Medical equipment has advanced tremendously since the very first surgery was performed. Innovations and new ideas continue to impact the often life-saving techniques of surgery, including minimally invasive procedures and robotic surgery options. However, even the best surgeon in the world will fail when using unsterile instruments.
TechNation contacted professionals familiar with sterilizers to find out the latest regarding these important pieces of health care equipment, including purchasing and servicing options. The panel of experts includes D. Wayne Ambroult, BMET III, Sterilizer Specialist with Banner Health; Neil Blagman, Product Engineer at Replacement Parts Industries Inc. (RPI); Marie LaFrance, Senior Product Manager, High Temperature Sterilization, STERIS Corp.; and Paul Strachan, Director at Novant Health.
Q: What are the latest advances or significant changes in sterilizers in the past two years?
Ambroult: I would say the Steris V-Pro H2O2 sterilizer has impacted the sterilization process because of its ability to process both lumen and non-lumen products in the same chamber and it is less expensive than its competitor.
Blagman: The most recent changes to tabletop sterilizers involve the ability to download run and cycle data to an external computer through the use of a built in USB port. This increase in on-board computer power also gives the manufacturer the ability to remotely diagnose cycle failures and error conditions through the same USB port. 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.
LaFrance: In the past, inspectors often checked if health care facilities had written sterilization policies and procedures in place, and if proper load content, cycle parameter and indicator records were kept on file. This is typically done manually and/or with an electronic instrument tracking system. Today, facilities are increasingly being asked to also show documentation of staff training and maintenance on their sterilization equipment.
Strachan: For service issues, being able to interact via a laptop (whether it is a sterilizer or washer) is a noted change in the past several years. We are seeing more of this. Also, there is an OEM that has standardized the user interface controls on all their latest models of sterilizers and washers.
Q: How have those changes impacted the sterilizer market?
Ambroult: It provides faster product turnaround time and reduced equipment processing costs in a more affordable and safer sterilizer.
Blagman: The tabletop sterilizers currently available today have been available unchanged for many years and are quite sufficient for almost all applications. However, as specialized medical instruments have become more complex, the techniques and equipment used to sterilize these devices must also be developed. The addition of vacuum systems and pulsed steam allow tabletop sterilizers to process the most complex instruments and packs.
LaFrance: These changes have made connectivity more important than ever. It created a need for a convenient way to remotely monitor equipment performance and maintenance. STERIS’ CS-iQ Sterile Processing Workflow Management Software offers scalable instrument-tracking and equipment-monitoring solutions, while ProConnect Response Center remotely monitors equipment performance and helps reduce downtime.
Strachan: Being able to troubleshoot the system with a laptop and creating a standardized user-friendly control panel are great features to have for the biomed and SPD staff. Anytime you provide features that truly improve the interaction with the system is a plus to be noted when purchasing time comes around.
Q: How will new advances and features impact sterilizer maintenance?
Ambroult: Sterilizers have become more efficient because of obvious design improvements and better designed electro-mechanical components as well as built-in self-diagnostics and monitoring capabilities.
Blagman: As tabletop sterilizers become more and more complex the 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 and when they are available from the manufacturer they can be relatively expensive.
LaFrance: With remote monitoring, sterilizer malfunctions can be proactively detected and diagnosed. It can decrease the time it takes to dispatch a technician, as well as reduce equipment downtime. Remote diagnosis also helps ensure the correct parts needed for a successful repair are brought on the first visit. When it is time for formal inspections, maintenance records can be electronically produced, eliminating the need to keep paper records.
Strachan: Like other devices that interface with a service laptop, this will definitely be a troubleshooting asset. Being able to retrieve error logs, histories and activate all valves and sensors is a much appreciated improvement. I am willing to bet at some point you may see sterilizers/washers being remotely diagnosed. Currently, we have scope washers that have this capability. Standardization of user functions across all models should be beneficial in minimizing user error associated service calls.
Q: How can a facility with a limited budget meet the sterilizer needs of today?
Ambroult: One way a facility might be able to better afford their sterilizer needs would be to research if there are upgrades that can be done to their existing sterilizer through the manufacturer. Upgrades to displays, controls, etc., can help extend the life of an older sterilizer by providing updated options offered on newer units. This isn’t always an option, but is definitely worth looking into when considering replacement versus equipment upgrades.
Blagman: As tabletop sterilizers have grown in size and sophistication they have become a major cost savings for smaller facilities and clinics. Using standard AC line voltages and power cords allows 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.
