Biosign SSI test pack

The individual who coined the phrase, "Timing is everything," must never have stepped foot in a sterile processing department.

While timing certainly is a critical element in instrument processing, the same can be said for temperature, pressure, maintenance, training, tracking, packaging, handling and scores of other factors. If one element is absent or compromised, that will impact the entire process and increase the risk for a range of adverse events — from patient infections and potential litigation to costly damage to instruments and equipment.

Unfortunately, when it comes to measuring the effectiveness of the sterilization process, it is anything but easy to visually determine whether the parameters have been adequately met. That’s particularly true in light of complex devices that have narrow components and nooks and crannies that make it easy for bioburden and other matter to become lodged, yet remain unseen. It’s because of such challenges that sterilization management tools, such as mechanical/electronic controls, chemical and biological indicators, equipment maintenance, and diligent record-keeping, to name a few, are so invaluable to central service departments’ quality assurance efforts.

Raven ProPact

"Sterilization quality assurance is a complex process that takes into account many different factors. It’s definitely something that can’t – or shouldn’t — be rushed," stressed Charles O. Hancock, president, Hancock & Associates, Fairport, NY.

Although rushing the process can be detrimental, sources acknowledge that products and processes that can reduce wait time and allow devices to be released more quickly are highly sought after by central service and operating room professionals.

Vendors of sterilization equipment and products are responding to those needs by expanding their product and service portfolios, and offering customers more solutions than ever that promise reliable, faster results and simplified usability.

Understanding indicators
Beyond the most basic mechanical and electronic controls that monitor time, temperature and pressure, CS staff are relying on chemical and biological indicators to further monitor the effectiveness of the sterilization process.

Hancock said biological indicators are considered the "gold standard" for sterilization monitoring because they consist of a standardized, viable population of microorganisms known to be resistant to the mode of the sterilization process being monitored. The Association for the Advancement of Medical Instrumentation recommends using biological indicators at least weekly, but preferably daily – a suggestion that Hancock fully supports.

In recent years, there’s been a surge in vendor competition, which has led to broader options and more cost-effective, faster alternatives. In addition to 3M’s Attest Rapid Readout biological indicator, a market mainstay that provides results in just one hour for flash sterilization cycles, three hours for standard steam cycles and four hours for ethylene oxide cycles, customers now have a bevy of other BI products at their disposal.

"There were instances where a company made a sterilizer and a biological indicator for that sterilizer, and there were no other alternatives on the market," explained Dan Dwyer, healthcare director of marketing for Raven Biological Laboratories, Omaha, NE. "Today, there are more options."

Raven recently developed the ProPACT (peracetic acid culture test kit), which is intended for use in monitoring the efficacy of the STERIS System 1 sterilization process. The BI offers 48-hour results, uses an existing incubator and allows for ambient storage, as opposed to refrigeration. Dwyer said the company is currently working to cut the incubation period to just 24 hours.

"We believe it’s important to give customers more options and to develop products that fit into systems that facilities already have in place," said Dwyer, noting that doing so helps keep costs down. He said Raven is also exploring other product development opportunities, such as a BI for the STERRAD system.

SPSmedical’s SporView VA Culture Set for the STERIS System 1 offers results in 24 hours, and can also be stored at room temperature. SPSmedical sells a complete line of sterility assurance products including biological indicators, chemical indicators, integrators, Bowie-Dick test packs, packaging and recordkeeping products. 

Chemical indicators, which are designed to respond with a chemical or physical change to one or more of the physical conditions within the sterilizer chamber, are also gaining momentum in the marketplace. This is especially the case for Class 5 integrating indicators, which are designed to react to all critical sterilization parameters and can serve as the basis for the release of processed items (excluding implants), per the AAMI standard ST46:2002, Steam Sterilization and Sterility Assurance in Health Care Facilities.

"Hospitals are looking for products that are not only reliable but also offer quick release of instruments," explained Kevin Davis, vice president of sales for Propper Manufacturing Co. Inc., Long Island, NY, noting that many hospitals simply can’t afford to keep instruments tied up waiting for the results of a biological indicator.

