In the past, the focus for reusable devices has been on validating the reprocessing efficacy with regards to infection control. Recently however, and especially with the advent of the new era of MDR, the focus has expanded to include the aspect of biocompatibility, e.g. how the numerous reprocessing cycles could impact the device and whether it continues to be safe for the patient throughout its life-cycle. It is also stated in ISO 10993-1.
The theory sounds simple, but in reality, it poses extra challenges for reusable devices as they are reused and reprocessed over and over again. With that, questions, including what is happing to the materials over the lifetime of the reusable devices as these materials are attacked with detergents, disinfectants and are exposed to high temperatures, need to be answered and explored.
This presentation will give more insights on:
- The design of a biological evaluation plan for reusable medical devices
- Current expectations of regulatory agencies
- Consideration from the biocompatibility perspective for first-time use, in-use, as well as end-of-life cycle for a reusable medical device