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SPD aims for turbocharged disinfectant, sterilant options Vendors aid process with advanced product portfolios by Julie E. Williamson
S terile processing is a department in flux and the same can be said of the equipment, products and services that comprise it. To keep up with ever-evolving instrumentation and customer demands, processing equipment has become increasingly sophisticated, allowing technicians to boost throughput and efficiencies, improve safety and outcomes, and advance the SPD’s overall quality improvement efforts.While the bells and whistles of today’s processing equipment are undeniably eye-catching, the solutions and chemistries they run on also call for more than a mere passing glance. Think of it this way: if the high-level disinfector or sterilizer is viewed as a high-performance vehicle then the disinfectant or sterilant is essentially the fuel that makes it run. More than ever, it’s a message that healthcare organizations – and, especially, SPD professionals – are hearing loud and clear, sources told Healthcare Purchasing News. "The focus on preventing healthcare-acquired infections has increased the awareness of healthcare facilities to incorporate best practices in terminal sterilization and high-level disinfection throughout the organization," noted Barbara Trattler, RN, MPA, CNOR, CNA, director of clinical education for Advanced Sterilization Products (ASP), Irvine, CA. "There is a real opportunity for sterile processing staff to take charge in promoting best practices in sterilization and high-level disinfection throughout their entire organization. SPDs have the core competencies in sterilization and high-level disinfection and should provide this specialized clinical expertise and knowledge to contacts throughout the healthcare facility." Product selection process gets sharper Heightened awareness of high-level disinfection and sterilization processes requires a keen understanding of the disinfectants and sterilants themselves. It’s a fact that’s certainly not lost on MedCentral Health System in Mansfield, OH. The organization’s sterile reprocessing department takes pride in its product selection and education process, and carefully evaluates the products’ compatibility, claims and safety prior to making a purchasing decision. According to department manager David Narance, RN, BSN, CRCST, disinfectants and sterilants must meet a specific set of criteria. "They need to be compatible with a wide range of medical devices and instruments, and safe for staff to use," he said, adding that it’s critical that SPD professionals always ask OEMs to provide recommended cleaning and disinfection agents. MedCentral Health System adopts a proactive product selection process and a collaborative team approach – one that involves input from the SPD, Environmental Services, Materials Management, and Infection Control and Safety. "We placed worker safety first, with a balance toward efficiencies and cost reduction," Narance said, noting that environmentally-conscious products also weigh heavily into the selection process. "We monitor very closely the products that are going into the waste stream and whenever there is an anticipated change, we inform the waste water management department here in our city/county and ask their permission to utilize the product," he added. "Fortunately, we are blessed today with a variety of chemistries and formulations that are safe for intended use and, to the credit of the industry, are now ‘green.’" Boston’s New England Baptist Hospital also takes the selection of disinfectants and sterilants seriously, taking care to properly educate staff on the wide range of formulations on the market and their ability to meet the department’s needs, based on the manufacturer claims. "It’s important to know what we are disinfecting and where it sits in Spaulding’s classification of medical devices. Selection of our disinfectants also relies on the claims of the disinfectant manufacturer and [whether] we are using the right level of disinfectant," said Mark Duro, CRCST, FCS, manager of NEBH’s Central Sterile Processing Department. Another important factor to consider, he stressed, is ensuring that staff allow the correct contact time according to manufacturer instructions. Only with that critical knowledge in place can organizations successfully navigate the sea of disinfectant and sterilant options and make the best purchasing decisions for their own unique needs, Duro reasoned. Advanced formulations abound Indeed, when it comes to disinfectants and sterilants, organizations have access to an ever-growing array of advanced options. "Kill time improvement and the ability of products to kill a wider variety of microorganisms," is one notable advancement of today’s disinfectant and sterilant segment, confirmed Patricia Confessore, Med/Surg senior product manager, Henry Schein Inc., Melville, NY. Also important, however, is marrying efficacy with ease of use, and user and environmental safety, and manufacturers are rising to the occasion there, as well – in many cases, offering improved delivery systems that simplify use and limit staff exposure. Olympus America Inc.’s latest high-level disinfection offering, for example, is a solvent named Acecide-C, a new peracetic acid-based HLD developed and tested for exclusive use with the Olympus Endoscope Reprocessor, the OER-Pro. Acecide-C, which is not yet available for commercial sale, has a contact temperature of 20 degrees C (room temperature) and achieves high-level disinfection in only seven minutes. "The chemistry is delivered in unique, easy to handle cassette bottles, which make disinfectant loading quicker and easier, and allows staff to have less exposure to the disinfectant solution," noted Alison Disbrow, product manager for Olympus cleaning, disinfection and sterilization products. Another HLD option for OER-Pro users is Aldahol, Olympus’ ready-to-use high-level disinfectant that achieves high-level disinfection in ten minutes. Aldahol, developed for use with heat-sensitive instruments (such as Olympus flexible endoscopes, including cystology and urology scopes), combines glutaraldehyde and isopropanol, and offers a 14-day life cycle. "Aldahol kills both mycobaterial and spore-forming bacteria within a reasonable exposure time and temperature. Because of Aldahol’s convenient use temperature of 20 degrees C, healthcare facilities are freed from the expense of having to continuously heat chemicals and monitor and record room temperatures," Disbrow continued.
