From washer-disinfectors and automated endoscope reprocessors to a wide array of sterilizers, manufacturers are equipping systems with versatile functionality to clean, disinfect and sterilize with ultimate confidence.

Enhanced connectivity, too, is helping to improve equipment uptime by allowing proactive troubleshooting. Erin Linville, director of marketing, Infection Prevention Technologies, STERIS Corporation, noted that "STERIS is currently focused on features related to ease of use and data connectivity. For example, our ProConnect remote monitoring solution can be connected to STERIS equipment to monitor these systems 24/7 and provide timely alerts and intervention, sometimes before the user knows there’s an issue."

Getinge 88 Turbo

Jim Gabalski, vice president marketing, North America, Getinge USA Inc., described the company’s continued investment in traceability solutions, with an expected release date of the latest offering made available to U.S. customers during the second quarter of 2011. The Getinge Online solution offers operators and Sterile Processing Managers a window into what is happening inside decontamination equipment. The system provides alerts via computer, cell phone or other device as to when a cycle has completed or if some type of issue such as a temperature deviation occurred during a cycle.

"Whether [the equipment] has a fault or a completion, it’s going to tell you that so you can actively manage the loading and unloading without wasting time," said Gabalski.

Semi-automatic and fully-automatic loading carts and trolleys, such as Getinge’s Air Glide System, further streamline processes with minimal staff intervention. "We’re building systems around those devices that allow them to be utilized to the max from beginning-to-end," he said.

While shaving a minute or two between cycles may not seem significant, "when you add those minutes together over time, it results in significantly more cycles out of a single piece of equipment," he asserted.

Service technicians can also use Getinge Online to remotely understand the history of a machine prior to making a service call. This allows them to review what’s been happening so when they arrive on site they can come prepared with needed parts and documentation. "You can do more of the diagnostic work using the information that the equipment makes available to you through Getinge Online, and therefore we can come prepared to troubleshoot and resolve with some precision," said Gabalski.

Getinge Online is an extension of Getinge’s T-DOC instrument and asset management system, which has been recently expanded with new offerings that allow users to track down to the instrument level through every phase of the sterile chain of custody, he added.

ASP STERRAD 100NX

New from ASP (Advanced Sterilization Products), the company recently launched its EXPRESS Cycle for the STERRAD 100NX System. "The new cycle sterilizes da Vinci 3-D endoscopes and other frequently-used devices without lumens in just 24 minutes," described Kira Paniagua, group product director for terminal sterilization. "The STERRAD 100NX System is a versatile performer, providing facilities the flexibility of three different cycles for instrument processing. In addition, ASP launched the ASP SteriTite Containers, which are designed to help facilities increase efficiency by providing an alternative to wrapped trays."

As the industry continues to go "green", "hospitals are considering the environment in their sterile packaging options," said Paniagua. ASP SteriTite Containers offer "a rigid alternative packaging solution for hospitals that are looking to reduce their usage of sterilization wrap."

"Ensuring that devices can be processed in STERRAD Systems and developing new enhancements are key to helping our customers drive efficiencies and productivity," Paniagua said. "For example, the STERRAD Sterility Guide (SSG), which is now available as a mobile app, quickly allows customers to determine which devices fall within the cleared claims for sterility. ASP is proud of the relationships we’ve built with leading Medical Device Manufacturers (MDMs), and we work closely with them to ensure that STERRAD Systems are included in their instructions for use (IFUs). Finally, the materials and lumen claims of STERRAD Systems extend even beyond heat- and moisture-sensitive devices, allowing customers to process many procedure sets together."

Using hydrogen peroxide gas plasma technology, the STERRAD 100NX System offers three cycles that sterilize instruments in less than one hour. In addition to the EXPRESS Cycle, the system also offers a 42-minute FLEX Cycle for up to two single-channel flexible endoscopes and a 47-minute STANDARD Cycle for most general surgical instruments. The system features enhanced technology and expanded lumen claims that allow customers to process single-channel flexible endoscopes, semi-rigid ureteroscopes, cameras, light cords, power drills, rigid scopes and a wide range of other instruments.

