Sterile processing professionals are always told that they can’t sterilize what isn’t clean. While that is an undoubtedly true and critically important message, it’s hard to ignore that effective sterilization also hinges on the sterilizer units themselves. After all, if sterilizers aren’t working properly or can no longer meet the demands of the increasingly busy Central Service and surgical services departments, the safety of the instrumentation – and the patients on which they are used – is called into question.

Despite sterilizers’ vital role in the patient care process, many healthcare organizations fail to dedicate the necessary resources to ensure that the equipment is up to par, and up to the task.

"I’m absolutely amazed by the old, outdated sterilization equipment that is still being used in many CS departments," said CS veteran and consultant Nancy Stierheim, CRCST, R.N., of Pittsburgh, PA. "I understand the financial challenges facing hospitals and I understand that equipment for use in CS is expensive, but [administrators] need to recognize the importance of the department and the importance of the equipment being used. There is so much terrific technology available today, but unfortunately, many facilities aren’t utilizing it."

Despite some facilities’ reluctance to invest in newer technology, research shows the sterilization market, as a whole, is hardly suffering. Frost & Sullivan, the Mountain View, CA-based market research firm, reports that the disinfection and sterilization market will capture more than $900 million in revenues in 2008 – a figure that amounts to a compounded annual growth rate of approximately 5%. Sterilization systems and sterilants comprise nearly 20% of the total market.

Another research firm, Business Communication Company Inc., predicts even an even stronger foothold for the U.S. sterilization equipment market. By 2010, BCC estimates the market will reach $1.1 billion.

At least some of that predicted growth can be linked to the nation’s aging population boom, which according to the Administration on Aging, totaled 35.9 million Americans in 2003 who were 65 years of age or older and represented approximately 12.3% of the total U.S. population.

"The relative size of the senior population will continue to grow over the years and falling mortality rates indicate that this demographic segment will live longer, as a result of improved medical facilities and newer treatment methods," Frost noted. "In turn, more medical treatment and attention will be required by the aging population, hence increasing the amount of sterilization need."

Pump up the volume
Although sterilizers haven’t evolved as rapidly as other healthcare technologies, manufacturers have nonetheless become increasingly committed to meeting customers’ current and future demands. Regardless of whether vendors offer steam, ethylene oxide, paracetic acid, ozone or gas plasma sterilizer systems, a number of innovative design elements and add-on features are being incorporated. That’s a real benefit for CS departments because they typically employ a mix of sterilizer technologies to handle their varying instrumentation requirements.

Some of the newest sterilizers to hit the marketplace feature shorter cycles and larger chambers that can accommodate bigger loads, without the need for a large footprint that would take up valuable space – two positive developments for time- and space-crunched CS professionals.

"It’s fair to say that in healthcare today, and in most other businesses as well, doing more with less is common. Sterilizer users want to process more items per cycle than ever before," noted Chip Moore, sterilizer product manager for Getinge USA Inc., Rochester, NY. "That’s driving the need for larger capacities, especially for the large floor-loading sterilizers that are pit-mounted and use a cart to save floor space."

Getinge’s 833HC Steam Sterilizer, for example, is a front loading unit that features a large 26.5-inch chamber. As a replacement unit, the 833HC Steam Sterilizer offers increased chamber loading capacity within the same wall openings and footprints of existing floor-loading sterilizers. STERIS’ newest sterilizer, the 60-inch Century Medium Steam Sterilizer, features a wider, elliptical chamber design that efficiently accommodates a larger load, without taking up more floor space than the previous generation of sterilizers. Advanced Sterilization Products, Irvine, CA, is also fulfilling facilities’ high-volume needs. The STERRAD 200 Sterilization System features a larger chamber that can process 150L in just 75 minutes, versus 16 hours with ethylene oxide. "Quick instrument turnaround eliminates the need for duplicate inventories," ASP notes.

TSO3, the Quebec-based manufacturer of the first and only ozone sterilizer, is already working on "substantial improvements" for its 125L unit, which debuted in 2004. According to Ann Hewitt, TSO3’s vice president of marketing and sales, a bigger chamber is in the works, and the company is also working to shorten the cycle time.

"If we could cut our current 4 ½ hour cycle time in half, that would be great. We’re working to see if that’s possible," she said.

Getinge 700 Series Steam Sterilizer

Opening doors to efficiency
Facilities can also count on improved sterilizer construction, as well as technological advancements that can improve outcomes and lower both operating and maintenance costs.

"Sterilizers are now constructed with high quality, corrosion-resistant stainless steel and contain fewer moving parts in order to increase system reliability," explained Marie LaFrance, senior product manager, High Temperature Sterilization, STERIS Corp., Mentor, OH. "In addition, vacuum pump technology helps to reduce water and overall utility consumption." Automatic start-up and shutdown utilities can also be programmed to conserve water, steam and electricity.

STERIS’ Steam Flush Pressure Pulse technology further boosts efficiency by offering the opportunity to reduce or eliminate the cost of Bowie-Dick testing (the testing is required for prevacuum cycles, however). What’s more, LaFrance pointed out that the Century- steam-activated door gasket is superior to air-activated gaskets in reducing the chance of air entering the chamber. "The non-lubricated gasket is the only one on the market to carry a full two-year warranty," she added.

