Most medical device manufacturers realize they need to have an environmental monitoring system (EM) within their facility. The EM establishes a count of microorganisms that are naturally occurring in the environment. Where manufacturers sometimes fall short is actually identifying those organisms.

One of the biggest challenges faced by hospitals today is the cleaning, sterilization and reprocessing of medical devices. Thousands of devices are cleaned and reprocessed each day at each hospital making it very difficult to reference and follow device specific IFU’s.  The process has now become even more complicated with recent regulatory changes.