Sterilizers play a critical role in healthcare. TechNation asked a panel of industry experts to share their insights regarding new technology, maintenance and training materials.
Our expert panel is made up of Marie LaFrance, Senior Product Manager at STERIS Corp.; Tim Koes, President of Technical Life Care Medical Company; Janet Prust, Global Marketing Manager with 3M Infection Prevention Division; and Connie Mansfield, Manager of Marketing Communications and Regulatory Compliance at PRIMUS.
LaFrance: Due to changes in AAMI standards, steam sterilization has been challenged to perform like never before. Sterilizer manufacturers must meet the requirement to process 25-pound sets (up from 16 pounds), which in some cases has doubled the total weight of the load processed. In addition, concerns about HAI rates and reduction in Immediate Use procedures has driven more processing to the main Sterile Processing Department, so in terms of productivity, some steam sterilizers are well equipped to handle the increased volume. AAMI has also recommended lumen testing, so that will be another challenge in validating cycles in the future.
Koes: Nothing in the past year per say, but over the past five years we have seen customers migrate towards a desire for “clean steam” using steam to steam heat exchangers or onboard electric boilers. This is mandatory in pharma, increasing its adoption in food service, and is starting to see significant benefits in the medical industry. Other technologies include resource efficiencies through connecting to the hospital’s chilled water system to reduce water used per cycle from 500-600 gallons down to 2.6 gallons (Belimed specific). Lastly, automation with sterilizers has assisted staff productivity where they can “set it and forget it” as opposed to continuously checking the remaining time on the cycle. Once the cycle is complete, the rack automatically unloads and then pulls in the next waiting rack.
Prust: While available in the market prior to the last year, the most significant and recent advances relate to connectivity of sterilizers to electronic instrument management systems and remote access to the sterilizer for a service provider. Access to electronic systems have been a long time coming in sterile processing but now, nearly all new sterilizers have these features available.
Mansfield: The sterilizer market continues its focus on green technologies including water conservation systems, sterilizer refurbishment and recycling components as LEED requirements have been instituted on virtually all new construction projects throughout the country.
LaFrance: The trend has been to reduce or eliminate the amount of immediate use sterilization done in the OR for fear of instruments being reprocessed and transported improperly, so sterilizers in the Sterile Processing Deaprtment will be logging more cycles than before. This makes ready availability of knowledgeable service technicians and good preventative maintenance a must to maximize equipment uptime. Of course, there will always be a need to process some items for emergency use, so the challenge in the future will also be to provide a safe, compliant way to do that. Some facilities are purchasing small steam sterilizers for quick-turnaround in the Sterile Processing Deaprtment, so whoever is servicing these units needs to be equipped to do that.
Koes: “Clean steam” eliminates chamber cleaning and additional utilization of the house boiler. Less impact on the house boiler equates to less maintenance through adding less makeup water and less chemistry with little to no consumption of the house steam. A more space efficient design and manufacturing is needed with the facilities/engineering team in mind. We found a manufacturer that has front service access to reduce the space requirement in the department and undesirable access points for service members (i.e less forearm burn marks as all service components moved forward.) This would be something our service techs would greatly appreciate.
Prust: Connection of the sterilizer to electronic systems helps to improve the accuracy of the process by providing better data to make decisions. This helps to improve the quality of the output, e.g. sterilized product. Remote access for service diagnosis and first-level assistance can save sterilizer downtime and optimize service support. Knowing when to send the service technician with an idea of the issue will speed the repair service to allow the sterilizer to be up and running faster.
Mansfield: The continuing focus on green technologies will drive sterilizer manufacturers to develop more ways to reuse, refurbish and develop a more efficient sterilizer. The importance of OEM provided operator and maintenance technician training programs will help facilities minimize their cost and maximize the life of the sterilizer by conducting timely routine preventive maintenance and “first responder” corrective activities. Simplicity is the key. With technology advances in controls and materials “hidden under the covers” operating personnel will continue to experience greater sterilizer capability, but with simpler and more user-friendly interfaces.
LaFrance: It’s not a stretch to argue that a healthcare system should prioritize its operational budget with the best sterilizer it can afford based on its particular needs. Without sterile instruments there are no surgeries. That said, when a facility truly considers the total cost of operating a sterilizer, and that includes utilities, instrument capacity, turnaround time, troubleshooting, service, compliance, etc., often times it’s not the lowest initial sticker price that ends up as the determining factor. Additionally, a certified pre-owned sterilizer could be an attractive option for limited-budget facilities.
Koes: Focusing again on “clean steam,” we have seen cost savings with instrument replacement and repair along with higher quality instrumentation being delivered to the surgeon for overall surgeon satisfaction. Other cost savings include the elimination of costly chamber cleaning and reduction of cold spots, which can cause wet packs, due to mineral buildup in the sterilizer jacket. Chilled water has proven to save millions of gallons of water annually and payback usually occurs within the first year. Automation limits the strenuous pushing and pulling of racks to reduce worker’s comp claims.
