Sterilizers play an important role in health care, especially when it comes to how shorter patient stays and fewer readmissions benefit a health care facility’s bottom line. Maintaining and repairing these devices is often the responsibility of the in-house HTM department and that can be challenging if the department does not have a specialist or experienced professional on staff. TechNation reached out to a variety of individuals to get their input on what it takes to maintain sterilizers as well as additional insights for these devices.
Participants in this roundtable article on sterilizers are STERIS Corp. Science and Technical Director Richard Bancroft, Replacement Parts Industries (RPI) Product Development Engineer Neil Blagman, ProHealth Care Biomedical Engineering Supervisor Dan Blaisdell and Advanced Sterilization Products (ASP) Director of Global Strategic Marketing Brian Thompson.
Q: What are the latest advances in sterilizers?
Richard Bancroft, STERIS Corp.
Bancroft: Sterilizers have been used for over 100 years for the sterilization of medical devices; steam has been used as the historical method of choice due to its efficiency in killing microorganisms. Steam sterilizers have changed very little in basic concept for many years, however technological advances have been implemented to ensure that air is removed adequately from loads and replaced with steam to ensure correct sterilization of complex loads and medical devices. These advances include such techniques as Steam Flush Pressure Pulse (SFPP) to remove air from loads without relying upon a vacuum system. The advent of modern sterilizer control systems gives more reliability to sterilization cycles, and allows integration with sterile processing workflow management software, such as STERIS CS-iQ. Increasingly, however, advances in medical devices have meant that some of these devices are manufactured using materials or construction configurations that are not compatible with steam sterilization, hence the need for low temperature sterilization methods. Increasingly, vapor-phase hydrogen peroxide is used for the sterilization of these devices.
Blagman: The addition of closed door drying, vacuum pumps and pulsed steam to tabletop sterilizers brings their abilities much closer to the most advanced bulk sterilizers. In addition the increasing use and sophistication of on-board computing power in tabletop sterilizers gives the service technician the ability to more thoroughly diagnose cycle failures and error conditions on site. In the world of high-level disinfectors the expanding use of exotic chemical treatments such as concentrated hydrogen peroxide, plasma degradation and ozone have mirrored the development of more complex surgical instruments with finer lumen and more complex hinges and moving surfaces.
Blaisdell: The latest advances in sterilizers include improvements in the electronic controls, operating software and the increased use of sensors to monitor sterilizer operation. Hydrogen peroxide sterilization is slowly eliminating the need for ethylene oxide sterilizers. Hydrogen peroxide sterilizer advancements allow for heavier loads and lower cycle times.
Thompson: Earlier this year, ASP launched the low-temperature sterilization systems the STERRAD 100NX and STERRAD NX with ALLClear Technology. The systems were designed specifically to address the challenges faced by Central Sterile Services Departments (CSSDs), and to help them deliver instruments to operating rooms faster and more efficiently. When paired with ASP Access, a smart information sharing technology, the systems automatically communicate with hospital networks and instrument tracking systems to enhance compliance and reduce the need for manual record keeping. The systems are easy to operate, which helps simplify staff training and minimizes the potential for human error. Finally, the systems were developed to automatically identify and fix issues that can cause cycle cancellations, resulting in fewer workload disruptions and greater efficiency for the CSSD staff.
Q: How have those changes impacted health care delivery in the United States?
Bancroft: The SFPP cycle offers many benefits, including time and cost savings. Since there is no vacuum drawn during conditioning there is no requirement to run a Bowie-Dick test if only SFPP cycles are employed. Because SFPP conditions loads above atmospheric pressure, air cannot be reintroduced into the chamber through leaks in the sterilizer plumbing. Sterile processing workflow management software allows for real-time information available hospital-wide, and reduces paper by managing documentation and record keeping electronically, including capture of biological and chemical indicator results. Low temperature sterilization using vapor-phase hydrogen peroxide can significantly reduce reprocessing times for devices that are compatible with these processes.
