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 prevention and control and instrument sterilization processes, and other professional organizations recommend abandoning the use of the term “FLASH” sterilization, which is now considered outdated, and replacing it with the term Immediate Use Steam Sterilization “IUSS.” ²
Background Information: “FLASH” Sterilization vs. “IUSS”
Surgical instruments must ordinarily be sterilized using terminal sterilization cycles within rigid sterilization containers, wrappers, or primary packaging designed to maintain the instruments’ sterility and which allow the devices to be stored for later use (“terminal sterilization”).”
“FLASH sterilization” is a term that was traditionally used to describe steam sterilization cycles where medical instruments and devices:
- are generally not packaged in preparation for sterilization.
- are subjected to an abbreviated steam exposure time and no or minimal drying time; and
- are used promptly (i.e., without being stored).”
- AAMI ST37:1996 clearly states Flash cannot be stored.
Per the ONE TRAY® IFU, the container should not be subjected to an abbreviated steam exposure time. ONE TRAY® was cleared with a validated 48-hour shelf life. Facilities should follow their internal storage policies.
In correspondence between ONE TRAY® and the FDA, the FDA stated that “a key distinction of Immediate Use Steam Sterilization (IUSS) is that it cannot and should not be stored.” ONE TRAY® ‘s intended use statement indicates that the FDA has validated a 48-hour storage period and is, therefore, not an IUSS packaging system.
Follow the ONE TRAY® IFU for use.
¹ Department of Health & Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality /Survey & Certification Group, Ref: S&C: 14-44-Hospital/CAH/ASC, Memorandum to State Survey Agency Directors, August 29, 2014.
² AAMI; Accreditation Association for Ambulatory HealthCare, Inc; AORN, Inc.; et al Immediate Use Steam Sterilization, MultiSociety Paper, 2011.
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