Applicable Standards
- ISO
- AAMI
- ASTM
Services Summary
Nelson Labs offers a full range of cleaning, disinfection and sterilization validation services to validate manufacturers’ reprocessing instructions for reusable medical devices. This is essential to ensuring that medical devices processed in a health care setting are safe for their intended use or reuse and that they remain safe over their life cycle.
Medical device manufacturers should validate end-of-life cycles for reusable or reprocessed medical devices to demonstrate functionality with repeated exposures and clinical simulations.
Cleaning Validations
Manufacturers of reusable medical devices such as reusable instruments, trays, surgical kits, etc. must have validated cleaning instructions in their instructions for use. The cleaning validation process includes contamination, cleaning using clinically relevant worst-case conditions and post-reprocessing effectiveness evaluations. Simulated-use testing practices are employed to simulate actual surgical procedures rather than direct inoculation methods. Options are available to use validated or customized test soils to create clinically relevant conditions. The reprocessing scientists at Nelson Labs actively serve on applicable AAMI, ASTM and ISO committees and have expertise in creating appropriate worst-case testing conditions to help device manufacturers meet regulatory expectations. Cleaning validations are performed in compliance with AAMI TIR12, ANSI/AAMI ST98, and FDA guidance documents. Testing is ISO17025 accredited and can be performed under GLP conditions.
Disinfection Validations
Following cleaning validation, a full disinfection validation is performed to validate the manufacturer’s disinfection instructions which require that each device or component be disinfected separately. Disinfection instructions are typically needed when a device cannot be sterilized using elevated temperatures (e.g., steam sterilization, dry heat) or is not compatible with ethylene oxide (EO) or other sterilization methods. Disinfection can be performed through chemical or thermal (e.g. A0) methods, both of which can be validated at Nelson Labs. Chemical disinfection validations should be performed with clinically relevant and approved disinfectants. Disinfection validations are performed in compliance with AAMI TIR12, and FDA guidance documents. Reprocessing scientists at Nelson Labs can assist with selection of appropriate inoculation locations and ensuring validations meet applicable guidelines.
Sterilization Validations
A sterilization validation test confirms the appropriate Sterility Assurance Level (SAL) of the medical device. The testing establishes the pertinent sterilization parameters for health care reprocessing instructions. Based on the data obtained through testing, the manufacturer will be able to provide health care facilities with validated sterilization parameters. The most common sterilization method for reusable medical devices is prevacuum steam sterilization. Additionally, Nelson Labs can validate using gravity steam sterilization, EO, liquid chemical, or dry heat.
End of Life Cycle testing
In addition, if a maximum number of uses is indicated in the instructions for use manufacturers should validate end-of-life cycles for reusable or reprocessed medical devices to demonstrate functionality after repeated exposures to the full reprocessing cycle. Nelson Labs can assist in study design and execution of functionality and repeated use studies. End of life testing has also come under more focus in recent years from a biocompatibility point of view. At Nelson Labs, reprocessing and biocompatibility experts work together to determine an appropriate end of life testing strategy for reusable medical devices from both a reprocessing and biocompatibility point of view.
Consulting services
Nelson Labs has the equipment and qualified personnel to help guide you from selecting worst-case devices for testing, developing instructions for use, to ensuring your testing setup complies with applicable guidelines for your target market. Our experts will provide individualized consultation and are here to help simplify the complex regulatory and standard recommendations.
Contact Us
If you have additional questions, contact one of our global offices by email or phone.
North America
Phone: +1 (801) 290-7500 or +1 (800) 826-2088
Email: [email protected]
Europe
Phone: +32 (0) 16 40 04 84
Email: [email protected]