3M Steri-Vac

Susan Flynn, Sterilization Assurance Technical Service, 3M Infection Prevention Division, described the unique advantages offered by ethylene oxide systems. "With proper installation and maintenance, a 100 percent ethylene oxide system remains one of the safest sterilization systems in the market. Recent survey results indicate that efficacy is the most important factor in the decision to purchase a new low temperature sterilization system. Over the last 50 years, ethylene oxide has been established as the ‘gold standard’ of efficacy for low-temperature sterilization and also provides the greatest penetrability and medical device material compatibility. It does not require any special packaging materials, such as polypropylene wraps or polyolefin pouches, as other systems often do. Ethylene oxide can penetrate all common packaging materials and device lumens and is compatible with most medical materials. The ‘trade-off’ of having such high material penetrability, however, is the residual ethylene oxide in the materials sterilized. To minimize staff and patient exposure, adequate aeration time is required, making the cycle time of ethylene oxide systems longer than that of other low temperature sterilants."

"Low-temperature sterilization systems continue to evolve," added Flynn. "Even with newer technological advancements that have led to faster sterilization processes, the 100 percent ethylene oxide system still remains one of the best options, providing proven efficacy, greater material compatibility and penetrability, along with a solid safety profile. While there is a place for other types of systems, and some can deliver faster cycle and turnaround times, their limitations in materials compatibility make 100 percent ethylene oxide systems a worthy consideration for any hospital administrator looking to define their portfolio of low temperature sterilization equipment."

Medivators DSD EDGE

The DSD EDGE from Medivators, cleared by the FDA for marketing in April 2010, is an automated endoscope reprocessor that uses single-use Rapicide PA (peracetic acid) High Level Disinfectant (HLD). Based on Medivators’ DSD-201 model, the DSD EDGE features two independently-controlled, asynchronous reprocessing basins that allow users to run simultaneous or independent cycles and provides fast turnaround with a reprocessing cycle as short as 22 minutes. Automated leak testing minimizes leak-related repair costs and a final alcohol purge facilitates drying of endoscope channels. An optional supplemental wash cycle provides additional and consistent cleaning of the endoscope. An optional data management system for cycle tracking and record keeping is also available.

"The most important consideration to improve efficiencies, productivity and quality outcomes is the selection of the best reprocessing system and related chemistries for the particular facility," said Alexa Chapin, associate product manager, Medivators, a Minntech Corporation Business Group. "Decision-making factors include: physical size/configuration of reprocessing area; number of procedures/day; number and type of scopes (EUS, ERCP vs colons/gastros); cycle and patient data capture, storage and analysis requirements; ventilation and environmental requirements; staff training and competency; financial considerations; and proper installation, start-up, and service of equipment."

Those making a transition from legacy STERIS SYSTEM 1 processors have been allowed additional time to weigh their options, according to Stephen Loes, vice president of marketing IPT, STERIS. "On March 18, 2011, we received written confirmation that the U.S. Food and Drug Administration had extended the time period for transitioning from the SYSTEM 1 processor to an alternative processing technology by an additional six months. As a result, STERIS will continue to support our current SYSTEM 1 Customers in the U.S. who have not transitioned to another device through February 2, 2012, the new date for completion of the transition."

While the announcement does buy facilities more time, Loes cautioned, "SYSTEM 1 customers must continue to diligently assess their processing needs and evaluate alternative process technologies to ensure they can complete the transition by February 2, 2012. The SYSTEM 1E Liquid Chemical Sterilant Processing System is an acceptable alternative for SYSTEM 1 users and offers several benefits over the existing SYSTEM 1."

STERIS Caviwave Pro Ultrasonic cleaning system with da Vinci tray

He described safeguards built into the STERIS SYSTEM 1E to help ensure that critical and semi-critical devices are ready for use. "The SYSTEM 1E critical parameters include temperature, time, and sterilant concentration. The sterilant temperature is monitored throughout the cycle via sensors that communicate with the system controller. If the temperature is out of specification at any time during the cycle, the cycle will abort. The exposure time for all critical steps is also monitored by the controller. If any step is not within the specified time, the cycle will abort.

