It is imperative to engage a testing company with expertise in regulatory compliance and contamination control to ensure the safety and efficacy of your medical devices and cleaning and disinfection processes. Element reusable medical device reprocessing validation services help you ensure the safety of your staff and your patients.
Reusable Medical Device Tests (GLP Compliant)
Every reusable medical device must be reprocessed before reuse to minimize risk of contamination. A standard reprocessing cycle includes cleaning and either sterilization or disinfection. These reprocessing Instructions for Use (IFU) must undergo validation to ensure they effectively remove various contaminants. Whether validating existing Instructions for Use (IFU) or helping to create new IFU with our guidance, our experts will develop a separate testing protocol for each processing category applicable.
Multiple standards discuss the validation and test methods for reprocessing reusable medical devices, such as AAMI TIR 12, AAMI TIR 30 (draft ST98), ANSI/AAMI ST58, ANSI/AAMI ST79, ISO 17664, and the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”.
Cleaning a reusable medical device prior to disinfection or sterilization is critical to ensure no soil remains that could limit the ability of the disinfection or sterilization process to kill organisms. A standard cleaning validation consists of soiling devices with a representative artificial soil and cleaning using the worst-case cleaning methods. A number of controls are performed alongside the test replicates to ensure that the test methodology used is appropriate for your device.
Disinfection or sterilization validation
Disinfection validations for reusable medical devices are performed to ensure the disinfection method chosen for the device effectively kills representative organisms. A device that cannot undergo sterilization will undergo either low-, intermediate-, or high-level disinfection depending on the criticality of the device and the potential exposure to pathogens. Devices are inoculated with representative organism(s), depending on the level of disinfection, and disinfected using a worst-case disinfection procedure. Surviving organisms are recovered using a suitable neutralizer and quantified to determine the efficacy of the disinfection IFU.
Sterilization validation studies for reusable medical devices ensure that the sterilization parameters chosen for your device adequately kill organisms. These are paired with dry time studies to ensure that the dry time post-steam sterilization is long enough to prevent residual moisture that could encourage microbial growth.
The Element advantage
In cases where reprocessing parameters are not ready for validation, Elements experts have the experience and knowledge to test parameters in a non-regulatory, R&D setting and finalize reprocessing instructions ready for the validation phase. 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.
If you'd like to learn more about our medical device reprocessing validation services, contact us today.
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