Reusable Medical Device Validation
Reusable Medical Devices need to be reprocessed before reuse to ensure that the risk of contamination is minimized. The reprocessing must include cleaning (the physical removal of soil/contaminants) and either sterilization or disinfection (the deactivation of microorganisms). Before the device can be brought to market the process for each of these actions must be validated to prove that it is effective. At Accuratus Lab Services we possess the knowledge, experience and infrastructure to perform these validations:
- Sterilization (Steam, Ethylene Oxide)
- Dry Time
- Disinfection (Low Level, Intermediate Level, High Level)
- Cleaning (With Quantitative Endpoints – Protein, Hemoglobin, Carbohydrate, TOC, Custom)
Whether validating the Instructions for Use (IFU) already developed or helping to create one with our guidance, Accuratus will develop a separate testing protocol for each processing category that is agreed upon by both parties. It will be scrupulously followed by the laboratory and overseen by the Accuratus Quality Assurance department as per 21 CFR Section 58 of the Code of Federal Regulations. When the testing is completed a final report is then issued detailing the testing performed, the results and the conclusion reached.
If the reprocessing parameters are not ready for validation our experience and expertise gives us the ability to help test parameters in a non-regulatory, R&D setting. Using a variety of detergents, disinfectants and processing parameters Accuratus can assist in finalizing a set of reprocessing instructions that can then go to the validation phase.
By following applicable guidelines and recommendations from both the Food and Drug Administration (FDA) and industry groups such as the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), and the American Society for Testing and Materials (ASTM), along with our participation in these groups one can be assured that the validation testing for cleaning, sterilization and disinfection performed at Accuratus will help any device meet the requirements for safe and efficacious use.