Prust: All facilities need both steam and low-temperature sterilization system (ethylene oxide and vaporized hydrogen peroxide) to process the complex devices used in hospitals and other healthcare delivery sites. It’s not an option. Which manufacturer to source from is the bigger decision for all types of sterilizers. Facilities should develop the business case for new equipment and analyze the impact of high-performing equipment on both throughput and service costs. For low-temperature systems, analyzing the instrument utilization is important to justify the costs. Not all heat and moisture sensitive devices are used again the same day so the lower cost, but longer cycle, systems like ethylene oxide can be a better financial choice for certain instruments. Facilities should also complete a careful comparison of the total costs for equipment from the different manufacturers that includes cost to run, cost to train and service analysis. What may be less expensive for the initial purchase may actually be more expensive to run and keep maintained.
Mansfield: In the current capital constrained economic environment, a refurbished sterilizer can be the answer for many cost-conscious end user customers. Control kits can save money by extending the life of older sterilizers while offering the latest in sterilizer controls, e.g., a color touch screen versus a touchpad. Trained first responders are my recommendation for saving repair costs and providing routine maintenance.
LaFrance: We talk to a lot of healthcare facilities who have been told that they need “clean steam” to operate their sterilizers, but that simply isn’t always the case. Many hospitals are unnecessarily spending money to outfit their sterile processing department infrastructure to accommodate “clean steam” when it’s not necessary. Not every facility needs it, but if you’re experiencing stained instruments, pitting, corrosion, darkened or black instruments, white spots on instruments, rapid generator heating element corrosion, stains and deposits on the linens of wrapped trays, or scale and rust deposits in the sterilizer chamber it may be worth the investment. Having your water regularly tested is a good first step to determine if you should be using “clean steam.”
Koes: Buy what you need, not what you think you need. Use data and workflow to vet out appropriate “rightsizing” of the department. By purchasing the largest chamber sterilizer, what are the resource implications upstream? How long does it take to fill the chamber to run a load? Will this meet the demands of the OR schedule and turnover of instruments? How much will the sterilizer cost per cycle to operate and how much will service support cost long term.
Prust: The useful service life for sterilizers is less than it was in the past due to the advanced electronics used for the equipment today. In the past it was not uncommon for a sterilizer to function fairly well for 15-20 years. Currently, most sterilizer manufacturers expect the useful service life to be 8-10 years primarily due to the part and electronic obsolescence related issues.
LaFrance: Availability of certified, validated parts is a key thing to consider. OEMs must meet strict FDA standards for testing and validation, as well as meet other pressure equipment standards. The FDA wants third parties to refurbish sterilizers to meet the OEM’s original specifications, but there is no provision for inspectors to ensure that.
Koes: Ratio of service cost to asset cost! This calculation considers warranty information, reliability, downtime, uptime, service technical skill level, response time, etc.
Prust: Because sterilizer features are continually being added, new cycles cleared by FDA and because parts often become obsolete, facilities should look at new equipment rather than used equipment. New, large, high ticket sterilizers are commonly only available direct from the manufacturer. Small, table top models are often sold and serviced through third-party suppliers who provide very good service. A careful up-front analysis considering all factors is what’s important and will provide the data needed by the facility to make the right decision for the need. It’s not an OEM vs. third-party decision; rather it should be a decision on what is the best solution for the facility.
Mansfield: When purchasing from a third party, a healthcare end user must ensure the selling company has a current FDA 510k to sell a specific brand and size steam sterilizer (new or used) to the healthcare market. If a third party is selling a remanufactured or refurbished sterilizer to the healthcare market, the sterilizer must meet the manufacturer’s original design specifications. If any changes are made to the original sterilizer, then the third-party provider must apply for and receive a FDA 510k. Because of the issues noted above, healthcare end users must be extremely cautious when purchasing from a used or aftermarket provider. Ensure the third-party sterilizer provider is properly representing the sterilizer being purchased. Purchasing from the OEM provides complete documentation at the time of purchase, factory support and greater aftermarket service. Always determine whether the third-party provider is able and willing to stand behind the sterilizer over its useful life and provide thorough aftermarket training, technical support and warranty. Always determine if a third-party supplier is fully compliant with quality requirements including ASME, UL, ISO 9001, ISO 13485, FDA 21 CFR Part 820, and cGMP.
LaFrance: Some healthcare systems are still using – and still happy with the performance of – sterilizers they purchased years ago. While it’s not completely necessary to buy new, the latest sterilizers will run more efficiently, accommodate larger or more delicate instrument sets, adhere to the latest compliance regulations and be more environmentally friendly. Water-saving devices, improved loading methods, including automation, and integral steam generators for medium sterilizers are all advances designed to decrease operating costs, improve ergonomics and increase productivity in a smaller overall footprint.
Koes: Personally, I do not think this is possible because you can’t rebuild a sterilizer to have a vacuum pump. Also, what are the cost/benefit to upgrading a control panel versus replacing a more resource efficient unit?
