Choosing the profession of sterile processing guarantees you never have to attend your child’s career day at school. My daughter asked if I could come to her school and discuss my job. After explaining to her that presenting the complex nature of sterile processing to first graders would probably not be a good idea, she said, “Well, don’t you just wash instruments?” Just wash instruments? Is that really all we do?
In addition to more than 20 years of experience in the field, I have been an instructor for certification preparation for the last seven years. I consistently stress to my staff and students that the one aspect that separates them from dishwashers is sterility assurance. In conducting sterility assurance level (SAL) monitoring; it is our responsibility to utilize all available monitors to provide the highest probability that the instruments processed will not result in a healthcare-acquired infections (HAIs).
There are four basic types of sterilization monitors available for use: Administrative monitors such as policies and procedures, physical monitors such as printouts and gauges, chemical monitors and biological monitors. The intent of this article is not to impart the protocol for appropriate use of each monitor, nor is it to promote any specific brand. The respective manufacturers should be consulted regarding the appropriate use of their monitors. Rather, the objective is to focus on the controversy that has developed between biological indicators and the recently released Class 6 chemical indicators.
Biological indicators (BIs) have been the gold standard for sterility assurance for decades while Class 6 indicators, although used extensively in Europe for more than 10 years, have only been introduced in the United States for the past year. BIs contain live bacterial spores resistant to the respective sterilant while Class 6 indicators are cycle-specific and are designed to react to all the parameters of steam sterilization. They are two different, unique monitors, so why the controversy? The issue is that according to the manufacturer and the Food and Drug Administration (FDA), both monitors can be used for load release.