Roundtable: Sterilizers

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?

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.

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.

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.

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.

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