Surgical instruments made from fiber-reinforced nylon by Xenco Medical LLC are being used for spinal procedures as a way to improve efficiency for medical facilities and safety for patients.
Founded in 2011, Xenco developed a single-use composite instrument that is lightweight and has the structural integrity to withstand all the forces and angles wielded by surgeons.
Xenco then attaches an implant device, often made of PEEK or titanium, to each instrument. The implants consist of interbodies, screws and plates that can be used in most cervical and lumbar procedures to stabilize the spinal construct.
There isn't another company like San Diego-based Xenco in the plastics industry, CEO Jason Haider said in a phone interview.
"We're the first to offer the instruments with our implants attached as a single solution. We see ourselves competing with the traditional implant companies," Haider said of companies like Stryker, Medtronic and Zimmer-Bionet.
After surgery, Xenco instruments can be disposed of with other medical waste at a cost of about 9-72 cents per pound or recycled into asphalt through a free Xenco takeback program. Either option costs less than current autoclave processes for sterilizing reusable instruments, Haider said, pointing to the water-intensive and time-consuming steps involved that don't guarantee removal of all contaminants.
Xenco says it takes 300-400 gallons of water and three and a half hours on average to sterilize and repack a tray of surgical instruments, which are typically made of steel and aluminum, for a spinal procedure. Haider puts the sterilization cost at almost $1,000 for each complex tray and says this expense could be eliminated with single-use instruments.
After sterilization of reusable instruments, only about 30 percent packed onto the next surgical tray are likely to be used by the doctor, but all will need to be cleaned again. Eliminating the sterilization and repacking costs for 70 percent of instruments could save a hospital up to $2.8 million, Haider said, pointing to a 2015 study about how a lean 5S approach to operating rooms can improve quality and efficiency of instrument availability.
Haider also looks at the financial implications of reusable instruments compared to surgery-ready systems in terms of patient volumes.
"Some spinal procedures only take two hours total so they miss an entire procedure waiting to sterilize everything," he said.
Then, there's the issue of infections linked to contaminated surgical instruments. Hospitals don't have to disclose this data, but problems sometimes become public. In 2015, Seattle Children's Hospital announced that as many as 12,000 young patients treated at its surgery center since 2010 may have had contact with instruments contaminated with blood and bone due to improper washing. The hospital offered free testing for diseases, including HIV and hepatitis C.
Reusable instruments can also deteriorate from repeated cycles of steam sterilization. Mineral deposits can alter surface properties and hamper precision, Haider said.
"With our instrument, because they're used only once, they're going into the surgeon's hands at peak condition and peak calibration so that when they turn it, they know it's accurate. That's been a big selling point for surgeons," Haider said.