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People, Places, Processes & Products that Influence the Supply Chain

 
 

INSIDE THE CURRENT ISSUE

December 2009

Central Services

Advanced automation, flexibility factor into washer and sterilizer wish lists

by Julie E. Williamson

Sterile processing professionals are no strangers to the concept of doing more with less, and as higher procedural volumes and increasing customer demands become even more commonplace, it stands to reason that SPDs are expecting more from their equipment vendors in an effort to better manage the burgeoning workload.

 

 

 

Skytron I-Series
I-3 and I-5
Washer-Disinfectors

Today’s washers and sterilizers are certainly dialing up the benefits, offering users improved performance and flexibility to better process new, more complex instrumentation, and enhanced automation and integration capabilities to drive operational efficiencies and throughput, boost data-gathering and record-keeping abilities, and in some cases, free up valuable time to allow staff to focus on other pressing tasks. Justifying the expense of a new system may also become easier thanks to technologies that are designed to operate more cost-effectively (and environmentally-friendly) through a reduction in water, energy and chemical consumption, and an improved ability to deliver faster, more reliable and consistent results.

"Healthcare facilities are under more pressure to decrease costs, which can be accomplished in a number of ways regarding CS equipment," noted Jason Simon, assistant product manager for Skytron’s CS and stainless products. "The amount of utilities consumed during operation, such as electricity and water and the processing time to turn instrumentation, represent the most common requests from our customers."

Healthcare customers may also be noticing that they can get more for their money these days. Not unlike other technology segments, today’s high-functioning, feature-robust washers and sterilizers are being offered at a more cost-effective price point – a fiscal perk that’s being driven, in large part, by healthcare facilities’ limited capital equipment budgets, which have led manufacturers to become even more competitive, added Simon.

Scrubbing washer challenges

Savvy, quality-focused sterile processing professionals know that instruments can’t be properly sterilized if they aren’t fully cleaned. While that understanding is undoubtedly essential for driving quality in the SPD, that’s only one key piece to the cleaning puzzle. The ongoing trend toward minimally invasive surgeries has led to the development of more complex instruments with increasingly narrow cannulas and delicate components.

Although minimally invasive procedures have been beneficial in terms of patient recovery and reduced length of stay, "these items are difficult to process via the standard methods," explained Don Socha, product marketing manager, ancillary equipment and system accessories, Getinge USA, Rochester, NY. 

Some advanced system technologies have helped, however – beginning with the development of automated ultrasonic cleaners that, within minutes, can reduce roughly 99 percent of debris, bacteria and organic matter from laparoscopic instruments – even narrow-lumened devices and those with delicate jaws and pins. The new 1101 model from Ultra Clean Systems Inc., Oldsmar, FL, for example, is a fully automated table-top ultrasonic cleaner that fills and drains on its own and is able to fully wash, rinse and dry instruments in a 17-minute cycle. "Although it’s a small, space-saving unit, the 1101 was designed with a longer basin to accommodate robotic and extremely long bariatric instruments," said Keith Cale, Ultra Clean Systems’ sales and marketing director. He added that the 25-pound capacity 1101 model features an "internal logic controller"to monitor the cleaning process and operates like the company’s 1150 floor model, only on a smaller scale; the 1101 can accommodate up to 12 lumened instruments, orthopedic reamers, and a range of other suction instruments, versus the 24 capacity with the 1150.

Ultra Clean Systems' Model 1101 ultrasonic cleaner

Washer-disinfectors are also becoming more sophisticated in their ability to clean a wide range of instruments – even delicate, hard-to-clean ones. "There’s an acknowledgement today of the fact that you can’t sterilize what isn’t clean — and you can’t just toss a lumened device into a machine and automatically expect it to come out clean. [Washer manufacturers] are increasingly focused on dealing with cleaning challenges. One example is how washers are now being developed with connections for lumened devices," explained Jonathan Wilder, Ph.D., president, Stericert Co., a division of H&W Technology LLC, Rochester, NY. "There are some great minds in this industry and they’re doing some great things these days."

The Reliance Vision Washer-disinfector from STERIS Corp., Mentor, OH, features a larger chamber, longer spray arms and outward-facing spray nozzles that generate overlapping spray patterns, while relocated water channels at the corners of the manifold further enhance spray coverage. Flexible lumen flushing ports on each rack level assist with hard-to-clean laparoscopic devices.

