In the past, the primary focus for reusable medical devices was on validating reprocessing efficacy with regard to infection control. However, with the advent of the new Medical Device Regulation (MDR), the scope has expanded to include the critical aspect of biocompatibility. This involves assessing how numerous reprocessing cycles impact the device and ensuring it remains safe for patient use throughout its lifecycle, as mandated by ISO 10993-1.
This webinar will delve into the complexities and challenges of maintaining biocompatibility in reusable medical devices. While the theory of ensuring biocompatibility sounds straightforward, in practice, it presents significant challenges. Reusable devices are subjected to repeated cycles of reprocessing, involving exposure to detergents, disinfectants, and high temperatures. These conditions can alter the materials of the devices over time, raising important questions about their long-term safety and performance.
Viewers will gain valuable insights into designing a comprehensive biological evaluation plan for reusable medical devices. The presentation will cover current expectations from regulatory agencies, highlighting the importance of continuous biocompatibility assessments from first-time use through the end-of-life cycle. Key considerations will include the effects of repeated reprocessing on device materials, potential risks posed by chemical and thermal exposures, and strategies to mitigate these risks.
By the end of this webinar, participants will be equipped with the knowledge to implement robust biocompatibility assessments and reprocessing validation protocols, ensuring their reusable medical devices meet the highest safety standards throughout their entire lifecycle. This session is essential for design teams, quality assurance professionals, and regulatory personnel involved in the development and maintenance of reusable medical devices.