Ebola may have highlighted the critical role sterilization plays in a modern hospital for civilians, but for health care professionals, the importance and challenge of meeting the ceaseless demands in a modern facility have long been understood. To that end, industry veterans and newcomers alike have responded with novel takes on old designs, concepts and automation straight out of high-tech manufacturing, and a trend toward pushing speed, customization, and a reduction of the physical burden of those involved in the process, all while finding ways to boost efficiency and cut costs without sacrificing safety.

In fact, some manufacturers of medical equipment are even turning to offsite sterilization contractors, though that approach is not currently feasible for most hospitals and health care providers.

A good example of the new direction for this critical part of the health care process is the sterile processing department at Virginia Mason Medical Center in Seattle.

During a recent remodeling completed over the summer, the department’s leaders sought to find equipment that would increase throughput and facilitate flow, using the principles of lean manufacturing taken from the Toyota Production System. This philosophy is in play throughout the entire hospital where, for example, employees are encouraged to report problems and defects without fear of repercussions. In Virginia Mason’s sterile processing department, it led to the purchase of pass-through Belimed washers and sterilizers that automatically load and unload, saving precious time and taking some of the physical burden off staff.

“Labor, obviously, is the most expensive part of everyone’s budget,” says Sam Luker, the director of sterile processing at Virginia Mason. “If you can get the equipment to work for you, you’re really going to be saving on FTEs and enhancing ergonomics for your team members, who are no longer going to have to load and unload those sterilizers.”

In fact, Luker notes that labor represents approximately 65 percent of his annual budget. “Designing principles of lean into the department remodel has resulted in operational, work flow, and equipment efficiencies that have helped reduce our labor expense by 8 percent,” Luker says.

Before, his staff had to push heavy loads of stainless steel surgical instruments manually into the autoclaves, work that could lead to injury. Now, Luker says, “our team members have more time to focus on instrument set assembly and inspection while the automated sterilizers load and unload themselves.

With preset cycles, the machines also allow for mistake-proofing of proper sterilization parameters for the different types of surgical instruments we process.” Luker estimates the machines, which can hold up to 24 full-size instrument sets in one cycle, save around five minutes of manual loading and unloading per cycle, along with reducing the burden of work on team members.

This compares to the previous sterilizers, which could accommodate only 12 full-size instrument sets and loading/unloading had to be coordinated, monitored, and performed manually for every cycle. “The automation and increased capacity of our new machines has reduced bottlenecks and doubled our sterilizer throughput,” Luker says.

While the automated machines are about 13 percent more expensive than non-automated sterilizers, Luker says, “In the end, the benefits outweigh the disadvantages.” Sterilizer manufacturer Belimed offers a service where representatives come in and streamline a hospital’s sterile processing department. They do simulation models, showing where the bottlenecks are and how to eliminate them. They also look at steam quality.

“More and more investment is being put into, ‘how do we make it more of a manufacturing facility?’” says Joe Smith, a product manager at Belimed. “It’s become much more of a manufacturing, reprocessing department.”

“What we’re taking out is not the time it takes to wash something, and disinfect, and sterilize,” Smith says. “We’re taking out all the waste: the time a machine takes to fill with water. The time it takes for a person to walk from point A to point B. When a cycle is done and the door opens, it’s dry, instead of opening the door and adding 30 more minutes onto the cycle.”

Smith says this year Belimed will be focusing their sterilization technology on accommodating more instrument trays per load, larger tray sizes and greater weight, and a user interface that’s easier to manage. And the latest trends are not just about speed and efficiency. Nancy Chobin, assistant vice president for sterile processing at St. Barnabas Health in New Jersey, says the automated washers and sterilizers can take up a lot of space, which is something that a lot of sterile processing managers just don’t have. “When you look at equipment, you can’t just look at productivity,” Chobin says. “You have to look at how much space you can save.”

