March 22, 2023
Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life
Biological evaluation for reusable devices may reasonably not be focused on “shelf life”. The heart of this question hinges first on general medical device principles regarding shelf life (or lack thereof) vs. stability over the device’s lifetime. Much can be said about that, so I won’t go too far down the rabbit hole about that here unless otherwise requested. But in summary, it has been established that not all medical devices have, or need, a shelf life. Yet all devices have a life-cycle within which there is an “expected life” (U.S. FDA), lifetime (ISO 13485, ISO/TN 24971), expected lifetime (EU MDR), etc.
Accordingly, I don’t believe that ISO 10993-1:2018 clause 4.7 (“The biological safety of a medical device shall be evaluated by the manufacturer over the whole life-cycle of a medical device.“) means that shelf life is an important point of biological evaluation for any medical device. Instead, the device’s shelf life is germane only if the device has a shelf life.