Neil Blagman, RPI
Blagman: As specialized medical instruments have become more complex the materials used in their construction have become more delicate and less heat resistant preventing the use of any steam sterilization techniques. This change in construction techniques and materials is driving manufacturers to develop new equipment to disinfect these thermally sensitive devices. These new disinfecting modalities are in turn driving even the smallest facilities to purchase new equipment in order to allow their clinicians the ability to deliver cutting-edge treatments and therapies. It seems, therefore, that many facilities are diverting more of their new equipment budget into the central processing department in order to keep up with the demand for new disinfection equipment.
Blaisdell: The sterilization becomes much more efficient. We can run larger and heavier loads, and run them more often. This allows us to turnover a greater volume of instruments/loads and also do it quicker. This allows other efficiencies to occur, such as not having to purchase additional sets of instruments and allowing more cases to be scheduled in the OR. The addition of rapid readout biological incubators, and running a biological in every load has also tremendously reduced the need for calling back instruments/loads when a problem does occur with a sterilizer.
Brian Thompson, Advanced Sterilization Products
Thompson: ASP systems are designed to help avoid catastrophic events due to healthcare-associated infections (HAIs). Any issues or delays during the sterilization process can cause disruption to operating room schedules and put patients in danger of HAIs. This new technology helps solve problems causing delays, and helps ensure doctors and patients can get critical instruments when they need them. New innovations enhance compliance, reduce the potential for human error, and detect and resolve issues that may cause cycle cancellations, all of which provide additional assurance that instruments are sterilized properly and efficiently.
Q: How do new advances and features impact sterilizer maintenance?
Bancroft: SFPP cycles can eliminate sterilizer downtime associated with leaks and saves the time and cost of reprocessing if a positive Bowie-Dick has been obtained while using pre-vacuum cycles. Sterile processing workflow management software allows viewing and printing of equipment status reports, including equipment monitoring results and daily maintenance notifications. The functionality and uptime of sterilizers and other CSSD equipment can be tracked with real-time visual dashboards that provide proactive management for CSSD equipment, including reminders for preventative maintenance and daily service tasks.
Blagman: As tabletop sterilizers and disinfectors become more and more complex, the service tools and diagnostics become more specialized and more complex. The addition of specialized extender cards, test fixtures and data boxes give the service technician a much more detailed view of the run conditions. Unfortunately, these advanced service tools are not always available to the average technician in the field. When they are available from the manufacturer, they can be relatively expensive.
Dan Blaisdell, ProHealth Care
Blaisdell: The additional sensors and programming can lead to more frequent problems, although this has not been the case in our facility. The more sophisticated programming can be a great aid in troubleshooting and resolving problems. However, doing a PM is more time consuming and costly due to the increased number of components and items that need to be serviced.
Thompson: Common challenges with the existing STERRAD systems include misaligned cassettes. A new hardware cassette delivery system is designed to reduce this challenge. Additional new hardware includes an improved hydrogen peroxide monitor, designed to increase the reliability of the system. In addition, ASP backs STERRAD systems with ALLClear Technology with a one-year full service warranty. The company provides professional installation and validation, in-servicing programs at the time of installation, advanced user training and on-site services support.
Q: How can a facility with a limited budget meet its sterilizer needs?
Bancroft: There will always be constraints on budgets, however patient safety is one area that cannot be compromised. Hospitals should consider what their requirements are for sterilization of medical devices; these requirements will then dictate the number and type of processes that need to be provided. Additionally, consideration should be given to the type and frequency of monitoring that is required. Finally, maintenance should be addressed. A well specified preventive maintenance plan will minimize breakdowns and associated costs and ensure that sterilizers and other equipment are working at optimum efficiency.
Blagman: As tabletop sterilizers have grown in size and sophistication they have become a major cost saving for smaller facilities and clinics. Using standard AC line voltages and power cords allow the facility to position the sterilizer anywhere they find most convenient. The fact that tabletop sterilizers use self-contained steam generation removes the need for external steam generators or boilers along with the costs of installing steam supply lines within the building. The use of self-contained reservoirs and collection bottles reduce the need for floor drains and feed water plumbing.
