With the growing use of reusable medical devices and the increased pressure on manufacturers to prove that their reprocessing instructions for use (IFU) are correct, the validation of cleaning, reprocessing and sterilization of reusable medical devices is critical.
At Lucideon, we’ll support you as you develop reusable medical devices and submit them for regulatory approval.
- Process design and development for the reprocessing of a medical device
- Validation of the effectiveness of a reprocessing method (cleaning, disinfection and sterilization)
- Validation of the compatibility of a device with the method
- Choice and identification of appropriate soils and detergents.
In our ISO 17025 and cGMP-accredited laboratories, we work to AAMI TIR12:2010, Designing, testing and labelling reusable medical devices for reprocessing health care facilities: A guide for medical device manufacturers, and AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, guidance.
What makes us unique?
- Unlike other laboratories, we can perform both chemical and biological testing
- We have a world-leading surface science facility that provides cleaning validation through surface analysis
- We are not just a test lab – we are materials experts who focus on providing solutions to your challenges, e.g. when a product, process, method or cleaning protocol fails
- We have many years’ experience in cleaning validation and have a proprietary program, VALIDATA, that provides quantitative, on-going third party cleanliness validation.
Surface contamination investigation
Application of Lucideon's cleaning validation procedure - Validata
Lucideon has worked with Greatbatch Medical to help them gain FDA approval.