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Although effective microbial kill is, of course, the primary function, today’s sterilizers are designed to tackle far more than that. Much like other healthcare equipment, sterilizers are becoming more flexible and intuitive, allowing for improved documentation and record-keeping, connectivity, and simplified functionality and operation – all while offering unsurpassed sterilization effectiveness, even for today’s more challenging devices. And that’s not all. More than ever, ergonomics, ease of use, throughput, and resource consumption are also playing into manufacturers’ designs, allowing SPDs to boost efficiencies and stay on top of demanding surgical case schedules and the operating room’s requirements for rapid device turnaround.

"This is such a dynamic industry," said medical device sterilization consultant Charles Hancock of Fairport, NY-based Charles O. Hancock Associates Inc. "While sterilizer technology may not be [a segment] that has advanced as rapidly as other types of healthcare equipment, it has still undergone some significant changes over the years."

TSO3’s 125L Ozone sterilizer

Those changes have been driven by both evolving consumer demands and competition in the marketplace. Sources agreed that high-tech, difficult to process medical devices, along with shifts in regulatory and sterilization standards, are placing more demands on SPDs, which, in turn, is forcing sterilizer manufacturers to develop advanced systems and features that can adequately meet those challenges.

If market research data is an effective barometer of consumers’ appreciation of equipment innovation, then sterilizer vendors surely deserve a pat on the back. Market research firm Frost & Sullivan, for one, predicts the disinfection and sterilization market (with sterilization systems and sterilants comprising approximately 20 percent of the total market segment) will exceed $900 million in 2008, representing an impressive compounded annual growth rate of roughly 5 percent.

Because space constraints are a pervasive problem for most healthcare facilities, there’s a greater need for sterilizers that can pack a big productivity and physical throughput punch, without taking up valuable square footage. Whether manufacturers offer steam, ethylene oxide, paracetic acid, ozone or gas plasma sterilizer systems, doing more with less appears to be a common theme.

"Space and throughput are very big issues we’re addressing," said Mike Carragher, sterilizer product marketing manager for Getinge USA Inc., Rochester, NY. "There’s a major focus on offering sterilizers with wider chambers, but without making the units bigger in the process." Getinge’s floor-loading 833 HC steam sterilizer, for example, features a 26.5-inch chamber that’s designed to allow large orthopedic trays to be turned sideways, thereby making it possible for operators to as much as triple their throughput, Carragher explained.

"The floor-loading system can also significantly reduce construction space costs," he continued, adding that instead of using three or four medium sterilizers, facilities can use just one larger, floor-loading unit.

STERIS Century Medium Steam Sterilizer

Karen Borg, worldwide vice president of marketing for Advanced Sterilization Products, Irvine, CA, echoed the need to provide customers with a variety of space-saving, productivity-boosting systems. "Some customers want smaller systems that can turn instruments around more quickly, while others want larger units that can accommodate a higher volume. We’re working hard to meet the needs of all our customers," she said. While ASP’s STERRAD 200 model, designed for SPDs in need of larger units, takes up no more space than earlier models, it features a bigger chamber that can process 150 liters in just 75 minutes. The STERRAD 200 System’s cycle time is more than 12 times faster than an ethylene oxide cycle, providing rapid instrument turnaround and increasing utilization of instruments. For tight-quartered ORs and surgery centers in need of speedier device turnaround, the tabletop STERRAD NX can process devices in just 38 minutes.

Another speedy, space-saving solution is STERIS’ System 1 Sterile Processing System. This tabletop, microprocessor-controlled unit can safely process delicate immersible surgical and diagnostic devices is just 30 minutes. Space-maximizing convenience is also built into other STERIS sterilizer systems, including the 60-inch Century Medium Steam Sterilizer that offers a wide, elliptical chamber that can accommodate larger loads, and the Amsco Eagle 3017 EO sterilizer that features a five cubic-foot chamber and two baskets that allow sterilization and aeration to be completed in one chamber.

