STERIS Corp. launched its first Class 6 products, the Verify SixCess Steam Emulating Indicators and Test Packs, which are monitoring devices that provide faster final reads to allow the immediate release of all loads and all items within the load.
Unlike biological indicators, which require incubation time before they show results, chemical indicators provide immediate results indicating whether the sterilizer, cycle, load or instrument pack has been exposed to one or more of the required variables (time, temperature, steam quality) necessary for a particular sterilization process or cycle. Until recently, there were five classes of chemical indicators in use in the U.S., each with different capabilities for various monitoring applications: 1. Process indicator - distinguishes between processed and unprocessed items and packs by indicating that an item has been exposed to a sterilization process. 2. Specific test indicator - used for specific test procedures defined in sterilization standards, such as a Bowie-Dick test to evaluate air removal in a sterilizer. 3. Single variable indicator - designed to react to one critical variable in a sterilization process. 4. Multivariable indicator - designed to react to two or more variables. 5. Integrating indicator - designed to react to all the critical variables of a sterilization process and to be equivalent to, or exceed, the performance requirements of a biological indicator
In early 2008 the Association for the Advancement of Medical Instrumentation (AAMI) and the FDA recognized a sixth classification of chemical indicators. Class 6 indicators are defined as emulating indicators, designed to react to all the critical variables of a sterilization process. In addition, their performance is matched specifically to recognized sterilization cycles. These cycle-specific chemical indicators are the most advanced technology in sterility assurance monitoring. They allow the immediate release of all sterilizer loads and provide a very high level of sterilization process assurance targeted for the steam cycles used today.
After completing validations of the Verify SixCess emulating indicators, STERIS has concluded that this technology consistently outperforms comparable load release indicators and test packs. For example, the Verify SixCess challenge packs and flash strips are able to detect air removal and steam penetration failures at the minimal recommended cycle exposure time.
The new Verify SixCess Class 6 emulating indicators are part of a complete quality control system for sterility assurance. They should not be used as the sole means for validation and monitoring of sterilization processes, the company said.
May 2008