ONE TRAY® was cleared in 2006 by the FDA with a validated 48-hour storage period following steam sterilization on a 4-minute prevacuum cycle at 270 degrees with no dry time required. The FDA has acknowledged that the product was cleared with this storage period within which processed devices should be used. Innovative Sterilization has conducted…
Understanding FLASH per the CMS 2014 document. In a memorandum from the Center for Clinical Standards and Quality/Survey & Certification Group on August 29, 2014, CMS outlined the changes in terminology with Flash sterilization and Immediate Use Steam Sterilization (IUSS). ¹ “Change in Terminology: “Flash” Sterilization vs. IUSS: Nationally recognized organizations with expertise in infection…
FLASH is an antiquated term; it is no longer used in our industry today. In 2011, the multi societies came together to remove the word FLASH from the industry. The new word the societies created was Immediate Use Steam Sterilization (IUSS). IUSS became the new term, that replaced Flash from the aspect of no dry…
It wasn’t until midway through his career as a neurosurgeon that Dr. George Cybulski, now chief medical officer of Vested Medical, Inc., in Illinois, first visited a sterile processing department to introduce himself and learn how it worked. That’s a step that few doctors ever take. In fact, Cybulski’s first visit to sterile processing generated…
It’s never too early to prepare for a survey. Did you know that you can reach out to the manufacturer of a product in question before, OR DURING a survey? Preparation for a survey/inspection should be an ongoing task as well as managing and keeping up with required documentation. A key point that is often…
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