Compromised Sterile Barrier

Product Recall

We learned this afternoon that a company providing sterile water and 0.9% sodium chloride solutions for irrigation were recalled due to a potential lack of sterility assurance. The compromised sterile barrier was identified during routine testing. In populations at risk, including patients that are immunocompromised, the use of affected product could result in potentially life-threatening reactions. A compromised sterile barrier is of concern in general when kits are repackaged and in sterilization containers with wet loads and with wrapped trays when moisture is found inside and out. In fact, water or moisture in a sterile package is a breeding ground for microorganisms. Wet loads are viewed as a failure in process and an adverse event to be investigated.

Don't be fooled when others say wet loads are okay.

Years ago, there was a clinicial educator who called herself the "Queen of Wet". It was believed at the time that all container systems are wet and require absorbant liners or drains. It was commonly accepted to be wet for flash sterilization, but why not use it for terminal sterilization too. I remember attending one of my first AAMI meetings and I thought I heard wrong. I understood that all sterilization packaging should be dry. After all, 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 still 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. They might recommend using an aborbant liner or two, to wick the moisture.

At Case Medical, we adhere to best practices and good ole common sense. We know that wet loads can be a vector for infections and can harm patients during medical procedures. Case Medical is so concerned about wet loads in our SteriTite sealed container that we validated our container system for reduced drying using only 5-8 minutes for a dry load and safer outcome. Now sets can be sterilized rapidly, safely, and according to standards even in an emergency.

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.

Kindest Regards,
Marcia Frieze and the Case Medical team

Case Medical is a US EPA Safer Choice Partner of the Year and supports best pratices and patient safety.