Getinge has proactively addressed instrumentation evolutions – and their associated challenges – directly with the device manufacturers. "We are working with instrument manufacturers in understanding their technology advancements and we, in turn, will ensure that those are incorporated into our continuing and ongoing development efforts," assured Socha.

Of course, quality-focused SPDs are also looking to washer-disinfector manufacturers to provide systems that offer greater efficiencies, performance improvement and an ability to more accurately monitor the cleaning process.

"It is my observation that the need for faster cycles, more throughput, and more accurate methods to measure equipment performance have been the driving force behind the washer-disinfector market," confirmed Simon. "Beyond these requests, increased automation, instrument tracking capabilities and integration are also driving factors that are in demand for the CSSD market."

Simon pointed out that Skytron is in the process of developing a complete line of CSSD products, including additional washer-disinfectors and sterilizers, that address energy consumption, reliability, automation, and integration with existing software. "Currently, the Skytron I-Series washer-disinfectors go a step beyond the traditional method of timed chemical injections by utilizing chemical flow meters which measure the volume of enzyme, detergent and/or lubricant injected into the wash chamber." Simon anticipates that, in the near future, the market will demand higher levels of performance testing for washer-disinfectors, as well as more accurate measurements, such as biological testing, for the systems.

Getinge’s newest washer-disinfector, the 88 series Turbo, offers faster cycle times and a larger capacity that increases throughput by as much as 40 percent, without the use of special chemicals or an impact on wash quality, by multi-tasking the non-value added steps in a cycle, such as heating the water.

Sophisticated, yet simplified

GETINGE 88 Turbo

Today’s washers are also helping take the guesswork out of the process through user-friendly, touch screen controls and displays, data management programs that offer at-a-glance process status, and maintain electronic records of each cycle.

STERIS’ Reliance Vision Washer/Disinfector, for example, can process loads as quickly as 20 minutes and features an integrated data management solution that lets staff observe cycle and process status, while monitoring chemistry volume and other time-based variables, and documenting each phase of the cleaning cycle. The data management system also links via RS-232 to any hospital-wide instrument tracking system to improve load traceability. What’s more, the Reliance Vision features integrated flow meters that provide verification of chemistry injection rates, according to STERIS.

Endoscopes, which have historically been a great cleaning and disinfection challenge, are getting a boost with high-performance washers that help automate the process.

"As with all reusable devices, flexible endoscopes must undergo thorough washing, cleaning and high-level disinfection between uses.  The greatest advancement in the washer segment is automating more of the manual steps in the cleaning process for flexible endoscopes," explained Barbara Trattler, RN, MPA, CNOR, CNA, director of clinical education for Advanced Sterilization Products, Irvine, CA.

"This advancement is more critical than ever, given the recent incidents in Tennessee and Florida, where dozens of people have potentially been exposed to either HIV or hepatitis due to improper manual reprocessing of endoscopes," she continued, adding that the recently released Clinical Evaluation and Assessment of Endoscope Reprocessing study also indicated inconsistency in manual GI endoscope reprocessing and the need for more automation. ASP’s EVOTECH ECR System is the first commercially available washer-disinfector in the U.S. to eliminate labor-intensive manual endoscope cleaning and the variability inherent in it (when selecting a cycle that includes a wash phase.  [Note: The system does not eliminate bedside pre-cleaning in the procedure room.] The EVOTECH ECR System uses a separate pump for each endoscope channel which allows for lumen blockage and leak testing. 

Cleaner and greener

The ASP STERRAD NX system combines speed and safety in sterilization in a compact size

Aside from clean, today’s washers are also delivering more "green," with systems that offer exceptional performance with lower water and energy consumption.

Getinge’s Turbo 88 features a new pump design, new air distribution design, unique heat exchanger, and automatic drying sensor — all of which contribute to lower water consumption and reduced energy usage, noted Socha. STERIS’ Reliance Vision Single-Chamber Washer uses only 38 gallons of water during each cycle, providing a water savings of at least 25 percent over the manufacturer’s previous generation of single-chamber washers. That reduced water consumption also translates into a reduction of cleaning chemistries because they are infected at rates per gallon of water, STERIS notes. The washer also consumes less energy due to a four-sided inflow pattern that increases air flow and delivers 30 percent faster drying, compared to previous generation washer-disinfectors (based on five-level rack and 50 hemostats per tray).

Despite the extensive benefits of the latest generation washer-disinfectors, Socha offered a surprising observation: that a large number of U.S. hospitals are still washing instruments by hand. 

