ABSTRACT
This chapter reviews sterilization practices in the United States includes the role of the voluntary standards established by the Association for the Advancement of Medical Instrumentation (AAMI). It examines the significant input that results from International Organization for Standardization standard-setting activities since 1990. In the 1960s, the Food and Drug Administration (FDA) had minimal control over the burgeoning use by the medical product industries of ethylene oxide and radiation. It appeared that the FDA waited for complaints from hospitals, medical practitioners and patients before initiating an investigation. The 1938 Food, Drug and Cosmetic Act placed the burden of proof on FDA to show that a product transported across state lines was in violation of the act. The Association for AAMI was formed in 1968 by several prominent physicians and surgeons who realized that the increasing application of diagnostic instrumentation and prosthetic medical devices would require guidance for the user and the servicing technicians.
