That sterility is among the most critical factors concerning medical devices is beyond question. The FDA has a set of clearly defined rules and requirements concerning sterilization of medical devices. This agency makes any firm reprocessing another manufacturer’s medical device the legal manufacturer and invests it with all the responsibilities for compliance, especially concerning sterility. When a medical device company fails to prove sterility, it is almost certain to witness either a voluntary recall or one that is mandated by the FDA. This rule applies even to those companies that are reprocessing their own medical device. In case the device is to be re-sterilized by the user facility, the company doing it must adhere to strict and precise cleaning and sterilization instructions, and should validate them. While reprocessing of single use devices has received a lot of attention concerning their regulatory requirements, attention to reprocessing reusable medical devices and t...