The sterile processing department has long been on the front lines in the war on cross-contamination and hospital acquired infections.In recent years, these departments have come under deeper scrutiny by accrediting bodies such as The Joint Commission. In turn, manufacturers are developing technology to make the sterilization process easier, faster and more efficient while ensuring stringent guidelines are met.

“The Joint Commission has taken a very active view toward the sterile processing departments,” says Joseph Smith, a product manager at Belimed. “Five years ago, sterile processing was not a focus of The Joint Commission. Today, they’re spending a minimum of three hours there.”

Need for validation
No matter the brand of equipment, or whether steam or low-temperature sterilization is used, a critical part of any sterile processing department is adherence to the instructions for use (IFU) as directed by device manufacturers, which validate that their device can be used in a specific system and with certain parameters for time and temperature.

It’s a big issue, especially for newer methods of low-temperature sterilization, says Nancy Chobin, who retired in July as vice president for sterile processing at Barnabas Health in New Jersey, and now runs Sterile Processing University, an online continuing education program, and consults with hospitals and surgical centers on sterile processing issues.

Last year, for example, South Carolina company TSO3 received FDA approval of a sterilizer that uses a combination of vaporized hydrogen peroxide and ozone, with what the company says is a cycle time of 46 minutes with a 75-pound load capacity. “I see too many people jumping on the bandwagon before verifying that their devices have been validated by the device manufacturer that their devices can be sterilized in these systems,” Chobin says.

Hospitals looking at purchasing new sterilizers should verify the information they’re given from the sales representative. If they’re making a switch from steam to another method, they should make sure all the devices used are validated for the new method. Device manufacturers are also constantly updating IFUs. “I usually tell people that you should get your specialty instructions for use at least once a year, or every other year,” Chobin says. “Compare instructions for use with what [you] already have.”

While sterilizer manufacturers have made things easier with preprogrammed cycles, it’s still important to follow IFUs for specific devices. Skytron, which launched its first line of steam sterilizers in September 2014, after being mostly known for surgical tables, lights and booms, programmed its equipment with recommended parameters from the Association for the Advancement of Medical Instrumentation guidelines, but also allows for customers to create custom cycles, ideally based on the manufacturer’s instructions.

“Not all device manufacturers are following the AAMI recommended cycles,” says Jason Simon, product manager for infection prevention at Skytron. “Unfortunately, you need to create and document your departmental processes in preparation for a worst-case scenario: if a patient is infected and it goes to court,” Simon says. “You need to show that you followed the manufacturer’s instructions.”

Angela Jensen, certified sterile processing and distribution supervisor at Rush Foundation Hospital in Meridian, Miss., maintains a book of up-to-date IFUs in alphabetical order by manufacturer for SPD staff. When her facility upgraded to Skytron equipment at the end of 2014, after using nearly 40-yearold steam sterilizers from industry veteran STERIS, the department preprogrammed custom cycles based off of the hard copies of the instructions. Jensen takes a hard line when it comes to following the guidelines and advises hospitals not to purchase a device until getting and reviewing the instructions, to make sure the proper sterilization processes are in place at the facility. “It is the manufacturer’s responsibility to supply us with the IFUs,” Jensen says. “Over time, vendors tend to know when they bring stuff in, who’s going to require something and who isn’t. My rule is if I don’t have paperwork, I don’t process it, period.”

To go paperless, sterile processing departments can subscribe to OneSOURCE, a comprehensive database of manufacturers’ validated IFUs. Smith, of Belimed, says the company is looking to develop a user interface that would have the ability to connect to the IFU database and easily access the manufacturer parameters directly from the sterilizers. Sterile processing departments also need to document that they are following manufacturer IFUs, either through paper or electronic records, which manufacturers are starting to provide.

“The Joint Commission [says] show me all your records and evidence you’re using [IFUs] on these sets,” Smith says. “They are treating this as a requirement.” These regulations, and the drive to bring down the number of hospital-acquired infections, are also driving the use of instrument-tracking software. This includes the CS-iQ Sterile Processing Workflow Management software from STERIS. Belimed offers software that can download the cycle parameters into any instrument-tracking program.

