STERIS Corporation Launches Next-Generation Sterility Assurance Technology in the U.S.

MENTOR, Ohio STERIS Corporation, a leader in sterility assurance monitoring technologies, announces the launch of its first Class 6 products, the Verify® SixCess™ Steam Emulating Indicators and Test Packs, which are now available in the United States. The Verify SixCess indicators are reliable, high-performing monitoring devices that provide faster final reads to allow the immediate release of all loads and all items within the load.

“The Verify SixCess technology is a major advance in sterilization monitoring,” says Marshall Dahneke, vice president and general manager STERIS’s Infection Prevention Technologies division. “At a time when hospitals will be more accountable than ever for

avoidable infections, it is especially important for STERIS to be able to offer the highest possible level of assurance that patient-care items have properly completed a steam sterilization process and are safe to use.”

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 United States, 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 Food and Drug Administration (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.

Heide Ames, product manager for sterility assurance products at STERIS, notes, “We are excited to offer a sterility assurance monitoring technology with so many benefits for patients and healthcare providers. The Verify SixCess indicators provide confidence for the user in so many ways. The Class 6 emulating indicator ink we use is a ‘best in class’ technology and is compliant with world indicator standards (ANSI/AAMI/ISO 11140). The SixCess cycle-specific design provides more process information, more accurately. In addition, the use of Verify SixCess

products allows a sterile processing department to immediately release all loads without the need to quarantine loads, use expensive readers or complete emergency release documentation, which will help the department streamline their workflow further and establish a consistent load release protocol.”

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.

Source: STERIS Corporation

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