Keenan and Mauzerall Revolutionize Ortho Tray Sterilization -

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FEBRUARY 2020 Keenan and Mauzerall Revolutionize Ortho Tray Sterilization ELIZABETH HOFHEINZ, M.P.H., M.ED. M aryellen Keenan, a 22-year veter- an at the Hospital for Special Sur- gery (HSS) and Michele Mauzerall, who launched and grew multiple businesses over the years, are about to revolution- ize sterilization in the hospital. It’s no secret that the medical establish- ment is engaged in a type of biological warfare in the OR. And with precious few advances in the sterilization realm over the past 30 years—and the pro- jected rise in total joint and spine sur- geries—it is about time for one. SteriCUBE / Source: PMBS, LLC It’s been a long time coming, but, for orthopedic company gave an entrepre- ilization technology was so promising, Kennan, it all started at HSS. “I was neur my name, promising that I was however, that we both decided to sole- both fortunate and privileged to learn the one to assist him with bringing his ly focus on bringing it to market. We the orthopedic ropes from pioneers product to the market. This was the obtained exclusive rights from the IP such as John Insall, Chit Ranawat and original owner of the intellectual prop- owner and began distributing the first Russ Warren. I saw every new implant erty (IP) on what would become the version of a multiple tray sterilization and technology you can imagine. And SteriCUBE System.” system in the U.S.” because I arranged for the vendor con- tracts, I became well versed in all of Mauzerall Joins the Sterilization The SteriCUBE System is a portable them. I required each vendor to sub- Revolution multiple tray sterilization container that mit FDA clearance and contraindica- drastically reduces contaminated trays tions for all new implants and medical It was a true “Eureka” moment says from the OR. Manufactured by PMBS, devices coming into the hospital. On Keenan. “At the first meeting with this LLC of Gulfport, Florida, this mobile top of that, every time the SPD (sterile entrepreneur I knew that this technol- sterilization system also does away with processing department) management ogy would forever alter how we sterilize the tons upon tons of wrappers that end position was vacant, I was asked to help trays. I asked Michele Mauzerall, who up in landfills each year. fill in. That allowed me to really observe had years of entrepreneurial experience workflow and productivity reports to with launching and growing businesses Imagine all of the trays for one procedure see where the inefficiencies occurred.” including marketing, medical practices being sterilized at once: trays from out- and ambulatory surgery centers (ASCs), side vendors, trays owned by the hospi- “During my years at HSS I cultivated to collaborate on this with me. At the tal, and power equipment. And because great relationships with industry lead- time she was in the process of launch- none of the items needs to be individually ers. After leaving HSS the CEO of an ing an OR efficiency business. This ster- wrapped, there is no possibility of con- ryortho.com | 1-888-352-1952 ORTHOPEDICS THIS WEEK FEBRUARY 2020 2 tamination via holes or tears or undetect- chased the company from him, did test- in diameter. When using a traditional ed wicking of germs through the paper ing for another year, all the while pull- blue wrap, you are only able to steam when inappropriately handled. ing the original product off the market.” sterilize down to 3.0mm by 400mm lumens. With our product, sterilization “One prototype design with filters only reaches the level of .7mm by 500mm on the main door left cold spots in the and 1.0mm by 850 mm.” back corners of the container. The next one had filters on two sides of the cabinet And they have the blessing of the medi- and there were cold spots in the middle cal mothership…the FDA. Keenan: “The of the cabinet. With the assistance from agency has cleared the SteriCUBE Sys- a third party, Sterile Services of Houston, tem for these new lumen sizes as well as Texas, they used a tool called a Datalog- cleared our product for offsite process- ger to help us confirm or reject our design ing. Specifically, the FDA cleared us for changes. Their tool has multiple sensors our ability to maintain sterility for 30 SteriCUBE / Source: PMBS, LLC that can be placed anywhere within the days following rigorous outdoor trans- cabinet to determine steam quality. They portation and storage outside the steril- FDA Clearance: DONE usually use these tests for autoclave vali- ization facility. Trays can be sterilized in dation. Every two seconds these sensors the SteriCUBE System off site and then But here is the latest news. The Steri- relayed to a computer the exact tem- transferred by vehicle to a hospital or CUBE System has just received a new perature and pressure from their vari- an ASC. Or hospitals can sterilize their FDA clearance that includes smaller, ous locations within the cabinet. That trays in the SteriCUBE System and then narrower and longer lumen sizes than information was then interpreted by transfer them to an offsite ASC. We have any other container on the market. It their technician to determine whether set the new bar for offsite sterilization, is the only container that can steam or not we were achieving optimal steam something that we hope will become a sterilize .7mm by 500mm or 1.0mm