Author: Williamson, Julie E
Date published: June 1, 2010
Decontamination and sterilization of surgical instrumentation Ls a highly complex process whose effectiveness hinges on consistent adherence to processing standards, manufacturers' instructions and department-wide policies and procedures. If one step in this intricate process falls short, sterility - and, subsequently, patient safety - can be called into question.
When one thinks of instrument processing, the focus tends to fall on the decontamination and disinfection/sterilization equipment itself. While such systems are undoubtedly amongst the most critical resources Sterile Processing Department professionals have at their disposal, their successful operation doesn't happen on its own. Much like SPD professionals are the unsung heroes of infection prevention and quality patient care, the same can be said oi disinfectants and sterilants. Without these chemistries, the disinfectors and sterilizers simply cannot do their job. Put simply, it's the equivalent of operating a top of the line washing machine without laundry detergent, attempting to steam-press garments without the presence of water, or trying to drive a sports car without gasoline.
Just as disinfection and sterilization equipment has become increasingly sophisticated to better meet the needs and challenges of the SPD, and the wide range of ever-evolving, increasingly complex instrumentation, so have the disinfectants and sterilants themselves.
"The emergence of alternative sterilization methods has played a role in the development and advancement seen within the disinfectant/slerilant segment," said Bradley Citatone, MBA, Ph.D., director of clinical affairs for Olympus America Inc., Center Valley, PA. "When !here mav becompatibilitv concerns, there are now more options available for different equipment."
A greater focus on healthcare-acquired infections, and the need for enhanced quality and patient safety practices, has also contributed to notable product enhancements.
"Disinfection and sterilization continue to play a pivotal role in the healthcare industry. A clean and updated Central Sterile department is paramount to the integrity of sterilized instruments," noted Ruth Arbuckle, senior marketing manager for Getinge USA, Rochester, NY. " Heightened awareness, key industry groups, continued emphasis on training, and safety and technological advancements have all been important in advancing the disinfectant/ sterilant segment in recent years."
Efficacy meets safety, sustainability
Indeed, today's disinfectants and sterilants noi only work better than previous formulas, but also simplify processes and streamline efficiencies, sources told Healthcare Purchasing Netvs.
"Today's sterilants and disinfectants are able to be more effective in achieving the desired outcome - sterilization for critical devices or high-level disinfection for semi-critical devices - faster and easier," said Candy LeBlanc, RN, BSN, senior manager, global training, ASP.
More than ever, SPDs have the opportunity to incorporate advanced technologies into the facility and offer valuable input to equipment and chemical manufacturers that will assist in the development of products that improve speed, reliability and safety - all at a competitive price point. "Facilities can meet the increased demand without compromising staffer patient safety," stressed Arbuckle.
The market has given rise to the development oi newer liquid chemical sterilants and high-level disinfectants. Specifically, SPD customers have access to lower-vapor solutions that help protect staff and the environment." Products introduced to the market are more user-friendly. They are designed to be safer for staff with low vapor formulas, as well as 'green-friendiv' solutions to protect the environment," confirmed Matt Rudolph, vice president and chief customer advocate for Spectrum Surgical Instruments Corp., Stow, OH. "The hospital does not have to invest in a ventilation hood as they would have to in the past with solutions that had strong vapors."
And that's not the only benefit of modemday solutions. Many disinfectants and sterilants don't require mixing and can be used directly out of the bottle. "This saves the [SPD staff] time as they don't have to prepare the solution," added Rudolph. Beyond that, less harsh and corrosive formulas allow for greater compatibility with the various materials used to manufacture surgical instruments, rigid and flexible scopes, and they can even help curb instrument and repair costs, he said.
Low-temp solutions heat up market
Although hydrogen peroxide is no longer new to the "marketplace (ASP's STERRAD was the first system to enter the market more than a decade ago), most would agree that it remains the leading breakthrough in the lowtemperature sterilization segment.
"The hydrogen peroxide sterilant that is used in the STERRAD System cassette is the only sterilant that meets the requirements to be transported by air," said LeBlanc. She further explained that the STERRAD System's hydrogen peroxide gas plasma process eliminates residual hydrogen peroxide horn a wide range of instrumentation, including ophthalmology devices.
Low-temperature technology continues to advance with the introduction of faster cycles that target the OR and Gl, and other companies have introduced hydrogen peroxidebased systems on a global scale.
"The kev benefit is rapid processing and reduction in required equipment inventory. TIi is has provided measurable benefits, even with the increased acquisition, operational and service costs with these systems," noted Janet M. Prust, business development manager for 3M Sterilization - Low Temperature Sterilization Systems and MSS products, St. Paul, MN. The next advancement she said, will be the combination ozone/ hydrogen peroxide low-temperature sterilization system currently under review by the FDA (the 3M Optreoz Low Temperature Sterilization system is approved in Canada and a CE mark has been obtained).
The Resert XL HLD by STERlS Corp., Mentor, OH, is an odorless, ready to use high-level disinfectant that includes 2 percent hydrogen peroxide as the active germicide. Formulated for reprocessing of heat-sensitive, semi-critical devices, such as endoscopes and their accessories, the solution can be used in manual soak applications or automated endoscope reprocessing systems designed for use with legally cleared, high-level disinfectant solutions. Resert XL HLD is formulated to be safe and environmentally friendly. It has a 15-month shelf life, needs no special venting during use or storage, and may be disposed of directly into sanitary sewers.
