At Case Medical, we adhere to best practices and good ole common sense.  Let’s understand why Case Medical is so concerned about wet loads in a sealed container that they found three, yes 3, ways to ensure that sets can be sterilized rapidly, safely, and according to standards even in an emergency.

The first line of defense against SSI’s is having reliably sterile bone-dry instruments. It’s said that “Water is the essence of Life” and simply denying microbes water denies them life and the ability to create infections. Yet there are those who champion the notion that residual water in a rigid container is no big deal, that the water is a sterile by-product of the sterilization process and of no concern.

In fact, water or moisture in a sterilization container is a breeding ground for microorganisms.  Wet loads are viewed as a failure in process and an adverse event to be investigated.  Only exception is for immediate use (IUSS) and even then, we can offer a safer option. Consider the risks associated with transporting hot steamy pans with no dry time, then transporting them to the OR where devices are quenched in water to cool.  Consider the wet load, the now wet surgical device, and even the moisture on the back table.  All this can be avoided entirely with a brief dry time.

All this can be avoided entirely with a brief dry time.  If IUSS is necessary in an emergency situation, Case Medical provides three alternatives, use our filter-less FlashTite valve or use our paper filter with our SteriTite universal container give 1-3 minutes of dry time and document if IUSS is truly required.  Better yet consider avoiding IUSS entirely. You may be familiar with our SteriTite universal container for steam and low temperature sterilization and the compatibility of our container with all devices that can be sterilized.  There is an even more compelling reason to switch to Case.

Here is familiar example, your schedule is backed up, sets are in short supply, the loaners are coming in a dozen at a time.  Did you know that the very same SteriTite container with paper filter reduces the amount of dry time required for terminal sterilization?  We did our risk analysis and obtained FDA 510k clearance for a minimum of 5 to 8 minute dry time reducing by half the time needed for terminal sterilization. Use it now or store for later use!

AAMI ST79 8.3. 1 recommends, “If 'wet packs' are observed, they should not be released. They should be reprocessed in a manner that ensures that excess moisture/condensation does not occur.”

IAHCSMM CRCST155: Moisture creates a pathway for microorganisms to travel from the outside of the sterilized package to the inside of the package

FDA raises the alarm: medical devices terminally stored with retained moisture could result in patient illness, injury, or death.

These are pretty clear statements from several reputable sources, it makes one think that it’s an open and shut case that ‘wet packs’ are not acceptable. Yet there are products in the marketplace which openly deny that ‘wet packs’ are a problem. For example, as recently as 2019 the FDA took action against a company promoting that moisture within a container was “sterile water” and thus safe for further storage.  The FDA issued a warning letter claiming that the company was marketing its surgical device sterilization trays for non-cleared purposes.

“These intended uses raise new questions of safety and effectiveness not addressed by the original clearance, including, but not limited to, an increased risk of microbial contamination,” the agency said.

Consider the Case Medical SteriTite Universal container, which delivers a consistently dry sterile product in 5-8 minutes, is FDA 510(k) cleared, and considered terminally sterilized for extended storage.

There is plenty of information out there and plenty of misinformation too, as Ronald Reagan said “Trust, but verify…” You can find the Case Medical 510(k) for 5-8 minute dry times here at our website. We support your department with quality products, education and safer outcomes.

Kindest Regards,
Marcia Frieze and the Case Medical team