"The best way to continue to improve efficiencies, improve the overall quality of the sterilization process, and reduce costs is to transition to washing the majority of instruments in mechanical washer-disinfectors."

Sterilizers get a boost

Much like modern-day washer-disinfectors, the latest sterilizers to hit the market are offering a one-two punch in terms of efficiency, flexibility and, above all, operability and performance efficacy.

"Evolving customer demands and competition in the marketplace are driving change. High technology, difficult to process medical devices, along with shifts in regulatory and sterilization standards are placing more demands on customers," reasoned Robert Mosher, vice president of marketing for Quebec-based TSO3 Inc. "This, in turn, is forcing sterilizer manufacturers to develop advanced systems and features that can adequately meet those standards."

New technologies that are safer on instruments, healthcare workers and the environment, while increasing the speed and flexibility of instrument reprocessing have significantly advanced sterilization, added ASP’s Trattler. "Technology is advancing very quickly and tomorrow’s sterilization systems must stay ahead of the release of new medical devices and surgical instruments," she said, noting that ASP is continuing to develop key relationships with medical device manufacturers to ensure that all new medical devices are validated with ASP’s STERRAD Sterilization Systems. Today’s ASP family of STERRAD Sterilization systems are based on hydrogen peroxide, which is safe for patients, staff and the environment because hydrogen peroxide residuals are non-toxic and non-carcinogenic. The only bi-products from STERRAD Sterilization Systems are water vapor and oxygen, eliminating the need for aeration or external ventilation, ASP notes.

In October, STERIS launched its next-generation AMSCO V-PRO 1 Plus Low-Temperature Sterilization System – a high-volume vaporized hydrogen peroxide sterilizer that now features a second, much faster cycle for non-lumened devices.

"By observing and working with our customers in their own facilities, we knew that the larger square chamber of the V-PRO 1 system was an important productivity booster for them," noted Nick Jacobs, global product manager for the Infection Prevention Technologies division at STERIS. "We also observed that the majority of the items our customers actually processed each day were not lumened devices. They were processing items such as cameras, cables, batteries, telescopes and defibrillator paddles." Because the original V-PRO 1 cycle was designed for both lumened and non-lumened devices, STERIS saw the opportunity to develop a new, shorter cycle to help processing staff become even more productive. The non-lumen cycle is completed in approximately 28 minutes; Comparatively, the lumen cycle takes approximately 55 minutes. The availability of both cycles allows facilities to tailor their workflow to specific types of instrument loads and optimize turnaround times. Existing Amsco V-PRO 1 owners who want to enhance their low-temperature processing productivity will have the option to upgrade to V-PRO 1 Plus capabilities.

Faster cycle times, coupled with a compact size, are hallmarks of ASP’s STERRAD NX System. The system offers a 28-minute cycle time, can be cart-mounted for mobility, and only requires a simple plug-in. ASP’s STERRAD 100NX System may be used to reprocess heat sensitive medical devices, and its expanded lumen capacity allows for the reprocessing of a wide range of general surgical instruments, plus single-channel flexible endoscopes and semi-rigid uretoroscopes. The system can process 80 trays within 16 hours or 51 trays in the STERRAD 100S System, compared to only six trays in Ethylene Oxide, ASP states. 

TSO3’s STERIZONE Sterilization System

Improvements are also being seen with steam and ethylene oxide sterilization systems. Although the process of steam sterilization hasn’t changed greatly, the control systems and steam generations have, according to Janet Prust, business development manager for 3M. "Internal steam generators are more efficient and more reliable," she said. On the EO side, Prust added that technological advancements, such as single-use cartridges, single-chamber sterilization and mechanical safety features, "have essentially eliminated occupational exposure risk."

The Amsco Evolution Steam Sterilizer, the latest technology to hit the steam product lineup this year, can process nearly double the amount of instruments by weight as compared to previous generation sterilizers, greatly increasing the sterile processing department’s productivity. "Instruments for an entire large ortho case can now be processed in a single load," said Marie LaFrance, senior product manager for steam sterilization at STERIS.   

TSO3, which manufacturers the 125L Ozone Sterilizer, is developing additional cycles that will all be substantially faster than the current 4.5 hour cycle — and all with improved materials compatibility. "These cycles are tailored toward a defined set of customer needs and will allow the sterilization of a wide range of medical instruments including some of the most challenging flexible endoscopes," said Mosher. TSO3 reports that STERIZONE 125L Sterilizer has proven superior efficacy to that of other oxidative methods with additional claims in the US and Canada for the sterilization of rigid endoscopes having a single stainless steel lumen as small as 0.9 mm internal diameter and 485 mm long. This year, TSO3 received additional approval from Health Canada for the sterilization of complex medical instruments including packaged, multi-channel flexible endoscopes, such as colonoscopes, gastroscopes, bronchoscopes, ureteroscopes, and choledochoscopes.

