This week we decided to revisit the topic of wet packs because a recent warning letter issued by the FDA, discussed in this news article, has breathed new life into the issue. There is also some robust related debate on the topic on the AAMI message board and other social media.
The purpose of this post is not to focus on what other companies may or may not have done wrong. Rather, we want to reiterate what Case Medical is doing right.
The Risks of Wet Packs
The risks associated with wet packs have been the topic of past Case Medical presentations and at least one previous blog post. In summary, Case Medical conforms to industry best practices that sets with retained moisture are not acceptable except in dire circumstances, and then documented. Others in the industry disagree and have marketed products on the assumption that wet packs do not pose a threat and may even be stored for later use. It is a point of view we do not share and have vigorously debated in open forum.
In our view the acceptable amount of moisture in a properly processed instrument set is ZERO, and the amount of time that instruments can be safely stored in a wet pack beyond immediate use is NEVER. Finally, terminal sterilization is defined by ANSI/AAMI ST77 4.2 as a dry outcome.
No empty boasts, we have FDA 510(k) clearance for terminal sterilization and for IUSS.
In the rare case where IUSS is required, the SteriTite® container with FlashTite® valves can provide virtually dry results with as few as three minutes of dry time. More importantly, SteriTite containers with paper filters are cleared for pre-vacuum terminal sterilization with a minimum dry time of five to eight minutes. Simply crack the autoclave door and allow for cool down.
Quality Products for Reliable Results
SteriTite containers' faster drying results are attributable to our superior materials and engineering: aircraft grade, anodized aluminum for better heat conductivity; a patented perforation pattern for better ventilation, and a precision manufacturing process that ensures a proper fit between lid and base even after years of use.
These new revelations around wet packs have resulted in a lot of anxiety and uncertainty about what is safe and where to go from here. Case Medical can be a resource for you. Contact us to discuss how this issue can be addressed in your facility using validated products and with minimal disruption.