Medisafe America has addressed the SPD’s growing need for streamlined efficiency with its Sonic Irrigator PCF, which is now a Class II thermal disinfector. The system eliminates the need to run instruments in a washer-disinfector, which saves time, while also requiring less water and detergent consumption. According to Medisafe, the SI-PCF is the only system on the market today that is tested and validated by surgical instrument manufacturers for cleaning da Vinci EndoWrist, Richard Wolf, Stryker, ConMed, and BOSS instruments. "The SI-PCF system uses the same critical cleaning parameters as Intuitive Surgical’s manual cleaning method, with the advantage of being able to clean and disinfect up to ten EndoWrist instruments simultaneously, in a single 45-minute cycle," noted Tina Bramlett, national territory sales manager for Medisafe America, Tampa, FL. Further, the system provides twice the standard ultrasonic cleaning action, combined with turbo individual instrument irrigation for cleaning – inside and out – 20 to 40 standard cannulated/laparoscopic instruments. More than ever, environmental benefits are also being touted by today’s disinfectant manufacturers. "With today’s sensitivity to environmental issues, as well as the heightened awareness of the healthcare industry’s specific contributions to toxic and dangerous waste, there is an increased focus on healthcare products that are environmentally conscientious," confirmed Chris Antonucci, market manager, GI consumables, STERIS Corp., Mentor, OH. "Some high-level disinfectants now emphasize their environmental benefits in addition to their patient and staff safety and antimicrobial efficacy profiles." There are currently HLD formulations on the market that are biodegradable and disposable and, therefore, don’t require dilution or chemical deactivation, added Antonucci. "These issues can be avoided in today’s GI suites and sterile processing departments." STERIS’ Resert XL HLD is the newest addition to the company’s oxidative chemistry family. This alternative HLD solution combines the effective attributes of oxidative formulas with a facility’s manual or validated process in their automated reprocessing system. It’s compatible for use with disposable devices, including flexible endoscopes and rigid devices when high-level disinfection is appropriate. The Resert XL HLD formulation combines a lower concentration of hydrogen peroxide (2 percent) and a blend of inert ingredients that help achieve rapid antimicrobial efficacy. It is virtually odorless and requires no special venting, measuring, mixing, or activation under recommended use conditions. Sterilant vendors step up efforts Not unlike HLDs, the sterilant segment is also brimming with an array of options thanks to the ever-growing presence of diverse and complex instruments. "Steam, plasma and liquid sterilants all have their proper time and place for use. What is critical is that the user is well educated on both the sterilant and the device," reasoned Brian Hvizdak, sterilizer product manager, Belimed Inc., Charleston, SC. "By following manufacturer’s written instructions for use, the user can ensure that the materials are compatible and that the patient will receive a sterile product." Not surprisingly, steam continues to hold its position as a leading sterilization method in the SPD due to its dependability, efficacy, per-cycle cost-effectiveness, and safety. Because of these time-honored benefits, vendors are expanding their range of autoclavable devices. Olympus, for example, offers autoclavable rod lens telescopes, HD camera heads, video laparoscopes, and the world’s first autoclavable flexible bronchoscope. Still, some devices call for more delicate sterilization methods, which explains the developments seen in the low-temperature sterilization segment and the push to terminally sterilize heat-sensitive devices more quickly and safely than ever before. "There is no question in my mind that the advent of second- and third-generation hydrogen peroxide technologies and ozone technology has improved throughput and worker safety," stressed Jonathan A. Wilder, Ph.D., president, H & W