Sterilization Quality Control: Your Path to Protecting Your Patients

By Craig Wallace

Protecting the patient is the objective of all infection prevention programs. Safe and effective processing of medical devices that have been used in surgery and patient care is a critical element of every healthcare infection prevention program. The sterilization processes used in healthcare are designed to kill all microorganisms on the medical devices, rendering them sterile. The problem, of course, is that you can’t see sterility. You can’t just look at the instruments after processing and decide if they are sterile and safe for use on a patient. You need a quality testing system designed to provide you with the information you need to decide if the instruments are safe for patient use.

Learning Objectives

1. Discuss the key elements of sterilization quality control.
2. Review the information provided by sterilization monitoring tests.
3. Examine the current best practice recommendations for sterilization monitoring.

About the Author

Craig Wallace, President of Wallace Sterilization Consulting, LLC, has over 26
years of experience in the field of medical device disinfection and sterilization.
Craig is the Convenor of the ISO Biological Indicator Working Group (TC 198, Working Group 4), the ISO committee responsible for international biological indicator performance standards, as well as a U.S. Technical Expert for Chemical Indicators (ISO WG 6) and Moist Heat Sterilization (WG 3). He is also the Co-Chair of the United States (AAMI) Biological Indicator Working Group,
and an active member of several other AAMI working groups including chemical
indicators, vaporized hydrogen peroxide sterilization, and ethylene oxide sterilization.