Blaisdell: Do your research and select a reputable vendor and appropriate model. If you are going to put them on a service contract, understand their service delivery capabilities. Understand the risk of purchasing reconditioned units. They may be cheaper in the short run but can cost you more in the long run.
Thompson: Customers can contact their ASP representative to discuss any current promotions that may help fit their budget. They offer technologies that help facilities reduce workflow interruptions, enhance compliance to hospital policies and instructions for use, and reduce the risk of operator error.
Q: What are the most important things to look for when deciding whether to go with an original equipment manufacturer or a reputable third-party sterilizer provider?
Bancroft: With the original equipment manufacturer (OEM), the hospital will not only have the guarantee that the personnel working on the equipment have received adequate training, but also that all parts used have been verified and validated together with the equipment. In either case, evidence should be sought that any maintenance or repair is conducted by certified technicians with approved components. In addition, OEMs often use specialist tools to optimize service times, thus reducing sterilizer downtime; a third-party provider typically cannot offer this.
Blagman: For many smaller clinics and medical facilities the sterilizer is an indispensable device. Even if the facility has a spare sterilizer or an opportunity to have their sterilization needs temporarily met off-site the delays in getting sterile instruments processed can lead to case backlogs. When considering service options the local third-party service company may be able to be on site quicker than the original equipment manufacturer which could save the facility downtime. Also, since the original equipment manufacturer may not have local representation the third-party service may save the facility an expensive travel charge.
Blaisdell: Verify that equipment from third-party vendors have all the proper updates and parts. If you decide to switch back to OEM service on a third-party unit, they may not work on the unit until it is put back to exact factory configuration/specs. This can be very costly to do.
Q: What else do you think TechNation readers need to know about purchasing and servicing sterilizers?
Bancroft: Steam sterilizers are designed and built to last for a very long time. But, as with every machine, it is only as good as its maintenance. Preventive maintenance should be scheduled, and occasionally parts might require repairing; in those cases it is important to include availability of components in the purchase consideration, in order to minimize downtime of the equipment and stress on the department. Critical parts, such as door seals or valves should have a long life (for example, two years for door seals, and typically no preventive maintenance required for pneumatic valves). Designs should never be over complicated and built as simply as possible. For example, the more components required for a door mechanism, the more likely failures are to occur over the equipment life; systems that only use a simple three-component system make daily use very easy with minimal preventive maintenance. Replacement parts should be validated by the OEM to ensure quality standards. The chamber should be fully jacketed to avoid excessive condensation onto the load, with the associated creation of wet packs after processing; the chamber is one of the major components of a sterilizer, and should be built to last for a very long time. Typically, an elliptical chamber has an inherently stronger design than a square or rectangular chamber. Daily tasks should be made as simple as possible; whether that may be by having the drain easily accessible close to the door for daily cleaning, or by using a large touch-screen display and control panel, with easy to use full text messages, rather than codes that have to be looked up in a manual. Familiarity of the user interface can significantly minimize operator error if this interface has a common look and feel to other equipment used in the department (e.g. low temperature sterilizer, washer-disinfector) and makes it significantly easier it to use.
Blagman: Tabletop sterilizers come in many different sizes and different manufacturers’ products have different capabilities and cycles. Before purchasing any sterilizers the facility should review the needs of their users and should size the sterilizer based on their anticipated needs and the types of instruments they are planning to sterilize.
Blaisdell: Call other facilities in the area that use their equipment. This way you will find out about the reliability of the equipment and whether they are getting prompt, adequate service. Whether servicing in-house or on contract, it is very important to pay attention to where and how the units are installed. Adequate room must be allowed for service. Some units are difficult to maintain due to the installation.
Thompson: ASP has been revolutionizing this space for a number of years dating all the way back to 1992 when we introduced our first STERRAD System to the market. We’ve used hydrogen gas plasma technology ever since the first introduction in 1992, and continue to use that technology to present day. It’s very effective at what it does, which is killing microorganisms, but it also very safe, both for health care workers as well as the environment. ASP plans to introduce several innovations globally in 2017 to help elevate the standard of care in sterilization.
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