Technology LLC, SteriCert Co. . "The replacement of large ethylene oxide cylinders with small, packaged sterilant containers is a major plus for SPD worker safety. Reduced sterilization cycle time also increases SPD flexibility." STERIS’ Amsco V-Pro 1 Low Temperature Sterilization System, launched in 2008, and the newer V-Pro 1 Plus Vaporized Hydrogen Peroxide system, launched in 2009, offer quick turnaround times, reduced moisture sensitivity and simple, one-touch operation that reflects a growing "do more with less" trend. "The V-Pro systems use a plasma-free process that terminally sterilizes instruments, either in 28 minutes in the non-lumen cycle, or in 55 minutes in the lumen cycle," said Renee Brown, product manager, infection prevention technologies, STERIS. Flexibility is at the heart of the ASP STERRAD Systems. The systems are designed for use in a broad range of healthcare settings, from the SPD to the OR, and deliver fast, low-temperature hydrogen peroxide gas plasma sterilization. The ASP STERRAD NX System provides speed, flexibility and sterility assurance in a compact size, making it ideal for ORs and surgery centers. The system provides dry, sterile and packaged instruments in 28 minutes for most general surgical instruments and 38 minutes for single-channel flexible endoscopes (Olympus offers several flexible endoscopes that are proven compatible with the STERRAD NX Sterilization System). Also in the ASP sterilization system lineup is the ASP STERRAD 100NX System, which features the first specialty cycle – the EXPRESS Cycle. At just 24 minute cycles, this is the fastest low-temperature sterilization cycle in the U.S., and broadens the range of instruments that can be processed. Ethylene oxide continues to hold its ground in the sterilization segment, as well – and for good reason. The sterilant offers great penetration and medical device material compatibility, and does not require any special packaging materials, such as polypropylene wraps or polyolefin pouches as other systems often do, according to Beth Fritcher, global marketing manager for 3M’s Infection Prevention Division, St. Paul, MN. "The trade-off of having such high material penetrability, however, is the residual ethylene oxide in the material sterilized," she explained, adding that to minimize staff and patient exposure, adequate aeration time is required, which makes the cycle times of ethylene oxide systems longer than that of other low-temperature sterilants. "However, taking into account the use of the 3M Rapid Readout Biological Indicators, load results are achieved in the same time-frame as other sterilization options that have standard 24-hour BI results." Today ‘s ethylene oxide sterilizers are also safer, thanks to single-use 100 percent EO cartridges, single-chamber sterilization and aeration, and mechanical safety features that have essentially eliminated occupational exposure risk. "Additionally, EO abaters are available for converting EO exhausted from the sterilizer airstream at a conversion rate of over 99.9 percent, which virtually eliminates EO emissions to the environment," said Fritcher. Measuring cycle success Notable advancements in the disinfection and sterilization segment aside, sources agreed that it’s imperative to consistently test and monitor cycles. Not only does routine cycle testing promote process quality and patient safety, diligent adherence to test strip instructions is something that surveyors are paying closer attention to today, according to Duro. "In the Massachusetts Chapter for Central Service Professionals’ email network we are hearing more and more that this is a common item [Joint Commission surveyors] look for," he said. "We need to ensure whether we need to document new expirations upon opening and we also need to ensure that testing occurs as instructed by the manufacturer." Vendors are doing their part to aid the process. Today, the entire ASP STERRAD Systems line now includes the ASP STERRAD CYCLESURE 24 Biological Indicator. This provides sterility assurance "through direct evidence that the sterilization process conditions are sufficient to kill spores," Trattler said.
