Yesterday, the Association for the Advancement of Medical Instrumentation (AAMI) issued a press release regarding steam sterilization. Their upcoming new publication will cover 26 specific additions/revisions to existing ST79 guidelines. Copies of the amended standards are expected to be available in published form by early August at the latest. Customers who have purchased the previous version will be able to download the updates via PDF without having to pay an additional fee.
These new standards will focus in part on chemical indicator (CI) use. There are now 6 classes of CIs that can be used in steam sterilizers. Class 1 indicators are very basic and merely distinguish whether or not a particular item or load has been run through a sterilizer. They don’t measure the specific parameters of a cycle. Class 2 CIs are used to monitor the integrity of an autoclave’s vacuum system. They react to air in the chamber and allow the operator to easily detect leaks and pump failure. This is often referred to as a Bowie Dick test.
Indicators in classes 3 and 4 monitor single and multiple cycle parameters respectively. They can be used to measure temperature and/or length of exposure. Many hospitals turn to class 5 indicators (also called integrators) as a substitute for biological indicators for day to day validation. This eliminates the waiting period necessary for culturing BI test results.
The newest level of indicators are referred to as Class 6. They are designed to be the most accurate CI on the market for use in steam sterilizers. However, because they were so recently developed, there is some confusion over the appropriate uses for these testing devices.
AAMI has not yet reached a consensus on any guidelines for the Class 6 CIs. The organization’s revised publication is designed simply to bring this new option to the attention of the Sterile Processing and Distribution community. The current revision does outline what steps personnel should take when a CI shows a “positive” result. The ST79 is being continually updated, so look for more information on this topic once the Steam Sterilization Hospital Practices Working Group has hashed out the details and decided on a final recommendation.
Additional Issues Addressed
Risk analysis is another topic of interest in the updated ST79. Since there is no perfect system, it makes sense to fully assess each sterilization process and all equipment to identify possible future points of failure. Having a protocol in place for handling the aftermath of an error or system breakdown is essential. Trying to come up with a sensible plan on the spur of the moment just doesn’t work. It takes careful planning to cover all eventualities. This applies especially to the potential legal consequences of accidental distribution of unsterile devices.
The AAMI is also addressing testing for flash sterilization and rigid container use. All of these updates are designed to make it easier for SPD techs to do their jobs well. Similarly, our free report is created to help hospital and lab equipment procurement agents make smart decisions. Save time searching for the best autoclave for your facility by reading this guide.