Super spreaders: The curious and consequential impact of spreaders on bioburden testing

Bioburden testing of medical devices or products determines the presence of the total number of viable microorganisms present on and/or within a device, which is expressed as colony forming unit(s) (CFUs) per device. Accurate bioburden results are critical and used by medical device manufacturers to determine the microbiological load of devices, assess control over manufacturing and assembly processes, and define appropriate sterilization dose.