With ASP’s STERRAD NX System, which debuted in 2005, a new multi-tiered chamber and enhancement in the delivery of hydrogen peroxide have led to reduced utility consumption and shorter cycle times. The unit employs a new vaporization system that removes most of the water from the hydrogen peroxide, improving diffusion of peroxide into lumens and allowing a broad range of instruments, such as single-channel endoscopes, to be processed.

"Achieving a higher standard of care with speed, versatility and safety by employing more efficient instrument processing and improved utilization of expensive surgical instruments is a top priority for busy healthcare professionals," noted David Powell, worldwide president of ASP. "The STERRAD NX System, with its fast cycle times, as well as the ability to terminally sterilize a wide range of surgical instruments, including single-channel flexible endoscopes, provides the flexibility needed to keep O.R.s on schedule."

Of course, ease of use, ergonomics and operating simplicity are also being factored into system designs. For starters, improved door functioning is becoming a priority, which is a good thing for smaller CS technicians who tend to struggle with manual doors of the past. STERIS’ Century Medium Steam Sterilizer features a patented, easy-open door locking mechanism, which allows for one-handed operation in just seconds.

Power doors, offered by STERIS, ASP and Getinge, are also gaining in popularity – and for good reason, as one CS manager explained.

"Power doors may not seem like a big deal, but they have been a real help here," said David Narance, reprocessing manager/clinician for MedCentral Health System, Mansfield, OH. "With the manual doors, [some technicians] had a hard time opening them if the person who used them last wrenched them too hard."

Intuitive controls and improved cycle versatility are also considered vital components of many of the latest sterilization systems. Getinge’s system controls allow users to program up to 20 different cycles, which helps support the many unique time and temperatures required by device manufacturers, according to Moore. Custom cycle names can be designated for each cycle and each cycle can be reconfigured for easy access. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating procedures.

STERRAD NX from Advanced Sterilization Products

Color displays that ensure high visibility in low-light situations are another user-friendly feature of many of the latest sterilizers. The STERIS Century System’s intuitive controls feature a bright, color LCD display and the Century Control System has a user-friendly interface and help screens for daily operation and troubleshooting. Getinge offers a 5.7-inch VGA color screen display and intuitive, soft key controls that facilitate fast on-screen cycle changes. ASP also touts an easy-to-read, easy-to-use, color-coded touch screen display that helps simplify operation.

Across the board simplicity is one of TSO3’s strongest selling points. The low-temperature ozone sterilizer uses only oxygen, water and electricity to generate ozone as the system sterilant. "There’s no cycle time, temperature or sterilant to deal with," said Hewitt. "You just open the door, load the unit, close the door and push the start button." The 125L ozone sterilizer operates on approximately one-third cup of water per cycle and costs less than $1 per cycle.

Enhanced integration, connectivity
Much like other medical capital equipment, sterilization systems are being designed with connectivity in mind to help users enhance their equipment capabilities, manage their instrument inventories and maximize their investments.

"As users, we need accuracy and information to make sure all parameters are met," said Stierheim. "Information is power and documentation is critically important."

Some of the "smarter" systems have the capability of verifying process effectiveness and can provide users with detailed logs to track instruments and cycles, and even staff productivity. Sources agreed that such capabilities are becoming increasingly important, particularly as facilities aim to better manage their instruments, track specific cases and meet more stringent reporting requirements.

"Hospitals are always seeking methods for improving their surgical productivity, protecting their investment in instruments and optimizing their reprocessing functions, all of which require the monitoring and management of processes," noted Nathan Carver, product manager, High Temperature Sterilization, STERIS. "This has resulted in the proliferation of instrument tracking systems that can track, manage and report on the facility’s complete inventory of instruments and the processes they go through." Carver added that to be completely effective and thorough, an instrument tracking process also requires interconnectivity with the hospital’s automated washing and sterilization systems.

Through STERIS’ new ConnectAssure Instrument Tracking Interface, users can seamlessly integrate cycle data from STERIS washing and sterilization equipment into the hospital’s instrument tracking software (hospitals should contact their instrument tracking provider to determine whether their software will integrate with the ConnectAssure interface, however). This interface enables paperless record-keeping, facilitates AAMI and JCAHO reporting compliance, and provides an interface between instrument tracking systems and sterilization and decontamination equipment.

An advanced capability of ASP’s STERRAD 200 Sterilization System includes reliable instrument tracking with a barcode reader option that helps monitor instruments within the cycle and archives their histories electronically. The STERRAD NX System also offers software for instrument tracking and networking.

Enhanced troubleshooting capabilities provide greater assurance that the sterilizers are working effectively. While the leading sterilization system vendors are developing units that can alert users to problems – and in some cases, even diagnose the problem – future capabilities show even greater promise.

"The technology exists today to have remote diagnostic capabilities," said Moore. "It won’t be long before the sterilizer calls for service before the users even know they have a problem."

Advancements in information technology will also spur positive developments in the future, predicted LaFrance.