The methods for sterilizing medical equipment and devices have remained pretty standard for decades — steam sterilization for most surgical devices and ethylene oxide or other chemicals for items that are heat and moisture sensitive. What has advanced in recent years is the technology to track what happens to the devices along the sterilization process, before they’re used on a patient. With cuts in Medicare payments around the corner for hospitals with comparatively high rates of patient infections, there’s more of a focus than ever on making sure equipment is properly sterilized.

In September 2013, STERIS Corporation released its CS-iQ Sterile Processing Workflow Management software, which allows hospital staff to track a device, or a set of devices, electronically capturing data on the sterilization process, as well as chemical and biological indicator test results. Staff can manually enter details, such as verifying that the biological indicators changed color and that the pack looks correctly sterilized upon opening.

“It’s a combination of various sources of data that you can either collect via computer access or [by] manually entering it,” says Dr. Gerald McDonnell, vice president of research and clinical services for STERIS. “It will probably always be a marriage of the two. That mimics essentially what the standards are.”

CS-iQ can also be used to monitor the washers and sterilizers and STERIS can inform their customers about maintenance issues that arise.

“We can actually tell them that a valve or a temperature indicator might soon need a repair,” McDonnell says.

Cathy Klein, product manager of instrument processing at Midmark, which manufactures smaller autoclaves for doctors’ offices, believes the tracking of instruments back to the patient record will continue to expand in hospitals and filter down to doctor’s offices as more and more procedures are done on an outpatient basis.

“What might have been an overnight procedure in the past, they want to move that to the office now,” Klein says. Most units on the market are self monitoring, with Midmark’s unit offering a printout that includes updates of the time, temperature and pressure every 30 seconds. Klein says the company has extensive digital methods for monitoring in their European product offering. The large steam sterilizers tend to have electronic monitoring.

Market growth
The worldwide sterilization products and services market is expected to grow from $4.7 billion in 2013 to $6.39 billion in 2018, with a 6.34 percent compound annual growth rate, according to a report earlier this year by technology research and advisory firm TechNavio.

The equipment market makes up close to 6 percent of the compound annual growth rate, while contract sterilization makes up about 8 percent of the compound annual growth rate, with more and more hospitals outsourcing their sterilization services to other companies.

More growth is expected in the Asia- Pacific region, where governments will likely introduce more stringent infection control regulations over the next several years, according to TechNavio’s analysts.

Endoscope reprocessing
Contaminated endoscopes are frequently connected to health care associated infections. The flexible scopes are particularly difficult to clean since most cannot be heat sterilized, and they also have multiple channels and plugs.

Steam sterilization is more economical, costing $1 per cycle versus $8 to $12 per cycle using hydrogen peroxide gas or ethylene oxide, says Casie Leiby, an analyst with MD Buyline, whose report on endoscope reprocessing was published earlier this year.

“A lot of the manufacturers are working on developing autoclavable scopes,” Leiby says.

With low-temperature endoscope reprocessing, it’s particularly important to use chemical test strips to test the minimum effective concentration of the disinfectant, and also biological indicator test strips, which validates the sterilization.

Several third-party vendors provide software to automate reprocessing documentation, notes Leiby. CS-iQ from STERIS can be used for endoscopes, while Medivators, a company that specializes in endoscope reprocessing, launched their own software for this. The Medivators software, called Endora, tracks endoscopes through each step of the reprocessing cycle, and can even send an email if any step in the reprocessing process is left out.

The steel standard
Some sterilizer manufacturers use carbon steel for the jacket instead of stainless steel. Since steam moves through the jacket to the sterilization chamber, that can lead to some rust particles being carried over to the chamber, says David Morganstern, director of sales and marketing at Tuttnauer, which provides compact, mid-range, large capacity steam sterilizers to hospitals.

“When that instrument dries, you have what looks like a rust spot,” Morganstern says. “Once that happens, it’s very likely that that instrument will continue to stain in that same spot.”

