ABSTRACT
Ensuring that medical devices and their component parts are free from contamination is exceptionally signi©cant for the medical device industry. Inadequate or improperly cleaned medical device products can harm patients. Potential consequences include litigation and, ultimately, even business failure. Many devices are sterile products, and anything labeled as sterile is something that the United States Food and Drug Administration (USFDA) or any European regulatory agency is going to see as possessing the highest level of risk to the public. As a result, the control of potential sources of contamination becomes of primary importance.