LaFrance: It’s important for CSSD managers to compare the current productivity of the department with existing equipment and the possible increase in productivity if new equipment is purchased. Today’s sterilizers are designed to process larger loads and are equipped with cost-saving features that can more than justify the investment. STERIS can provide site-specific life-cycle cost and productivity analyses to help determine customer needs.
Strachan: Sterilizers have a very long life span compared to other devices or modalities. Planning for the future cannot be stressed enough, especially if you have a limited budget. As previously mentioned, keeping up with the small issues will often prevent more costly repairs and downtimes. Sometimes it may make sense to retire a problematic system ahead of its life span. Check with the OEM and see if they can provide a replacement solution within your budget. Also, third parties can be a great source for refurbished options that may be a good fit for your budget.
Q: What are the most important things to look for when deciding whether to go with an original equipment manufacturer or a third-party sterilizer provider?
Ambroult: I would have to say one should not just consider equipment cost but also manufacturer technical support, parts availability, service availability, equipment warranty, equipment longevity, and ease of operation by department personnel. In terms of maintenance and support, response time and quality of parts would be important. Are they using OEM or third-party parts?
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 down time. Also, since the original equipment manufacturer may not have local representation the third-party service may save the facility an expensive travel charge.
LaFrance: At first, it may seem prudent to go with the lowest-cost alternative when purchasing a steam sterilizer. However, third-party products and quality may not compare to an OEM offering, and safety is a key consideration. STERIS pre-owned products must meet stringent quality and performance guidelines during the remanufacturing process. For instance, the AMSCO C Steam Sterilizer is STERIS’ certified and preowned steam sterilizer offering. It is equipped with updated controls and software that meet the current AAMI standard and has been thoroughly tested and cleared for use by the FDA.
Strachan: We typically use a combination of OEM and third-party providers for service when the situation calls for this. I would suggest knowing what kind of training the third party has had. What qualifies them to do the work? If they cannot provide any documentation around this that would be a deal breaker. Response time is also a consideration. Who can get there the fastest will play an important role in who you call. A good way to determine whether to go with OEM or third party, particularly with service, is how they treat you without a service contract in place. For purchases, whether OEM or third party, it is important to ask what kind of support you can expect to receive after the sale.
Q: How can HTM departments ensure they receive the necessary literature and training tools when purchasing sterilizers?
Ambroult: I would have to say that when purchasing equipment, it is important to include in the purchase contract not just operator manuals but also service manuals with parts breakdown, schematics, etc. and, if desired, factory training for biomedical personnel. Most importantly, the purchase contract must include “in service” for department personnel to ensure they know how to safely operate the equipment.
Blagman: Sterilizers are capital equipment and like any other piece of capital equipment when the purchase order is issued it should include, in writing, the purchase of any necessary service documentation, tools and training needed for the HTM department to develop the skills to troubleshoot and service the sterilizer.
LaFrance: Operator manuals should be supplied at no charge with every sterilizer purchase. As a full-service supplier, STERIS also includes equipment in-service training both on-site and in electronic format. Clinical education for staff is also delivered on an ongoing basis. STERIS Service also offers extensive training programs for biomedical technicians, should a facility opt to service their own equipment.
Strachan: I highly recommend that CE is involved in the ordering process for new equipment. It is much easier at this time to ask questions regarding training and literature. The ordering departments may not think about training/literature for the in-house biomed. Better yet, it is very important to have and keep a good working relationship with the SPD manager as well as maintaining relationships with the OEM sales team.
Q: What else do you think TechNation readers need to know about purchasing and servicing sterilizers?
Ambroult: Things to consider when purchasing and servicing sterilizers should include equipment reliability, equipment cost, parts availability, manufacturer service and support. Do they need a full-service contract or scheduled maintenance only with time and materials as needed? What is the response time? Is there 24/7 support? How far will the service technician travel? All of these factors should be considered.
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.
LaFrance: Steam sterilizers are a long-term investment. If not on a regular maintenance contract, sterilizers should be inspected at least twice a year to maintain peak performance and avoid costly future repairs. Periodic calibration of equipment is also necessary to ensure cycle efficacy and patient safety. Be aware that special tools may be required to effectively perform this procedure and seek appropriate advice from the OEM.
Strachan: Whether the service is provided by the OEM, third-party or in-house, it is important to stay on top of maintenance. Addressing even the smallest of problems and leaks will go a long way in decreasing failures and downtime.
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