By: Emily Mitzel, Consulting Manager
Published: Medical Design Technology
Appropriate cleaning of cardiovascular devices is extremely important. If the device is not clean, it can lead to infection, sepsis, septic shock, blood clots, blockages, chemical impact, or toxicological repercussions. Medical device manufacturers must have an understanding of what is considered clean for their devices and which special considerations are necessary when testing cardiovascular devices. While today’s cardiovascular devices have become more sophisticated and complex, FDA 501(k) and premarket authorization (PMA) requirements have become more extensive and detailed.