FDA Clearance: DONE
But here is the latest news. The SteriCUBE System has just received a new FDA clearance that includes smaller, narrower and longer lumen sizes than any other container on the market. It is the only container that can steam sterilize .7mm by 500mm or 1.0mm by 850mm lumen sizes. There was no FDA-imposed limitation to the quantity of these tiny diameter and extra-long lumens because the testing was done with a higher quantity that would ever be used in a single procedure. What does that mean? That when Mr. Jones’ surgeon uses a cannulated screw, the gentleman on the table will not be exposed to some nefarious organism during his spine surgery.
The Long Slog Toward FDA Clearance
Keenan and Mauzerall had to invest heavily in design upgrades to get the SteriCUBE System ready for FDA review. “With the original design, known as the SCORES Units, we found that some moisture could be retained inside the cabinet, usually on the lower filters, due to a design flaw. The original inventor wasn’t keen on making the necessary design changes, so we ultimately purchased the company from him, did testing for another year, all the while pulling the original product off the market.”
“One prototype design with filters only on the main door left cold spots in the back corners of the container. The next one had filters on two sides of the cabinet and there were cold spots in the middle of the cabinet. With the assistance from a third party, Sterile Services of Houston, Texas, they used a tool called a Datalogger to help us confirm or reject our design changes. Their tool has multiple sensors that can be placed anywhere within the cabinet to determine steam quality. They usually use these tests for autoclave validation. Every two seconds these sensors relayed to a computer the exact temperature and pressure from their various locations within the cabinet. That information was then interpreted by their technician to determine whether or not we were achieving optimal steam saturation. With our final design, and the one we ultimately launched as the SteriCUBE System, not only did they find no cold spots, but they discovered the steam quality within the cabinet was actually superior to an empty autoclave. They reported ‘enhanced steam stabilization’ making for highly effective steam saturation with less temperature variability. In addition, the floor is pitched downward to a filtered drain, and this design improvement allows all moisture to be removed incredibly quickly.”
Finding the Contaminated Needle in the Haystack…
“Rigid containers can only steam sterilize down to a certain lumen level,” says Keenan. “But this is ineffective, particularly for spine and trauma surgeons, who are working with a cannulated hole for the guidewire. This wire is usually 1mm in diameter. The cannulation of micro screws can be as small as .8mm in diameter. When using a traditional blue wrap, you are only able to steam sterilize down to 3.0mm by 400mm lumens. With our product, sterilization reaches the level of .7mm by 500mm and 1.0mm by 850 mm.”
And they have the blessing of the medical mothership…the FDA. Keenan: “The agency has cleared the SteriCUBE System for these new lumen sizes as well as cleared our product for offsite processing. Specifically, the FDA cleared us for our ability to maintain sterility for 30 days following rigorous outdoor transportation and storage outside the sterilization facility. Trays can be sterilized in the SteriCUBE System off site and then transferred by vehicle to a hospital or an ASC. Or hospitals can sterilize their trays in the SteriCUBE System and then transfer them to an offsite ASC. We have set the new bar for offsite sterilization, something that we hope will become a benchmark in the near future.”
