robust.
Reprocessing Cycle:
Reusable medical devices must be reprocessed before reuse to minimize contamination risk. The reprocessing cycle includes cleaning, sterilization, or disinfection, and the Instructions for Use (IFU) must be validated to ensure they effectively remove contaminants. Whether validating existing IFUs or creating new ones, our experts will develop a tailored testing protocol for each applicable processing category.
Cleaning Validation:
Cleaning a reusable medical device prior to disinfection or sterilization is critical to ensure no soil remains that could limit the ability of the disinfectation or sterilization process to kill organisms. Cleaning validation involves soiling devices with a representative artificial soil and using the worst-case cleaning methods. Test controls are performed to confirm the methodology is suitable for your device.
Disinfection and Sterilization Validation:
Disinfection validation ensures the chosen method effectively kills representative organisms. Depending on the device's criticality, disinfection can be low, intermediate, or high-level. Devices are inoculated with pathogens, disinfected using worst-case procedures, and surviving organisms are quantified to assess efficacy. Sterilization validation ensures the chosen sterilization parameters effectively eliminate organisms. This includes dry-time studies to prevent residual moisture, which could encourage microbial growth.
Which labs offer this service
Which labs offer this service
Our team operates from Life Science hubs across the world, providing global access to our expert capabilities. Find your nearest Life Science testing hub on our Locations Page.
Standards we test to and products we test
- Reusable medical devices
- Medical instruments requiring autoclave sterilization
- Devices requiring high-level disinfection
- Devices with complex cleaning requirements
- Medical equipment with specific marking requirements
Your Challenges, Our Solutions
Regulatory Compliance Complexity
Technical Validation Hurdles
Process Parameter Uncertainty
Selecting The Best Testing Partner
Why Choose Element
Standards Leadership
Comprehensive Support
Global Testing Network
Historical Excellence
Related services
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Reusable Medical Device Life Cycle Validation
Comprehensive life cycle validation for reusable medical devices. Supporting compliance, patient safety, and regulatory approval through expert testing and risk mitigation.
Frequently asked questions
Why is cleaning validation critical?
Cleaning validation ensures no soil remains that could compromise disinfection or sterilization efficacy. This is critical because any remaining soil could limit the ability and subsequent processes to kill organisms, potentially endangering patients and staff. We validate using representative artificial soil and worst-case cleaning methods.