Stericert’s EBI 20-TF soak and sonic bath dataloggers allow the user to ensure that the baths were at the proper temperature, and they provide a visible warning if temperature is too cold or too hot. Stericert also just introduced a rental service for in-chamber sterilizer dataloggers that allows users to measure temperature inside the load during the cycle and ensure that all parts of the load reach the required temperature for the required time (250°F/15 minutes or 270°F/4 minutes). "These measurements are especially critical for complex instruments and heavy trays. Sterilization and disinfection are processes, and for success, you have to control them," Wilder reasoned. In addition to reading and following manufacturer instructions for use and providing adequate staff training, Olympus’ Disbrow further recommends that SPD professionals and other staff involved in instrument processing perform functionality testing and visual inspections of solvents prior to use and take care to properly handle the solutions as outlined by the manufacturer’s provided instructions. A bright horizon However advanced today’s disinfectant and sterilant segment may be, sterile processing professionals still have high hopes for even more product developments. Duro envisions a dream disinfectant that kills on contact. "This would be great as it can be tough to ensure that adequate contact is occurring." His version of the perfect liquid sterilant is one that is safe for staff to use, requires no special ventilation, is fast-acting and easy to test, and works at any temperature. Narance’s ideal formulation is an "all-inclusive, high-level disinfectant that would be safe for use on saws and drills." While some dream-worthy formulations and methods will be difficult, if not impossible, to bring to light, manufacturers are hard at work and more committed than ever to improving their product lines. Experts generally agree that improved kill times, enhanced flexibility, and increased safety and efficacy will continue in the months and years ahead. "As they do today, future disinfectant and sterilant chemistries will need to facilitate quick processing of delicate and expensive items to help improve turnaround times and lower the required inventories that need to be on hand," said Nancy Kaiser, senior manager for Consumable Product Technologies, STERIS Science and Technology division. "Also, smaller devices and lumens will have smaller spaces that disinfectants and sterilants must permeate and flow through. Devices with smaller channels are more susceptible to clogging and blockage, so chemistries that do not fix proteins or other soils, and are compatible with a broader range of newer materials, will become a requirement." Some predict advancements on the steam sterilization front, as well. Hvizdak of Belimed noted that steam quality is one area that’s increasingly being discussed. "While steam is generally considered a dependable and safe sterilant, steam quality is an often overlooked detail. While guidelines for impurity levels in steam do no currently exist in the U.S., many facilities are proactively exploring improvements to their steam quality, such as the use of clean steam generated from treated water sources." And here’s even more good news: some are looking for steam sterilization to eliminate extended cycles. "As instruments become more complex, their processing requirements could vary even more than they already do," Wilder pointed out. "Current studies of steam cycles show promise to eliminate this issue and improve SPD throughput."  
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INSIDE THE CURRENT ISSUE |
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CS Connection |
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SPD aims for turbocharged disinfectant, sterilant options Vendors aid process with advanced product portfolios by Julie E. Williamson
S terile processing is a department in flux and the same can be said of the equipment, products and services that comprise it. To keep up with ever-evolving instrumentation and customer demands, processing equipment has become increasingly sophisticated, allowing technicians to boost throughput and efficiencies, improve safety and outcomes, and advance the SPD’s overall quality improvement efforts.While the bells and whistles of today’s processing equipment are undeniably eye-catching, the solutions and chemistries they run on also call for more than a mere passing glance. Think of it this way: if the high-level disinfector or sterilizer is viewed as a high-performance vehicle then the disinfectant or sterilant is essentially the fuel that makes it run. More than ever, it’s a message that healthcare organizations – and, especially, SPD professionals – are hearing loud and clear, sources told Healthcare Purchasing News. "The focus on preventing healthcare-acquired infections has increased the awareness of healthcare facilities to incorporate best practices in terminal sterilization and high-level disinfection throughout the organization," noted Barbara Trattler, RN, MPA, CNOR, CNA, director of clinical education for Advanced Sterilization