Propper manufacturers the Vapor Line PCD, which is a reusable process challenge device for monitoring the prevacuum sterilization process at 270-274 degrees F. According to Propper, the device presents a significant challenge to steam penetration in standard cycles, and offers results immediately after cooling the Vapor Line PCD. Propper also offers the Pass-Fail disposable challenge pack for both gravity-displacement and prevacuum cycles at 250 degrees F and 272 degrees F. The Pass-Fail provides immediate results and was designed for easy readability. The stable dark color of the integrator’s bar allows facilities to keep documentation of correct sterilization exposure as long as necessary.

Davis stressed the value of such color stability. "Some indicators revert back to their original color after a period of time," he said. "Imagine having to trace a product and pull out the results of a once-verified indicator only to find that the indicator has now reverted back to the original color."

Cardinal Health, McGraw Park, IL, offers a complete line of machine, pack and load control products that utilize advanced (purple to green) ink technology. Cardinal reports that the newer chemical indicators have been engineered to measure further into the sterilization cycle than a biological spore and can provide the SPD with confidence that a sterility assurance level of 106 has been achieved. Certain chemical indicator technology can even indicate if a sterilizer is beginning to fall out of control and should be serviced, according to Debra Schotz, director of marketing, sterility assurance, Cardinal Health.

While there is obvious value in using Class 5 indicators to release product more quickly, experts warn against using such items as a substitute for a biological indicator.

"Looking to Class 5 indicators to replace BIs is not appropriate," said Janet Prust, marketing manager for biological indicators, 3M Sterilization Assurance. "BIs remain the only direct measure of the [success] of the cycle."

Hancock agreed, explaining that it’s critical to have a challenge device that is representative of the load being sterilized. "Only a BI can determine spore kill."

Numerous products are available that combine a chemical indicator with a biological, essentially giving the customer the best of both worlds: the ability to release product more quickly based on the results of the Class 5 integrating indicator, along with the ability to fully validate spore kill with a BI.

"There has been movement toward using these types of integrators within test packs for the immediate release of sterilization loads. The Class 5 indicators’ immediate results, coupled with their performance equivalence to biological indicators make them desirable for facilities that require immediate use of the sterilized items," said Heide Ames, product manager, Sterility Assurance, STERIS Corp., Mentor, OH. The newest addition to the STERIS portfolio is the Verify C5 series of Class 5 integrating indicators.

"What appears to be a simple yellow to blue color change [with the C5 series integrator] is actually a complex series of reactions that require all the critical parameters of steam sterilization," Ames explained, adding that the reactions are controlled in such a way that the performance of the integrator has been correlated to the performance of a biological indicator. "This same technology has been incorporated into test packs for routine monitoring of sterilization cycles. These test packs provide a cost-effective alternative to the typical BI test packs used to monitor sterilization loads."

Advanced Sterilization Products offers the STERRAD CycleSure Biological Indicator, a self-contained indicator that includes a built-in chemical indicator on the BI vial cap. The CycleSure BI, developed for routine monitoring of STERRAD sterilization systems, is designed for easy readability and interpretation, and provides a 48-hour color readout. The bacterial growth medium remains purple if the spores have been killed; a yellow color indicates bacterial growth.

The Biosign SSI test pack with instant read from Getinge USA, Rochester, NY, gives the user instant reassurance based on a result from a steam integrator card and a 24-hour biological result.

Focus on cleanability
Embracing the concept that "sterile isn’t sterile unless clean is clean," the vendor community is placing a growing emphasis on products that monitor the cleaning process. Similarly, device manufacturers are becoming increasingly aware that their designs must allow for thorough cleaning.

"There has been a lot of frustration on the decontamination side because devices have typically been designed with the O.R. in mind and not the [SPD]. As a result, those in decontam are often challenged with devices that are very delicate and difficult to clean," said Ralph Basile, vice president of marketing for Healthmark Industries Co., St. Clair, MI. "If instruments are not easy to clean, those in decontam need to be given the tools to do so."