Ozone sterilizer manufacturer TSO3 is hoping to introduce a next-generation model within the next two years or so that can handle larger loads and significantly reduce the already short 4 ½ hour cycle time.

Because some cash-strapped facilities may lack the budget for brand-new sterilizer purchases, options exist that make it possible for them to retrofit their existing units with more modern, efficient technology. Such is the case for those with existing ethylene oxide sterilizers that use Oxyfume and Medifume EtO sterilant blends. By retrofitting their existing EtO sterilizers with the Stericert control system by H&W Technology facilities can experience significant cycle improvements. Stericert allows existing EtO sterilizers to run both a traditional 16-hour cycle, as well as a shorter 10-hour economy cycle.

"This is a great option for facilities that want shorter cycles, but don’t want to purchase an entirely new EtO sterilizer. We can simply take what they already have and bring it up to speed," said H&W Technology’s co-founder Jonathan Wilder. Aside from the significantly reduced cycle time, Stericert also decreases EtO consumption by more than 25 percent, saving the hospital money, decreasing the frequency of tank changes, and making it an investment that quickly pays for itself.

Easy does it

3M’s 8XL Steri-Vac Sterilization System

While the process of sterilization itself isn’t exactly a simple one, the operation of sterilizer units is a far lesser challenge thanks to updated features that blend ease of use and ergonomic design elements with built-in properties that offer unsurpassed flexibility, safety and automation.

Aside from easy-operating door mechanisms that make loading and unloading a snap, corrosion-resistant chamber construction, and intuitive touch-screen displays that provide an at-a-glance view of the cycle — among other design elements — today’s systems afford the opportunity to program an unprecedented amount of cycles. Getinge system controls, for example, offer up to 22 pre-selected cycles, allowing operators to select more and varied cycles, while also assigning unique names to each one (drills, for example, can be assigned their own cycle and named appropriately, thereby simplifying the process for the end user and reducing the likelihood for errors). Another bonus of Getinge’s flexible control systems is that users can program in parameters to meet extended cycle requirements imposed by device manufacturers.

Better data delivery and documentation capabilities are also attractive functions of today’s feature-rich sterilizer systems. Enhanced system connectivity and interface capabilities make it possible for users to maintain detailed cycle logs, while also being able to track instruments and specific cycles, as well as staff productivity. STERIS, for one, has teamed up with Censis Technologies to develop instrument tracking software that can meet an SPD’s specific needs, regardless of size and complexity. The STERIS Instrument Management Solutions software is also expandable to coincide with a hos-pital’s growth projections, and helps SPDs manage inventory costs, increase sterile processing productivity and provide safeguards to ensure that proper sterilization methods are used and that the right instruments are in the right trays, Nathan Carver, product manager for STERIS, pointed out.

Aside from that, STERIS has developed an interface between its sterilizer and the STERIS Instrument Management Solutions software that enables the automatic transfer of sterilization cycle data, and stores and retrieves this compliance data to eliminate the time-consuming process and cost of manual load documentation. According to Carver, this is just the beginning.

"Going forward, STERIS will continue to develop new technologies that will drive connectivity and improvements in the SPD, the OR and throughout the hospital."

Getinge 833HC Floor-loading Steam Sterilizer

ASP’s STERRAD 200 has also been designed to provide users with improved instrument traceability and enhanced connectivity. A barcode reader option helps users monitor instruments within the cycle and archive their histories electronically; reports can be printed with every cycle. Getinge’s T-Doc asset management system – originally developed as a pure instrument tracking system – also makes it possible for users to quickly and easily generate productivity and cycle parameter reports. While the system is an obviously well-suited to the SPD, Carragher said it can also be tied into OR management systems and other areas as well.

3M, (Minneapolis, MN) customers have relied on the performance of the 3M Steri-Vac Sterilization Systems for more than 35 years. Steri-Vac sterilizers use ethylene oxide (EO), the method proven to be effective for sterilization of temperature- and moisture-sensitive medical devices. 3M’s position in 100% EO sterilization is the result of continuous research and innovation. For example, the easy-to-handle, single-dose 3M Steri-Gas EO Cartridges contain the exact amount of EO for each load.