Products (ASP), Irvine, CA. "There is a real opportunity for sterile processing staff to take charge in promoting best practices in sterilization and high-level disinfection throughout their entire organization. SPDs have the core competencies in sterilization and high-level disinfection and should provide this specialized clinical expertise and knowledge to contacts throughout the healthcare facility." Product selection process gets sharper Heightened awareness of high-level disinfection and sterilization processes requires a keen understanding of the disinfectants and sterilants themselves. It’s a fact that’s certainly not lost on MedCentral Health System in Mansfield, OH. The organization’s sterile reprocessing department takes pride in its product selection and education process, and carefully evaluates the products’ compatibility, claims and safety prior to making a purchasing decision. According to department manager David Narance, RN, BSN, CRCST, disinfectants and sterilants must meet a specific set of criteria. "They need to be compatible with a wide range of medical devices and instruments, and safe for staff to use," he said, adding that it’s critical that SPD professionals always ask OEMs to provide recommended cleaning and disinfection agents. MedCentral Health System adopts a proactive product selection process and a collaborative team approach – one that involves input from the SPD, Environmental Services, Materials Management, and Infection Control and Safety. "We placed worker safety first, with a balance toward efficiencies and cost reduction," Narance said, noting that environmentally-conscious products also weigh heavily into the selection process. "We monitor very closely the products that are going into the waste stream and whenever there is an anticipated change, we inform the waste water management department here in our city/county and ask their permission to utilize the product," he added. "Fortunately, we are blessed today with a variety of chemistries and formulations that are safe for intended use and, to the credit of the industry, are now ‘green.’" Boston’s New England Baptist Hospital also takes the selection of disinfectants and sterilants seriously, taking care to properly educate staff on the wide range of formulations on the market and their ability to meet the department’s needs, based on the manufacturer claims. "It’s important to know what we are disinfecting and where it sits in Spaulding’s classification of medical devices. Selection of our disinfectants also relies on the claims of the disinfectant manufacturer and [whether] we are using the right level of disinfectant," said Mark Duro, CRCST, FCS, manager of NEBH’s Central Sterile Processing Department. Another important factor to consider, he stressed, is ensuring that staff allow the correct contact time according to manufacturer instructions. Only with that critical knowledge in place can organizations successfully navigate the sea of disinfectant and sterilant options and make the best purchasing decisions for their own unique needs, Duro reasoned. Advanced formulations abound Indeed, when it comes to disinfectants and sterilants, organizations have access to an ever-growing array of advanced options. "Kill time improvement and the ability of products to kill a wider variety of microorganisms," is one notable advancement of today’s disinfectant and sterilant segment, confirmed Patricia Confessore, Med/Surg senior product manager, Henry Schein Inc., Melville, NY. Also important, however, is marrying efficacy with ease of use, and user and environmental safety, and manufacturers are rising to the occasion there, as well – in many cases, offering improved delivery systems that simplify use and limit staff exposure. Olympus America Inc.’s latest high-level disinfection offering, for example, is a solvent named Acecide-C, a new peracetic acid-based HLD developed and tested for exclusive use with the Olympus Endoscope Reprocessor, the OER-Pro. Acecide-C, which is not yet available for commercial sale, has a contact temperature of 20 degrees C (room temperature) and achieves high-level disinfection in only seven minutes. "The chemistry is delivered in unique, easy to handle cassette bottles, which make disinfectant loading quicker and easier, and allows staff to have less exposure to the disinfectant solution," noted Alison Disbrow, product manager for Olympus cleaning, disinfection and sterilization products. Another HLD option for OER-Pro users is Aldahol, Olympus’ ready-to-use high-level disinfectant that achieves high-level disinfection in ten minutes. Aldahol, developed for use with heat-sensitive instruments (such as Olympus flexible endoscopes, including cystology and urology scopes), combines glutaraldehyde and isopropanol, and offers a 14-day life cycle. "Aldahol kills both mycobaterial and spore-forming bacteria within a reasonable exposure time and temperature. Because of Aldahol’s convenient use temperature of 20 degrees C, healthcare facilities are freed from the expense of having to continuously heat chemicals and monitor and record room temperatures," Disbrow continued.