"The concentration of sterilant is monitored through a number of safeguards," Loes continued. "First, extensive testing under various environmental conditions established the useful life of S40 Sterilant Concentrate, ensuring that even at the end of its useful life the sterilant will deliver an effective dose of peracetic acid (when handled and used as directed). Second, conductivity monitoring is automatically performed by the processor to ensure that the single-use chemistry has been delivered. Finally the SYSTEM 1E chemical indicator, which was recently cleared by FDA for use with the SYSTEM 1E, provides additional confirmation of the appropriate concentration under actual use conditions."

A biological indicator is not required for use, Loes clarified: "The FDA guidance document for liquid chemical sterilants and high-level disinfectants does not require the use of a BI for a liquid chemical sterilant. Therefore, FDA cleared the SYSTEM 1E Liquid Chemical Sterilant Processing System for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive devices with the monitoring capabilities that are controlled by the processor and without requiring a BI to monitor the process. A BI is not required because SYSTEM 1E efficacy has been validated under worst-case conditions using inoculated medical devices. Monitoring and control of critical parameters by the SYSTEM 1E processor confirms that the process conditions during clinical use match those of the process validation (when used and maintained as directed)."

"Two additional enhancements with SYSTEM 1E (as compared to SYSTEM 1)", he explained, "are the addition of the MaxPure Filter integrity test at the end of every cycle, and the addition of the UV light. These enhancements provide additional verification that successful device reprocessing has been achieved. A failure associated with either the filter integrity test or the UV light will result in the processor aborting the cycle."

ASP offers two potential solutions for customers seeking an alternative to their STERIS System 1 Processor – the STERRAD NX System for customers seeking a terminal sterilization alternative and the EVOTECH Endoscope Cleaner and Reprocessor (ECR) for customers seeking a high-level disinfection alternative, Paniagua offered.

"The STERRAD NX System utilizes an advanced hydrogen peroxide gas plasma process to rapidly sterilize a wide range of instruments at a low temperature, including most single-channel flexible scopes," she said. "It offers a 28-minute STANDARD Cycle time and the flexibility of having dry, packaged, sterilized instruments available for use anytime, enabling customers to handle more caseloads without delays. Its compact size makes the system ideal for operating rooms and surgery centers."

Also from ASP, "the EVOTECH ECR is the first commercially available system to eliminate labor-intensive manual cleaning of endoscopes and the human variation inherent in it," she noted. "The EVOTECH ECR establishes a consistently high standard of automated endoscope cleaning and high-level disinfection that is comparable to professional society guidelines for manual cleaning. In addition, the advanced automation offered by the EVOTECH ECR features integrated leak testing, an onboard MEC monitor, a built-in alcohol flush, and computer tracking of all cycle parameters to provide customers with confidence from start to finish."

Langford LIC Parametirc Release Instrument Processor

Langford IC Systems offers another potential alternative to the STERIS SYSTEM 1 with the LIC Instrument Processor System. According to Terry Langford, president, the LIC system is "unique in that the technology eliminates the need for connectors and is designed to process a variety of surgical and diagnostic medical instruments, with lumens and without lumens including but not limited to endoscopes in a single chamber."

Langford explained that the LIC System "delivers the three critical steps required to process a reusable medical instrument, i.e. integrates cleaning to far less than 6.4 micrograms of protein per square centimeter residue, disinfects to greater than 10^-6 with no surviving microorganisms, and rinses off the germicide residue with a unique filtered ozonated final rinse water process that has been validated to achieve a level of purification that is equal to the level of disinfection achieved during processing by the instrument processing system."

All three steps are "validated and require no user interaction during the cycle," said Langford. Because the device being processed remains throughout the disinfection and final rinse steps in the LIC system following cleaning, this eliminates the risk of touch contamination by machine operators, he added.

"Cleaning to the lowest possible quantifiable level of clean and validating having done so provides the key to successful sterilization," said Langford. "The FDA is on record as emphatically stating that one cannot sterilize without first properly cleaning."

Further, Langford explained, "The LIC Instrument Processing System eliminates manual cleaning which cannot be validated. The FDA applies and enforces a quantifiable level of clean of 6.4µg/cm² of residual protein to the reprocessing of Single Use Devices (SUDs) to ensure their sterility which begs the question, why not all reusable instruments as well? We have provided the FDA with the validation criteria and test methods for verifying mechanical cleaning to a level of far less than 6.4µg/cm² of protein residue. This information was cleared by the FDA under 510(k) K060458. The Health Care Industry is now in the possession of cleaning validation data that meets the FDA’s requirement for standardized criteria for the quantifiable validated cleaning of all medical devices which is outlined in their February 2002 Guideline for Washer, Washer Disinfectors. The FDA, under their charter of ensuring safe and effective devices could make the decision to mandate this standard to all reusable surgical and diagnostic instruments in the near future."

