ABSTRACT
This chapter discusses the various forces that direct the validation of sterilization processing used for medical devices by defining what the Food and Drug Administration (FDA) looks for in the validation studies and by noting what types of problems the FDA observes during reviews of validation studies. The purpose of the validation study is to demonstrate that a process is capable of consistently achieving sterility at the desired sterility assurance level without adversely affecting the product or its package. The Advancement of Medical Instrumentation guidelines and International Organization for Standardization standards for the sterilization of medical devices are voluntary in the United States, but are considered acceptable by the FDA with few exceptions for the validation and operation of sterilization processes. The need for a thorough analysis of bioburden is an area often underestimated in the validation process. Solid and rigorous validation studies are an essential tool in providing the public with devices that can be trusted to be sterile.
