Reprocessing Validations of Reusable Medical Devices

Reprocessing validations of Reusable medical devices have seen overlooked for quite some time and therefore importance to these validations have taken a back seat until recently. With the upcoming MDR requirements and US FDA Scrutiny over reusable medical devices has shed a light to their importance and significance. The presentation will highlight some of the key aspects of what is required for validation studies for these type of devices and how to perform these validations. It will give a perspective of what is needed to overcome these validations and where in the design phase do these validations make their presence. Alpa Patel explains the importance of disinfection validations as well as sterilization validations.

[@furqanali4621]

Thanks a lot! That was extremely helpful! I have a question. What if we already validated the reprocessing procedures (cleaning, disinfection and sterilization) and now we want to validate the a minimum number of reprocessing cycles that our product can undergo without it’s safety, functionality etc. being significantly affected? How many samples do we need in this case? What tests are necessary? Is contamination necessary? Do we have to go through every one of the three procedures in each cycle or we can simplify?

[@King-gh5qd]

This was so helpful Can u pls tell me how to report the validation process?