STERILE PROCESSING
closed and sits under a counter in their clinics. We also have small containers that have U.S. Food and Drug Administration (FDA) clearance for tabletop autoclaves, ideal for clinics and physician’s offices.” Frieze also noted how she has seen movement from wrapped trays to sealed containers and from open case carts to closed case carts since the late 1990s. “A sealed container provides the utmost in containment during storage and transport of sterilized medical devices,” said Frieze. “Where open case carts used to be commonly used, closed case carts have replaced them as a more secure option. At Case Medical, we manufacture both sterilization containers and case carts that meet current standards for storage, transport, and handling. We use only reusable materials that are anodized and passivated for corrosion resistance.”
SteriTite Stainless Steel Case Carts from Case Medical
Frieze added, “Further, both our containers and case carts have a unique barcode for tracking and tracing, working seamlessly with our CaseTrak360 software. No need for sticky labels, tarps to cover the open carts or wrap for sterile packaging.”
Safely securing devices during transport With more healthcare facilities transporting instruments and trays between various locations, keeping these assets orga- nized and protected from damage has grown in importance. Manufacturer of engineered materials and custom packag- ing solutions Spartech has developed its MediSheet solution to securely retain medical devices on mounting cards placed within sterile packaging during shipment, storage, and ulti- mately surgery.
Spartech strategic accounts manager, Kendall Faulstich, noted, “Other medical product applications for MediSheet include everything from medical trays to safely securing tubes used during colonoscopy procedures. It’s available in sheet and custom die-cut cards.”
Considering efforts to reduce healthcare’s environmental foot- print, Spartech manufactures MediSheet using a polyethylene material. “It is a more environmentally friendly alternative com- pared to PVC when medical waste is incinerated for disposal,”
said Faulstich. “In addition, this option can replace lidded trays to reduce the amount of material used in the packaging.”
Instrument containment goes high tech Digital solutions are transforming healthcare in many ways. So why not sterile processing? Here is the story of how Zuno Medical developed its rigid sterilization containers with elec- tronic monitoring.
The surgical team is preparing for a procedure. They open
a standard rigid container and there is no filter, or they find a hole in a wrapped instrument set. The case is delayed until another instrument set can be found and reprocessed, and in the worst case, the procedure is cancelled.
“As orthopedic representatives in the operating room (OR), the founders of Zuno Medical experienced countless instrument processing errors,” said Allan McNichol, CEO of Zuno Medical. “With current subjective methods to evaluate sterile barriers such as OR staff holding blue wrap to the light, they thought to themselves ‘there has to be a better way.’” The result is the Zuno Smart Container, “the first-ever ster- ilization container designed to increase efficiency across both SPD and OR by improving turnover times,” according to McNichol. During the autoclave sterilization cycle, the Zuno Smart Container creates a vacuum seal, eliminating a porous barrier and the need for container disposables—saving prep time in SPD and evaluation time in the OR. The container continues to maintain and monitor the seal during transport and storage, enabling objective verification that the container’s sterile barrier has not been compromised.
“At Zuno, we’ve embarked on a journey to develop a sustain- able, disposable-free container and truly invest in the evolu- tion of sterile processing,” McNichol explained. “It takes only seconds to prep and with the absence of a porous barrier, sets no longer need to cool in an autoclave either, which further reduces turnover time.”
Zuno Smart Container A two-step verification system consisting of both a visual and
a tactile check allows users to confirm the sterile barrier is intact at any time and most critically before a set arrives in the OR. “It’s been a long journey. Running smart devices inside a
high-pressure steam autoclave is not necessarily an easy task,” McNichol continued. “We’re extremely proud to have received FDA De Novo clearance in a brand-new category—rigid ster- ilization containers with electronic monitoring.” The Zuno Medical team worked extensively with SP and OR teams in hospitals and surgery centers across the country to develop the Zuno Smart Container and ensure it met their needs. There were some valuable lessons learned along the way, including key design features such as a green checkmark instead of just a green light for users who may be color blind and space-saving concepts taking limited storage capabilities into account.
Having secured FDA clearance, Zuno Medical is plan- Spartech Medisheet 36 October 2023 • HEALTHCARE PURCHASING NEWS •
hpnonline.com
ning commercialization of the Zuno Smart Container for Q4 of 2023. HPN
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