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How Am I Supposed to Clean and Sterilize My Devices? 
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In this Webisode we will address one of the most common questions asked by our customers today. “What information should I follow to determine approved cleaning and sterilization instructions?”

This issue of IFU compliance is a hot topic and area of focus for many healthcare facilities right now, and we are going to explore this subject today, looking closely at what the AAMI standards have to say. In addition we’ll also discuss some practical options for you and your facility.

First, let’s look at the amendment to AAMI standard ST79 for sterilization. In section 7.2.2 it states:

“The written IFU of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized…The manufacturer’s written IFU should be kept on file and periodically reviewed for any updates. If there are no specific written IFU instructions in the labeling, then the manufacturer should be contacted directly to provide a documented method.” 1

AORN also supports AAMI ST79 and state in their AORN Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment that “The manufacturer’s written, validated instructions for handling and reprocessing should be obtained and evaluated to determine the ability to ade¬quately clean and reprocess the equipment within the health care facility before purchasing surgical instruments and powered equipment.” 2

Because the Joint Commission and other agencies want to make sure you are following the most updated standards and instructions, it has become the facility’s responsibility to comply with the latest IFUs. Medical device manufacturers, or MDMs, are continually updating IFUs to meet regulatory guidelines; so even an IFU that is only two to three years old may already be out of date.

How can you streamline this process of being up to date with IFUs?

In this dynamic environment and increasing focus on IFU compliance we are pleased to report that STERRAD® Systems are currently listed in IFUs by many device manufacturers for terminal sterilization. At ASP, we work closely with many Medical device companies to make sure we maintain the most current IFUs for instruments listed in our online reference tool, the STERRAD® Sterility Guide, also known as the SSG. Every device listed in the SSG is backed by an acknowledgment from the device manufacturer in their labeling or instructions for use.

It’s worth noting that we are constantly adding new devices to the SSG. In fact in the last two months alone, we added thousands oflistings. As a general purpose sterilizer, STERRAD® Systems can process many stainless steel accessories and instruments, as well as the critical devices listed on the SSG.

Visit SSG http://www.sterradsterilityguide.com/.

Or for more information, visit ASP at http://www.aspjj.com.

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