Medisafe America has addressed the SPD’s growing need for streamlined efficiency with its Sonic Irrigator PCF, which is now a Class II thermal disinfector. The system eliminates the need to run instruments in a washer-disinfector, which saves time, while also requiring less water and detergent consumption. According to Medisafe, the SI-PCF is the only system on the market today that is tested and validated by surgical instrument manufacturers for cleaning da Vinci EndoWrist, Richard Wolf, Stryker, ConMed, and BOSS instruments. "The SI-PCF system uses the same critical cleaning parameters as Intuitive Surgical’s manual cleaning method, with the advantage of being able to clean and disinfect up to ten EndoWrist instruments simultaneously, in a single 45-minute cycle," noted Tina Bramlett, national territory sales manager for Medisafe America, Tampa, FL. Further, the system provides twice the standard ultrasonic cleaning action, combined with turbo individual instrument irrigation for cleaning – inside and out – 20 to 40 standard cannulated/laparoscopic instruments. More than ever, environmental benefits are also being touted by today’s disinfectant manufacturers. "With today’s sensitivity to environmental issues, as well as the heightened awareness of the healthcare industry’s specific contributions to toxic and dangerous waste, there is an increased focus on healthcare products that are environmentally conscientious," confirmed Chris Antonucci, market manager, GI consumables, STERIS Corp., Mentor, OH. "Some high-level disinfectants now emphasize their environmental benefits in addition to their patient and staff safety and antimicrobial efficacy profiles." There are currently HLD formulations on the market that are biodegradable and disposable and, therefore, don’t require dilution or chemical deactivation, added Antonucci. "These issues can be avoided in today’s GI suites and sterile processing departments." STERIS’ Resert XL HLD is the newest addition to the company’s oxidative chemistry family. This alternative HLD solution combines the effective attributes of oxidative formulas with a facility’s manual or validated process in their automated reprocessing system. It’s compatible for use with disposable devices, including flexible endoscopes and rigid devices when high-level disinfection is appropriate. The Resert XL HLD formulation combines a lower concentration of hydrogen peroxide (2 percent) and a blend of inert ingredients that help achieve rapid antimicrobial efficacy. It is virtually odorless and requires no special venting, measuring, mixing, or activation under recommended use conditions. Sterilant vendors step up efforts Not unlike HLDs, the sterilant segment is also brimming with an array of options thanks to the ever-growing presence of diverse and complex instruments. "Steam, plasma and liquid sterilants all have their proper time and place for use. What is critical is that the user is well educated on both the sterilant and the device," reasoned Brian Hvizdak, sterilizer product manager, Belimed Inc., Charleston, SC. "By following manufacturer’s written instructions for use, the user can ensure that the materials are compatible and that the patient will receive a sterile product." Not surprisingly, steam continues to hold its position as a leading sterilization method in the SPD due to its dependability, efficacy, per-cycle cost-effectiveness, and safety. Because of these time-honored benefits, vendors are expanding their range of autoclavable devices. Olympus, for example, offers autoclavable rod lens telescopes, HD camera heads, video laparoscopes, and the world’s first autoclavable flexible bronchoscope. Still, some devices call for more delicate sterilization methods, which explains the developments seen in the low-temperature sterilization segment and the push to terminally sterilize heat-sensitive devices more quickly and safely than ever before. "There is no question in my mind that the advent of second- and third-generation hydrogen peroxide technologies and ozone technology has improved throughput and worker safety," stressed Jonathan A. Wilder, Ph.D., president, H & W Technology LLC, SteriCert Co. . "The replacement of large ethylene oxide cylinders with small, packaged sterilant containers is a major plus for SPD worker safety. Reduced sterilization cycle time also increases SPD flexibility." STERIS’ Amsco V-Pro 1 Low Temperature Sterilization System, launched in 2008, and the newer V-Pro 1 Plus Vaporized Hydrogen Peroxide system, launched in 2009, offer quick turnaround times, reduced moisture sensitivity and simple, one-touch operation that reflects a growing "do more with less" trend. "The V-Pro systems use a plasma-free process that terminally sterilizes instruments, either in 28 minutes in the non-lumen cycle, or in 55 minutes in the lumen cycle," said Renee Brown, product manager, infection prevention technologies, STERIS. Flexibility is at the heart of the ASP STERRAD Systems. The systems are designed for use in a broad range of healthcare settings, from the SPD to the OR, and deliver fast, low-temperature hydrogen peroxide gas plasma sterilization. The ASP STERRAD NX System provides speed, flexibility and sterility assurance in a compact size, making it ideal for ORs and surgery centers. The system provides dry, sterile and packaged instruments in 28 minutes for most general surgical instruments and 38 minutes for single-channel flexible endoscopes (Olympus offers several flexible endoscopes that are proven compatible with the STERRAD NX Sterilization System). Also in the ASP sterilization system lineup is the ASP STERRAD 100NX System, which features the first specialty cycle – the EXPRESS Cycle. At just 24 minute cycles, this is the fastest low-temperature sterilization cycle in the U.S., and broadens the range of instruments that can be processed. Ethylene oxide continues to hold its ground in the sterilization segment, as well – and for good