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 time sterilization. IUSS and Flash, however, are not the same.
Let’s look at the term FLASH. What did it mean?
AAMI ST37:1996
A FLASH sterilization cycle is one that has been designed to meet the following criteria:
- The cycle is preprogrammed to a specific time/temperature setting established by the manufacturer based on the type of sterilizer control (i.e., gravity-displacement, prevacuum, or steam- flush pressure-pulse) and selected by the user based on the configuration of the load (i.e., the presence or absence of porous materials). For other types of hospital steam sterilization cycles, it is assumed that porous materials (e.g., packaging) will be present in the load.
- The items to be processed are usually unwrapped, although a single wrapper may be used in certain circumstances if the sterilizer manufacturer’s instructions permit. Some rigid, reusable sterilization container systems have been designed and validated by the container manufacturer for use with flash cycles.
- Since drying time is not usually part of a preprogrammed flash cycle, the items processed are assumed to be wet at the conclusion of the cycle.
- The processed item(s) must be transferred immediately, using aseptic technique, from the sterilizer to the actual point of use, usually the sterile field in an ongoing surgical procedure. Regardless of whether or not the items are wrapped, there is NO storage or shelf life of flash-sterilized items because of the probability of contamination after the sterilizer door is opened and the items are removed.
The FLASH cycle is known for a no dry time cycle, it achieves sterility in the same degree as terminal or IUSS sterilization. A sterility assurance level of 1×10-6 is the standard any packaging systems must achieve to prove the level of sterility required by the FDA. And to make it even safer, the FDA requires packaging systems to achieve the SAL in half the amount of time. Thus a 4-minute steam cycle had to prove 10-6 In 2 minutes to get a 4-minute clearance by the FDA.
FLASH Sterilization:
“FLASH” steam sterilization was originally defined by Underwood and Perkins as sterilization of an unwrapped object at 132°C for 3 minutes at 27-28 lbs. of pressure in a gravity displacement sterilizer.
ONE TRAY® Clearance as written on FDA 510(k)
2006 Intended Use
The ONE TRAY® Sealed Sterilization Containers are intended to be used for rapid sterilization of instruments or instrument sets in flash cycles. The containers are intended to be used to hold medical devices during steam sterilization. The complete line of ONE TRAY® Sealed Sterilization Containers can be processed in both flash steam pre-vacuum and gravity cycles.
Note: ONE TRAY® was cleared with a validated 48-hour storage period. FLASH containers and IUSS containers cannot be stored for later use.
Follow ONE TRAY® the IFU for use.
CD 388
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