Beyond the basics

Sterilizer manufacturers are also touting faster, more reliable monitoring capabilities. The Amsco Evolution Steam Sterilizer, for example, offers sensor technology, along with the STERIS ProConnect Response Center – a proactive remote monitoring system that enables quick troubleshooting and minimizes system downtime. Getinge’s series of sterilizers feature intuitive control panels that offer audible and visual feedback, real-time, continuous display of cycle values with cycle countdown, quick, on-screen editing of cycle parameters, and comprehensive, process fault messaging.

In 2005, 3M updated the software control of the Steri-Vac 8XL, and made it possible for customers to upgrade the 3M Steri-Vac 5XL. 3M and Materials Management Microsystems are also collaborating and offering new 3M equipment interface modules for Microsystems SPM Asset Management systems. "This includes the 3M Attest Monitoring interface module that connects 3M Attest Auto-reader for 3M Attest Rapid Readout biological indicators directly to SPM for automated reading and recording of BI results," said Prust, noting that additional interface modules are in development.

Today’s sterilizers, regardless of their type, are also becoming greener – a trend that will surely continue in the future. "Steam sterilizers will continue to improve in the area of utilities consumption. Mechanical systems and cycles will continue to be refined to reduce water, steam and electricity usage. Automation will also be a key element in enhancing productivity and worker safety," predicted LaFrance. The V-Pro 1 Plus uses the same compact VAPROX HC Sterilant as its predecessor, which provides up to 15 cycles per container and sterilizes toxic by-products. When used according to manufacturer’s directions, the system requires no special venting.

TSO3’s 125L System uses only readily available oxygen and water, which minimizes customers’ cost of operation; Sterilant cost per cubic foot of usable space is only 26 cents.

Future functionality

In the future, feature enhancements will likely be as varied as the sterilizer systems themselves. Sterile processing professionals can look for greater automation and process improvements to ensure reprocessing consistency and minimize operator training requirements.

"New technology will likely be embedded to ensure flawless tracking of medical devices, and data may be logged and integrated with medical center data management software," said Trattler, adding that hospitals will also continue seeking solutions that reduce steps in the lengthy process required to assure sterilization or high-level disinfection.

3M’s Prust predicts sterilizers will evolve in their control capabilities and their ability to communicate throughout the system for efficient department management, compliance requirements, improved, measurable productivity, and enhanced diagnostics. "Additional technologies in low-temperature sterilization will also emerge and be more efficacious and user-friendly," she reasoned.

Further, in an effort to decrease downtime, "sterilizers should become more service-friendly by sensing [instruments and devices] that are close to failing," predicted Skytron’s Simon.

Socha anticipates even more user-friendly controls, alternative construction materials, further reductions in utility consumption, and improved connectivity into a knowledge management system, or an evolved version of the asset management/scheduling program that is currently available.

New sterilization technologies are also in the works. Millennium Surgical Corp., Narberth, PA, is investigating the development of sterilization technology that it predicts could be the solution to the high cost of sterilization equipment, high operating and maintenance costs, inconsistent performance and the deterioration of instruments caused by high heat and use of water/steam. The sterilization process in this new technology begins after cleaned instruments are put into a vacuum-sealed container or pouch. The container or pouch is then attached to the gas input unit for sterilization; in fewer than five minutes, the container or pouch is delivered sterile and sealed, with no residual gases inside. The container or pouch can be safely transported to point of use without compromise, and the instruments will be cool and dry and ready for use.

"In addition, a process indicator — akin to a chemical indicator in that it will give an electronic indication that the process was completed to full specification — will be offered. An internal chemical indicator that changes color to indicate the process was completed, and a biological indicator that certifies 100% kill by automatic test in 15 minutes, will also be available. This will certify sterility by permitting the pouch or kit to remain sealed. The latter will be available for all instrument sterilizers," said Millennium Surgical Corp.’s president, Robert Edelstein. The company anticipates FDA approvals and real world use within two years.

Advanced automation, flexibility top washer-sterilizer wish lists

Steam quality: The last unknown in steam sterilization