saturation. With our final design, and benchmark in the near future.” by 850mm lumen sizes. There was no the one we ultimately launched as the FDA-imposed limitation to the quan- SteriCUBE System, not only did they tity of these tiny diameter and extra- find no cold spots, but they discovered long lumens because the testing was the steam quality within the cabinet was done with a higher quantity that would actually superior to an empty autoclave. ever be used in a single procedure. They reported ‘enhanced steam stabili- What does that mean? That when Mr. zation’ making for highly effective steam Jones’ surgeon uses a cannulated screw, saturation with less temperature vari- the gentleman on the table will not be ability. In addition, the floor is pitched exposed to some nefarious organism downward to a filtered drain, and this during his spine surgery. design improvement allows all moisture to be removed incredibly quickly.” The Long Slog Toward FDA Clearance Finding the Contaminated Needle in Keenan and Mauzerall had to invest the Haystack… heavily in design upgrades to get the SteriCUBE System ready for FDA review. “Rigid containers can only steam steril- SteriCUBE / Source: PMBS, LLC “With the original design, known as ize down to a certain lumen level,” says the SCORES Units, we found that some Keenan. “But this is ineffective, partic- Sterile Processing Departments Get- moisture could be retained inside the ularly for spine and trauma surgeons, ting No Respect…Or Extra Funds cabinet, usually on the lower filters, due who are working with a cannulated to a design flaw. The original inventor hole for the guidewire. This wire is usu- “Sterile processing departments (SPDs) wasn’t keen on making the necessary ally 1mm in diameter. The cannulation really lag behind other areas of the hos- design changes, so we ultimately pur- of micro screws can be as small as .8mm pital, sometimes with dangerous conse- ryortho.com | 1-888-352-1952 ORTHOPEDICS THIS WEEK FEBRUARY 2020 3 Stericube Saves Significant Time Keenan: “We save approximately 1.5 hours in processing time by eliminat- ing the need to wrap or individually containerize each tray, plus time saved by eliminating pre-heating instruments in the autoclave, running longer than needed cycles, and cracking the door of the autoclave post sterilization. Some- times hospitals run full loads of mixed sets of instruments on extended cycles as a precaution and to ensure everything SteriCUBE / Source: PMBS, LLC comes out dry. Unfortunately, not only does that hinder throughput but some- quences,” adds Mauzerall. “Fortunately, manufacturers to validate this shorter times there are delicate instruments or there is a movement to get SPD staff cer- dry time in the SteriCUBE System so even power equipment that may become tified. At the present time, however, we they can change their IFUs (Instruc- damaged or wear out faster from these remain at a point where an SPD employ- tions for Use) when using our contain- extended cycles. Manufacturers’ IFUs ee could well have never worked in the er. While all manufacturers’ trays are are critical for the proper care and main- medical field before and they may have FDA cleared for use in the SteriCUBE tenance of instruments and devices.” only received a small amount of on the System, an abbreviated dry time would job training. One facility in Georgia told allow the facilities to greatly increase us they were losing SPD employees to a their throughput. A few vendors have Target warehouse that offered a higher already validated their devices for this hourly wage. Another big issue that 10-minute dry time.” occurs every time a hospital expands is that the concentration is often only Emphasizing the role of the instru- on increasing the OR capacity, which ment manufacturers, Keenan adds, is the money maker for the hospital, “Our constant refrain is that hospitals yet they rarely do anything to augment must use the sterilization cycle dictated sterile processing. And with hip, knee by the instrument manufacturer’s IFU and spine surgeries on the rise, how can and should not follow those of the con- they process a growing number of trays tainer. Some hospitals say, ‘What if we with the same resources?” just want a 10-minute drying cycle?’ We always instruct them to follow the SteriCUBE / Source: PMBS, LLC “While the majority of manufacturers instrument manufacturer’s IFU.” call for a 4-minute sterilization with a 30-minute dry cycle,” says Keenan, “the “There are instances when a hospital has “Surgical delays waiting for instruments, SteriCUBE System is able to safely out- taken, for example, a Stryker product and late start times, and overtime expense pace that norm.” performed a 4-minute sterilization cycle are just some of the reasons that sav- followed by 10 minutes of drying time, ing time in the OR is critical. On top “The SteriCUBE System is FDA cleared but the Stryker instructions called for 30 of decreasing the instrument process- for a 4-minute sterilization cycle fol- minutes of drying time. If that patient gets ing time we then save about 10 minutes lowed by a 10-minute minimum dry an infection this could end up in court. opening time in the OR. The problem time. This product can dry up to 300 When the sterilization records are com- comes in convincing the hospital that pounds of instruments in 10 minutes pared against the manufacturer’s IFU then the extra 10 minutes saved in the OR is with no remaining moisture whatso- the vendor is off the hook and the hospi- valid. Hospitals tend to respond with, ever. Now we need all the instrument tal is 100% on the hook.” ‘That’s great if this will allow us an extra ryortho.com | 1-888-352-1952 ORTHOPEDICS THIS WEEK FEBRUARY 2020 4 case per day, but what if you can’t find the from blue to black that shows that the As for an imprimatur, the company has surgeon for the on-time start?’ In an ASC contents underwent sterilization.” all of its equipment tested at Highpower [ambulatory surgery center], however, we Labs. “They do all of our validation stud- expect the surgeon will be present, or at “Before we release a SteriCUBE System ies for our FDA submissions,” says Mau- least easier to find…and if you can add from the production line it goes through zerall. “There are several reputable medi- another orthopedic case per day per room a series of internal tests including a pres- cal device validation labs in the industry, in an ASC, the surgeons will be quite sure test. This is one of several ways we and we chose Highpower Labs to per- pleased.” Keenan notes that they have a confirm the welds are solid and that the form our studies. They have considerable smaller version SteriCUBE for ASCs that reusable gaskets are sealing properly. The knowledge with packaging systems and was just cleared as well by the FDA. cabinet must maintain a specific amount do these types of tests routinely. We will of pressure over a specific amount of time continue to invite instrument manufac- Less Handling, Less Risk in order to pass our final inspection analy- turers to validate a shorter dry time with- sis. Once in the market we teach our cus- in our containers so that they may change Too many cooks can spoil the broth and tomers how they can confirm the repeated their IFUs to include an abbreviated dry too many touches can spoil the implant. seal ability of each cabinet as well.” cycle when sterilized in the SteriCUBE Keenan: “Research has shown that a System. This will allow for an increase in wrapped container is handled on average “For each new customer, we spore test to throughput that is greatly needed in both 14 times between the time it is removed verify that the facility’s steam is capable hospitals and ASC settings.” from the autoclave and when it is opened of achieving the needed parameters for in the OR, meaning that it is not surpris- sterilization within the SteriCUBE prior Mauzerall adds, “Also critical is that we ing how many times trays are rejected due to putting it into clinical use. This is have the FTO (freedom to operate), i.e., to holes or tears. Rigid containers are a when we set up each SteriCUBE System we are not infringing on any existing great alternative to wraps when it comes and in-service the SPD and OR staff. The intellectual property.” to being greener but research has shown transfer carts are adjusted to lock onto that they do not help with throughput, the sterilizer for a smooth transition of This sets the SteriCUBE System apart from minute for minute there are no time sav- the cabinet from the cart into the auto- any possible competitors in the multiple ings associated with their use, and there clave chamber. Following the steriliza- tray sterilization space. With thirteen (13) have been several publications concern- tion cycle, the cabinet is returned to the granted patents and many more to come, ing compromised sterile barriers when transfer cart where it can be brought to it is clear this company has spent consid- these containers are not re-validated.” the OR (or stored for up to 30 days in the erable resources securing the intellectual event of a cancellation or patient delay).” property rights to this technology. This Locking Down Safety has likely been one of the factors leading Future? Better Wear Shades… this Women-Owned company to secure Mauzerall told OTW, “Our container contracts with large GPOs within the U.S. has been called a ‘Giant Rigid Con- Hospitals are hearing about the SteriCUBE. tainer’ or a ‘Sterilizable Case Cart.’ Particularly with the new FDA clearance Safer, faster, cheaper…Maryellen Keen- There is a tremendous amount of pres- and increased versatility. “We will also begin an and Michele Mauzerall have a win- sure applied to our filters, unlike other making smaller containers as well to be able ner on their hands…and so will hospi- rigid containers, so each time the filters to have cannulated instrument sets, power tals that make the SteriCUBE System an are inspected one can visually con- equipment, and a retractor set for small integral part of their process. firm a significant seal has been made. trauma cases so as to be able to bring safety Each filter port—as well as both front to those patients as well,” states Keenan. To find out more about the SteriCUBE, door locks—is secured with an integ- please visit their website at www.thes- rity lock, complete with indicator dot, “We are currently in discussions with tericube.com. ♦ prior to sterilizing the instrument trays. several large companies about licensing When the indicator dots change color distribution,” she adds. Orthopedics This Week is published 40 times a year by RRY Publications LLC 100 West Main Street, Suite 350 Lansdale, Pennsylvania 19446 1-888-352-1952 www.ryortho.com Reprinted with permission of RRY Publications LLC © Copyright 2020 RRY Publications LLC ryortho.com | 1-888-352-1952