While reduction of risk to the healthcare worker and patient are key aspects of regulatory review for any new system, Prust pointed out that all lowtemperature steriiants are nonetheless potentially hazardous materials and must be handled in a safe manner according to manufacturer's instructions.
Patient safety is also a key factor in the development of today's high-level disinfectants. ASFs EVOIECH ECR offers a process that is automatically controlled and utilizes technology that does not reuse high-level disinfectants from one device to another. " Each patient gels a device disinfected with fresh disinfectant," said LeBlanc. The disinfectant is monitored by a Minimum Effective Concentration monitor that ensures that the correct concentration of disinfectant solution is used to achieve highlevel disinfection. "This provides healthcare professionals with consistency and efficiency in endoscope reprocessing by eliminating the sutijectivitv of interpreting test strips to determine if the high-level disinfectant meets the MEC"
EO, glutaraldehyde hold their ground
Products with extended useful life cycles are also gaining prominence. To meet the needs c >f hea ? ^sensitive den ices, Ol ympus developed Aldahol, a new high-level (disinfectant with a useful life cycle of 14 days that frees a facility from the expense of having to continuously heat chemicals and monitor and record room temperatures.
A combination of glutaraldehyde and isopropanol, .Aldahol is rapidly effective against all vegetative bacteria, fungi, and virus types. "Aldahol HDL has been demonstrated to have· enhanced activity against spore-forming bacteria and is both important and clinically relevant for use against organisms such as Clostridium difficile," said Catalone.
Of course, the standby ethylene oxide still plavs an important role in the low-temperature sterilant segment. Although EO has not undergone anv significant recent changes - aside from the realization by the market that it is likely impossible to go "EO free" - Prust said that EO continues to Lx the most effective low-temperature sterilant due to its ability te' penetrate materials and provide efficacy even in devices of challenging design, including those with very long, narrow lumens. " It is still the best technology to provide a terminally sterili/ed multi-channel flexible endoscope," she explained.
Prust acknowledged that the lengthy cycle time and regulatory requirements associated with EO are a concern for some facilities; however, "technological advances, including single-use cartridges, single chamber sterilization and aeration, and mechanical safety features have essentially eliminated occupational exposure risk, and many hospitals are beginning to understand this. Mixed gas systems using HCFC/fiO mixtures are in the process of being phased out." 3M continues to market the 3M Steri- Vac I CK) percent ethylene oxide sterilization systems and the company is anticipating that it will offer a "new to the world" technology/ which is currently under FDA review.
When it comes to instrument sterilization, steam still seems to reign supreme. Not only is it the most prevalent method for device sterilization, it remains among the most costeffective sterilization methods available. While its sterilization properties haven't evolved, the device market itself has, which has made it possible for facilities to safely steam sterilize a wider array of devices.
Olympus, for example, offers a range of autoclaveable products, including rod lens telescopes, HD camera heads, video laparoscopes, and the world's first autoclaveable flexible bronchoscope.
Regardless of the disinfectant or sterilant used, safety, efficacy and efficiency will ultimately depend on proper, consistent use by staff. One common mistake employees make when using disinfectants and sterilants is failing to follow proper dilution ratios, according to Spectrum's Rudolph.
"If a product requires dilution, the incorrect ratio will decrease the efficiency [and efficacy] of the product. Also a strong dilution could cause damage to the instruments/' he warned. And don't ignore the required processing time of the solution. "If not used for the proper length of time, disinfection/ sterility could be compromised."
Another common, yet serious, mistake is assuming that the reprocessor knows the intended use of a particular device, according to consultant and sterilization expert Charles Hancock, RAC, president of Charles O. Hancock Associates Inc., Fairport, NY. One example might be assuming that flexible endoscopes will never penetrate a membrane and, hence, sterile condition is not required.
" But if it does, the reprocessor will never know," he explained.
Solutions on the horizon
Industry experts are anticipa ting significant changes ahead for the disinfectant/ sterilant segment. U1BLmC pointed to the current market trend of custom cycles for specific instrumentation, which she says will increase tu ma round times based on the instrument being processed.
"There is also a focus on improving the efficiency of reprocessing with more customized packaging and tracking," she continued, adding that this advancement would help instrumentation move more efficiently through sterile processing - from the OR to the SPD and on to the end user. "It would also mean healthcare facilities would have less inventory to manage and would experience quicker turnaround."
Fast-paced emergency departments, smaller ambulatory clinics, more outpatient procedures and a renewed emphasis on universal healthcare will also play a key role in future product developments, according to Getinge' s Arbuckle. "[These] will all contribute to an increase in patient load and drive demand for technological advances in size, speed and throughput oi disinfection and sterilization equipment - all delivered without compromise to quality or safety."
Olympus' Catalane envisions a future with advanced technology designed to be fully automated and to provide for an enhanced, traceability-focused system The development of advanced fluid dynamics will also continue, and will be necessary in providing "robust, highly effective cleaning."
Some are also paying careful attention to the apparent move toward terminal sterilization, which means that a device has been processed in a system that delivers a sterility assurance level of 10" (a one in a million chance of a nonsterile occurrence). "There is a definite move toward a preference fora terminally sterilized device for use in the Oli. versus a high-level disinfected device. FDA and AORN have both issued statements to this effect," said Prust.
Hancock anticipates the continued development of chemistries that will minimize adverse material effects and improve turn-around times by increasing effectiveness of the chemical agent.
"I think greater use of thermal disinfection will eventually become more accepted in the USA on economic grounds."