Luker says that with an OR volume of more than 77 cases per day, the current demand is m13.8 instrument sets per case cart, with an average of 53.4 instruments in each set. “As a result, we need sterilizers with the capacity to meet our customer demand,” Luker says. To address the need for more productivity without additional space, Belimed has been focusing on minimizing equipment footprint while maximizing throughput capacity.

“Our SPD [sterile processing department] design team applies proven lean manufacturing principles and process simulation studies with the primary focus on process efficiency,” Smith says. “The combination of these two results in roughly 30 percent more space for future growth or other needs in the SPD.”

Breaking into the sterilizer market
While established companies like Getinge and STERIS have the greatest representation among hospitals, there are other companies now bringing new sterilizers to the market One such company is Skytron — mostly known for surgical tables, lights and booms, — which officially launched its Integrity line of steam sterilizers in September. “It was challenging to take a 100-year-old technology and bring something unique to the market,” says Jason Simon, Skytron’s product manager for infection prevention.

The company, which partnered on the product with Sakura Seiki, a leader in steam sterilization in Japan, also used recommended parameters from the Association for the Advancement of Medical Instrumentation guidelines. Simon says the idea was for the new product to meet the needs of sterile processing managers by creating a fast and easy way to create custom and extended steam cycles.

Simon says, for example, that with an older sterilizer, if a facility gets a new da Vinci Xi handpiece that needs to be sterilized for a four-minute exposure time and 50-minute dry cycle, they would have to erase one of the cycles and reprogram it for that one tray. Then it would take another 15 minutes to change it back. With Skytron’s sterilizers, users can create custom steam cycles in just a few seconds and add a button with a shortcut for the cycles to the tabletlike LCD touch screen.

“We really made a very simple, intuitive control system,” Simon says. The company started a reference-site program a couple of years ago and installed units at several facilities around the country. “Because Skytron was new to the sterilization world, we wanted to make sure we had a number of facilities around the country that would take a perceived risk by going with an unknown product,” Simon says. “We saw it as a natural fit as far as our product mix and our focus on the OR. We always knew infection prevention was somewhere we’d want to go.”

Filling new markets
Sterilizer manufacturers are also looking to fill new markets. David Morganstern, director of sales and marketing for Tuttnauer, says the company is waiting for FDA clearance on a new product that is geared toward ambulatory surgery centers. He says it will fill the niche between a tabletop sterilizer and a larger piece of equipment. Tuttnauer has also been active in detailing the role sterilizers would play in a hospital’s response to an outbreak of Ebola or other highly infectious diseases. Regional networks should consider buying and storing a couple of mobile, double-door sterilizers with effluent systems and have them sitting on a shelf ready to go, Morganstern says.

Click here to check out the DOTmed Virtual Trade Show for sterilizers.

DOTmed Registered Sterilizers February 2015 Companies

Names in boldface are Premium Listings.
Domestic
Stephen Knight, Knights Medical Electronics, CA
Lucas Dennington, HSS, Inc., CO
Randall Norris, Bayside Biomedical Services Inc, FL
Bill Lockley, BioMed Techs, Inc., FL
Moshe Alkalay, Hi Tech Int'l Group, FL
DOTmed Certified
Richard Johnson, SE Medical Systems, LLC, GA
Brent Juillerat, Supply4GI, MN
DOTmed Certified
Dave French, Mediquip Parts Plus, Inc., MO
Alison Fortin, Global Inventory Management, NH
DOTmed Certified
DOTmed 100
DARREN WALKER, DURALINE SYSTEMS, NY
DOTmed Certified
DOTmed 100
Craig Marcin, Modern Medical Systems Co., NY
Scott Scholl, Medical Inventory Control, OK
Juan Sandoval, Monterrey Medical Equipment, TX
Steve Beno, Sterilizer Services, Inc., WI
DOTmed Certified

International
Francisco Javier Núñez Pérez, Medical Cables, Spain