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The Roundtable: Sterilization equipment

In this month’s roundtable, experts weigh in on trends in sterilization. They explain how new sterilization methods and technological advancements in equipment might affect the considerations of a purchasing team when shopping for these strictly

Tue Jul 03 2012By TechNation Magazine

In this month’s roundtable, experts weigh in on trends in sterilization. They explain how new sterilization methods and technological advancements in equipment might affect the considerations of a purchasing team when shopping for these strictly regulated devices. There are significant regulatory considerations – the FDA is currently revising its reprocessing guidelines, and The Joint Commission has issued stringent standards on device maintenance and training. Those changes present new challenges for maintenance and equipment management in particular. In today’s sterilization environment, experts say evidence is paramount: now is not the time to do things the way they’ve always been done.

This month’s responders include Ralph Basile, vice president of marketing at Healthmark and Steve Kovach, the company’s director of education; Cathy Rocco, RN, senior clinical education consultant for Advanced Sterilization Products; and Jonathan A. Wilder, Ph.D., president of H & W Technology, LLC, at Stericert Co.

WHAT ARE THE BIGGEST TRENDS RIGHT NOW IN THE STERILIZATION EQUIPMENT MARKET?

BASILE AND KOVACH: There are technological trends. In particular are the introduction of new types of sterilization. The great challenge is developing a “cold” sterilization method that can be safe and effective with all medical devices. Currently, one method has not been validated for all instrumentation. The result is a hodge-podge of methods that must be cobbled together for a complete solution.

There are regulatory trends. The FDA is in the process of rewriting their guidelines for device reprocessing. These changes, along with efforts by AAMI and others, will hopefully lead to more thorough instructions and devices that are easier to reprocess. A major focus is related to the cleaning of medical devices. Designing instruments that can more easily be cleaned in a healthcare setting and verifying that the cleaning process was effective are likely to be the result of these regulatory efforts.

The other is how to go green with equipment and accessories for the sterilization process. One example is the reusable Bowie-Dick product that can reduce the waste stream and still provide valuable information. Another is a reusable PCD for the BI test. Lastly is electronic recording keeping of all the results from the sterilization process.

ROCCO: One of the biggest trends in the marketplace is standardizing all manufacturers’ Instructions for Use (IFUs). Every reusable equipment manufacturer has different sets of parameters for the sterilization process with variable drying times. This can cause a bottleneck in the sterile processing department, as the parameters on sterilizers have to be changed in order to comply with the different IFUs – which may mean that just one item can be processed at a time. To help healthcare professionals comply with IFUs, ASP developed the STERRAD Sterility Guide (SSG). The SSG enables healthcare professionals to quickly and easily identify which devices fall within STERRAD System sterility claims and is available online and as a mobile app.

WILDER: I am seeing trends that are not so much for equipment as for expanded capability. Everyone wants more throughput with the same or fewer employees. But no one wants a failure. Older machines, especially washers, are being replaced with machines that give more capability. Instrument-specific inserts for endoscopic equipment are an example of what SPDs are looking for. Limited space and utilities tend to make people think harder for more flexible solutions. Newer washers with automatically selected cycles based upon the rack used are a key part of this. Also, reduced cost of ownership and increased reliability. Place a new steam sterilizer in a booth at IAHCSMM and crowds flock to it, hoping that it would be a better solution than they have. This is not to say that what they have is bad, but we all want better equipment, not just good equipment...

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