Tracy Tuttle, an equipment service technician in the biomed services department at the Parkview Health System in Fort Wayne, Indiana, agrees that stainless steel is the way to go for sterilizers. The system has had units with copper piping, and it’s difficult for a health system that deals with all different types of water — one hospital in the system is served by 14 different wells.

“No one has perfect water and stainless steel really stands up to a lot of different things,” Tuttle says. “Some water has high lime, other water has high calcium. At first you’re not going to have an issue, but probably six to 10 years, that’s when you’re going to see issues with bad water.”

The dreaded ‘wet pack’
“Wet packs,” when an item in a set of surgical instruments contains visible moisture, is an issue that many hospitals have to contend with, and it causes a big loss of time and money when instruments have to be reprocessed. Morganstern says the cause often has to do with steam quality and sterilizers that are not well-insulated, leading to more condensation in the sterilizer jacket, the area around the chamber. Using a steam trap and a drip leg is also important, especially if sterilizers are not constantly in use, so most of the condensation will go into the drip leg and not the steam line.

“The central supply and the OR, where they interface with facilities, is much more critical than a lot of people give it credit for,” Morganstern says. “They should be a friend of facilities and, with respect to their steam quality, should have a better understanding of what they’re getting and facilities should have a better understanding of what they need and why.”

Click here to check out the DOTmed Virtual Trade Show for sterile processing

Clean in a flash
The sterilizer market, like most of the medical equipment industry, has had its share of regulatory challenges. Most recently for sterilizers, rules were clarified for use of the abbreviated sterilization cycles for surgical instruments that were not going to be stored, and would be used soon after. Previously called flash sterilization, the term was changed to immediate use sterilization a few years ago, after the Association for the Advancement of Medical Instrumentation (AAMI) worked with several other health care organizations and regulatory agencies to come up with new recommendations for this quicker process, which went from a three-minute to a 10-minute cycle.

Regulations really haven’t changed much, though companies are seeing more enforcement of regulations around sterilization and pushing for recommended practices. That has to do with monitoring the sterilizer and validating that your autoclave is meeting appropriate time, temperature and pressure. Tuttle says that staff at the facilities he works with do a daily air removal and biological tests.

Walk in and wheel in
More facilities are moving away from solely wiping down equipment such as wheelchairs and IV poles, which is a cumbersome process, and installing decontamination rooms. The VaproQuip Decontamination Room from STERIS uses a low-temperature dry vapor, and while it doesn’t replace the manual wipe down process, it provides additional assurance of the decontamination process, McDonnell says.

There are also UV decontamination processes, such as the PATHOGON UV Disinfection System from STERIS, which can be wheeled into the operating room, intensive care unit or a general ward. A hybrid of the two, using the technology of a fixed system, but that can be built into existing hospital infrastructure, uses hydrogen peroxide gas. STERIS has introduced these systems in the last few years.

“These new types of systems that have come out can provide a greater level of assurance,” McDonnell says.

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

DOTmed Registered HCBN August 2014 - Sterilizers Companies

Names in boldface are Premium Listings.
Domestic
frank bell, bell biomed, Inc., CA
Veronica Villanueva, Comerlat Enterprises LLC, CA
G. John Oggel, Green Cross Medical/ GOMED, CA
DOTmed 100
Steve Rice, Plaza Medical, Inc., CO
DOTmed Certified
James Blount, Biomed Plus, LLC, LA
DOTmed Certified
John Gladstein, Medical Device Depot, MD
DOTmed Certified
Brent Juillerat, Supply4GI, MN
DOTmed Certified
Patrick Bemis, Technical Life Care, MN
David Wright, Sterilelink, NC
DARREN WALKER, DURALINE SYSTEMS, NY
DOTmed Certified
DOTmed 100
Jim Filer, BioMedtronics Service, OH
Frank Bell, Bell Biomed, Inc., CA
Lucas Dennington, HSS, Inc., CO
Dave French, Mediequip Parts Plus, MO
John Hall, Staber Industries, OH
Amy Pritchard, Auxo Medical, VA

International
Andro Atoshvili, Tbilisi Medical U Central Clinic, Georgia