reason. The sterilant offers great penetration and medical device material compatibility, and does not require any special packaging materials, such as polypropylene wraps or polyolefin pouches as other systems often do, according to Beth Fritcher, global marketing manager for 3M’s Infection Prevention Division, St. Paul, MN. "The trade-off of having such high material penetrability, however, is the residual ethylene oxide in the material sterilized," she explained, adding that to minimize staff and patient exposure, adequate aeration time is required, which makes the cycle times of ethylene oxide systems longer than that of other low-temperature sterilants. "However, taking into account the use of the 3M Rapid Readout Biological Indicators, load results are achieved in the same time-frame as other sterilization options that have standard 24-hour BI results." Today ‘s ethylene oxide sterilizers are also safer, thanks to single-use 100 percent EO cartridges, single-chamber sterilization and aeration, and mechanical safety features that have essentially eliminated occupational exposure risk. "Additionally, EO abaters are available for converting EO exhausted from the sterilizer airstream at a conversion rate of over 99.9 percent, which virtually eliminates EO emissions to the environment," said Fritcher. Measuring cycle success Notable advancements in the disinfection and sterilization segment aside, sources agreed that it’s imperative to consistently test and monitor cycles. Not only does routine cycle testing promote process quality and patient safety, diligent adherence to test strip instructions is something that surveyors are paying closer attention to today, according to Duro. "In the Massachusetts Chapter for Central Service Professionals’ email network we are hearing more and more that this is a common item [Joint Commission surveyors] look for," he said. "We need to ensure whether we need to document new expirations upon opening and we also need to ensure that testing occurs as instructed by the manufacturer." Vendors are doing their part to aid the process. Today, the entire ASP STERRAD Systems line now includes the ASP STERRAD CYCLESURE 24 Biological Indicator. This provides sterility assurance "through direct evidence that the sterilization process conditions are sufficient to kill spores," Trattler said.
Stericert’s EBI 20-TF soak and sonic bath dataloggers allow the user to ensure that the baths were at the proper temperature, and they provide a visible warning if temperature is too cold or too hot. Stericert also just introduced a rental service for in-chamber sterilizer dataloggers that allows users to measure temperature inside the load during the cycle and ensure that all parts of the load reach the required temperature for the required time (250°F/15 minutes or 270°F/4 minutes). "These measurements are especially critical for complex instruments and heavy trays. Sterilization and disinfection are processes, and for success, you have to control them," Wilder reasoned. In addition to reading and following manufacturer instructions for use and providing adequate staff training, Olympus’ Disbrow further recommends that SPD professionals and other staff involved in instrument processing perform functionality testing and visual inspections of solvents prior to use and take care to properly handle the solutions as outlined by the manufacturer’s provided instructions. A bright horizon However advanced today’s disinfectant and sterilant segment may be, sterile processing professionals still have high hopes for even more product developments. Duro envisions a dream disinfectant that kills on contact. "This would be great as it can be tough to ensure that adequate contact is occurring." His version of the perfect liquid sterilant is one that is safe for staff to use, requires no special ventilation, is fast-acting and easy to test, and works at any temperature. Narance’s ideal formulation is an "all-inclusive, high-level disinfectant that would be safe for use on saws and drills." While some dream-worthy formulations and methods will be difficult, if not impossible, to bring to light, manufacturers are hard at work and more committed than ever to improving their product lines. Experts generally agree that improved kill times, enhanced flexibility, and increased safety and efficacy will continue in the months and years ahead. "As they do today, future disinfectant and sterilant chemistries will need to facilitate quick processing of delicate and expensive items to help improve turnaround times and lower the required inventories that need to be on hand," said Nancy Kaiser, senior manager for Consumable Product Technologies, STERIS Science and Technology division. "Also, smaller devices and lumens will have smaller spaces that disinfectants and sterilants must permeate and flow through. Devices with smaller channels are more susceptible to clogging and blockage, so chemistries that do not fix proteins or other soils, and are compatible with a broader range of newer materials, will become a requirement." Some predict advancements on the steam sterilization front, as well. Hvizdak of Belimed noted that steam quality is one area that’s increasingly being discussed. "While steam is generally considered a dependable and safe sterilant, steam quality is an often overlooked detail. While guidelines for impurity levels in steam do no currently exist in the U.S., many facilities are proactively exploring improvements to their steam quality, such as the use of clean steam generated from treated water sources." And here’s even more good news: some are looking for steam sterilization to eliminate extended cycles. "As instruments become more complex, their processing requirements could vary even more than they already do," Wilder pointed out. "Current studies of steam cycles show promise to eliminate this issue and improve SPD throughput."
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