Prust: Yes, it is possible through active participation in continuing education programs that are widely available for sterilization. The professional organizations and manufacturers both offer a wide range of educational programs where the latest technology is described. It’s important for biomeds to attend programs related to sterilization equipment. Meeting with manufacturer representatives is another avenue for information on the latest technology.
Mansfield: Purchasing a PRIMUS PRI-Furb provides a sterilizer that meets ASME standards, is compliant with FDA regulations, is refurbished to the latest sterilizer design using many new components, is fully documented and has completed a full comprehensive factory acceptance test. Older sterilizers operating in the field may be refurbished from top to bottom. To upgrade to the latest software and control systems, control kits can be an effective and relatively inexpensive way of extending the life and capability of an older Steris, Getinge, or Beta Star steam sterilizer. Other effective ways to upgrade existing sterilizers without purchasing new is to add an aftermarket system such as drain water quench, reverse osmosis, and/or a water conservation system for a small to medium sterilizer. Purchases of other aftermarket new technologies including ergonomic loading carts, drop leg loading carts for space constrained operating environments and heavy duty loading carts for especially heavy loads provide ways to upgrade sterilization systems without purchasing a new sterilizer.
LaFrance: It’s extremely important to do your homework when investing in a sterilizer, and that includes working with an experienced provider; one that fully understands the unique dynamics of sterile processing and the OR; one that’s an innovator and has a track record of standing behind its products. If your provider does not offer the necessary tools for training and educating staff on proper use and troubleshooting of the equipment – both at the time of the sale and ongoing – you’re working with the wrong provider. And let’s not overlook the need for clinical expertise. With increased rates of staff turnover the availability of continuing education courses is also more critical.
Koes: Again, force your department to make data driven decisions in picking the appropriate size for today and projected growth into the future. Why are you picking this model or vendor? Why this size chamber? Don’t simply pick a vendor “because that’s what we always used” or because I am friends with the Service Tech.” Be a change agent, just as you want your doctors and nurses to utilize best practice when treating patients through research and technology, you also need to appropriately research the best options to ultimately support patients and staff with the safest most effective healthcare possible. There is a wealth of knowledge and tools through numerous websites to obtain material and training videos.
Prust: The up-front assessment must be done well and include a careful, detailed analysis of the options and the benefit to the facility so purchasers can feel confident. All of the needed information is available either from the supplier or within the facility. Take the time to do a detailed assessment. It will justify the spend and ensure the right purchase is made. Look at suppliers you know are reliable, and provide comprehensive support packages. Looking at the training materials and support literature should be done before the purchase is made, not after. This support should be a factor in the purchase decision.
Mansfield: Newer vertical and horizontal sliding door sterilizers should always be selected versus older hinged door models that are costly to maintain and have experienced several field safety issues (doors coming off during operation and numerous operator burns). Most important is Total Cost of Ownership (TOC). Always make sure that “apples to apples” comparisons are done when purchasing a new steam sterilizer. Total Cost of Ownership not only includes the acquisition costs, but a host of other salient issues. Not all steam sterilizer companies support their older control platforms, but instead require customers to make expensive upgrades in order to maintain their sterilizer controls. Other hidden costs include sterilizer set-up/deployment costs, operating and maintenance costs, change management costs, infrastructure support costs, environmental impact costs, insurance costs, and disposal/decommissioning costs.
LaFrance: Providers who have an in-depth understanding of sterile processing and the intricacies needed to keep you up and running fully supporting the OR also understand the need for continual maintenance, repair and inspection of sterilizers. One of the key factors in the selection of a sterilizer provider is finding a capable, well-rounded partner to work with from a biomedical perspective. A provider that has ample service coverage, training programs (both on-site and online) is crucial to the success of the surgical department. Biomed needs to be comfortable in an established partnership with its sterilization providers, since they are the experts on the equipment they manufacture.
Koes: What is the impact on infection control? How does this impact patient safety or staff safety? This is the true kill phase of harmful viruses and bacteria (washers simply deem safe to handle) and with that comes a need for proper usage and maintenance. This single piece of equipment is arguably the most important in the whole process and needs to be treated that way.
Prust: It’s important for biomeds to understand how the sterilizers in their facilities function, how they are used and be able to provide some level of first line troubleshooting. Often sterilizers under a preventative maintenance agreement with a service provider are hands-off for the biomed. Sterilizers are critical medical devices and as such, biomeds should be knowledgeable and involved in the purchase and maintenance.
Mansfield: Water quality is very important to the efficient and effective operation of a steam sterilizer. As an analogy, poor water quality for a sterilizer is equivalent to adulterated gasoline for an automobile. Proper maintenance and operating training are critical to the longevity, uptime, and cost of operating a steam sterilizer. Always maintain the original design state of the sterilizer – do not use non-standard parts and never allow the sterilizer’s original design to be compromised. Only purchase sterilizers from an OEM or an OEM’s representative.
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