Healthmark offers several tools for monitoring the cleaning process. The ProFormance (TOSI) soil test, marketed since 1999, monitors the effectiveness of the automated instrument washer process and helps take the guesswork out of the process, according to Basile. Aside from helping determine whether the cleaning process was effective, a positive TOSI result also helps indicate where the failure occurred. Among the latest products to be added to Healthmark’s portfolio are the TempaChek-DL data logger and the EndoCheck. The TempaChek-DK data logger independently checks, logs and records the complete temperature profile of an automated instrument washer, including thermal disinfection. The data logger also provides a complete log of surface temperatures throughout the cleaning cycle. The EndoCheck is a "miniature chemistry set" designed to check for blood and bioburden in the biopsy channel of the flexible endoscope.

It may seem difficult to understand why the industry, by and large, has lacked tools for monitoring the cleaning process, particularly since it is well understood that effective cleaning is critical to the success of sterilization. But Hancock stressed that key factors — such as a lack of a standardized challenge — are at the root of the delay.

"The shortcomings with the products available now are that they aren’t really representative of today’s medical devices, which can be very difficult to clean," he explained.

Cynthia Spry, R.N., international clinical consultant for Advanced Sterilization Products, echoed Hancock’s concerns, adding that having no standard for "clean" exacerbates the challenge. "A lot of companies out there, including ASP, are focusing on [process monitoring for cleaning], and I think that’s a positive step in the right direction. But the real challenge at this point is getting a test soil that adequately represents each load," she said.

Still, Hancock and Spry contend that, despite such limitations, tests currently on the market serve a valuable purpose because they set a benchmark for a minimum level standard of clean. They predict that in the future, their use will become routine.

Dwyer said BI vendors and device manufacturers can also play a bigger role in the process. "It may be that BI manufacturers will work with scope manufacturers, for example, to develop a product that can be introduced into the devices to test cleaning," he said. "I think we can all play a bigger role in this area."

Eye on education
Of course, even the best products won’t be effective unless ongoing education is at the core of the sterilization quality assurance program. More than ever, vendors are offering myriad educational opportunities, including Web-based programs, seminars, inservices and even more detailed consultative services.

"Education is critical. Even the smallest error can lead to serious infection," stressed STERIS’ Ames. "Staff must be trained not only on the ‘hows’ but also on the ‘whys.’ Managers are often so focused on teaching how to do something that they don’t explain the reason for its importance to the infection control process. Understanding why something is done helps prevent shortcuts, lazy technique and other errors."

Getinge, through its Verified Performance Programs, offers continuous educational opportunities and performs onsite reviews of operations. According to Chip Moore, sales manager for Getinge Sourcing LLC, the company works with facilities to establish detailed processes and protocols, and has even helped departments write and update standard operating procedures. "The more knowledge they have to do the job effectively, the better."

Vendors are also seeing value in educating O.R. staff, including physicians, on the various steps and requirements of sterile processing – a move that could have a positive impact on unrealistic demands being placed on already over-burdened SPDs. Propper is focusing some of its educational efforts on physician offices, training physicians on proper sterilization technique. The company also offers posters and diagnostic charts that show results (including marginal failures) of Bowie Dick tests and other process testing products to aid interpretation.

3M has also developed a variety of educational tools for physicians and other surgical staff, including quick reference wall charts and interactive educational programs. Prust said 3M also works on educating CS and O.R. staff on the latest standards. "Interpreting standards can be a challenge. Arming staff with good information is a key piece of the process." If CS is knowledgeable, understands the standards and has the documentation to support their processes and policies, that will empower staff to stand up to any unrealistic demands being placed upon them, she explained.

ASP also offers a wide range of educational opportunities, including infection control-related seminars for O.R. and CS staff. The company is committed to advancing sales force training to push their knowledge beyond the basic product and service level. "Our sales force is a good resource for information. We expect them to know more than just the products. They also fully understand the steps in the process," said Spry.

She recognized that getting physicians involved – and even interested – in aspects of instrument processing can be difficult, but stressed the importance of interdepartmental and interdisciplinary communication. "I’m seeing it happen more between CS and O.R., but there’s still work to do," Spry said. She recommends using O.R. committee meetings — where physicians are present – as a forum to briefly address key issues related to instrument processing.

Sources generally agreed that mandatory certification of CS staff will also go a long way in building and maintaining quality processes within the SPD – as well as prompting even more product advancements in the marketplace.