scope:

Introduction

Healthcare sterile processing and medical device manufacturing professionals of today need a comprehensive understanding of sterilization processes and how to produce sterile product. Device manufacturers are required to provide information to the Food and Drug Administration (FDA) on how they will address the manufacturing of all products and how reusable products are to be cleaned and sterilized by the end user or sterile processing professional. For device manufacturers to fulfill this obligation, an understanding of the cleaning and sterilization processes used in health care is required. Sterile processing professionals must ensure that

a) their sterilization processes meet quality assurance standards;

b) they are adhering to these processes;

c) the methods used for the products that they process are verified; and

d) the processes used for the sterile products they create are validated.

This book is intended to be used as a textbook by medical device manufacturers, healthcare sterile processing professionals, and students of sterilization. It explains concepts and provides examples and definitions for sterilization science, quality management, validation theory, and cleaning and sterilization practices, focusing on steam sterilization as a model process for hospital application and on product quality assurance testing methods used in U.S. hospitals.