Nixa firm adds sterilization services

Tech Medical Services Inc. owner Ken Anderson last month opened a medical device resterilization facility unique to the Springfield area.

Anderson’s TMS Sterilization – housed in a 15,000-square foot building alongside Tech Medical Services at 1110 Gerald St. in Nixa – specializes in resterilizing single-use medical devices for hospitals, free-standing surgery centers and clinics, Anderson said.

“We’ve been doing business with hospitals for 25 years so we’re not the new kid on the block, so to speak,” said Anderson, who has operated Tech Medical Services – a manufacturer and distributor of medical devices – for the past 26 years.

TMS Sterilization takes single-use medical devices that have never been used, but have an expired manufacturer’s sterility date – such as trocars used for laparoscopic surgery – and resterilizes them for two more years, he said.

TMS currently is running its sterilization process 24 hours a day, five days a week, with between 100 and 500 devices resterilized per day using the company’s two sterilizers, Anderson said.

The process is highly regulated by the U.S. Health Department’s Food and Drug Administration to ensure that single-use resterilized devices are safe to use in medical facilities in the United States and around the world.

FDA spokesman Michelle Bolek said the agency’s expectations for reprocessed single-use devices are the same as those for reusable medical devices sterilized according to its manufacturer’s instructions. The FDA has found that the chance for contamination of resterilized devices is slim.

“There is only a one-in-a-million chance that a microbe would survive the sterilization process,” she said. “We also expect the device to be fully functional, just like a new device, for the number of reprocessing cycles cleared for the device and stated in its instructions for use.”

Resterilization companies are required to submit to the FDA a 510(k) premarket notification before the devices can return to the marketplace, Bolek said.

This process, while tedious, provides a green alternative for hospitals to reuse equipment, instead of throwing devices away and purchasing new ones for a higher cost, Anderson said.

“Generally, it’s about 60 percent off of their original price, so that’s a huge savings for them,” he said.

Anderson said hospitals have the option to repurchase the resterilized devices, dispose of them or donate them to a charity TMS works with – such as Initiative to Haiti. If a hospital decides to dispose of the devices, TMS may resterilize the devices and sell them to another client, he said.

TMS Sterilization currently is handling resterilization requests from Tech Medical Services’ customers, including NewHope Bariatrics and More of Life Weight Loss Surgical Center in Overland Park, Kan., and Cameron Regional Medical Center in Cameron, north of Kansas City, Anderson said.

Koby Whitmore, Cameron Regional’s manager of surgical services, said buying resterilized devices from TMS helps the 53-bed hospital lower its purchasing costs.

“I really haven’t done a cost study, but in a year’s time the cost difference was about $18,000,” she said. “The products are certainly equally as good. We’ve never had any performance issues. We’ve never had any infection control issues, and it’s been a really good avenue for us.”

Whitmore said the FDA’s strict guidelines for the resterilization process give medical providers assurance to use products through companies such as TMS. According to the FDA, each of the steps in the resterilization process must be validated by the firm, and Anderson indicated TMS’ process can range between 20 and 40 steps.

Handling a majority of the steps for TMS is Brandi Jones, a certified registered central service technician, who is the only technician working in the company’s certified clean room where the air is recirculated and filtered 10 times an hour all day long to prevent particles from contaminating anything in the room.

In the clean room, Jones inspects, repackages and reseals packaged devices and transfers them to an adjacent room where TMS’ two sterilizers are located. In each step, Jones signs off on a sheet assigned to each individual device that will follow it through the process and then be stored by TMS for five years, Anderson said.

St. Louis-based Mercy partners with Tempe, Ariz.-based Stryker Sustainability Solutions for its resterilized single-use items. Verifying that companies follow FDA standards for reprocessing and resterilizing is a top priority for the health care provider, said Jeff Hawkin, Mercy’s administrative director of perioperative services in Springfield.

“The biggest thing is when you partner with somebody you want to make sure that they have FDA clearance on all their items,” he said.

Stryker disassembles each device it receives, then inspects, cleans, sanitizes, sterilizes, repackages and returns the device to Mercy. When Mercy first partnered with Stryker in 2009, it took between 30 and 45 days to get devices back as the parties established a product queue, Hawkin said.

“Now, there’s continually product in the line so we send in five devices and they’ve got five devices of ours they were working on and they return those,” he said, noting Stryker also recycles devices Mercy does not want returned.

“Ninety percent of what we collect is actually recycled and not reprocessed,” he said. “[It’s] broken down into plastics and metals – broken down and reused to develop other products just like you’d recycle at home.”

In turn, using resterilized devices has saved the health care provider $1.7 million and kept 80,000 pounds from local landfills in fiscal 2012, according to Nancy Corbett, Mercy’s director of media relations.

“Mercy Springfield alone saved $460,670 in reprocessing medical devices in fiscal year 2012,” she said.

TMS Sterilization is currently building its client base and is scheduled to hold a grand opening Aug. 3. The company also intends to hire up to 10 employees for the initiative – including certified registered central service technicians to work in the clean room, Anderson said.

“Yes this is a profit business, but on the other side of the coin, I think in our own little way we’re providing something back to the community,” he said. “We’re providing something back to these folks that work in the hospitals and hopefully are cutting our health care costs.”