HPN's most recent Blogline post comes from Thomas K. "Chip" Moore, consultant and owner of the Sterilization-Answer-Man.com. Retired from Getinge in 2007 after a 39-year career in sales and marketing, Moore has more than 20 years experience working on AAMI Committees and is active on selected Working Groups, was a member of the AAMI Sterilization Standards Committee, and is a member of IAHCSMM and the AORN Specialty Assembly for Sterile Processing. He also served as an Ex-Officio Board member for NYSACSP for three years. He was recipient of the 2003 IAHCSMM Award of Honor and was selected by Healthcare Purchasing News as one of the 30 most influential industry people.
In his article, Moore examines the performance and validation standards set forth in Hospital Steam Sterilizer guidance document ANSI/AAMI ST8, and asks whether these test requirements are sufficiently robust, given today's mixed loads.
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“If you happened to manage a company that manufactures sterilizers for use in US healthcare, what steps would you take to sell a steam sterilizer in the United States? The first step is to recognize that sterilizers are used to process reusable medical devices for patient use, and sterilizers are considered as Class II medical devices. Therefore, they are regulated by the Food and Drug Administration (FDA). Before any Class II device can be placed into commercial distribution, the FDA must grant clearance of the labeling claims for the sterilizer. Many of those labeling claims are developed through a process called performance validation. Fortunately, a guidance document exists to help the sterilizer manufacturer develop performance data to base those labeling claims. Once the FDA clears the sterilizer for US commercial distribution, the product is considered safe and effective when the user follows the written instructions for use (IFU).
The guidance document for healthcare sterilizers is a nationally recognized standard, developed through the consensus method at the Association of the Advancement of Medical Instrumentation (AAMI). The document is ANSI/AAMI ST8, the Hospital Steam Sterilizer guidance document. The ST8 committee updates the document every five years. The current ST8 document was published in 2008. Yet, does the performance and validation testing contained in ST8 reflect current healthcare sterilization practices? This article will attempt to review those performance challenges and compare them to practices found today in US healthcare facilities, both large and small.”
To read the entire article, visit
http://www.hpnonline.com/dailyupdates/Moore-SterilizationValidation.pdf
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The article asks if any users currently use a 250-degree/wrapped/gravity-displacement cycle and my response is, "Yes." We, about once-per-month, process silicone-filled breast sizers. Manufacturer IFU's instruct us to use a 250-degree/gravity-displacement cycle.
ReplyDeleteWe run all of our standard cycles at 270 degrees/steam-flush,pressure-pulse with a 10-minute exposure and a 45-minute dry time. It appears that the SFPP cycle is treated essentially as the pre-vac cycle for instrument compatability, however, very few product manufacturers appear to have actually validated these cycles based on a review of respective IFU's.
I have expressed concerns regarding the use of pressure and the potential effect of trapping air in items with long lumens, but have not found any information to support or refute these concerns.
Hi Ken, yes, the breast sizers would be a good example and a reason to keep the 250F wrapped goods cycles. Are there other reasons? Could you ask Steris whether they sell the SFPP cycle into the European markets? Just about all European cycles go sub atmospheric at the beginning of the cycle due to air removal and steam penetration inside lumens.
ReplyDeleteNice Articles Thank for Information.
ReplyDelete