The 3M model 8XL is the largest capacity model. The large 7.9 cubic foot (224 liters) chamber with a full-sized lower basket and 2 half-sized upper baskets provides economical processing of large loads or lar-ger surgical instruments. The model 8XL has a sensing system that continuously monitors and controls relative humidity during the preconditioning phase to optimize moisture required for the exposure cycle (two temperature cycles, 55° C and 37° C).

Improved diagnostics are also moving front and center, and vendors generally agree that customers can look for even more advanced capabilities in the future, including more widespread availability of remote diagnostic systems and cost-effective, built-in systems that can monitor critical parameters, such as steam and water quality.

SciCan Medical, Pittsburgh, PA, makes the STATIM Cassette Autoclave. The autoclave offers a complete, biologically validated, 6-minute sterilization cycle for unwrapped instruments. This is an 85% reduction over a common ‘chamber’ style autoclave. The instruments are placed in a removable cassette allowing aseptic transportation to the proce-dure upon completion of an unwrapped cycle. Cycle times are also shorter on wrapped instruments as well. Shorter cycle times can potenitally save on instrument inventory due to faster turn around.

While system advancements are undoubtedly raising consumer interest, the same can also be said for units that focus on simplicity. Overall operational simplicity is a major selling point for TSO3’s 125L Ozone Sterilizer. According to Ann Hewitt, vice president of sales and marketing for TSO3, the unit is not only safe and economical — using only oxygen, water and electricity to generate ozone as the system sterilant – it operates with the simple push of a button.

The SciCan Statim Cassette Autoclave

"Placing the instruments in the unit, closing the door and pushing a start button is all that’s required. It doesn’t get much easier than that." The system is also cost-effective, with the average cycle costing less than a dollar. Hewitt said the updated AAMI recommendations outlined in the newly revised steam sterilization document ST:79, which recommends the use of biological indicators for every load, may make the low-cost operation of the ozone sterilizer even more attractive.

Although Hewitt acknowledges that most facilities will have a hard time giving up their steam sterilizers because they lack the instrument inventory to allow for the more lengthy 4 ½ hour ozone sterilizer cycle times, she said TSO3 is already fielding calls from facilities inquiring about how they could make the switch.

For all the positive developments, there’s one major issue that could potentially spell big trouble for sterilizer manufacturers and those who operate the equipment: extended sterilization cycles.

When the FDA began mandating that device manufacturers provide customers with one valid method of cleaning and sterilization that spurred a great deal of concern and confusion for processing personnel. "The problem is that the processing method device manufacturers provide often is not one facilities can use because the sterilizers they have in place aren’t designed to accommodate those extended cycles,"Hancock explained.

Exacerbating the problem is that many device manufacturers have increased the cycle time recommendations to meet European requirements (which are actively addressing prion issues, including how to best manage the risks of Creutzfeldt Jakob Disease and its variant form).

"They’re trying to meet European and North American requirements, but because there’s a tremendous mismatch in terms of the process challenge being presented in Europe versus North America, it’s essentially comparing apples to oranges," he continued.

Advanced Sterilization Products’ Sterrad NX System

In the absence of refined recommendations from device manufacturers, sterilizer vendors and those that operate the equipment are scrambling for their own solutions. Although sterilizer manufacturers’ efforts are admirable, Hancock said it’s a classic case of putting the cart before the horse.

"Sterilizer manufacturers are doing their best to respond, but the confusion is coming from the device manufacturers themselves. For this problem to be manged, the makers of these devices need to be the ones to address it."

Hancock is keeping a close eye on "troubling developments" on the device manufacturer side that could create problems for facilities on numerous fronts. A number of device makers, particularly those that manufacture complex devices, are proposing and pursuing the development of dedicated cleaning and sterilization technology that can process their own specific devices, he said.