Size and time matter
Manufacturers are also responding to surgical equipment that is becoming larger and heavier. Companies are making wider sterilizers for orthopedic surgical instrument trays, says Chobin. They’re also going back and revalidating sterilizers for heavier trays. “We are seeing a lot of changes where they’re listening to their customers,” Chobin says.

Simon, of Skytron, says sterilizer manufacturers and clinical staff are getting smarter about what capacity means for effectiveness of the sterilization cycle. “Years ago, it was common sense — if we overloaded the sterilizer, everything was going to come out wet,” Simon says. “Now, users are more aware of the validated throughput on the sterilizer itself.”

With space at a premium, companies are also paying attention to the size of their machines. Tuttnauer, which provides compact, mid-range and large capacity steam sterilizers to hospitals, received FDA clearance last year for its 5075HSG, a narrow mobile autoclave with a chamber volume of 160 liters. The company first offered it in the laboratory market and now markets it to smaller facilities, such as outpatient surgery centers, which is where many procedures are moving.

“It’s smaller and at a lower price point,” says David Morganstern, director of sales and marketing at Tuttnauer. “It has all the capability of a full-size unit in a smaller footprint. In addition, in keeping with our responsibility for the environment, the unit comes standard with a built-in vacuum pump, resulting in lower water usage compared to the traditional venturi water ejector.”

Cycle times are also getting shorter. On the new Skytron equipment that Rush Foundation Hospital recently purchased, the dry time for all cycles except daVinci robotics is now 30 minutes, which is 20 minutes faster than the older equipment, where dry times had to be extended to compensate for the age and inefficiency of the equipment. “Because of the efficiency of the newer equipment, the cooldown process is reduced as well,” Jensen says. “We have probably saved on average 30 to 45 minutes in overall processing time per instrument load because of the reduction in dry time and increased cool-down efficiency, not to mention an estimated 33 percent reduction in water consumption per cycle.”

The Skytron Integrity 270 sterilizer is equipped with standard electronic cycle data that is recorded on a CompactFlash memory card, so the hospital doesn’t have to print each cycle record. This helps reduce the cost of paper supplies and eliminates the need to store the paper rolls for documentation purposes, as the data can be transferred to an existing PC and stored in an Excel file, Jensen says. “Overall, our efficiency within the department has been increased because of the efficiency of the sterilization equipment and we are able to release loads sooner to meet the demands of the OR schedule,” Jensen says.

Maintenance with monitoring
Remote monitoring is another relatively recent offering from sterilizer manufacturers. Belimed offers a remote monitoring technology, which uses sensors attached to the high-performance parts and inside the chamber of the sterilizer to monitor temperature, pressure and water flow. If a certain component starts to fall below a certain threshold, a service technician is notified with various communication methods.

This is “well before it ever gets to the point where it aborts a cycle or where a load is deemed non-sterile,” Smith says. “A sterilizer doesn’t just break, it starts to wear down. It will give off signals with the right sensors attached.” Smith says about 20 percent of its customer base has signed on to the service, and that the company is putting more of an emphasis on marketing it in 2016.

STERIS’ CS-iQ can also be used to monitor the washers and sterilizers for maintenance issues, and Tuttnauer offers remote monitoring, as well as the ability for hospitals to link up to eight sterilizers with a local computer for central supply supervisors to monitor in-house. Morganstern, of Tuttnauer, says the company provides standard in-service training to make sure its customers understand the equipment. “For a lot of facilities we go one step further and also offer training to the technical support staff [in the] biomed department,” Morganstern says.

The market for contract sterilization
Contract sterilization is generally limited to companies that sterilize single-use devices for the device manufacturers. Some hospitals have turned to contract sterilization for duodenoscopes, which are particularly challenging to disinfect, says Kathleen Hoffman, senior vice president for global environmental, health and safety at Sterigenics.

“We have a higher sterility assurance level than the high-level disinfection methods used at many hospitals with a liquid chemical disinfecting agent,” Hoffman says. The majority of hospitals have preferred to do the work in-house as contract sterilization comes with increased costs. Facilities have to increase the inventory of scopes if they’re sending them out to be sterilized and it also may be difficult to find a contract sterilization company that’s local, Hoffman says.