He noted that the yardstick of less than 6.4µg/cm² of protein residue came about as a result of the FDA seeking a quantifiable cleaning measure in an assay form, versus simply visibly verifying the level of cleanliness. In 2003, AAMI published TIR30:2003, "A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices". TIR30 reported test results came from a laboratory at the University of Manitoba. The University of Manitoba study defined the worst case protein soiling for endoscopes as 115 µg/cm² and the best case residual protein level as 6.4 µg/cm². The FDA embraced the 6.4 µg/cm² as the measure of cleaning for reprocessing single use devices. While this provided a benchmark starting point, today, "the FDA currently would like to see a mechanical cleaner clean to far lower levels than that," Langford emphasized.

The easy-to-use system is controlled by its validated software and numerous sensors guaranteeing that the operating parameters that ensure validated cleaning and disinfecting results are achieved. If for some reason a required parameter is not met the cycle is automatically aborted and the user is alerted via an audible and written alarm, Langford explained.

While Langford IC System’s standalone cleaner and instrument cleaner/processor have received FDA 510(k) clearance for the processing of bronchoscopes, the company has also submitted a 510(k) application for a second generation instrument processor that is under review to include all endoscopes. The submittal also provides the FDA with LIC’s updated standardized criteria and test methods for validating mechanical cleaning in response to FDA’s request for cleaning requirements that meet or exceed the original AAMI TIR30 recommendation of 6.4µg/cm² of residual protein they apply to the SUD reprocessing industry. We have provided them with the standardized criteria and test methods for a worst case soiling of endoscopes that far exceeds the AAMI TIR30 soiling of 115 micrograms of protein per centimeter squared (we soil a colonoscope with an average of 800 micrograms) and then clean it to less than 2 micrograms of protein per centimeter squared," said Langford.

Langford IC also has plans to file for marketing clearance for a cleaner/ozone sterilizer that forgoes chemicals for liquid ozone, he added.

Vendors are also loading washer-disinfectors with features designed to improve outcomes along with productivity. "For example, through the development of innovative spray patterns used in combination with our high impingement cycle options, STERIS has validated 20 minute instrument cycle times for our washer/disinfectors – this means that hospitals can buy less equipment to process the same number of trays; saving space, utilities, water and money," said Linville.

Recent advancements to STERIS washer/disinfector technology, she explained, include "the use of PC, touch screen controls to allow users to interface intuitively with the equipment (i.e. using icons like an iPhone or laptop), and to quickly capture electronic cycle records, link to tracking systems and verify all critical parameters of completed cycles; development of water saving features that minimize cycle time, water consumption and chemistry usage; units providing dual speed pumps so that customers can select from high impingement (normal) or low impingement (gentle) cycle options to meet all of their processing needs; development of innovative validated cycles as fast as 20 minutes that meet the FDA intermediate disinfection standards and IS0 15883 A_o 600 levels; and washer cleaning indicators that provide additional assurance that the necessary parameters are being met throughout the day, much like DART tests provide for steam sterilizers."

The Medisafe Sonic Irrigator (SI) PCF automated cannulated instrument cleaning system, launched in 2004, is validated for cleaning and thermal disinfection of da Vinci EndoWrist instruments. In addition to a standard ultrasonic-only mode for convenient cleaning of standard instrument sets and trays, the Medisafe SI PCF system can be purchased with a thermal disinfection option included or as an upgrade at a future time as budgets allow, noted Gary Jordan, president, Medisafe America.

Besides a dedicated da Vinci cycle for cleaning up to 10 EndoWrist instruments in an approximately 45-minute cycle, "the SI PCF has been tested, validated and approved by leading surgical instrument manufacturers as the automated cleaning process of choice for their instruments. In addition, the SI PCF has the capacity to connect and flush 20+ MIS cannulated or fine lumen instruments per cycle," he added.