Locking Down Safety
Mauzerall told OTW, “Our container has been called a ‘Giant Rigid Container’ or a ‘Sterilizable Case Cart.’ There is a tremendous amount of pressure applied to our filters, unlike other rigid containers, so each time the filters are inspected one can visually confirm a significant seal has been made. Each filter port—as well as both front door locks—is secured with an integrity lock, complete with indicator dot, prior to sterilizing the instrument trays. When the indicator dots change color from blue to black that shows that the contents underwent sterilization.”
“Before we release a SteriCUBE System from the production line it goes through a series of internal tests including a pressure test. This is one of several ways we confirm the welds are solid and that the reusable gaskets are sealing properly. The cabinet must maintain a specific amount of pressure over a specific amount of time in order to pass our final inspection analysis. Once in the market we teach our customers how they can confirm the repeated seal ability of each cabinet as well.”
“For each new customer, we spore test to verify that the facility’s steam is capable of achieving the needed parameters for sterilization within the SteriCUBE prior to putting it into clinical use. This is when we set up each SteriCUBE System and in-service the SPD and OR staff. The transfer carts are adjusted to lock onto the sterilizer for a smooth transition of the cabinet from the cart into the autoclave chamber. Following the sterilization cycle, the cabinet is returned to the transfer cart where it can be brought to the OR (or stored for up to 30 days in the event of a cancellation or patient delay).”
Future? Better Wear Shades…
Hospitals are hearing about the SteriCUBE. Particularly with the new FDA clearance and increased versatility. “We will also begin making smaller containers as well to be able to have cannulated instrument sets, power equipment, and a retractor set for small trauma cases so as to be able to bring safety to those patients as well,” states Keenan.
“We are currently in discussions with several large companies about licensing distribution,” she adds.
As for an imprimatur, the company has all of its equipment tested at Highpower Labs. “They do all of our validation studies for our FDA submissions,” says Mauzerall. “There are several reputable medical device validation labs in the industry, and we chose Highpower Labs to perform our studies. They have considerable knowledge with packaging systems and do these types of tests routinely. We will continue to invite instrument manufacturers to validate a shorter dry time within our containers so that they may change their IFUs to include an abbreviated dry cycle when sterilized in the SteriCUBE System. This will allow for an increase in throughput that is greatly needed in both hospitals and ASC settings.”
Mauzerall adds, “Also critical is that we have the FTO (freedom to operate), i.e., we are not infringing on any existing intellectual property.”
This sets the SteriCUBE System apart from any possible competitors in the multiple tray sterilization space. With thirteen (13) granted patents and many more to come, it is clear this company has spent considerable resources securing the intellectual property rights to this technology. This has likely been one of the factors leading this Women-Owned company to secure contracts with large GPOs within the U.S.
Safer, faster, cheaper…Maryellen Keenan and Michele Mauzerall have a winner on their hands…and so will hospitals that make the SteriCUBE System an integral part of their process.
To find out more about the SteriCUBE, please visit their website at www.thestericube.com.
